nct_id
string | updated_at
timestamp[us] | brief_title
string | official_title
string | acronym
string | study_type
string | overall_status
string | study_first_submit_date
timestamp[ms] | start_date
timestamp[ms] | primary_completion_date
timestamp[ms] | completion_date
timestamp[ms] | phases
sequence | enrollment_count
float64 | minimum_age
float64 | maximum_age
float64 | sex
string | healthy_volunteers
bool | brief_summary
string | detailed_description
string | eligibility_criteria
string | lead_sponsor_name
string | lead_sponsor_class
string | org_study_id_info
dict | why_stopped
string | expanded_access_info
dict | last_update_submit_qc_date
timestamp[ms] | last_update_post_date_struct
dict | study_first_post_date_struct
dict | std_ages
sequence | study_population
string | sampling_method
string | oversight_has_dmc
bool | design_info
dict | conditions
sequence | keywords
string | interventions
null | locations
list | collaborators
list | arm_groups
null | outcomes
dict | overall_officials
list | study_references
string | misc_info_module
string | condition_browse_module
dict | intervention_browse_module
dict | mesh_terms
dict |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT03210857 | null | Effects of Voluntary Neck Extension on Cerebral Blood Flow, in Breath-hold Divers Ending an Apnoea of Two Minutes or More. | Effect of Voluntary Neck Extension in the Occurrence of an Increase in the Pulsatility Index of Right Internal Carotid Artery in the Amateur Diver, Performing an Apnoea of Two Minutes or More: a Prospective, Monocentric, Open Interventional Study | APNECK | INTERVENTIONAL | COMPLETED | 2017-07-05T00:00:00 | null | 2017-07-24T00:00:00 | 2017-07-24T00:00:00 | [
"NA"
] | 15 | 18 | 51 | MALE | true | The aim of this study is to demonstrate the effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more. | In literature concerning apnoea, accidents have been described during neck extension.
Accidental drowning are frequent on the French coast every year and many of them concern apneists victims of apnoeic blackout.
Neck extension is thus suspected to possibly produce an apnoeic blackout at the end of the dive since 1965, when Sir Sciarli (diving medicine pioneer) suspected this hypothesis.
Physiologically, during a dive in apnea, the human cardiovascular system is subjected to a parasympathetic dominance, via the apnea reflex and the diving reflex. This parasympathetic dominant could be reinforced during a neck extension at the end of snorkeling during the ascent.
Hypothesis: the neck extension at the end of apnea contributes to increase the pulsatility index of the right internal carotid artery by vagal component and thus causes a decrease in cerebral blood flow and may lead to the initiation of syncope in the healthy amateur free diver or underwater fisherman. | Inclusion Criteria:
* Major (≥18 years), under the age of 51
* Male
* Can hold an apnea of 2 minutes or more
* Practicing for less than 2 years the apnea at the rate of at least 10 sessions of apnea in the year
* Not having a known cardiovascular history : any form of heart rhythm disorder, Ischemic heart disease, angina, arteriopathy, any valvular pathology, high blood pressure ...
* No known respiratory history (asthma, Chronic Obstructive Pulmonary Disease, bronchiectasis, pulmonary emphysema, pneumothorax, pleurisy, pulmonary infection, lobectomy ...)
* No neurological history of type: epilepsy, deficit syndrome, iterative loss of knowledge, recent head trauma with loss of consciousness
Exclusion Criteria:
* - Minors and persons over 51 years of age
* Person under curators or trusteeship
* Person with a history of cardiovascular, respiratory or epilepsy as cited by the French Federation of Study and Submarine Sports, which poses as a contra-indication to the practice of apnea: Cardiac insufficiency, Obstructive Cardiomyopathy, syncopal risk pathology (valvulopathies type aorting narrowing or mitral narrowing), paroxysmal tachycardia, non-paired auriculo ventricular block 2/3, stroke, uncontrolled hypertension after stress test, recent infarction, angina, pericarditis. Asthma stage 3, severe Chronic Obstructive Pulmonary Disease, bronchiectasis, pulmonary emphysema, pneumothorax, pleurisy, pulmonary infection, lobectomy ...) Epilepsy, deficit syndrome, iterative loss of knowledge, recent head trauma with loss of consciousness in difficulty, symptomatic cervical or lumbar disc herniation
* Patient with medical treatment affecting the cardiovascular or respiratory system (for example: ventolin, betablocker ...) | Nantes University Hospital | OTHER | {
"id": "RC17_0163",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-07-05T00:00:00 | {
"date": "2017-08-15",
"type": "ACTUAL"
} | {
"date": "2017-07-07",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Subject will realize an apnea of 2 minutes or more, depending on his abilities, and some parameters will be measured.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Healthy Amateur Divers"
] | ["apnea", "neck extension", "syncope", "diving blackout", "right internal carotid arteria", "pulsatility index", "healthy trained apnoea divers", "doppler ultrasonography"] | null | [
{
"city": "Nantes",
"country": "France",
"facility": "Nantes hospital",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more",
"timeFrame": "2 minutes or more: at the breaking point of apnea."
}
],
"secondary": null
} | [
{
"affiliation": "Nantes University Hospital",
"name": "Antoine ANDRE, Doctor",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012120",
"term": "Respiration Disorders"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D012818",
"term": "Signs and Symptoms, Respiratory"
}
],
"browseBranches": [
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Apnea",
"id": "M4361",
"name": "Apnea",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M16353",
"name": "Syncope",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14957",
"name": "Respiration Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15623",
"name": "Signs and Symptoms, Respiratory",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001049",
"term": "Apnea"
}
]
} | null | {
"conditions": [
{
"id": "D001049",
"term": "Apnea"
}
],
"interventions": null
} |
NCT05098457 | null | Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction | A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies | None | INTERVENTIONAL | WITHDRAWN | 2021-09-16T00:00:00 | null | 2023-02-19T00:00:00 | 2023-11-18T00:00:00 | [
"NA"
] | 0 | 18 | null | ALL | true | A prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies | null | Inclusion Criteria:
1. Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
2. Men and non-pregnant, non-breastfeeding women aged 18 years or older.
3. MMVS grade of 2, 3 or 4 (mild to substantial loss of fullness in the midface area) on each side of the face as assessed by the Blinded Evaluator. The MMVS for each side of the face does not need to be equal, however the difference between the two sides should be limited to 1 grade.
4. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
5. Intent to undergo treatment for correction of midface volume deficit.
Inclusion criteria 6-7 apply to female subjects only
6. If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at the screening/baseline visit, prior to treatment/injection, and at the end of study visit.
7. Negative UPT for women of childbearing potential at the screening/baseline visit and all injection visits.
Exclusion Criteria:
1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
2. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject).
3. Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
4. Previous facial surgery (e.g. facial fat removal, facelift and sinus surgery) in or near the treatment area that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
5. Any previous aesthetic procedures or implants:
* Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite or Poly-L-Lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat in the face regardless of time.
* Previous HA filler or collagen filler in or near the treatment area within 12 months.
* Previous botulinum toxin treatment in or near the treatment area within 6 months.
* Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and ultrasound) in or near the treatment area within 6 months.
* Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in or near the treatment area within 6 months.
* Previous treatment with cryotherapy in or near the treatment area within 6 months.
6. History of cancer or previous radiation near or on the area to be treated.
7. Presence of any disease or lesions near or on the area to be treated, e.g.,
* Inflammation, active or chronic infection (e.g., in mouth, dentals, head);
* Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or herpes zoster;
* Scars or deformities;
* Cancer, or precancerous conditions (e.g. actinic keratosis or actinic cheilitis).
8. Evidence of scar-related disease or delayed healing activity within 1 year prior to the baseline visit, or subjects susceptible to keloid formation, hyperpigmentation or hypertrophic scarring.
9. Presence of tattoo, piercing, beard or facial hair, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
10. Presence of a dental, oral, or facial condition which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment; e.g. has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities. Any planned procedure (e.g. dental implants, tooth extractions, orthodontia) during the study period, that would make the subject unsuitable for inclusion in the opinion of the Investigator.
11. An underlying known disease, a surgical or medical condition that would expose the subject to undue risk, e.g. human immunodeficiency virus (HIV), active hepatitis, autoimmune disease, history of bleeding disorders, connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, or scleroderma.
12. Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g. aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), Omega 3 or Vitamin E), within 14 days prior to injection. Omega 3 and Vitamin E are acceptable only as part of a standard multivitamin formulation.
13. Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. immunosuppressive monoclonal antibodies, antiviral treatment for HIV or hepatitis).
14. Treatment with systemic corticosteroids (inhaled corticosteroids are allowed) within 3 months prior to Baseline visit.
15. Use of topical facial corticosteroids or prescription retinoids near or on the area to be treated within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the Baseline visit, or plan to receive such treatment during participation in the study.
16. Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol, e.g.
* Subject is not likely to avoid other prohibited facial cosmetic treatments;
* Subject is not likely to complete the study because of other commitments;
* Subject is anticipated to be unavailable for visits, incapable of understanding the investigational assessments or having unrealistic expectations of treatment result;
* Subject who has a concomitant condition (e.g. acute viral or bacterial infection with fever) that might confuse or confound study treatments or assessments.
17. Subject who plan to lose or has a medical condition that may cause them to lose a significant amount of weight during the course of the study.
18. Study center personnel, close relatives of the study center personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
19. Participation in any other interventional clinical study within 30 days before treatment. | Galderma R&D | INDUSTRY | {
"id": "43N1EU2008",
"link": null,
"type": null
} | Sponsor decision | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-10-18T00:00:00 | {
"date": "2022-08-25",
"type": "ACTUAL"
} | {
"date": "2021-10-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Cheek Wrinkles",
"Midface Contour Deficiencies"
] | null | null | [
{
"city": "Cologne",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 50.93333,
"lon": 6.95
},
"state": null
},
{
"city": "Darmstadt",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 49.87167,
"lon": 8.65027
},
"state": null
},
{
"city": "Duesseldorf",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 51.22172,
"lon": 6.77616
},
"state": null
},
{
"city": "Duesseldorf",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 51.22172,
"lon": 6.77616
},
"state": null
},
{
"city": "Hamburg",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null
},
{
"city": "Hamburg",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null
},
{
"city": "Munich",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": null
},
{
"city": "Wuppertal",
"country": "Germany",
"facility": "Galderma Research Site",
"geoPoint": {
"lat": 51.27027,
"lon": 7.16755
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Demonstrate non-inferiority of GP0112 versus a comparator-control in cheek augmentation and correction of midface contour deficiencies",
"timeFrame": "3 Months"
}
],
"secondary": [
{
"description": null,
"measure": "Effectiveness of GP0112 and comparator-control based on the Medicis Midface Volume Scale (MMVS) assessment",
"timeFrame": "6, 9, 12 and 13 Months"
},
{
"description": null,
"measure": "Effectiveness of GP0112 on the Global Aesthetic Improvement Scale (GAIS)",
"timeFrame": "3, 6, 9, 12 and 13 Months"
},
{
"description": null,
"measure": "Effectiveness of GP0112 and comparator-control using the FACE-Q",
"timeFrame": "3, 6, 9, 12 and 13 Months"
},
{
"description": null,
"measure": "Effectiveness of GP0112 and comparator-control using Subject Satisfaction Questionnaire",
"timeFrame": "3, 6, 9, 12 and 13 Months"
},
{
"description": null,
"measure": "Effectiveness of GP0112 and comparator-control in returning to social engagement",
"timeFrame": "3, 6, 9, 12 and 13 Months"
},
{
"description": null,
"measure": "Safety of GP0112 in cheek augmentation and correction of midface contour deficiencies adverse events (AEs)",
"timeFrame": "Up to 13 Months"
},
{
"description": null,
"measure": "Safety of GP0112 in cheek augmentation and correction of midface contour pre-defined expected post-treatment events",
"timeFrame": "Up to 13 Months"
}
]
} | [
{
"affiliation": "Galderma R&D",
"name": "Study Director",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D000779",
"term": "Anesthetics, Local"
},
{
"id": "D000777",
"term": "Anesthetics"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D000889",
"term": "Anti-Arrhythmia Agents"
},
{
"id": "D061567",
"term": "Voltage-Gated Sodium Channel Blockers"
},
{
"id": "D026941",
"term": "Sodium Channel Blockers"
},
{
"id": "D049990",
"term": "Membrane Transport Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
{
"abbrev": "AnArAg",
"name": "Anti-Arrhythmia Agents"
},
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Protocol",
"id": "M11014",
"name": "Lidocaine",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4107",
"name": "Anesthetics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4109",
"name": "Anesthetics, Local",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4213",
"name": "Anti-Arrhythmia Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23177",
"name": "Sodium Channel Blockers",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30025",
"name": "Diuretics, Potassium Sparing",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008012",
"term": "Lidocaine"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "D008012",
"term": "Lidocaine"
}
]
} |
NCT01906866 | null | Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities | A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities | None | INTERVENTIONAL | COMPLETED | 2013-07-11T00:00:00 | null | 2018-03-27T00:00:00 | 2018-03-27T00:00:00 | [
"PHASE3"
] | 125 | 2 | 17 | ALL | false | The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks. | This is a randomized placebo-controlled study in children diagnosed with autism spectrum disorders (ASDs) and neurodevelopmental disabilities caused by neurogenetic diseases.
Children who are found to be eligible for the study will follow a 4-week, basic sleep hygiene and behavioral intervention wash-out period, and will continue in a 2-week single-blind (SB) placebo run-in period. Then, they will be randomized in a 1:1 ratio to receive either Circadin® 2 mg or placebo for 3 weeks in a double-blind treatment period.
After 3 weeks of treatment, on the last day of Week 5 ±3 days (Visit 3), sleep variables will be assessed to determine if dose modification (an increase to 5 mg) is required. Children will then continue on 2 or 5 mg of Circadin® or placebo for an additional double-blind period of 10 weeks. This double-blind period will be followed by an open-label period of 13 weeks. At the end of the 13-week open-label period on the last day of Week 28 ±3 days (Visit 5), sleep variables will be assessed to determine if a potential additional dose modification (i.e., an increase either to 5 mg for patients who are still on 2 mg or an increase to 10 mg for patients who are on 5 mg) is necessary (If a dose increase is decided upon, the dose increase should be from 2 mg to 5 mg, or 5 mg to 10 mg). Children will continue at 2, 5, or 10 mg Circadin® in an open-label period for another 78 weeks of follow-up, which will include continuous safety monitoring and 2 efficacy assessment time points at Weeks 41 and 54. The study will end with a 2-week SB placebo run-out period.
Each patient will participate in the study until the end of the second open-label safety follow-up period, and 2 week run-out period. The study duration will be 112 weeks, including the 4-week wash-out period with sleep hygiene and behavioral intervention. | Inclusion Criteria:
To be eligible for study entry, all patients must satisfy all of the following criteria at screening:
1. Must be children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug
2. Must have written informed consent provided by a legal guardian and assent (if needed)
3. Must have a documented history of ASD according to or consistent with the ICD-10 (International Classification of Diseases) or DSM-5/4 (Diagnostic and Statistical Manual of Mental Disorders) criteria, or neurodevelopmental disabilities caused by neurogenetic diseases (i.e., Smith-Magenis syndrome, Angelman syndrome, Bourneville's disease \[tuberous sclerosis\]) as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.
4. Must have current sleep problems including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND/OR ≥0.5 hour sleep latency from light off in 3 out of 5 nights based on parent reports and patient medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)
5. May be on a stable dose of non-excluded medication for 3 months, including anti- epileptics, anti-depressants (selective serotonin reuptake inhibitors \[SSRIs\]), stimulants, all mood changing drugs and β-blockers. (Only morning administration of β-blockers is allowed since β-blockers at night have the potential to reduce endogenous melatonin levels and might cause disturbed sleep)
6. The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, stimulants, etc.
After completing 4 weeks of sleep hygiene training (for those who need it) and 2 weeks of placebo run-in, patients will be eligible to continue the study if they comply with the following:
* Continue to fulfill sleep problem criteria (see Inclusion Criterion 4) based on the completed Sleep and Nap Diary entered into the electronic case report form
* Parents demonstrate compliance in Sleep and Nap Diary completion (5 out of 7 nights). Compliance means that in at least 5 out of 7 nights per week (total of 2 weeks before each scheduled visit) the parents complete the diary pages with all mandatory questions
* Continue to fulfil all other eligibility criteria
Exclusion Criteria:
Children who meet any of the following criteria will be excluded from participating in the study:
1. Have had treatment with any form of melatonin within 2 weeks prior to Visit 1
2. Have a known allergy to melatonin or lactose
3. Have a known moderate to severe sleep apnea
4. Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances
5. Did not respond to previous Circadin® therapy based on past medical history records in the last 2 years
6. Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1 (Section 7.1)
7. Are females of child-bearing potential that are not using contraceptives and/or breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception.)
8. Pregnant females
9. Are currently participating in a clinical trial or have participated in a clinical trial involving medicinal product within the last 3 months prior to the study \[this does not include patients who participated in the Phase I Pharmacokinetics (PK) study who can be already included in the study\]
10. Children with known renal or hepatic insufficiency | Neurim Pharmaceuticals Ltd. | INDUSTRY | {
"id": "NEU_CH_7911",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-07-21T00:00:00 | {
"date": "2024-04-23",
"type": "ACTUAL"
} | {
"date": "2013-07-24",
"type": "ESTIMATED"
} | [
"CHILD"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
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"Sleep Disorders"
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NCT02971566 | null | Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler. | Splanchnic Oxygenation and Perfusion Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler: Pattern Assessment and Correlation With Feeding Intolerance | AREDF-SO | OBSERVATIONAL | COMPLETED | 2016-11-19T00:00:00 | null | null | null | null | 20 | 1 | 2 | ALL | false | Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries places preterm infants at significant risk for developing gastrointestinal complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous intestinal perforation. Due to the fear of the aforementioned conditions, the establishment of adequate enteral feeds is frequently hampered in this population. Previous postnatal Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance have a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed; to date, however, it is not known whether this hemodynamic impairment persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion, monitored by Near-infrared spectroscopy (NIRS).
This observational prospective study aims:
* to assess the patterns of abdominal oxygenation and perfusion in response to enteral feeds in AREDF preterm infants at different phases of enteral feeding establishment;
* to evaluate a possible correlation with the development of gastrointestinal complications. | Intrauterine growth restriction (IUGR) is a major cause of perinatal morbidity and mortality. Severe IUGR is often due to impaired placental circulation, with absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries. Fetuses with AREDF adapt to chronic hypoxia by undergoing a blood flow redistribution, which favors cerebral perfusion at the expense of the mesenteric district. The resulting hypoxic-ischemic injury of the intestinal mucosa represents a major risk factor for the post-natal development of gastrointestinal complications, such as necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP) and feeding intolerance (FI). Due to the fear of the aforementioned conditions, the establishment of adequate enteral feeding in AREDF preterm infants is often difficult; hence, the identification of infants at highest risk for GI complications could aid their delicate nutritional management.
Postnatal Doppler studies have shown a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed in AREDF preterm infants who later developed feeding intolerance. A similar Doppler impairment and lower values of splanchnic oxygenation at feeding introduction have been described in non-IUGR preterm infants with later GI complications. To date, however, it is not known whether the impaired mesenteric blood flow observed after the first feed in high-risk AREDF infants persists over time, or if it correlates with reduced splanchnic oxygenation and perfusion.
This observational prospective study aims:
* to assess the patterns of abdominal oxygenation and perfusion in response to enteral feeds in AREDF preterm infants at different phases of enteral feeding establishment;
* to evaluate a possible correlation with the development of gastrointestinal complications.
Infants admitted to the Neonatal Intensive Care Unit (NICU) are consecutively enrolled in the study if fulfilling the following criteria: gestational age ≤34 weeks, stable clinical conditions, documented evidence of antenatal umbilical Doppler impairment.
Exclusion criteria are:
* Enteral feeding prior to the enrollment
* Major congenital abnormalities (including congenital heart diseases, gastroschisis, exomphalos)
* Hemodynamic instability, hypotension, patent ductus arteriosus, anemia, sepsis or other infections at time of NIRS monitoring
Written, informed consent to participate in the study is obtained from the parents/legal guardians of each infant before enrollment.
Enrolled infants undergo a continuous monitoring of splanchnic oxygenation (SrSO2) at enteral feeding introduction (15 ml/kg/die volumes administered within the first 48 hours of life) and full enteral feeding (FEF) achievement (enteral intake ≥150 ml/kg/die) from 30' before to 3 h after feed administration by means of INVOS 5100 oximeter (Somanetics Corporation, Troy, MI, USA).
A simultaneous monitoring of peripheral oxygen saturation (SpO2) is be performed in order to calculate splanchnic fractional oxygen extraction (SFOE) ratio (\[SpO2-SrSO2\]/SpO2). SrSO2 values recorded during hypoxic episodes (SpO2 \<85%) are excluded from statistical analysis.
GI complications are defined as NEC stage ≥2, SIP and/or FI (enteral feeding withholding ≥1 day because of suggestive clinical signs). Enrolled infants are retrospectively divided into two groups: lack (group 1) vs. development (group 2) of GI complications.
Data are analyzed using IBM SPSS Statistic version 20.0.0 (IBM Corporation, IBM Corporation Armonk, New York, United States). Clinical characteristics in the study groups are compared by Mann-Whitney U test for continuous variables and chi-square test for categorical variables. Mann-Whitney U test is used to compare abdominal SrSO2 and FSOE patterns in response to feeds between groups 1 and 2. | Inclusion Criteria:
* gestational age ≤34 weeks
* stable clinical conditions
* documented evidence of antenatal umbilical Doppler impairment
* written informed consent obtained from parents/guardians
Exclusion Criteria:
* Enteral feeding prior to the enrollment
* Major congenital abnormalities (including congenital heart diseases, gastroschisis, exomphalos)
* Hemodynamic instability, hypotension, patent ductus arteriosus, anemia, sepsis or other infections at time of NIRS monitoring | IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER | {
"id": "SO-2016-AREDF",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-11-22T00:00:00 | {
"date": "2016-11-23",
"type": "ESTIMATED"
} | {
"date": "2016-11-23",
"type": "ESTIMATED"
} | [
"CHILD"
] | 20 preterm infants admitted to the Neonatal Intensive Care Unit of Sant'Orsola-Malpighi University Hospital and fulfilling the inclusion criteria are going to be enrolled. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Placental Insufficiency",
"NEC - Necrotizing Enterocolitis",
"Newborn, Premature",
"Feeding Disorder Neonatal"
] | ["feeding intolerance", "preterm infants", "near infrared spectroscopy", "abnormal antenatal Doppler"] | null | [
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"city": "Bologna",
"country": "Italy",
"facility": "Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital",
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"lat": 44.49381,
"lon": 11.33875
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}
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"timeFrame": "3.5 hours"
}
],
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"measure": "Increase/reduction of FSOE after enteral feeds",
"timeFrame": "3.5 hours"
}
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"affiliation": "IRCCS Azienda Ospedaliero-Universitaria di Bologna",
"name": "Luigi T Corvaglia, Prof",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT06835166 | null | Effect of Intraoperative Position Change on Hemodynamics and Electrocardiography | Effect of Intraoperative Position Change on Hemodynamics and Cardiac Electrophysiological Balance Index in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2025-02-06T00:00:00 | null | 2025-04-25T00:00:00 | 2025-05-20T00:00:00 | null | 80 | 18 | 65 | ALL | false | The combined effects of obesity-related cardiac structure and function changes, comorbidities, pneumoperitoneum technique, and reverse Trendelenburg position may complicate anesthesia management by affecting intraoperative hemodynamics and cardiac function. Increased intra-abdominal pressure leads to various physiological changes through mechanical and neurohormonal responses. Furthermore, pneumoperitoneum and reverse Trendelenburg position are reported to stimulate the sympathetic nervous system and increase the risk of cardiac arrhythmia.
Obesity-related changes in cardiac structure and function have been shown to predispose to cardiac conduction and repolarization disorders. It has also been stated that obesity directly affects cardiac electrophysiology.
Moreover, obese patients may have hidden risks associated with the development of cardiac arrhythmias due to the adverse contributions of the cardiovascular effects of anesthesia, pneumoperitoneum, and patient positioning during laparoscopic intervention.
The index of cardiac electrophysiological balance (iCEB) is a non-invasive marker calculated by the QT/QRS ratio that can predict malignant ventricular arrhythmias.
The aim of this study was to investigate the effects of intraoperative patient positions on hemodynamics and the index of cardiac electrophysiological balance (iCEB) during laparoscopic sleeve gastrectomy in morbidly obese patients. | Morbidly obese patients who will undergo laparoscopic sleeve gastrectomy will be included in the study.
Patients will be taken to the operating room without premedication after a minimum of 8 hours of fasting. Venous access will be established with a 22 G angiocatheter on the operating table. Routine heart rate, arterial blood pressure, peripheral oxygen saturation (SpO₂), body temperature, bispectral index (BIS) (Bispectral Drager Vista 120 system, Covidien, USA) monitoring will be performed. BIS will be kept between 40 - 60. In addition, 12-lead ECG (Cardioline®) will be used for electrocardiogram (ECG) measurements.
Mechanical ventilation will be provided with a tidal volume of 8 mL/kg (IBW) and a positive end expiratory pressure (PEEP) of 8 cmH₂O. The respiratory rate will be adjusted to maintain end-tidal carbon dioxide (EtCO2) at 35 to 45 mmHg.
Targeted Fluid Management (GDFM) will be provided by continuous Pleth Variability Index (PVI) monitoring by placing a Pulse CO-Oximeter sensor system (Masimo rainbow set® Masimo Corporation, Irvine, CA, USA) on the patients' 4th finger. Hemodynamic targets are both PVI and mean arterial pressure. Fluid loading prescription is based on a PVI value greater than 13%, and vasopressor use is based on a mean arterial pressure \< 65 mmHg. If necessary, additional fluids and norepinephrine will be given to maintain mean arterial pressure \> 65 mmHg.
A 12-lead ECG will be taken at five intraoperative position measurement points (1. Supine-monitored; 2. After induction; 3. Under general anesthesia-Supine-abdominal inflated; 4. Abdominal inflated-(30% upright) Reverse Trendelenburg; 5. Abdominal deflated-(30% upright) Reverse Trendelenburg). Hemodynamic monitoring \[systolic blood pressure (SBP), diastolic blood pressure (DAB), mean arterial pressure (MAP), heart rate (HR)\] will be recorded at 5 simultaneous measurement points. All hemodynamic measurements and ECG recordings will be made 3 minutes after the position change to ensure standardization, allow the response to settle after the position change, and prevent the possibility of exaggerated or false data.
All patients will have their surgeries performed by the same surgical team and intra-abdominal pressure will be kept below 15 mmHg.
Demographic data (age, gender, height, weight, BMI), American Society of Anesthesiologists (ASA) physical status classification, preoperative assessment information (comorbidities, medications used), duration of surgery and anesthesia, amount of fluid administered, and amount of norepinephrine to be used when needed will be recorded.
Power analysis was calculated as follows:
Repeated measures, within factors Options: Pillai V, O'Brien-Shieh Algorithm Analysis: A priori: Compute required sample size Input: Effect size f = 0.25 α = 0.05 Power (1-β ) = 0.95 Number of groups = 1 Number of measurements = 5 Corr among rep measures = 0 Output: Noncentrality parameter λ = 20.3125000 Critical F = 2.5226149 Numerator df = 4.0000000 Denominator df = 61.0000000 Total sample size = 65 Actual power = 0.9523977 Pillai V = 0.2380952 Considering that there may be data loss in ECG measurements and evaluations, the number of cases was determined as 80 patients.
Intraoperative hemodynamic and ECG (Heart-electrophysiological balance index (iCEB = QT/QRS ratio) changes in 5 positions will be evaluated. | Inclusion criteria:
* Adult patient planned for elective primary laparoscopic sleeve gastrectomy surgery
* Body Mass Index (BMI) ≥ 40 kg/ / m²
* Age ≥ 18
* ASA physical health class II-III.
Exclusion criteria:
* Patient refusal to participate in the study
* Those who underwent revision laparoscopic sleeve gastrectomy
* Emergency laparoscopic sleeve gastrectomy surgery (stump leakage, etc.)
* Secondary surgery in addition to elective laparoscopic sleeve gastrectomy
* Patients with previous recurrent abdominal surgery
* Patients with electrolyte imbalance
* Direct laryngoscopy in ramp position
* Multiple intubation attempts due to difficult intubation
* Preoperative arrhythmia and heart failure (ejection fraction \< 30%)
* Renal and liver failure
* Patients who require \> 8 ml/kg for tidal volume | Firat University | OTHER | {
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NCT04766866 | null | sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term. | Protocol of the PE37 Study: A Multicenter Randomized Trial of Screening With sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term | PE37 | INTERVENTIONAL | RECRUITING | 2021-02-08T00:00:00 | null | 2026-12-31T00:00:00 | 2026-12-31T00:00:00 | [
"NA"
] | 9,132 | 18 | null | FEMALE | true | * Preeclampsia (PE) affects \~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world.
* Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved.
* Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings.
* Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate.
* Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe.
* The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes.
* The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of \>90th centile will be used to define high risk of PE and offer IOL from 37w.
* If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide. | Finding an effective prediction and prevention for term PE remains an unsolved challenge. From previous recent evidence it seems clear that prediction very close to term may achieve a high detection rate, but there is no evidence as to which strategy might be effective in preventing PE in high-risk women. The investigators postulate that a solution that would be applicable in most settings worldwide would require a simplified, pragmatic, approach. The rationale of this proposal is that PE could be reduced with a single-step lab test screening followed by induction of labor (IOL).
A single-step lab measure to detect PE. Combined algorithms using angiogenic factors with Doppler ultrasound and maternal features seem to achieve the highest performance in detecting pre-clinical PE. However, the need to train staff and change pregnancy care protocols renders difficult generalization in high-resource and even more low-resource settings. On the contrary, single lab tests can be more easily incorporated into the mainstream clinical practice and provide a widespread solution for high-resource settings and specially sub-optimal healthcare systems heavily affected by the consequences of term PE. Angiogenic factors are the obvious candidate for these purposes. The sFlt1/PlGF ratio at 35-36w predicts term PE with a DR of 82% and is a standardized lab test nowadays, realizable by ELISA with widely available automated lab platforms. Normal values in late pregnancy have been reported and are fairly similar among different populations. As preliminary research for this study, the investigators have confirmed that the gestational-age adjusted normal values of sFlt1/PlGF matched quite remarkably those previously published in different populations across Europe. A one-step screening with sFlt1/PlGF would select a 5-10% of the population with the highest risk for PE.
IOL at 37 weeks as an intervention in women at high-risk for PE. Previous trials based on statins have failed to show a reduction of PE in high-risk women. IOL at 37 weeks is an alternative to avoid PE in those high-risk women. IOL has consistently been demonstrated to be safe ( ) and does not affect long-term maternal quality of life ( ). Both the HYPITAT and the DIGITAT randomized trials showed that IOL did not increase caesarean rates or adverse neonatal outcomes ( ). A recent large randomized trial in the US has shown that even in low-risk women, universal IOL decreased cesarean section rates and was well accepted ( ). While in low-risk pregnancies labour induction has been found to be beneficial from 39 weeks (ARRIVE study), in women with placental-related conditions such as hypertension (HYPITAT) or small-for-gestational age (DIGITAT) it is 37+ weeks when the trade-off between neonatal and maternal benefits makes induction recommendable.
Therefore, the investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-36.6 w followed by IOL at 37w in those women found to be at high risk might represent a feasible and reproducible strategy, applicable worldwide, to reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes.
Individual participant data, study protocol, statistical analysis plan and informed consent form will be available with publication by email addresses after approval of a proposal with a signed data access agreement | Inclusion Criteria:
* Nulliparous women
* Singleton pregnancies
* \>18 years old
* 35.0-36.6 weeks of gestation
* Maternal written consent form
Exclusion Criteria:
* Fetuses/neonates with major malformations or genetic anomalies that could modify the timing of delivery or has an impact on obstetric outcome
* Suspected fetal growth restriction (estimated fetal weight \<3 centile or between the 3rd and 10th centile together with abnormal Doppler in the mean uterine artery Doppler pulsatility index, or in umbilical artery pulsatility index or in the middle cerebral artery or in the cerebral umbilical index (CPR))
* Participation in another interventional study that could modify the timing of delivery. | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER | {
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"date": "2021-02-23",
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NCT03158766 | null | Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID) | Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID): a Prospective Cohort | SPInE-ID | OBSERVATIONAL | COMPLETED | 2017-05-15T00:00:00 | null | 2019-08-15T00:00:00 | 2021-05-22T00:00:00 | null | 108 | 18 | 65 | ALL | false | Subclinical infection of the intervertebral disc after lumbar disc herniation surgery has been correlated to chronic low back pain and vertebral endplate changes. The most commonly reported agent is Propionibacterium acnes. However, the real incidence is unclear, as it has been reported in some series ranging from 3.7% to 46%. Recently, a systematic review concluded that there is a relationship between P. acnes and endplate changes, but, there are so far no studies to verify whether the reported presence of that pathogen in the intervertebral discs is due to local infection or whether intraoperative contamination occurred during the collection of samples.
Thus, the main objective of this study is to estimate the incidence of subclinical infection in patients surgically treated for lumbar disc herniation.
To this end, a prospective cohort study will be conducted with a minimum of 95 patients between 18 and 65 years of age who have been submitted to surgery after failure of conservative treatment. The extruded disc will be removed and cultured for bacterial identification. As controls, the ligamentum flavum and the multifidus muscle, taken respectively before and after removal of the herniated fragment will also be cultured. Patients will be followed-up for a year and MRI will be done at the end of this period. | INTRODUCTION Low back pain is a frequent condition in the population, as well as vertebral endplates abnormalities, described by Modic et al.(1,2), that affect up to 6% of the general population, and, up to 46% of patients with low back pain(3). Modic type I changes are described as vertebral bone marrow edema related to acute low back pain(4). When Modic changes are detected, chances of one presenting unspecific low back pain are 4.5 times higher(1,2).
Subclinical infection caused by low-virulence pathogen can possibly lead to vertebral endplate abnormalities, detected in magnetic resonance imaging (MRI) studies, and differentiation between infection and Modic changes may be difficult(5,6). Subclinical infection can also be associated with increasing low back pain(7). Albert et al(8) reported 61 patients who had undergone surgical treatment for lumbar disc herniation where 46% of cases had a positive culture. The same authors also reported that 80% of patients with a positive culture for anaerobic pathogens presented Modic type I changes at the adjacent vertebra after a two-year follow-up, against 44% of patients with negative culture. Some studies demonstrated the presence of low-virulence pathogens in intervertebral disc tissue cultures(6-10), most commonly reported to Propionibacterium acnes.
Chronic low back pain and Modic type I changes have been treated with antibiotics for up to 100 days with superior outcomes compared to sham treatment(7). Patients were treated with amoxicillin/clavulanate (500mg/125mg)(7) based on the study where sciatica is associated with Propionibacterium acnes(8).
However, Carricajo et al(11) suggest that the presence of P. acnes in the intervertebral discs is due to either external surgical or laboratory contamination. These authors detected positive disc culture in only 3.7% of cases out of 54 patients. Furthermore, same authors demonstrated that samples of spinal muscle and ligamentum flavum collected intraoperatively at the end of procedure had positive cultures in 14.8% of cases with a negative disc culture.
A systematic review performed by Urquhart et al(12) concluded, that there is moderate evidence that a relationship between positive culture with Modic type I changes and low back pain exists, although there was low evidence for relationship of cause. For that, authors concluded that new studies should be made to determine whether pathogens in the disc are originated from external contamination or if they are truly involved in the development of chronic back pain.
HYPOTHESIS Lumbar disc herniation is related to subclinical infection of the intervertebral disc Null hypothesis: incidence of subclinical infection is the same as incidence of cases without infection in patients with lumbar disc herniation treated with surgery.
OBJECTIVES Main purpose of this study is to identify if the presence of a infection pathogen in the intervertebral disc is real or if it is intraoperative contamination.
Secondary objectives are to analyze clinical prognostic factors in patients and diagnosis of infection.The study also proposes to analyze the relationship between radiological changes (Modic I and II) and infection.
METHODS
Study design:
An open prospective cohort study will be performed at a single center, (Hospital Israelita Albert Einstein - HIAE) taking 1 year for recruiting, and ending 1 year after inclusion of last patient. Patients' data will be collected with a specific form created for this study. Patients will be summoned for a new magnetic resonance image of the lumbar spine one year after their surgical procedure.
All included patients will go through further treatment of ten sessions of postoperative physical therapy.
Population:
Patients who have failed conservative treatment for lumbar disc herniation undergoing lumbar decompression open surgery (microdiscectomy) will be consecutively included in the study.
Patient enrollment in the study:
Patients accepting their participation will date and sign the Informed Consent Form (ICF). After ICF is properly signed, patient will undergo an interview to complete initial demographic data and pretreatment forms.
Patient recruitment will be carried out for 24 months, when 95 patients shall be included (details of estimated n reported at sample size determination).
Patient allocation:
Patients will undergo surgery according to surgeons' preference. Attending surgeons will determine chosen operative technique according to their experience and preference.
Blinding:
Patients will not have access to the results of tissue cultures for pathogens, as well as the attending physician.
The radiologist that will analyze imaging studies of performed magnetic resonance will also be blinded to patients' data or laboratory culture results. A blinded investigator will analyze pain and function scores.
Early stopping of participation in the study:
Patients will be excluded from the study when:
* Withdrawn of ICF
* Diseased
* Patient selection flaw - incompatible eligibility criteria
* Lost to follow-up
* If patient presents clinical symptoms of infection such as severe lumbar or radicular pain, fever with no other detected foci, abnormal ESR, CRP, leucogram, and, altered imaging studies that leads to interruption of blinding of the results of culture exams.
Study stages
Sample collection:
Included patients will undergo standard fashion general anesthesia and prepped with clorhexidine solution. Intravenous antibiotics prophylaxis will be administered within first hour before skin incision, according to standard protocol of HIAE Infection Control Committee published at the hospital Pharmaceutics Manual.
Preoperative blood sample will be collected for leucogram, Erythrocyte Sedimentation Rate (ESR), and C-Reactive Protein (CRP). Same laboratory will be repeated at 1, 6 and 12 months time-point.
The excised herniated disc fragment will be immediately sent to microbiology laboratory analysis in a universal sterile container (screw cap tube) in no more than 30 minutes to be processed as follows. Same process will be applied to samples of deep muscle and ligamentum flavum at the end of the surgical procedure. Three cultures of the intervertebral disc will be done, as well as three of the ligamentum flavum and three of the multifidus muscle for each patient.
Search for pathogens:
Herniated intervertebral disc will be split in three equally sized fragments of over 2x2x5 mm and squashed in a laminar flow cabinet until homogeneous material is achieved. Same process will be carried out for the ligamentum flavum and multifidus muscle samples, although split in three fragments. Tissues will be cultured in specific growth medium and incubated according to the respective culture:
Similar criteria used by the Infectious Diseases Society of America (IDSA) to detect joint replacement infection will be adopted, which is the recommendation on at least two positive tissue cultures by the same pathogen to confirm diagnosis of infection(13).
* A - Aerobic culture For aerobic cultures, samples will be cultured in 5% sheep blood agar, chocolate agar and MacConkey agar plate, and will be placed in a 35°C incubator (CO2 atmosphere) for 5 days. If a positive bacteria culture is detected in the plate, the colony will be identified by MALDI TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) Microflex LT (Bruker Daltonics/BD).
* B - Anaerobic culture For anaerobic culture, tissue will be cultured in a Thioglycolate tube and incubated in a 35°C incubator for up to 21 days. If turbidity occurs at the Thioglycolate medium, material will be cultured in anaerobic blood agar and incubation at 35°C will be done in an anaerobic atmosphere. After growing of colonies, identification will be done by MALDI TOF.
* C - Histological analysis Anatomic pathology analysis of the other fragment of the herniated disc (2x2x5 mm) will be done. Sample will be transported in a universal container with tamponaded formalin (10%), followed by dehydration in alcohol diafanized in xylol and inclusion in paraffin (60-65°C), which will be stained in hematoxylin-eosin (HE) and GRAM staining.
* HE: Histological cuts of 4μm will be performed, followed by clearing with xylol for 10 minutes twice, embedding with alcohol under increasing concentrations and stained with hematoxylin for 5 minutes, running water for 5 minutes, eosin for 1 minute and running water for 2 minutes followed by assembly of glass microscope slide with Entellan®.
* GRAM: Another slide will be embedded with crystal violet for 1 minute, running water for 1 minute followed by lugol for another 1 minute and additional wash with running water. Unstaining of the slide will be done with alcohol 95% for 10 seconds followed by running water and then, stain with fuchsine for 30 seconds, running water wash again, drying and slide assembly with Entellan®.
* D - Molecular analysis of pathogens Positive cultures that present aerobic or anaerobic pathogens culturing, will be isolated and stowed refrigerated in -80°C freezer for posterior molecular analysis.
Molecular typing will be performed through Pulsed Field Gel Electrophoresis technique of isolated samples according to the protocol described by Oprica et al.(14) using Spe-I restriction enzyme and Bionumerics software for analysis of results.
Questionnaires See outcome measures
Imaging studies Magnetic resonance imaging studies will be performed in Siemens or General Electric 1.5T devices.
Lumbar disc herniation will be diagnosed through MRI in eligible patients. Included patients will be submitted to new MRI 12 months after surgery.
Two radiologists with expertise in musculoskeletal MRI will independently classify and perform measurements.
Confounding variables Data on the following confounding variables will be collected: age, gender, alcohol intake, smoking, body mass index (BMI), spinal injections with corticoid within 6 months before surgery, usage of oral corticoids up to 3 months before surgery, diabetes.
Since this information may change over time, data will be considered at time of last assessment before surgery.
Statistical planning Rate of subclinical infection (or Modic change) will be obtained by the ratio between number of positive cultures from surgical samples and total number of patients, and estimates will follow 95% confidence intervals. After infection cases are identified, we will investigate if there is an association between detected infection and patient outcomes by logistic regression models for Modic changes, ordinal logistic regression for Modic volume and size, and linear regression or general linear models for numeric outcomes, such as: low back pain, quality of life and function. All models will consider confounding variables such as: smoking and alcohol intake, diabetes, corticosteroids injection, BMI, gender, and age. Results will be presented as effects estimates such as odds ratio or mean ratio, 95% confidence intervals and p values. Study dropout cases, for any reason, will be considered for final analysis.
Sample size calculation Sample size was calculated to estimate of incidence of subclinical infection in patients with lumbar disc herniation. Considering that the rate of infection lies around 46%(3), we need to observe a minimum of 95 patients to achieve a 95% confidence interval with 10% absolute accuracy.
The necessary sample size to analyze secondary endpoints will depend on the observed rate of cases with subclinical infection in our study sample. If the observed rate is too small, an increase in the number of included patients will be needed. To better evaluate this, the sample size calculation will be revisited by the time we have reached half of initially planned sample size (48 patients). | Inclusion Criteria:
* Subjects between 18 and 65 years of age; both genders; with diagnose of lumbar disc herniation undergoing open decompression surgery (microdiscectomy). Patients willing and able to go through all phases of clinical investigation and rehabilitation will be included. An Informed Consent Form (ICF) must be signed.
Exclusion Criteria:
* Patients with previous lumbar disc surgery at the same level at any point of life; patients undergoing chemotherapy; patients with any immune deficiency; patients previously submitted to disc injection and/or discography; patients submitted to previous endoscopic disc surgery; patients with fusion performed at the same stage of decompression surgery; patients with any other infection within the last six months or usage of antibiotics within the last two months; patients with incomplete specific form or data; decline to participate or sign the ICF. | Hospital Israelita Albert Einstein | OTHER | {
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] | [{"pmid": "3336678", "type": "BACKGROUND", "citation": "Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9. doi: 10.1148/radiology.166.1.3336678."}, {"pmid": "3289089", "type": "BACKGROUND", "citation": "Modic MT, Masaryk TJ, Ross JS, Carter JR. Imaging of degenerative disk disease. Radiology. 1988 Jul;168(1):177-86. doi: 10.1148/radiology.168.1.3289089. No abstract available."}, {"pmid": "18787845", "type": "BACKGROUND", "citation": "Jensen TS, Karppinen J, Sorensen JS, Niinimaki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J. 2008 Nov;17(11):1407-22. doi: 10.1007/s00586-008-0770-2. Epub 2008 Sep 12."}, {"pmid": "8083266", "type": "BACKGROUND", "citation": "Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64."}, {"pmid": "17624684", "type": "BACKGROUND", "citation": "Albert HB, Kjaer P, Jensen TS, Sorensen JS, Bendix T, Manniche C. Modic changes, possible causes and relation to low back pain. Med Hypotheses. 2008;70(2):361-8. doi: 10.1016/j.mehy.2007.05.014. Epub 2007 Jul 10."}, {"pmid": "20213295", "type": "BACKGROUND", "citation": "Ohtori S, Koshi T, Yamashita M, Yamauchi K, Inoue G, Suzuki M, Takaso M, Orita S, Eguchi Y, Ochiai N, Kishida S, Kuniyoshi K, Nakamura J, Aoki Y, Ishikawa T, Arai G, Miyagi M, Kamoda H, Takahashi K. Existence of pyogenic spondylitis in Modic type 1 change without other signs of infection: 2-year follow-up. Eur Spine J. 2010 Jul;19(7):1200-5. doi: 10.1007/s00586-010-1358-1. Epub 2010 Mar 8."}, {"pmid": "23404353", "type": "BACKGROUND", "citation": "Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13."}, {"pmid": "23397187", "type": "BACKGROUND", "citation": "Albert HB, Lambert P, Rollason J, Sorensen JS, Worthington T, Pedersen MB, Norgaard HS, Vernallis A, Busch F, Manniche C, Elliott T. Does nuclear tissue infected with bacteria following disc herniations lead to Modic changes in the adjacent vertebrae? Eur Spine J. 2013 Apr;22(4):690-6. doi: 10.1007/s00586-013-2674-z. Epub 2013 Feb 10."}, {"pmid": "11438138", "type": "BACKGROUND", "citation": "Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available."}, {"pmid": "21150662", "type": "BACKGROUND", "citation": "Agarwal V, Golish SR, Alamin TF. Bacteriologic culture of excised intervertebral disc from immunocompetent patients undergoing single level primary lumbar microdiscectomy. J Spinal Disord Tech. 2011 Aug;24(6):397-400. doi: 10.1097/BSD.0b013e3182019f3a."}, {"pmid": "17573158", "type": "BACKGROUND", "citation": "Carricajo A, Nuti C, Aubert E, Hatem O, Fonsale N, Mallaval FO, Vautrin AC, Brunon J, Aubert G. Propionibacterium acnes contamination in lumbar disc surgery. J Hosp Infect. 2007 Jul;66(3):275-7. doi: 10.1016/j.jhin.2007.04.007. Epub 2007 Jun 18."}, {"pmid": "18487245", "type": "BACKGROUND", "citation": "Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16."}, {"pmid": "16701513", "type": "BACKGROUND", "citation": "Oprica C, Emtestam L, Lapins J, Borglund E, Nyberg F, Stenlund K, Lundeberg L, Sillerstrom E, Nord CE. Antibiotic-resistant Propionibacterium acnes on the skin of patients with moderate to severe acne in Stockholm. Anaerobe. 2004 Jun;10(3):155-64. doi: 10.1016/j.anaerobe.2004.02.002."}, {"pmid": "3236394", "type": "BACKGROUND", "citation": "Alcohol drinking. IARC Monogr Eval Carcinog Risks Hum. 1988;44:1-378. No abstract available."}] | {"versionHolder": "2025-06-18"} | {
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NCT05977166 | null | Hyperbaric on Pulmonary Functions in Post Covid -19 Patients. | Influence of Hyperbaric Oxygen on Pulmonary Functions in Post Covid-19 Patients. | None | INTERVENTIONAL | COMPLETED | 2023-06-11T00:00:00 | null | 2022-06-21T00:00:00 | 2023-06-01T00:00:00 | [
"NA"
] | 72 | 21 | 66 | ALL | false | Purpose of the study is to investigate the effect of hyperbaric oxygen on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients, The effect of breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients.and the difference between the effect of hyperbaric and breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients
Seventy two covid-19 patients from both genders ranged in age chronology from twenty one to sixty six years will be conducted to participate in this study .Selection of the study sample and evaluate of pulmonary functions improvement as well as hyperbaric oxygen therapy will be conducted at Agriculture Hospital in El Mansoura town.
The study sample will be divided randomly into two equal groups of(A\&B).All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.
The Body mass index (BMI) of each participated patient will be determined by measuring weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI 25.0-29.9 Kg/ . Also using Digital spirometer SMP 21/01 RD (Russian) for measuring of FVC parameters , to be less than 80% ,FEV1 to be less than 80% and Pulse Oximeter for measuring Oxygen saturation to range from 90%to 95% assessment will be done before and after treatment.
The obtained results of this study will measure Forced vital capacity (FVC), Forced expiratory volume (FEV1) and oxygen saturation to determine the significant improvement of participated patients. | null | Inclusion Criteria
* 1. post Covid -19 patients (2weeks after recovery).
2.post Covid -19 patients with deficiency in forced vital capacity (less than 80%) forced expiratory volume (less than 80%) lower oxygen saturation (90%-95%).
3.age (21-66)years old.
4.both gender.
5.BMI 25.0-29.9.
Exclusion Criteria:
1. COPD or other respiratory diseases.
2. Neurological disease.
3. mental illness.
4. Critically ill patients with intubation.
5. smokers.
6. Inner ear diseases.
7. pregnancy. | Cairo University | OTHER | {
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NCT00000466 | null | Postmenopausal Estrogen/Progestin Interventions (PEPI) | null | None | INTERVENTIONAL | COMPLETED | 1999-10-27T00:00:00 | null | null | null | [
"PHASE3"
] | null | 45 | 64 | FEMALE | false | To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation. | BACKGROUND:
The life expectancy of American women is 78 years. More than one-third of those years are postmenopausal, during which time the risk of coronary heart disease is increased. The current United States estimate of more than 40 million women over the age of 50 indicates a large segment of the population at increased risk for coronary heart disease. Heart disease accounts for a third of all deaths in 50-69 year old women. In 1978, for example, approximately 66,000 of the 210,000 deaths in women 50-69 were attributed to heart disease.
Premenopausal women have a lower rate of ischemic heart disease compared to men of similar age. Surgically induced or natural early menopause increases the risk of ischemic heart disease. These facts have focused interest on estrogens as possible mediators of the beneficial effects, and pointed to the need for further study of their relationship to atherosclerosis risk factors.
Estimates from the Lipid Research Clinics Program indicate estrogen use in approximately one third of postmenopausal women. Analysis of Lipid Research Clinics data confirmed that administration of estrogens results in lower plasma low density lipoprotein levels and elevated plasma high density lipoprotein levels. Thus, the ratio of high density lipoprotein/low density lipoprotein levels is substantially increased. Given the inverse relationship between high density lipoprotein levels and coronary heart disease risk, this effect of estrogens on the plasma lipoproteins could be expected to further reduce coronary heart disease risk in women.
Although the bulk of currently available evidence suggests benefit, some controversy concerning the effects of postmenopausal estrogens on morbidity and mortality from coronary heart disease persists. Analysis of the Lipid Research Clinics Follow-up Study population indicated a potentially profound beneficial effect of postmenopausal estrogen use. Mortality from all causes decreased considerably in postmenopausal estrogen users, and the effect was most pronounced in hysterectomized and oophorectomized women. Similar results have been observed for cardiovascular deaths. These benefits appeared to be mediated by the higher high density lipoprotein levels associated with postmenopausal estrogen use. Framingham data are the primary sources reporting possible detrimental effects of postmenopausal estrogen use on cardiovascular morbidity; mortality from all cause and cardiovascular disease was not reported to vary by use.
NHLBI convened a Trans-NIH Estrogen Working Group to make recommendations to NHLBI on the feasibility of undertaking a clinical trial of the effects of postmenopausal estrogen use on cardiovascular disease mortality. The Working Group identified a number of important research questions which needed to be answered to elucidate the effects of postmenopausal estrogen use on risk factors for cardiovascular disease and osteoporosis. This initiative was the result of the Working Group's deliberations and recommendations.
DESIGN NARRATIVE:
There were seven clinical centers and a coordinating center in this randomized, double-blind clinical trial. The women were allocated to one of five treatment arms: placebo; conjugated equine estrogen (CEE), 0.625 milligrams per day; conjugated equine estrogen, 0.625 milligrams per day plus cyclic medroxyprogesterone acetate (MPA), 10 milligrams per day for 12 days per month; CEE, 0.625 milligrams per day plus consecutive MPA, 2.5 milligrams per day; CEE, 0.625 milligrams per day plus cyclic micronized progesterone (MP), 200 milligrams per day for 12 days a month. The four primary endpoints were chosen to represent four biological systems related to the risk of cardiovascular disease and included high density lipoprotein cholesterol (HDL-C), systolic blood pressure, serum insulin, and fibrinogen. Recruitment began in October 1989 and ended in February 1991. Baseline data collected included blood pressure, resting heart rate, weight, waist/hip ratios and endometrial biopsy. Laboratory evaluations included lipid panel, high density lipoprotein cholesterol, insulin and glucose, bone density, fibrinogen, and in three clinics, additional hemostasis factors, renin substrate, plasma renin activity, aldosterone, and oral post-heparin lipase activity. All women underwent an endometrial aspiration biopsy at baseline and annually thereafter. Additional biopsy specimens were obtained if there was noncyclic endometrial bleeding. All women also had baseline and annual mammograms. Other data were collected on quality of life, exercise, diet, alcohol use, and smoking. Participants were followed at three, six and twelve months post-randomization, and at six month intervals thereafter for three years. Post-trial analyses of existing data sets were funded for three years by the cooperative agreement mechanism beginning August 1, 1994. A three-year safety follow-up funded through the contract mechanism began in 1994. It included three annual visits at which endometrial biopsies, mammograms, and some limited health information were obtained.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. | Postmenopausal women, ages 45 to 64. One third of the subjects had had a hysterectomy. | National Heart, Lung, and Blood Institute (NHLBI) | NIH | {
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"date": "1999-10-28",
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"Myocardial Ischemia",
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August 1995"}, {"pmid": "8569016", "type": "BACKGROUND", "citation": "Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 1996 Feb 7;275(5):370-5. doi: 10.1001/jama.1996.03530290040035."}, {"pmid": "7587216", "type": "BACKGROUND", "citation": "Bush TL, Espeland MA, Mebane-Sims I. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. Introduction. Control Clin Trials. 1995 Aug;16(4 Suppl):1S-2S. doi: 10.1016/0197-2456(94)00119-n. No abstract available."}, {"pmid": "7587218", "type": "BACKGROUND", "citation": "Espeland MA, Bush TL, Mebane-Sims I, Stefanick ML, Johnson S, Sherwin R, Waclawiw M. Rationale, design, and conduct of the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):3S-19S. doi: 10.1016/0197-2456(94)00033-y."}, {"pmid": "7587217", "type": "BACKGROUND", "citation": "Johnson S, Mebane-Sims I, Hogan PE, Stoy DB. Recruitment of postmenopausal women in the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):20S-35S. doi: 10.1016/0197-2456(94)00111-f. No abstract available."}, {"pmid": "7587219", "type": "BACKGROUND", "citation": "Wood PD, Kessler G, Lippel K, Stefanick ML, Wasilauskas CH, Wells HB. Physical and laboratory measurements in the PEPI Trial Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):36S-53S. doi: 10.1016/0197-2456(95)96882-c. No abstract available."}, {"pmid": "7587220", "type": "BACKGROUND", "citation": "Miller VT, Byington RL, Espeland MA, Langer R, Marcus R, Shumaker S, Stern MP. Baseline characteristics of the PEPI participants. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):54S-65S. doi: 10.1016/0197-2456(94)00113-h. No abstract available."}, {"pmid": "7489228", "type": "BACKGROUND", "citation": "Stefanick ML, Legault C, Tracy RP, Howard G, Kessler CM, Lucas DL, Bush TL. Distribution and correlates of plasma fibrinogen in middle-aged women. Initial findings of the Postmenopausal Estrogen/Progestin Interventions (PEPI) study. Arterioscler Thromb Vasc Biol. 1995 Dec;15(12):2085-93. doi: 10.1161/01.atv.15.12.2085."}, {"pmid": "7817832", "type": "BACKGROUND", "citation": "Marcus R, Greendale G, Blunt BA, Bush TL, Sherman S, Sherwin R, Wahner H, Wells B. Correlates of bone mineral density in the postmenopausal estrogen/progestin interventions trial. J Bone Miner Res. 1994 Sep;9(9):1467-76. doi: 10.1002/jbmr.5650090920."}, {"pmid": "8607727", "type": "BACKGROUND", "citation": "Greendale GA, Bodin-Dunn L, Ingles S, Haile R, Barrett-Connor E. Leisure, home, and occupational physical activity and cardiovascular risk factors in postmenopausal women. The Postmenopausal Estrogens/Progestins Intervention (PEPI) Study. Arch Intern Med. 1996 Feb 26;156(4):418-24."}, {"pmid": "8729156", "type": "BACKGROUND", "citation": "Barrett-Connor E, Schrott HG, Greendale G, Kritz-Silverstein D, Espeland MA, Stern MP, Bush T, Perlman JA. Factors associated with glucose and insulin levels in healthy postmenopausal women. Diabetes Care. 1996 Apr;19(4):333-40. doi: 10.2337/diacare.19.4.333."}, {"pmid": "9366624", "type": "BACKGROUND", "citation": "Greendale GA, James MK, Espeland MA, Barrett-Connor E. Can we measure prior postmenopausal estrogen/progestin use? The Postmenopausal Estrogen/Progestin Interventions Trial. The PEPI Investigators. Am J Epidemiol. 1997 Nov 1;146(9):763-70. doi: 10.1093/oxfordjournals.aje.a009352."}, {"pmid": "9400035", "type": "BACKGROUND", "citation": "Langer RD, Pierce JJ, O'Hanlan KA, Johnson SR, Espeland MA, Trabal JF, Barnabei VM, Merino MJ, Scully RE. Transvaginal ultrasonography compared with endometrial biopsy for the detection of endometrial disease. Postmenopausal Estrogen/Progestin Interventions Trial. N Engl J Med. 1997 Dec 18;337(25):1792-8. doi: 10.1056/NEJM199712183372502."}, {"pmid": "9288699", "type": "BACKGROUND", "citation": "Barrett-Connor E, Slone S, Greendale G, Kritz-Silverstein D, Espeland M, Johnson SR, Waclawiw M, Fineberg SE. The Postmenopausal Estrogen/Progestin Interventions Study: primary outcomes in adherent women. Maturitas. 1997 Jul;27(3):261-74. doi: 10.1016/s0378-5122(97)00041-8."}, {"pmid": "9190973", "type": "BACKGROUND", "citation": "Smith EM, Johnson SR, Figuerres EJ, Mendoza M, Fedderson D, Haugen TH, Turek LP. The frequency of human papillomavirus detection in postmenopausal women on hormone replacement therapy. Gynecol Oncol. 1997 Jun;65(3):441-6. doi: 10.1006/gyno.1997.4703."}, {"pmid": "9141548", "type": "BACKGROUND", "citation": "Espeland MA, Stefanick ML, Kritz-Silverstein D, Fineberg SE, Waclawiw MA, James MK, Greendale GA. Effect of postmenopausal hormone therapy on body weight and waist and hip girths. Postmenopausal Estrogen-Progestin Interventions Study Investigators. J Clin Endocrinol Metab. 1997 May;82(5):1549-56. doi: 10.1210/jcem.82.5.3925."}, {"pmid": "9529266", "type": "BACKGROUND", "citation": "Espeland MA, Marcovina SM, Miller V, Wood PD, Wasilauskas C, Sherwin R, Schrott H, Bush TL. Effect of postmenopausal hormone therapy on lipoprotein(a) concentration. PEPI Investigators. Postmenopausal Estrogen/Progestin Interventions. Circulation. 1998 Mar 17;97(10):979-86. doi: 10.1161/01.cir.97.10.979."}, {"pmid": "9611701", "type": "BACKGROUND", "citation": "Legault C, Espeland MA, Wasilauskas CH, Bush TL, Trabal J, Judd HL, Johnson SR, Greendale GA. Agreement in assessing endometrial pathology: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. J Womens Health. 1998 May;7(4):435-42. doi: 10.1089/jwh.1998.7.435."}, {"pmid": "10068383", "type": "BACKGROUND", "citation": "Greendale GA, Reboussin BA, Sie A, Singh HR, Olson LK, Gatewood O, Bassett LW, Wasilauskas C, Bush T, Barrett-Connor E. Effects of estrogen and estrogen-progestin on mammographic parenchymal density. Postmenopausal Estrogen/Progestin Interventions (PEPI) Investigators. Ann Intern Med. 1999 Feb 16;130(4 Pt 1):262-9. doi: 10.7326/0003-4819-130-4_part_1-199902160-00003."}, {"pmid": "9773716", "type": "BACKGROUND", "citation": "Espeland MA, Hogan PE, Fineberg SE, Howard G, Schrott H, Waclawiw MA, Bush TL. Effect of postmenopausal hormone therapy on glucose and insulin concentrations. PEPI Investigators. Postmenopausal Estrogen/Progestin Interventions. Diabetes Care. 1998 Oct;21(10):1589-95. doi: 10.2337/diacare.21.10.1589."}, {"pmid": "9701620", "type": "BACKGROUND", "citation": "Hall SL, Greendale GA. The relation of dietary vitamin C intake to bone mineral density: results from the PEPI study. Calcif Tissue Int. 1998 Sep;63(3):183-9. doi: 10.1007/s002239900512."}, {"pmid": "9840563", "type": "BACKGROUND", "citation": "Greendale GA, Reboussin BA, Hogan P, Barnabei VM, Shumaker S, Johnson S, Barrett-Connor E. Symptom relief and side effects of postmenopausal hormones: results from the Postmenopausal Estrogen/Progestin Interventions Trial. Obstet Gynecol. 1998 Dec;92(6):982-8. doi: 10.1016/s0029-7844(98)00305-6."}, {"pmid": "10449693", "type": "BACKGROUND", "citation": "Cushman M, Legault C, Barrett-Connor E, Stefanick ML, Kessler C, Judd HL, Sakkinen PA, Tracy RP. 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Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study. Arch Intern Med. 2002 Mar 25;162(6):665-72. doi: 10.1001/archinte.162.6.665."}, {"pmid": "12738166", "type": "BACKGROUND", "citation": "Simon JA, Symons JP. Bleeding patterns of the hormone replacement therapies in the postmenopausal estrogen and progestin interventions trial. Obstet Gynecol. 2003 May;101(5 Pt 1):1020; author reply 1020-1. doi: 10.1016/s0029-7844(03)00113-3. No abstract available."}, {"pmid": "12423841", "type": "BACKGROUND", "citation": "Lindenfeld EA, Langer RD. Bleeding patterns of the hormone replacement therapies in the postmenopausal estrogen and progestin interventions trial. 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NCT01676766 | null | Novel Quantification Methods for Fluorescence to Detect Progression in Stargardt Disease | Novel Quantification Methods for Fundus Flavoprotein Fluorescence and Lipofuscin Fluorescence to Detect Progression in Stargardt Disease | None | OBSERVATIONAL | TERMINATED | 2012-08-23T00:00:00 | null | null | null | null | 2 | 5 | 18 | ALL | false | The purpose of this study is to utilize flavoprotein fluorescence and fundus autofluorescence to detect progression of Stargardt macular dystrophy in a pediatric population over the course of a year with the hope of aiding future therapeutic risk-benefit decisions and assessment of outcomes.
Stargardt macular dystrophy is the most common of the juvenile-onset macular dystrophies. Despite determination of ABCA4 as the causative gene, clinicians have been challenged by variability in clinical phenotypes. Given the recent initiation of clinical trials to assess novel treatments (e.g. gene therapy), there is a need to identify patients with the worst prognosis.
The investigators have observed that pediatric patients lose central visual function faster than their adult counterparts. Thus, they present an ideal cohort with which to determine the utility of novel modalities to detect early change. These include flavoprotein fluorescence, a new imaging technique for detecting mitochondrial dysfunction developed at the University of Michigan. Fundus autofluorescence (FAF) is another commonly utilized technique of evaluating hereditary eye diseases. The investigators have developed a novel means of quantifying FAF signatures that will allow documentation of severity as well as detection of progression. | This study will evaluate whether more sophisticated testing and analytic methodologies, including fundus autofluorescence (FAF) and a novel non-invasive method to measure retinal flavoprotein fluorescence (FPF) may be used to better predict Stargardt macular dystrophy progression and monitor treatment effects than conventional modalities such visual acuity and visual field. This method involves the use of novel statistical methods to assess the heterogeneity of fundus autofluorescence images.
Participants will complete 3 visits to the University of Michigan Kellogg Eye Center. Each visit will take approximately 2.5 hours. The initial visit will include a routine clinical eye examination, measurement of best-corrected visual acuity, indirect ophthalmoscopy, microperimetry, frequency-domain optical coherence tomography, Goldmann visual fields, fundus flavoprotein fluorescence (FPF) imaging, and fundus autofluorescence (FAF) and fundus photography. Patients will return for evaluation at 6 and 12 months after their initial visit to repeat testing and imaging. | Inclusion Criteria:
* Between the age of 5 and 18 years old
* Clinical diagnosis of Stargardt Disease
* Molecular confirmation of Stargardt Disease (with 2 identified mutations in ABCA4)
* Visual acuity better than 20/100
Exclusion Criteria:
* Limited central vision, defined as visual acuity worse than 20/100
* A diagnosis of any other retinal degenerative disease | University of Michigan | OTHER | {
"id": "HUM 64388",
"link": null,
"type": null
} | Flavoprotein fluorescence machine for the trial is not working so the trial was terminated. No study data was collected prior to termination. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-08-28T00:00:00 | {
"date": "2016-11-08",
"type": "ESTIMATED"
} | {
"date": "2012-08-31",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT"
] | We will perform an observational clinical study of 25 pediatric patients with Stargardt Disease recruited from the retinal degeneration clinic at the University of Michigan who have two mutations in ABCA4. | NON_PROBABILITY_SAMPLE | false | {
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"timePerspective": "PROSPECTIVE"
} | [
"Stargardt Disease"
] | ["Stargardt Disease", "Macular degeneration", "Retinal dystrophy"] | null | [
{
"city": "Ann Arbor",
"country": "United States",
"facility": "Kellogg Eye Center",
"geoPoint": {
"lat": 42.27756,
"lon": -83.74088
},
"state": "Michigan"
}
] | [
{
"class": "OTHER",
"name": "Midwest Eye Banks"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline in pixel intensity quantification of fundus autofluorescence at 6 months",
"timeFrame": "0 months, 6 months"
},
{
"description": null,
"measure": "Change from baseline in pixel intensity quantification of flavoprotein autofluorescence at 6 months",
"timeFrame": "0 months, 6 months"
}
],
"secondary": [
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"description": null,
"measure": "Change from baseline in pixel intensity quantification of fundus autofluorescence at 12 months",
"timeFrame": "0 months, 12 months"
},
{
"description": null,
"measure": "Change from baseline in pixel intensity quantification of flavoprotein autofluorescence at 12 months",
"timeFrame": "0 months, 12 months"
}
]
} | [
{
"affiliation": "University of Michigan Kellogg Eye Center",
"name": "K. Thiran Jayasundera, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "19277237", "type": "BACKGROUND", "citation": "Elner SG, Elner VM, Field MG, Park S, Heckenlively JR, Petty HR. Retinal flavoprotein autofluorescence as a measure of retinal health. Trans Am Ophthalmol Soc. 2008;106:215-22; discussion 222-4."}, {"pmid": "19491721", "type": "BACKGROUND", "citation": "Field MG, Elner VM, Park S, Hackel R, Heckenlively JR, Elner SG, Petty HR. Detection of retinal metabolic stress resulting from central serous retinopathy. Retina. 2009 Sep;29(8):1162-6. doi: 10.1097/IAE.0b013e3181a3b923."}, {"pmid": "18625939", "type": "BACKGROUND", "citation": "Field MG, Elner VM, Puro DG, Feuerman JM, Musch DC, Pop-Busui R, Hackel R, Heckenlively JR, Petty HR. Rapid, noninvasive detection of diabetes-induced retinal metabolic stress. Arch Ophthalmol. 2008 Jul;126(7):934-8. doi: 10.1001/archopht.126.7.934."}, {"pmid": "20398653", "type": "BACKGROUND", "citation": "Chen B, Tosha C, Gorin MB, Nusinowitz S. Analysis of autofluorescent retinal images and measurement of atrophic lesion growth in Stargardt disease. Exp Eye Res. 2010 Aug;91(2):143-52. doi: 10.1016/j.exer.2010.03.021. Epub 2010 Apr 14."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D015785",
"term": "Eye Diseases, Hereditary"
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"id": "D005128",
"term": "Eye Diseases"
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"id": "D012162",
"term": "Retinal Degeneration"
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{
"id": "D012164",
"term": "Retinal Diseases"
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{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
}
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"abbrev": "BC11",
"name": "Eye Diseases"
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"name": "All Conditions"
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"term": "Stargardt Disease"
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"term": "Macular Degeneration"
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} | null | {
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"term": "Stargardt Disease"
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"term": "Macular Degeneration"
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} |
NCT00939666 | null | Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer | Minimal Invasive Treatment for Patients With Good Response to Chemoradiation With Selection and Follow-up by MRI: a Single Arm Phase-II Feasibility Study in Rectal Cancer | None | INTERVENTIONAL | COMPLETED | 2009-07-14T00:00:00 | null | 2014-09-01T00:00:00 | 2014-09-01T00:00:00 | [
"NA"
] | 28 | 18 | null | ALL | false | The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed. | The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME) or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed. | Inclusion Criteria:
* 18 years or older
* Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response: Clinical complete response (ycT0N0) or very good response (ycT1-2N0) after pre-operative chemoradiation will be determined clinically (digital rectal examination, endoscopy), radiologically (contrast-enhanced-MRI) and pathologically (biopsy)
* Informed consent and capability of giving informed consent
* Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient (in other words that the patient understands the experimental base of the study).
Exclusion Criteria:
* Recurrent rectal cancer.
* Distant metastasis.
* Unable or unwilling to comply to the intensive follow-up schedule.
* Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) we will exclude patients. MRI is crucial for response evaluation and follow-up and can not be omitted in patients that follow the alternative strategies ('wait-and-see policy' or TEM). | Maastricht University Medical Center | OTHER | {
"id": "MEC 09-2-034",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-07-14T00:00:00 | {
"date": "2017-03-24",
"type": "ACTUAL"
} | {
"date": "2009-07-15",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Locally Advanced Rectal Cancer"
] | ["Rectal cancer", "Chemoradiation", "Response", "Wait-and-see policy", "Transanal endoscopic microsurgery"] | null | [
{
"city": "Maastricht",
"country": "Netherlands",
"facility": "Maastricht University Medical Center",
"geoPoint": {
"lat": 50.84833,
"lon": 5.68889
},
"state": null
},
{
"city": "Roermond",
"country": "Netherlands",
"facility": "Laurentius Hospital Roermond",
"geoPoint": {
"lat": 51.19417,
"lon": 5.9875
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Local recurrence",
"timeFrame": "2 and 5 years"
}
],
"secondary": [
{
"description": null,
"measure": "Overall survival",
"timeFrame": "2 and 5 years"
},
{
"description": null,
"measure": "Disease-free survival",
"timeFrame": "2 and 5 years"
},
{
"description": null,
"measure": "Distant metastasis-free survival",
"timeFrame": "2 and 5 years"
},
{
"description": null,
"measure": "Quality of life",
"timeFrame": "6 weeks to 1 year"
},
{
"description": null,
"measure": "Compliance",
"timeFrame": "2 and 5 years"
},
{
"description": null,
"measure": "Percentage of patients that chooses the minimal invasive strategies over standard surgery",
"timeFrame": "2-5 years"
}
]
} | [
{
"affiliation": "Maastricht University Medical Center, Maastricht, The Netherlands",
"name": "Geerard L Beets, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "22067400", "type": "RESULT", "citation": "Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7."}, {"pmid": "33725387", "type": "DERIVED", "citation": "Haak HE, Zmuc J, Lambregts DMJ, Beets-Tan RGH, Melenhorst J, Beets GL, Maas M; Dutch Watch-and-Wait Consortium. The evaluation of follow-up strategies of watch-and-wait patients with a complete response after neoadjuvant therapy in rectal cancer. Colorectal Dis. 2021 Jul;23(7):1785-1792. doi: 10.1111/codi.15636. Epub 2021 Apr 2."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Neoplasms by Site"
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"term": "Neoplasms"
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"term": "Intestinal Diseases"
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"id": "M14846",
"name": "Rectal Neoplasms",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17890",
"name": "Colorectal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10448",
"name": "Intestinal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8886",
"name": "Gastrointestinal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7256",
"name": "Digestive System Neoplasms",
"relevance": "LOW"
},
{
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"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10444",
"name": "Intestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14844",
"name": "Rectal Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D012004",
"term": "Rectal Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D012004",
"term": "Rectal Neoplasms"
}
],
"interventions": null
} |
NCT04484766 | null | Preeclampsia Associated Vascular Aging | Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy | PAVA | OBSERVATIONAL | UNKNOWN | 2020-04-15T00:00:00 | null | 2021-12-10T00:00:00 | 2023-06-30T00:00:00 | null | 120 | 18 | null | FEMALE | false | To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment | The clinical observation that women with pre-eclampsia have a high risk of early onset cardiovascular disease with increased disease-associated mortality has led to the hypothesis that the endothelial status of these women is characterized by early onset of aging. We want to investigate the relationship between endothelial aging and pregnancy disorders such as pre-eclampsia, which are dominated by endothelial dysfunction. Do endothelial changes precede pregnancy and cause pre-eclampsia and later accelerated cardiovascular aging, or does pre-eclampsia trigger premature endothelial aging in affected individuals for the first time? The aim of this study is to investigate the cardiovascular health of women 10 to 20 years after pre-eclampsia and to compare it with that of women with uneventful pregnancies. In addition, the potential long-term endothelial protective effect of the NO-donor pentaerithrityltetranitrate (PETN) is investigated.
This in vivo study will be extended in vitro by the analysis of senescence induction in endothelial cells after pre-eclampsia associated stress. Additionally, the potential protective effect of PETN on stress-induced senescence will be evaluated.
The ultimate goal is to establish a prospective long-term study on the effect of PETN on vascular health in women with pre-eclampsia to assess whether treatment of endothelial dysfunction during pregnancy could reduce endothelial aging and thus premature cardiovascular morbidity and mortality in millions of women. | Inclusion Criteria:
* Participants of the PETN pilot study from 2002-2008
* controls: uneventful pregnancies from 2002-2008
* Patients with pre-eclampsia with PETN treatment 10-20 years ago
* Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago
* Written Informed Consent
* Singleton pregnancy
Exclusion criteria:
* Patients who refuse to participate in the study
* Impossibility of the outpatient presentation | Jena University Hospital | OTHER | {
"id": "2019-1498",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-07-20T00:00:00 | {
"date": "2023-04-14",
"type": "ACTUAL"
} | {
"date": "2020-07-24",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with pre-eclampsia 10 to 20 years ago. The patients are matched with the next consenting patient who gave birth without pregnancy complications. Only singleton pregnancies born between the 24th and 42nd week of pregnancy are considered.
Patients with and without PETN treatment are recruited from the patients who participated in the PETN pilot study from 2002 to 2008. In addition, patients are recruited who received PETN treatment as a personalised therapy trial. These are matched by patients without treatment. The matching includes the indication for treatment, the week of pregnancy at diagnosis and the percentiles of fetal growth | NON_PROBABILITY_SAMPLE | false | {
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"timePerspective": "PROSPECTIVE"
} | [
"Pre-Eclampsia"
] | null | null | [
{
"city": "Jena",
"country": "Germany",
"facility": "Universitätsklinikum Jena",
"geoPoint": {
"lat": 50.92878,
"lon": 11.5899
},
"state": "Thüringen"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "vascular health as combined outcome",
"timeFrame": "1 day 10-20 years after pregnancy"
},
{
"description": null,
"measure": "Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN",
"timeFrame": "1 day 10-20 years after pregnancy"
},
{
"description": null,
"measure": "Endothelial cell senescence using senescence characterization of young and treated HUVEC cells",
"timeFrame": "1 day 10-20 years after pregnancy"
}
],
"secondary": null
} | [
{
"affiliation": "Klinik für Geburtsmedizin",
"name": "Anna Multhaup, Dr. med.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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},
{
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"term": "Pregnancy Complications"
},
{
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"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
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}
],
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"name": "Heart and Blood Diseases"
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"id": "T2019",
"name": "Eclampsia",
"relevance": "HIGH"
}
],
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{
"id": "D011225",
"term": "Pre-Eclampsia"
},
{
"id": "D004461",
"term": "Eclampsia"
}
]
} | null | {
"conditions": [
{
"id": "D011225",
"term": "Pre-Eclampsia"
},
{
"id": "D004461",
"term": "Eclampsia"
}
],
"interventions": null
} |
NCT01641666 | null | Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599) | An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam | None | INTERVENTIONAL | WITHDRAWN | 2012-07-11T00:00:00 | null | null | null | [
"PHASE3"
] | 0 | 18 | null | ALL | false | This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam. | Each participant will participate in the trial for a maximum of 80 weeks from the time the participant signs the Informed Consent Form (ICF) through the final contact. After a Screening phase of approximately 4 to 8 weeks, each participant will receive treatment for approximately 36-48 weeks depending on response at Treatment Week 8.
A 4-week lead-in period with PEG2b plus RBV will be followed by 32 weeks boceprevir plus PEG2b/RBV. At treatment Week 36 participants will be assigned to the following treatments depending on the virologic response at Week 8 and cirrhotic status:
1. For non-cirrhotic participants with undetectable hepatitis C virus (HCV)-RNA on Week 8, all treatment will be discontinued at Week 36.
2. For non-cirrhotic participants with detectable HCV-RNA on Week 8, only boceprevir treatment will be discontinued at Week 36 and PEG2b and RBV treatment will continue to Week 48.
3. For cirrhotic participants, the boceprevir plus PEG2b/RBV treatment will continue to Week 48.
The study has a futility rule at Week 12 at which point all subjects with detectable HCV-RNA levels will be discontinued. All participants will have a post-treatment follow-up period of at least 24 weeks. | Inclusion Criteria:
* Weight ≥ 40 kg to ≤ 125 kg
* Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
* Must have documented Chronic Hepatitis C Genotype 1 infection
* Must have failed prior treatment with interferon plus ribavirin
* Must have completed treatment with interferon plus ribavirin for at least 12 weeks
* Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic
* Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit
Exclusion Criteria:
* Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
* Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
* Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
* Treatment with any investigational drug within 30 days prior to the Screening visit
* Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
* Participation in any investigational trial within 30 days of the Screening visit
* Evidence of decompensated liver disease
* Child Pugh score \> 6 (Class B and C)
* Diabetic and/or hypertensive participants with clinically significant ocular examination findings
* Pre-existing psychiatric conditions
* Clinical diagnosis of substance abuse
* Active or suspected malignancy
* Pregnant or nursing | Merck Sharp & Dohme LLC | INDUSTRY | {
"id": "P08599",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2012-07-13T00:00:00 | {
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"type": "ESTIMATED"
} | {
"date": "2012-07-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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"description": null,
"measure": "Percentage of Participants Achieving Sustained Virologic Response (SVR)",
"timeFrame": "Follow-Up Week 24"
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{
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"measure": "Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period",
"timeFrame": "Treatment Week 1 to Treatment Week 24"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
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"term": "Digestive System Diseases"
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{
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"term": "Hepatitis, Viral, Human"
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{
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"term": "Virus Diseases"
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{
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"term": "Infections"
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{
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{
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},
{
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{
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"term": "Communicable Diseases"
},
{
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"term": "Flaviviridae Infections"
},
{
"id": "D002908",
"term": "Chronic Disease"
},
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
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"abbrev": "BC01",
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"abbrev": "BC06",
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"name": "All Conditions"
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],
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},
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"id": "M9591",
"name": "Hepatitis",
"relevance": "HIGH"
},
{
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"id": "M9611",
"name": "Hepatitis C",
"relevance": "HIGH"
},
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"id": "M21613",
"name": "Hepatitis C, Chronic",
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
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},
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": [
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"id": "D006506",
"term": "Hepatitis A"
},
{
"id": "D006526",
"term": "Hepatitis C"
},
{
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"term": "Hepatitis C, Chronic"
},
{
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"term": "Hepatitis"
},
{
"id": "D006521",
"term": "Hepatitis, Chronic"
}
]
} | {
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{
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},
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],
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],
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"relevance": "LOW"
},
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"relevance": "LOW"
}
],
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"term": "Ribavirin"
},
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"term": "Peginterferon alfa-2b"
},
{
"id": "D016898",
"term": "Interferon-alpha"
}
]
} | {
"conditions": [
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"term": "Hepatitis A"
},
{
"id": "D006526",
"term": "Hepatitis C"
},
{
"id": "D019698",
"term": "Hepatitis C, Chronic"
},
{
"id": "D006505",
"term": "Hepatitis"
},
{
"id": "D006521",
"term": "Hepatitis, Chronic"
}
],
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"term": "Peginterferon alfa-2b"
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{
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]
} |
NCT04171466 | null | Metagenomic and Metabolomic Reconstitution of Gut Microbiota After Broad Spectrum Antibiotic Therapy | A Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy of a Multi-strain Synbiotic (SH-DS01) to Restore Gut Barrier Integrity and Gut Microbiota Composition After Antibiotic Administration. | None | INTERVENTIONAL | COMPLETED | 2019-11-19T00:00:00 | null | 2022-09-07T00:00:00 | 2022-09-07T00:00:00 | [
"NA"
] | 46 | 18 | 55 | ALL | true | In the United States, healthcare providers prescribe over 270 million antibiotic prescriptions each year. While antibiotics have transformed medicine and methods of treating life-threatening bacterial infection, broad spectrum antibiotics also induce disruption of resident gut microbial communities by altering both composition and function. This disruption of microbial community dynamics has been demonstrated at the taxonomic level, yet the extent of functional disruptions to microbial metabolic output and host cells remains understudied in humans. This study explores the impact of a broad spectrum antibiotic cocktail on microbial communities throughout the gastrointestinal tract, and the impact of a defined, multi-strain consortia of probiotic organisms following antibiotic exposure. | null | Inclusion Criteria:
1. Males \& Females 18-55 years of age, inclusive
2. BMI of 18.5 - 29.9 kg/m2, inclusive
3. Waist circumference \< 102 cm in males or \< 88 cm in females
4. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.
5. Healthy as determined by laboratory results, medical history, and physical exam by QI
6. Agrees to abstain from use of fermented foods or beverages with live bacteria or products containing active cultures for the duration of the study
7. Agrees to avoid alcoholic beverages and drugs containing alcohol during antibiotic treatment period and for at least one day after (days 0-8)
8. Agrees to avoid high caffeine intake (no more than 1 cup of coffee or 300 mg of caffeine/day) during antibiotic treatment period of the study (days 0-7)
9. Agrees to refrain from intake of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) during antibiotic treatment period of the study (days 0-7) and 72 hours prior to prior to lactulose and mannitol test
10. Agrees to refrain from using drugs and supplements containing aluminum, magnesium, sorbitol and/or mannitol 72 hours prior to lactulose and mannitol test.
11. Agrees to comply with all study procedures
12. Agrees to maintain current level of physical activity throughout the study
Exclusion Criteria:
1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial
2. Allergy or sensitivity to antibiotics (Ciprofloxacin, Metronidazole), Lactulose or Mannitol, or investigational product's active or inactive ingredients
3. Use of antibiotics or antifungals within three months prior to enrollment, including topical antibiotics or antifungals.
4. Clinically significant abnormal laboratory results at screening as assessed by the QI
5. Use of PPIs and H2-antagonists
6. Use of tobacco products
7. Type I or type II diabetes mellitus or treatment with anti-diabetic medication
8. Unstable metabolic diseases or chronic diseases as assessed by the QI
9. Self-reported current or pre-existing thyroid condition.
10. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
11. Current or history of any significant diseases of the gastrointestinal tract that may impact study outcomes as assessed by the QI
12. Significant cardiovascular event in the past 6 months. If the event occurred greater that 6 months ago and if on stable medication may be included after assessment by the QI on a case by case basis
13. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
14. Self-reported an autoimmune disease or an immune-compromised state
15. Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
16. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
17. Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
18. Self-reported blood/bleeding disorder. To be confirmed by the QI on a case by case basis
19. Cancer in the five years prior to enrollment, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable following case by case assessment by QI.
20. Clinically significant illness in the four weeks prior to randomization
21. Current use of prescribed medications listed in Section 7.3.1
22. Current use of over-the-counter medications, supplements, foods and/or drinks listed in Section 7.3.2
23. Current use of any probiotic, prebiotic and symbiotic product unless willing to undergo a 4-week washout and abstain from consuming such products during the study.
24. Medical use of cannabinoid products
25. Use of any cannabinoid products (including synthetics) within one month of study entry
26. Alcohol or drug abuse within the last 12 months
27. High alcohol intake (\>2 per day or a total of \>10 standard drinks per week)
28. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
29. Participation in other clinical research trials 30 days prior to screening
30. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant | Seed Health | INDUSTRY | {
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Probiotic supplementation restores normal microbiota composition and function in antibiotic-treated and in caesarean-born infants. Microbiome. 2018 Oct 16;6(1):182. doi: 10.1186/s40168-018-0567-4."}, {"pmid": "30265691", "type": "BACKGROUND", "citation": "De Wolfe TJ, Eggers S, Barker AK, Kates AE, Dill-McFarland KA, Suen G, Safdar N. Oral probiotic combination of Lactobacillus and Bifidobacterium alters the gastrointestinal microbiota during antibiotic treatment for Clostridium difficile infection. PLoS One. 2018 Sep 28;13(9):e0204253. doi: 10.1371/journal.pone.0204253. eCollection 2018."}, {"pmid": "27159972", "type": "BACKGROUND", "citation": "Kristensen NB, Bryrup T, Allin KH, Nielsen T, Hansen TH, Pedersen O. Alterations in fecal microbiota composition by probiotic supplementation in healthy adults: a systematic review of randomized controlled trials. Genome Med. 2016 May 10;8(1):52. doi: 10.1186/s13073-016-0300-5."}, {"pmid": "23520586", "type": "BACKGROUND", "citation": "Rodgers B, Kirley K, Mounsey A. PURLs: prescribing an antibiotic? Pair it with probiotics. J Fam Pract. 2013 Mar;62(3):148-50."}, {"pmid": "30139941", "type": "BACKGROUND", "citation": "Nagpal R, Wang S, Ahmadi S, Hayes J, Gagliano J, Subashchandrabose S, Kitzman DW, Becton T, Read R, Yadav H. Human-origin probiotic cocktail increases short-chain fatty acid production via modulation of mice and human gut microbiome. Sci Rep. 2018 Aug 23;8(1):12649. doi: 10.1038/s41598-018-30114-4."}, {"pmid": "23828891", "type": "BACKGROUND", "citation": "Smith PM, Howitt MR, Panikov N, Michaud M, Gallini CA, Bohlooly-Y M, Glickman JN, Garrett WS. The microbial metabolites, short-chain fatty acids, regulate colonic Treg cell homeostasis. Science. 2013 Aug 2;341(6145):569-73. doi: 10.1126/science.1241165. Epub 2013 Jul 4."}, {"pmid": "19938193", "type": "BACKGROUND", "citation": "Cox MA, Jackson J, Stanton M, Rojas-Triana A, Bober L, Laverty M, Yang X, Zhu F, Liu J, Wang S, Monsma F, Vassileva G, Maguire M, Gustafson E, Bayne M, Chou CC, Lundell D, Jenh CH. Short-chain fatty acids act as antiinflammatory mediators by regulating prostaglandin E(2) and cytokines. World J Gastroenterol. 2009 Nov 28;15(44):5549-57. doi: 10.3748/wjg.15.5549."}, {"pmid": "29095058", "type": "BACKGROUND", "citation": "Ho L, Ono K, Tsuji M, Mazzola P, Singh R, Pasinetti GM. Protective roles of intestinal microbiota derived short chain fatty acids in Alzheimer's disease-type beta-amyloid neuropathological mechanisms. Expert Rev Neurother. 2018 Jan;18(1):83-90. doi: 10.1080/14737175.2018.1400909. Epub 2017 Nov 14."}, {"pmid": "16530515", "type": "BACKGROUND", "citation": "Resta-Lenert S, Barrett KE. Probiotics and commensals reverse TNF-alpha- and IFN-gamma-induced dysfunction in human intestinal epithelial cells. Gastroenterology. 2006 Mar;130(3):731-46. doi: 10.1053/j.gastro.2005.12.015."}, {"pmid": "20823239", "type": "BACKGROUND", "citation": "van Baarlen P, Troost F, van der Meer C, Hooiveld G, Boekschoten M, Brummer RJ, Kleerebezem M. Human mucosal in vivo transcriptome responses to three lactobacilli indicate how probiotics may modulate human cellular pathways. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4562-9. doi: 10.1073/pnas.1000079107. Epub 2010 Sep 7."}, {"pmid": "30193113", "type": "BACKGROUND", "citation": "Suez J, Zmora N, Zilberman-Schapira G, Mor U, Dori-Bachash M, Bashiardes S, Zur M, Regev-Lehavi D, Ben-Zeev Brik R, Federici S, Horn M, Cohen Y, Moor AE, Zeevi D, Korem T, Kotler E, Harmelin A, Itzkovitz S, Maharshak N, Shibolet O, Pevsner-Fischer M, Shapiro H, Sharon I, Halpern Z, Segal E, Elinav E. Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT. Cell. 2018 Sep 6;174(6):1406-1423.e16. doi: 10.1016/j.cell.2018.08.047."}, {"pmid": "30182044", "type": "BACKGROUND", "citation": "Spiller RC. Hidden Dangers of Antibiotic Use: Increased Gut Permeability Mediated by Increased Pancreatic Proteases Reaching the Colon. Cell Mol Gastroenterol Hepatol. 2018 Jul 11;6(3):347-348.e1. doi: 10.1016/j.jcmgh.2018.06.005. eCollection 2018. No abstract available."}] | {"versionHolder": "2025-06-18"} | {
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NCT04730466 | null | Cognitive Rehabilitation as a Balance Rehabilitation Strategy in Patients With Parkinson's Disease | Validation of Cognitive Rehabilitation as a Balance Rehabilitation Strategy in Patients With Parkinson's Disease: Study Protocol for a Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2021-01-25T00:00:00 | null | 2022-06-30T00:00:00 | 2022-07-22T00:00:00 | [
"NA"
] | 46 | 18 | null | ALL | false | Parkinson's disease (PD) is the second most common neurodegenerative disorder. PD is characterized by motor symptoms, such as bradykinesia, tremor, and rigidity. Although balance impairment is characteristic of advanced stages, it can be present with less intensity since the beginning of the disease. Approximately 60% of PD patients fall once a year and 40% recurrently These falls may be correlated with the inability to achieve compensatory movements to regain balance when their center of gravity tends to swing outside their range of stability, which is reduced in this disease. On the other hand, cognitive symptoms affect up to 20% of patients with PD in early stages and can even precede the onset of motor symptoms. There are cognitive requirements for balance and can be challenged when attention is diverted or reduced, linking a worse balance and a higher probability of falls with a slower cognitive processing speed and attentional problems. Cognitive rehabilitation of attention and processing speed can lead to an improvement in postural stability in patients with Parkinson's. The investigators present a parallel and controlled Randomized Clinical Trial (RCT) to assess the impact on balance of a protocol based on cognitive rehabilitation focused on sustained attention through the NeuronUP platform (Neuronup SI, La Rioja, España) in patients with PD. This therapy opens the possibility of new rehabilitation strategies for prevention of falls in PD, reducing morbidity and saving costs to the health system. | Parkinson's disease (PD) is the second most common neurodegenerative disorder. This disease is characterized by motor symptoms, such as bradykinesia, tremor, and rigidity. Non-motor symptoms such as cognitive impairment, anosmia, sleep disorders, or depression are also part of the disease, and although their prevalence is very high, non-motor symptomsare often underdiagnosed.
One of the cognitive characteristics in PD is the slowness in the processing of information, which includes deficits in processing speed and attention, cognitive inflexibility, and forgetfulness. These symptoms may appear from the initial stages of the disease.
Approximately 60% of PD patients fall once a year and 40% do so regularly. These falls may be correlated with the inability to achieve compensatory movements to regain balance when their center of gravity generally oscillates outside their limits of stability (LOS), which is reduced in this disease. Some authors point out that reaction times and processing speed may be a marker of postural instability since a reduced speed is associated with difficulty in making turns. This is in line with Pantall's findings, indicating that cognitive function and postural control normally progressively worsen with disease progression.
The relationship between cognitive impairment and postural instability in PD patients may be specific for tasks that assess the dorsolateral prefrontal cortex and its frontal-subcortical connections. The main cognitive functions whose affectation would influence a worse balance and gait performance would be attention and executive functions. Varalta et al specified that balance is related to executive functions and attention, while functional mobility is more related to cognitive impairment, verbal fluency, and attentional capacity.
Some authors point out that within the executive functions the component with the greatest weight in this relationship would be the inhibitory control. Dual-task performance has also been established as a good indicator of falls in patients with early-stage PD and no previous history of falls. The studies that carried out a one and a half years follow-up of the participants concluded that the deterioration of executive functions acts as a predictor of future falls in patients with PD.
Cognitive rehabilitation through neurorehabilitation platforms and neuropsychological rehabilitation in patients with Parkinson's disease has shown to be effective in improving processing speed, attention, and executive functions.
Although the relationship between cognitive deficits and postural stability seems to be demonstrated, the investigators have not found studies that, through cognitive rehabilitation, seek a stability improvement.
The investigators working hypothesis is that the group that receives rehabilitation of the speed of information processing and sustained attention will improve their postural stability compared to the group that does not undergo any therapy. | Inclusion Criteria:
* Idiopathic Parkinson's disease (diagnosed according to the UK Parkinson´s Disease Society Brain Bank criteria).
* Stage \<III Hoehn-Yahr with no obvious motor fluctuations.
Exclusion Criteria:
* Visual-perceptual difficulties.
* Peripheral sensory disturbances due to polyneuropathy.
* Cerebellar alterations.
* Severe cognitive impairment (MoCA \<24).
* Moderate or severe active depression (BDI\> 14).
* Dependence (mRS\> 3).
* Dopaminergic medication changes in the last 30 days.
* Structural changes MRI Severe comorbidity (cancer, severe COPD ...).
* Atypicality data for idiopathic PD. | Universidad Francisco de Vitoria | OTHER | {
"id": "Balanc-EP",
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} | Unknown | {
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} | 2021-01-25T00:00:00 | {
"date": "2023-04-21",
"type": "ACTUAL"
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"date": "2021-01-29",
"type": "ACTUAL"
} | [
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study will be a parallel, randomized and controlled experimental study. The patients included in the sample will be randomly distributed into two groups: Cognitive rehabilitation (experimental) and No therapy (control). The randomization of the sample will be carried out through the website: http://www.randomization.com/.",
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] | ["Parkinson Disease", "Balance", "Information Processing Speed"] | null | [
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"meshes": [
{
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"term": "Parkinson Disease"
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"conditions": [
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"term": "Parkinson Disease"
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"interventions": null
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NCT05435066 | null | Development and Validation of Harbinger Health Test for Early Cancer Detection | Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test | CORE-HH | OBSERVATIONAL | ACTIVE_NOT_RECRUITING | 2022-06-14T00:00:00 | null | null | 2026-07-03T00:00:00 | null | 10,000 | 20 | 79 | ALL | true | This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection. | null | Inclusion Criteria:
* Inclusion Criteria - Both arms
Subjects must meet the following criteria in order to be included in the research study:
* Written or electronic informed consent
* Subject is 20 - 79 years of age at the time of signature of the informed consent form (ICF)
* Male or female subjects
Inclusion Criteria Arm 1 - Cancer Subjects Arm 1 subjects enrolled in the study must meet the following inclusion criteria.
* A confirmed diagnosis or high suspicion of cancer (stage I to IV solid cancer or hematologic cancer) by imaging within 180 days prior to enrollment; not to include myelodysplastic and myeloproliferative syndromes
* Subject's cancer diagnosis is based upon assessment of a pathological specimen or high suspicion of cancer by imaging
* Subject's cancer is treatment-naïve
Inclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts)
Arm 2 subjects enrolled in the study must meet the following inclusion criteria:
* Subject's health permits participation and the subject is not suspected of having cancer based on provider assessment.
* The subject was not diagnosed with cancer or received cancer treatment within the last 5 years (persons with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted).
Part 1B Only :
- Subject has no known current cancer and has 1 of the follow conditions:
o An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional serrated adenoma ≥10mm
Exclusion Criteria:
Subject self-reporting OR available medical records at the time of screening are acceptable for assessment of all exclusion criteria.
Exclusion Criteria - Both arms
Subjects who meet any of the following criteria will be excluded from study entry:
* Subject is suffering from any febrile illness defined as a temperature \>101.5°F within the last 48 hrs.
* Subject is pregnant (by self-report of pregnancy status).
Exclusion Criteria Arm 1 - Cancer Subjects
Subjects who meet any of the following criteria will be excluded from study entry:
* Subject with a prior history of cancer within 5 years will not be allowed to participate in the study
* More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breast cancer and newly diagnosed lung cancer would be excluded; subject with prior (\>5 years ago) treated breast cancer without recurrence and presenting with newly diagnosed lung cancer would be eligible).
* Subject is currently receiving, or has in the past received, any of the following definitive therapies to treat their current cancer:
* Surgical treatment, surgical removal, or surgical management of the cancer beyond that required to establish the cancer diagnosis. Surgical or biopsy procedures that remove more tissue than required to establish the cancer diagnosis, or that were performed to manage symptoms or initiate cancer treatment prior to blood sample collection will be considered 'definitive' and are not permissible regardless of the residual tumor mass remaining in the subject.
* Chemotherapy (local, regional, or systemic) including chemoembolization targeted therapy;
* Immunotherapy including cancer vaccines;
* Hormone therapy; or
* Radiation therapy (a single dose of palliative radiation prior to study start is allowed).
* The subject is a recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Subject who has undergone a bowel preparation for a gastrointestinal malignancy within 3 days of an anticipated blood draw.
Exclusion Criteria Arm 2 - Non-cancer Subjects
Subjects who meet any of the following criteria will be excluded from study entry:
- The subject is the recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. | Harbinger Health | INDUSTRY | {
"id": "HH-PRT-0001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-06-27T00:00:00 | {
"date": "2025-01-17",
"type": "ACTUAL"
} | {
"date": "2022-06-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Newly diagnosed cancer subjects and non-cancer subjects | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Cancer"
] | ["cancer", "early detection", "blood-based cancer screening", "cfDNA", "cancer diagnosis"] | null | [
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{
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NCT01338766 | null | Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression | Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE) | STRiDE | INTERVENTIONAL | UNKNOWN | 2011-04-18T00:00:00 | null | null | null | [
"NA"
] | 100 | 18 | null | ALL | false | The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate. | This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical study enrolling 100 subjects following a pre-specified protocol with no site enrolling more than 30 subjects. All eligible subjects providing written informed consent and meeting study eligibility criteria will receive a facet preserving decompression using the FDA cleared iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using a precision estimate assuming a 55% positive response rate.
In addition to baseline characteristics and procedural parameters, subject outcomes will be assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase with annual follow-up contact through 5 years to evaluate retreatment for the original indication at these late time points. | Inclusion Criteria:
1. Adult (\> 18 years of age)
2. Leg/buttock pain, with or without back pain
3. Grade 1 degenerative spondylolisthesis (≤25% slippage)
4. NRS pain score for leg pain of 4/10 or greater
5. ODI score of 30/100 or greater
6. Failed non-operative medical management for a period of at least 6 months
7. Confirmed clinical diagnosis of lumbar spinal stenosis
8. Confirmation of central and/or lateral recess stenosis with or without foraminal stenosis, at one level or at two adjacent levels from L2-S1, with concordant symptoms. Subjects with central and/or lateral recess stenosis and spondylolisthesis at one level, may have symptomatic central, lateral recess or foraminal stenosis treated at one adjacent level. A "below-the pedicle" pass to decompress a third segment can be completed provided laminotomies are performed at no more than 2 levels. Subjects that, following an intraoperative decision, have a 3-level laminotomy and decompression will not be considered enrolled. Confirmation of spinal stenosis is shown on MRI or CT scan with evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
9. Ability to give voluntary, written informed consent to participate in this clinical investigation and ability to participate in follow up examinations and complete patient questionnaires
Exclusion Criteria:
1. Back pain only
2. Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
3. History of pathologic fractures of the vertebrae
4. Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
5. Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
6. Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
7. Prior surgery of the lumbar spine
8. Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
9. Spondylolysis (pars fracture) at any level in the lumbar spine
10. Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
11. Vascular claudication in the lower extremities
12. Cauda equina syndrome
13. Evidence of active (systemic or local) infection at time of surgery
14. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
15. Tumor in the spine or a malignant tumor except for basal cell carcinoma.
16. Prisoner or transient
17. Any significant psychological disturbance past or present, psychotic or neurotic that could impair the consent process or ability to complete subject self-report questionnaires
18. Involved in pending litigation of the spine or worker's compensation related to the back
19. Inability to communicate clearly in the English language
20. Morbid obesity (BMI \> 40)
21. Pregnant, nursing, or planning on becoming pregnant.
22. History of narcotic abuse
23. Current involvement in another drug or device clinical trial
24. Uncontrolled diabetes
25. Irreversible coagulopathy or bleeding disorder (patients on anticoagulant therapy may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.)
26. Plans to relocate in the next 2 years
27. Subject unwilling to undergo a blood transfusion, if necessary | Baxano Surgical, Inc. | INDUSTRY | {
"id": "CP-1967",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-04-19T00:00:00 | {
"date": "2014-04-23",
"type": "ESTIMATED"
} | {
"date": "2011-04-20",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
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"Spondylolisthesis",
"Lumbar Spinal Stenosis"
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{
"affiliation": "Neurological Surgery Medical Associates",
"name": "Sylvain Palmer, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT04640766 | null | Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults | Feasibility Open Label Study Evaluating the Use of Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults | None | INTERVENTIONAL | COMPLETED | 2020-11-18T00:00:00 | null | 2022-10-18T00:00:00 | 2022-10-18T00:00:00 | [
"NA"
] | 18 | 18 | 60 | ALL | false | This is a single-arm, open-label feasibility study. Participants will be assigned and will undergo a novel neurofeedback intervention, targeting down-regulation of deep limbic structures, specifically the amygdalae. Participants will complete 12 neurofeedback sessions delivered twice weekly over 6 consecutive weeks. The intervention will be delivered via the PRISM platform. | The objectives include: 1)Training the NYU team on the electric finger print electroencephalography neurofeedback (EFP-EEG-NF) technology and provide them with hands-on experience; 2) Assessing participants' ability to learn the feedback paradigm (i.e. control the EFP-EEG-NF signal; time to achieve learning; assess learning curves); 3) Exploring preliminary results assessing target symptoms (e.g. AISRS and BRIEF-A). | Inclusion Criteria:
* Adults ages 18-60 years, inclusive at the time of consent
* Able to provide signed informed consent
* Any gender
* Subjects with a current primary DSM-5 diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, or combined presentations) as confirmed by the ACDS Version 1.2.
* Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS score of ≥ 28 at screening. Subjects who are receiving pharmacological treatment for ADHD at screening must have a minimum AISRS score of ≥ 22 at screening
* Not requiring treatment for any comorbid psychiatric condition for at least 2 months
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal hearing
* No intention of changing medication or psychotherapy for the duration of the study at the time of recruitment
Exclusion Criteria:
* Concurrent substance abuse and/or history of substance use within 6 months
* Use of any prescribed benzodiazepine
* Lifetime bipolar disorder, psychotic disorder, autism, intellectual disability. Comorbid mood and anxiety disorders determined by the MINI will be permitted if they are not the primary focus of clinical attention
* Active suicidality within past year, or history of suicide attempt in past 2 years
* Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
* Any unstable medical or neurological condition
* Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \[TBI\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
* Any psychotropic medication
* Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \[CPT\], Prolonged Exposure \[PE\], Eye Movement Desensitization and Reprocessing \[EMDR\]); continuation of established maintenance supportive therapy will be permitted
* Significant hearing loss or severe sensory impairment
* Enrollment in another research study testing an experimental, clinical, or behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months | NYU Langone Health | OTHER | {
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"measure": "Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)",
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},
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},
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"name": "Lenard Adler, MD",
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"abbrev": "BC10",
"name": "Nervous System Diseases"
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NCT00530166 | null | Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients. | A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma | None | INTERVENTIONAL | TERMINATED | 2007-09-13T00:00:00 | null | null | null | [
"PHASE2"
] | 26 | 18 | 65 | ALL | false | The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma. | Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period. | Inclusion Criteria:
* Medically confirmed diagnosis of persistent asthma
* Able to demonstrate reversibility of at least 12% with albuterol inhalation
* Use of short-acting b-2 agonists for rescue \>= 5 times within 2 weeks prior
* Able to produce an FEV1 between 45 and 85% of predicted
* Willing to perform study procedures for about 14 weeks.
Exclusion Criteria:
* Use of inhaled corticosteroids within 4 weeks
* Use of oral/parenteral corticosteroids within 8 weeks
* Use of long-acting beta-2 agonists or montelukast within 2 weeks
* History of life-threatening asthma attack within 3 months
* Female of child bearing potential. | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY | {
"id": "CR013087",
"link": null,
"type": null
} | Lack of efficacy following an interim analysis | {
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"nctId": null,
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} | 2007-09-13T00:00:00 | {
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} | {
"date": "2007-09-17",
"type": "ESTIMATED"
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} | [
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NCT00290966 | null | Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer | Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease | None | INTERVENTIONAL | COMPLETED | 2006-02-09T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 610 | 18 | 75 | ALL | false | Phase II:
Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm.
Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups.
Phase III:
Primary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).
Main secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).
Other secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary. | null | Inclusion Criteria:
* Patient's consent form obtained, signed and dated before beginning specific protocol procedures.
* Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
* Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion (e.g. lymph node).
* Performance status Karnofsky index \> 70%.
* Life expectancy of more than 3 months.
* Adequate haematological and biochemistry parameters
* No prior palliative chemotherapy, previous adjuvant (and/or neo-adjuvant) chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant (or neo-adjuvant) therapy and first relapse.
Exclusion Criteria:
* Pregnant or lactating women.
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures.
* Other tumor type than adenocarcinoma (leiomyosarcoma ; lymphoma).
* Any prior palliative chemotherapy. Prior adjuvant (and/or neo-adjuvant) chemotherapy with a first relapse within 12 months from the end of adjuvant (or neo-adjuvant).
* Prior treatment with taxanes. Prior CDDP as adjuvant (and/or neo-adjuvant) chemotherapy with cumulative dose \> 300 mg/m². | Sanofi | INDUSTRY | {
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] | ["docetaxel", "stomach neoplasm"] | null | null | null | null | {
"other": null,
"primary": [
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"measure": "to detect a significant increase in time to progression in favor of docetaxel plus cisplatin and 5-FU compared to cisplatin plus 5-FU. Tumor assessments (assessed with WHO criteria) had to be performed every 8 weeks until progression",
"timeFrame": null
}
],
"secondary": [
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"timeFrame": null
}
]
} | [
{
"affiliation": "MD Anderson Cancer Center, Houston, Texas, US",
"name": "Jaffer Ajani, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "University hospital Gasthuisberg, Leuven, Belgium",
"name": "E. Van Cutsem, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
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NCT04077866 | null | B7-H3 CAR-T for Recurrent or Refractory Glioblastoma | B7-H3-Targeted Chimeric Antigen Receptor (CAR) T Cells in Treating Patients With Recurrent or Refractory Glioblastoma | None | INTERVENTIONAL | RECRUITING | 2019-08-26T00:00:00 | null | 2025-06-01T00:00:00 | 2025-08-01T00:00:00 | [
"PHASE1",
"PHASE2"
] | 40 | 18 | 75 | ALL | false | This is a randomized, parallel-arm, phase I/II study to evaluate the safety and efficacy of B7-H3 CAR-T in between Temozolomide cycles comparing to Temozolomide alone in treating patients with glioblastoma that has come back or does not respond to the standard treatment. The antigen B7-H3 is highly expressed in glioblastoma of a subset of patients. B7-H3 CAR-T, made from isolated patient peripheral blood mononuclear cells, can specifically attack patient glioblastoma cells that expressing B7-H3. | Background
* B7-H3 is expressed in 70% of patients with glioblastoma
* B7-H3 is not expressed in normal tissues especially not in central nervous system. Therefore, it is an attractive GBM target for CAR-T therapy
* The investigators constructed a retroviral vector encoding a chimeric antigen receptor (CAR) targeting B7-H3, which can mediate CAR transfer into patient T cells with high efficiency.
Objectives
* To evaluate the safety and tolerability intratumoral/intracerebroventricular injection of B7-H3 CAR-T when used in between Temozolomide cycles
* To compare the overall survival (OS) and progression-free survival (PFS) of R/R GBM patients treated with B7-H3 CAR-T in between Temozolomide cycles vs Temozolomide alone
* To access the pharmacokinetics and pharmacodynamics of B7-H3 CAR-T in between Temozolomide cycles
Design
* Experimental group: Patients autologous T cells are activated and transduced with retrovirus containing B7-H3 CAR. CAR-T cells are expanded ex vivo and infused back to patients via intratumoral or intracerebroventricular injection through an Ommaya catheter. 3 injections of CAR-T are planned at two different doses with 1-2 weeks intervals. The CAR-T injections occur in between Temozolomide (TMZ) cycles. Temozolomide treatment during the cycles of CAR-T injections will be stopped and resumed next cycle. Patients may receive additional CAR-T cycles at the discretion of the principal investigator and oncologist.
* Control group: Patients will receive regular cycles of Temozolomide treatment with 5 days of treatment and 23 days of interval. | Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative.
* Histologically confirmed diagnosis of World Health Organization (WHO) classification grade IV glioblastoma (GBM).
* Clinical Pathology confirms B7-H3 positive tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score \>= 50).
* Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
* Suitable for the surgery of the placement of the Ommaya catheter.
* Eastern Cooperative Oncology Group (ECOG) =0 or 1 (need to be confirmed before intratumoral or intracerebroventricular injection)
* \>= 8 weeks after completion of front-line radiation therapy
* \>= 6 weeks after completion of nitrourea chemotherapy
* \>= 14 days after completion of Temozolomide or other chemotherapy
* 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline (4 weeks for Bevacizumab). Patients with other chronic AEs are in the investigator's judgement
* Blood cell count： White blood count (WBC) \>= 2000/μL；Neutrophil count \>= 1500/μL；Platelets \>= 100 x 103/μL；Hemoglobin \>= 9.0 g/dL
* Serum Creatinine \<= 1.5×ULN or Creatinine Clearance Rate (Cockcroft and Gault) \> 30 mL/min/1.73 m2
* Alanine Transaminase (ALT) \<= 5×ULN and total bilirubin \< 2.0mg/dL
* Lung function: Oxygen (O2) saturation \>= 92% on room air and \< CTCAE grade 1 dyspnea
* Heart function: Left ventricular ejection fraction (LVEF) \>= 40% by multigated acquisition (MUGA) scan or echocardiogram
* Normal coagulation function: prothrombin time (PT)，activated partial thromboplastin time (APTT) and international normalized ratio (INR)
* Good blood vessel condition for leukapheresis
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity within one year after B7-H3 CAR-T infusion
Exclusion Criteria:
* Other active malignancy in the past 2 years except non-melanoma skin cancer, completely surgical removed low grade tumor, post-therapeutic limited-stage prostate cancer, biopsy confirmed in situ cervical carcinoma, PAP test confirmed squamous intraepithelial lesions
* Participant is undergoing or planning to take other anti-tumor therapies
* Participant is systematic steroid-dependent, or is expecting to be treated with systematic steroid
* Active immunodeficiency virus (HIV) or hepatitis B or hepatitis C virus infection
* Active infection from fungi, bacteria and/or viruses
* Known history of the following cardiac diseases in the past 6 months: New York Heart Association (NYHA) defined grade III or IV heart failure, cardiac angioplasty, myocardial infarction, unstable angina and other clinically significant heart diseases
* Known history and/or clinically evident central nerve system diseases: seizure, epileptic seizure, aphasia, paralysis, stroke, severe brain damage, dementia, Parkinson's Disease, cerebellar diseases, organic brain syndrome and psychiatric disorders
* Autoimmune diseases
* Pregnant or breastfeeding females
* Therapeutic doses of corticosteroid within 7 days before leukapheresis or 72 hours before B7-H3 CAR-T infusion
* Cytotoxic chemotherapy without lymphocytotoxicity within 1 week before leukapheresis except that the treatment has been stopped for more than 3 half-lives of the drug
* Lymphocytotoxic chemotherapy (cyclophosphamide, Ifosfamide and bendamustine) within 2 weeks before leukapheresis
* Other clinical trials drugs within 4 weeks before leukapheresis except that the drug has no effect or the disease has progressed, and the treatment has been stopped for more than 3 half-lives of the drug
* Radiotherapy within 6 weeks before leukapheresis
* Prior trials of CAR-T or other cell therapy
* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) | Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER | {
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},
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},
{
"description": null,
"measure": "Disease response (ORR, CR, PR, DOR)",
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}
]
} | null | [{"pmid": "35468680", "type": "DERIVED", "citation": "Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121."}] | {"versionHolder": "2025-06-18"} | {
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NCT00206466 | null | Biologic Correlative Taxotere/AC | A Randomized Multicenter Trial of Neoadjuvant Taxotere and Adriamycin/Cytoxan(AC): A Biologic Correlative Study | TAX/AC | INTERVENTIONAL | COMPLETED | 2005-09-13T00:00:00 | null | null | null | [
"PHASE2"
] | 70 | 18 | null | FEMALE | false | We are asking you to take part in a research study of biomarkers (characteristics or traits of the genes inside cancer cells). We want to learn if these biomarkers could help us learn how well your breast cancer may respond (improve) to chemotherapy (drugs to treat cancer). | Breast cancer and systemic chemotherapy: Systemic chemotherapy for operable breast cancer significantly decreases the risk of relapse and death. However, it is not possible to identify those patients at the outset who are likely to respond to adjuvant treatment and which type of treatment should be used. Adjuvant treatment given before surgery (neoadjuvant therapy) has a number of advantages in breast cancer, including a reduction in the requirement for mastectomy. Access to the primary tumor during early treatment allows for in vivo testing for predictive markers obtained by core biopsies that occur with successful treatment.
Predictive markers in breast cancer: Prognostic factors like tumor size and nodal involvement are important indicators for breast cancer survival but have not been shown to be predictive of sensitivity to chemotherapy. With endocrine therapy, the prime example of a predictive marker is estrogen receptor (ER) expression, which predicts for response to tamoxifen and other endocrine treatments. However, predictive markers for chemotherapy are not established. Overexpression of c-erbB-2 might be associated with decreased response to CMF and increased response to anthracycline-based treatment, but these observations are still contentious. Expression of topoisomerase II may also reflect responsiveness to anthracycline chemotherapy. Recently, some emerging data also suggest that c-erbB2 may be a marker of taxane sensitivity. As such, we lack predictive biomarkers that could give early information on how effective chemotherapy is and whether additional treatment might be beneficial. A test for chemotherapy sensitivity, equivalent to ER in predicting response to endocrine therapy, would greatly facilitate treatment decisions so that in an ideal scenario, the treatment of each individual patient could be based on specific features of her disease.
Neoadjuvant chemotherapy: Preoperative chemotherapy for large tumors (\>3cm) or inoperable breast cancer is well established and is the standard of care for locally advanced breast cancer. Data from large series of patients have demonstrated that preoperative (neoadjuvant) chemotherapy leads to significant reduction of tumor size (downstaging) and improves both the rate and the cosmetic results of breast-conserving surgery. A recent large randomized trial involving 1,523 patients compared preoperative and postoperative chemotherapy (NSABP B-18). Although results of this study have shown no difference in disease-free survival and survival in women on preoperative or postoperative doxorubicin and cyclophosphamide chemotherapy, significant downstaging of tumors was achieved so that more patients who received preoperative therapy were able to undergo breast-conserving surgery. The rate of breast conservation in NSABP B-18 was 85% in patients with tumors greater than 3 cm, with less than 5% of patients reported to have progressive disease while receiving neoadjuvant chemotherapy.
cDNA arrays: High-Throughput Quantitative Profiling of Gene Expression: With the advent of high-throughput quantitation of gene expression and cDNA technology, it is now possible to study expression of many genes simultaneously to characterize expression patterns in different breast cancers that may distinguish molecular phenotypes associated with clinical response to a treatment. In a recent report, a molecular classification of leukemia was demonstrated. Bone marrow aspirates taken from 38 patients with acute leukemia were evaluated for expression of 6,817 human genes. The 50 best discriminating genes were used to create a predictive index that was then applied to new samples and was found to accurately assign them as AML or ALL.
Preliminary data for differential patterns of gene expression in responders vs non-responders of Taxotere chemotherapy: We conducted a pilot study to investigate gene expression patterns on core biopsies of human breast cancers in responders and non-responders to Taxotere chemotherapy.
RNA was isolated from core biopsies of primary breast cancers taken from women before initiation of Taxotere chemotherapy. Clinical response was assessed after 12 weeks of treatment. We compared patterns of gene expression statistically in order to identify genes differentially expressed between responders and non-responders to this single chemotherapeutic agent.
Overall, these genes efficiently cluster tumors into 3 groups: CR, PR, and NR. We have selected 2337 genes from these data for further analysis. As expected, the majority of these genes show heterogeneous expression patterns independent of treatment response, but six large gene clusters (approximately 180 genes) appear to predict likelihood of response to Taxotere therapy. Consistent with an apoptosis-induction mode of action for taxanes, responsive tumors appear to have higher expression of stress-related proteins, such as mitochondrial proteins involved in apoptosis (cytochromes, proteasome subunits), and higher levels of motility-related microfilament proteins (actin, myosin, and tropomyosin). Non-responders patterns are more complex but show elevated levels of some microtubule proteins presumed to be targets of Taxotere therapy (tubulins, tubulin-interacting proteins) and elevated levels of inflammatory-response genes. Surprisingly, non-responders also showed elevated proliferation (KI67) and oncogene (ABL1, MYC and JUNB) expression levels. This molecular portrait of Taxotere resistance differs from the expected profiles of general chemoresistance. Quantitative RT-PCR and immunohistochemistry studies to confirm these differential gene patterns of expression are in progress for all 40 patients. | Inclusion Criteria:
1. All patients must be female.
2. Signed informed consent.
3. Primary breast cancers must be of clinical and/or radiologic size \>3 cm, and deemed surgically operable.
4. Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
5. Adequate bone marrow function: Hematocrit of greater than 30%, total neutrophil count must be \>1.5 x 109/L and platelets of \> 100 x 109/L prior to the start of any cycle.
6. Renal function tests: creatinine within 1.5 times of the institution's upper limit of normal (ULN).
7. Liver function tests: Total serum bilirubin within ULN, and liver transaminases within 2.5 times ULN, and alkaline phosphatase within 5 times ULN.
8. Electrocardiogram showing no acute ischemic changes.
9. Performance status (WHO scale) \<2.
10. Age \> 18 years.
11. Patients older than 70 years of age should have left ventricular ejection fraction within ULN by MUGA or 2D Echocardiogram.
Exclusion Criteria:
1. Patients with metastatic breast cancer.
2. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
3. Women who are lactating or breastfeeding.
4. Severe underlying chronic illness or disease.
5. Peripheral neuropathy - grade 2 or greater.
6. Patients on other investigational drugs while on study will be excluded.
7. Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
8. Prior taxane or anthracycline chemotherapy for malignancy.
9. Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.
10. No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. | Baylor Breast Care Center | OTHER | {
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} | [
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] | ["neoadjuvant", "chemosensitivity", "chemotherapy", "breast cancer", "tumor", "taxotere", "AC"] | null | [
{
"city": "Houston",
"country": "United States",
"facility": "Baylor Breast Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
}
] | [
{
"class": "OTHER",
"name": "Baylor College of Medicine"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The primary objective this extension study is to obtain enough additional cases evaluable for microarray analyses to complete our studies to identify profiles of a small number of genes that are predictive of response.",
"timeFrame": "10 years"
}
],
"secondary": [
{
"description": null,
"measure": "To determine pathologic complete response and to correlate this to a prospectively determined Taxotere gene expression profile;time to tumor progression;overall survival",
"timeFrame": "10 years"
}
]
} | [
{
"affiliation": "Baylor Breast Center",
"name": "Mothaffar C Rimawi, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
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"term": "Breast Diseases"
},
{
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"term": "Skin Diseases"
}
],
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"abbrev": "BC04",
"name": "Neoplasms"
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{
"abbrev": "BC17",
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"abbrev": "All",
"name": "All Conditions"
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],
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"id": "M5220",
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"relevance": "HIGH"
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{
"asFound": null,
"id": "M5218",
"name": "Breast Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
]
} | {
"ancestors": [
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"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D050257",
"term": "Tubulin Modulators"
},
{
"id": "D050256",
"term": "Antimitotic Agents"
},
{
"id": "D050258",
"term": "Mitosis Modulators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D000903",
"term": "Antibiotics, Antineoplastic"
},
{
"id": "D059005",
"term": "Topoisomerase II Inhibitors"
},
{
"id": "D059003",
"term": "Topoisomerase Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D007166",
"term": "Immunosuppressive Agents"
},
{
"id": "D007155",
"term": "Immunologic Factors"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018501",
"term": "Antirheumatic Agents"
},
{
"id": "D018906",
"term": "Antineoplastic Agents, Alkylating"
},
{
"id": "D000477",
"term": "Alkylating Agents"
},
{
"id": "D019653",
"term": "Myeloablative Agonists"
}
],
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "ARhu",
"name": "Antirheumatic Agents"
},
{
"abbrev": "BDCA",
"name": "Bone Density Conservation Agents"
},
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
}
],
"browseLeaves": [
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"asFound": "Skills",
"id": "M7492",
"name": "Doxorubicin",
"relevance": "HIGH"
},
{
"asFound": "Skills",
"id": "M227339",
"name": "Liposomal doxorubicin",
"relevance": "HIGH"
},
{
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"id": "M6727",
"name": "Cyclophosphamide",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M16403",
"name": "Tamoxifen",
"relevance": "LOW"
},
{
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"id": "M1668",
"name": "Docetaxel",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M26197",
"name": "Tubulin Modulators",
"relevance": "LOW"
},
{
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"id": "M26196",
"name": "Antimitotic Agents",
"relevance": "LOW"
},
{
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"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4224",
"name": "Antibiotics, Antitubercular",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10212",
"name": "Immunosuppressive Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10201",
"name": "Immunologic Factors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20604",
"name": "Antirheumatic Agents",
"relevance": "LOW"
},
{
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"id": "M20942",
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"relevance": "LOW"
},
{
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"id": "M3820",
"name": "Alkylating Agents",
"relevance": "LOW"
}
],
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{
"id": "D000077143",
"term": "Docetaxel"
},
{
"id": "D004317",
"term": "Doxorubicin"
},
{
"id": "D003520",
"term": "Cyclophosphamide"
},
{
"id": "C506643",
"term": "Liposomal doxorubicin"
}
]
} | {
"conditions": [
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"id": "D001943",
"term": "Breast Neoplasms"
}
],
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"id": "D000077143",
"term": "Docetaxel"
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"term": "Doxorubicin"
},
{
"id": "D003520",
"term": "Cyclophosphamide"
},
{
"id": "C506643",
"term": "Liposomal doxorubicin"
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} |
NCT05011266 | null | Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | COMBO | INTERVENTIONAL | RECRUITING | 2021-08-16T00:00:00 | null | 2026-06-01T00:00:00 | 2026-06-01T00:00:00 | [
"PHASE2",
"PHASE3"
] | 180 | 18 | 65 | ALL | false | This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.
The NYSPI site, which provides study oversight (no direct participant involvement) is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023. | This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. Adding buprenorphine-naloxone after the patient initiated XR-naltrexone will not produce mu opioid agonist effect but kappa antagonist effects of buprenorphine may provide additional relief of protracted withdrawal, craving, and mood disturbances persisting in patients treated with XR-naltrexone and possibly contributing to premature treatment discontinuation and relapse. This is a parallel arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with XR-naltrexone administered every four weeks. Individuals with Opioid Use Disorder (OUD) and beginning treatment with XR-naltrexone for maintenance treatment will be randomized to treatment with adjunctive buprenorphine-naloxone or placebo with 5 additional doses of XR-naltrexone, given every four weeks, and weekly medication management. The study will provide detoxification and a first XR-Naltrexone injection if a participant consents before the first XR-naltrexone injection. In all participants randomization will occur after first XR-NTX injection. Buprenorphine-naloxone (sub-lingual (SL), 4/1 mg/day) or placebo will be started after a first XR-naltrexone dose and tapered off at study completion. | Inclusion Criteria:
* Individuals between the ages of 18-65 (inclusive) interested in antagonist-based relapse prevention treatment
* Meets current DSM-5 criteria for current opioid use disorder of at least six months duration supported by urine toxicology positive for opioids OR positive naloxone challenge (defined by 3-point increase in COWS) if seeking detoxification and XR-NTX induction OR confirmed recent detoxification treatment for opioids.
* In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) with no clinically significant abnormalities
* Participants who completed detoxification and received XR-NTX are eligible for the study. Participants may be enrolled up to 2 weeks following an initial XR-NTX injection given in any outside research or community-based treatment setting (inpatient, outpatient residential).
* Seeking treatment for opioid use disorder, willing to accept treatment with XR-NTX and, in the judgment of the treating physician, is a good candidate for naltrexone-based treatment.
* Voluntarily seeking treatment for opioid use disorder.
* Able to give written informed consent to participate in the study and showing a thorough understanding of the difference between agonist and antagonist-based treatment.
Exclusion Criteria:
* Methadone maintenance within 2 weeks of XR-NTX induction or any use of methadone in the week prior to XR-NTX induction
* Maintenance on buprenorphine or frequent buprenorphine use in the week prior to XR-NTX induction (must be using no more than 8 mg of buprenorphine per day for no more than 3 days per week). If consenting after initial XR-NTX injection, any use of buprenorphine since XR-NTX induction is exclusionary.
* Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make a detoxification and naltrexone initiation, or maintenance treatment with XR-NTX in combination with buprenorphine, hazardous (relative contraindications) or requires a different level of care. Examples include:
1. Disabling or terminal medical illness (e.g., uncompensated heart failure, severe acute hepatitis, cirrhosis or end-stage liver disease) as assessed by medical history and/or review of systems.
2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview.
3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included).
4. Suicidal or homicidal
* AST/ALT \> 3x normal limit
* Pregnancy, lactation, or a plan of becoming pregnant. Women need to have negative blood pregnancy test at screening and agree to practice dual contraceptives.
* Physiological dependence on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
* History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
* Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.
* Individuals above 60 with possible early cognitive decline or other neurodegenerative conditions as evidenced by a score of less than 25 on a Mini Mental Status Exam screen.
* Participants who had 30 or more opioid-free days prior to randomization will not be eligible.
* Participants more than 2 weeks following an initial XR-NTX injection (given in any outside research or community-based treatment setting, for example inpatient, outpatient residential). | New York State Psychiatric Institute | OTHER | {
"id": "IRB #8171",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-08-16T00:00:00 | {
"date": "2025-05-13",
"type": "ACTUAL"
} | {
"date": "2021-08-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "parallel arm, double-blind, placebo-controlled buprenorphine compared to placebo",
"maskingInfo": {
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"maskingDescription": "double blind masking",
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Opioid-use Disorder"
] | ["opioid use disorder", "treatment", "buprenorphine", "extended release naltrexone"] | null | [
{
"city": "Rockville",
"country": "United States",
"facility": "Avery Road Treatment Center (ARTC)",
"geoPoint": {
"lat": 39.084,
"lon": -77.15276
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"state": "Maryland"
},
{
"city": "New York",
"country": "United States",
"facility": "Stars/Nyspi",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
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"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Institute on Drug Abuse (NIDA)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Proportion of participants receiving XR-naltrexone injections",
"timeFrame": "20 weeks"
}
],
"secondary": null
} | [
{
"affiliation": "New York State Psychiatric Institute",
"name": "Adam Bisaga, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D000079524",
"term": "Narcotic-Related Disorders"
},
{
"id": "D064419",
"term": "Chemically-Induced Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
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],
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"abbrev": "BC25",
"name": "Substance Related Disorders"
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"name": "Behaviors and Mental Disorders"
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"name": "All Conditions"
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"id": "M12244",
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"relevance": "HIGH"
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"relevance": "HIGH"
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"relevance": "LOW"
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"term": "Opioid-Related Disorders"
},
{
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]
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"term": "Analgesics, Opioid"
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{
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"term": "Central Nervous System Depressants"
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{
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"term": "Physiological Effects of Drugs"
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"term": "Analgesics"
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{
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"term": "Sensory System Agents"
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{
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"term": "Peripheral Nervous System Agents"
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{
"id": "D009292",
"term": "Narcotic Antagonists"
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"browseBranches": [
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"abbrev": "NarcAntag",
"name": "Narcotic Antagonists"
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"name": "All Drugs and Chemicals"
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"name": "Alcohol Deterrents"
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"name": "Analgesics"
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"name": "Central Nervous System Depressants"
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"id": "M12221",
"name": "Naloxone",
"relevance": "HIGH"
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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"asFound": null,
"id": "M12243",
"name": "Narcotic Antagonists",
"relevance": "LOW"
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],
"meshes": [
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"term": "Buprenorphine"
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{
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"term": "Buprenorphine, Naloxone Drug Combination"
},
{
"id": "D009270",
"term": "Naloxone"
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]
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{
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"term": "Buprenorphine, Naloxone Drug Combination"
},
{
"id": "D009270",
"term": "Naloxone"
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]
} |
NCT00311766 | null | A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa | A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Epidermolysis Bullosa | None | INTERVENTIONAL | TERMINATED | 2006-04-04T00:00:00 | null | null | null | [
"PHASE2"
] | 30 | 2 | null | ALL | false | The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD). | EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5. | Inclusion Criteria:
* Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient
* Diagnosis of junctional or dystrophic EB.
* Patients who present with Hallopeau-Siemens subtype may be enrolled.
* At least one active, unroofed EB erosion on the limb or on the trunk.
* Lesion size 5 to 50 cm2, inclusive.
* Stable lesion present for 14-60 days before enrollment.
* More that one member in a family can be enrolled as long as that member is treated to a different cohort with an assurance that the study medication will not be shared.
* No clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher.
Exclusion Criteria:
* Clinical evidence of local infection of the index (targeted) lesion.
* Use of any investigational drug within the 30 days before enrollment.
* Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
* Use of systemic or topical steroidal therapy within the 30 days before enrollment.Inhaled steroids are allowed.
* Use of systemic antibiotics within the 7 days before enrollment.
* Current or former malignancy.
* Arterial or venous disorder resulting in ulcerated wounds.
* Diabetes mellitus.
* Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.) | RegeneRx Biopharmaceuticals, Inc. | INDUSTRY | {
"id": "SSEB",
"link": null,
"type": null
} | Lack of patient availability and expiration of study drug | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-04-04T00:00:00 | {
"date": "2014-05-12",
"type": "ESTIMATED"
} | {
"date": "2006-04-06",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Epidermolysis Bullosa"
] | ["Epidermolysis Bullosa", "cutaneous wound-healing", "chronic wound-healing", "Thymosin Beta 4", "laminin-5"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)",
"timeFrame": "70 days"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Participants Whose Wounds Have Healed",
"timeFrame": "56 days"
}
]
} | [
{
"affiliation": "RegeneRx Biopharmaceuticals, Inc.",
"name": "David R Crockford",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012868",
"term": "Skin Abnormalities"
},
{
"id": "D000013",
"term": "Congenital Abnormalities"
},
{
"id": "D012873",
"term": "Skin Diseases, Genetic"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
},
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D012872",
"term": "Skin Diseases, Vesiculobullous"
}
],
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"abbrev": "BC26",
"name": "Wounds and Injuries"
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"name": "All Conditions"
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"name": "Diseases and Abnormalities at or Before Birth"
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"abbrev": "Rare",
"name": "Rare Diseases"
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],
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{
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},
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},
{
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},
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},
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"id": "M15675",
"name": "Skin Diseases, Vesiculobullous",
"relevance": "LOW"
},
{
"asFound": "Epidermolysis Bullosa",
"id": "T2098",
"name": "Epidermolysis Bullosa",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D004820",
"term": "Epidermolysis Bullosa"
}
]
} | null | {
"conditions": [
{
"id": "D004820",
"term": "Epidermolysis Bullosa"
}
],
"interventions": null
} |
NCT02123966 | null | An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease | An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease | None | INTERVENTIONAL | TERMINATED | 2014-04-23T00:00:00 | null | null | null | [
"PHASE2"
] | 10 | 4 | null | ALL | false | This research study is evaluating the effectiveness of topical sirolimus combined with topical steroid therapy, as a possible treatment for oral cGVHD. | Topical steroid therapy can be effective in managing oral cGVHD symptoms. However, a certain proportion of participants will not experience an adequate response to topical steroids and continue to have some degree of discomfort. Sirolimus is a non-steroidal immunosuppressive medication that has demonstrated efficacy in the management of cGVHD. Based on this, it is believed that a topical formulation applied inside the mouth may also demonstrate efficacy on a localized basis.
The purpose of this study is to assess the safety and efficacy of topical sirolimus as a swish and spit solution for the treatment of oral cGVHD in participants that have not had an adequate clinical response to topical steroid therapy alone. | Inclusion Criteria:
* While there will be no restrictions on concurrent systemic medications, all subjects must be on a stable immunomodulatory medication regimen for 7 days prior to beginning the study without plans to adjust doses during the following four-week study period. Dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) during the study intervention period are allowed and do not constitute a trial violation. Changes in medications for non-cGVHD medical conditions will not affect eligibility.
* Age 4 years and older.
* Patients with symptomatic oral chronic graft-versus-host disease (sensitivity score ≥ 4).
* Stable topical steroid therapy with dexamethasone, clobetasol, or budesonide oral solutions (5 min, four times a day) for seven days prior to study enrollment.
* Stable systemic cGVHD medication regimen for seven days prior to study enrollment. Dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) for the month prior and during the study intervention period are allowed and do not constitute a trial violation.
* The effects of sirolimus on the developing human fetus are unknown. For this reason and because immunosuppressants agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of topical sirolimus administration.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients already using topical sirolimus therapy.
* Patients who have an allergy/intolerance to sirolimus.
* Sensitivity score ≤ 3.
* Inability to comply with study instructions.
* Pregnant or breastfeeding.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded due to the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued if the mother is treated with sirolimus.
* HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sirolimus. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. | Dana-Farber Cancer Institute | OTHER | {
"id": "14-090",
"link": null,
"type": null
} | Due to slow accrual, study team has decided to end the study early. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-04-24T00:00:00 | {
"date": "2018-07-24",
"type": "ACTUAL"
} | {
"date": "2014-04-28",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Chronic Graft-versus-Host-Disease",
"Oral Mucosal Disease Due to Graft-versus-host Disease"
] | ["Chronic Graft-versus-Host-Disease", "Oral mucosal disease"] | null | [
{
"city": "Boston",
"country": "United States",
"facility": "Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
},
{
"city": "Boston",
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage of Participants With a Subjective Sensitivity Score Response",
"timeFrame": "Pre treatment and after the 28 day (4 weeks) cycle of treatment"
}
],
"secondary": [
{
"description": null,
"measure": "Change Pre-to-post Treatment in Oral Health Impact Profile Assessment",
"timeFrame": "Pre treatment and after the 28 day (4 weeks) cycle of treatment"
}
]
} | [
{
"affiliation": "Brigham and Women's Hospital",
"name": "Nathaniel S Treister, DMD, DMSc",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "25529383", "type": "BACKGROUND", "citation": "Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18."}, {"pmid": "9332805", "type": "BACKGROUND", "citation": "Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x."}] | {"versionHolder": "2025-06-18"} | {
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{
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{
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{
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{
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{
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{
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{
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],
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{
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{
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{
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{
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{
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{
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{
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{
"asFound": null,
"id": "M14977",
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"relevance": "LOW"
},
{
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"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
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{
"asFound": null,
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"name": "Lung Diseases, Obstructive",
"relevance": "LOW"
},
{
"asFound": "Graft Versus Host Disease",
"id": "T2832",
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"relevance": "HIGH"
},
{
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"id": "T1303",
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"relevance": "HIGH"
},
{
"asFound": null,
"id": "T871",
"name": "Bronchiolitis Obliterans",
"relevance": "LOW"
},
{
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],
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"term": "Bronchiolitis Obliterans Syndrome"
},
{
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"term": "Graft vs Host Disease"
}
]
} | {
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{
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},
{
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"term": "Antibiotics, Antineoplastic"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
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"term": "Antifungal Agents"
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{
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{
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"term": "Immunologic Factors"
},
{
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"term": "Physiological Effects of Drugs"
}
],
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"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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{
"abbrev": "AnEm",
"name": "Antiemetics"
},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
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{
"abbrev": "Resp",
"name": "Respiratory System Agents"
}
],
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{
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},
{
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"id": "M21960",
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"relevance": "HIGH"
},
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"name": "Temsirolimus",
"relevance": "LOW"
},
{
"asFound": null,
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"name": "MTOR Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21711",
"name": "Budesonide",
"relevance": "LOW"
},
{
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},
{
"asFound": null,
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{
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{
"asFound": null,
"id": "M4224",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M6252",
"name": "Clotrimazole",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11796",
"name": "Miconazole",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4254",
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
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"name": "Immunologic Factors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020123",
"term": "Sirolimus"
}
]
} | {
"conditions": [
{
"id": "D000092122",
"term": "Bronchiolitis Obliterans Syndrome"
},
{
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"term": "Graft vs Host Disease"
}
],
"interventions": [
{
"id": "D020123",
"term": "Sirolimus"
}
]
} |
NCT04946266 | null | Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers | Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers | MFI2-PREDICT | OBSERVATIONAL | UNKNOWN | 2021-06-22T00:00:00 | null | 2021-12-01T00:00:00 | null | null | 260 | 18 | null | ALL | false | An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment. | null | Inclusion Criteria:
* Adult patient
* Localized kidney tumors\> T1a
* Patient having signed an informed consent
* Patient affiliated to a health insurance plan
* Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes
Exclusion Criteria:
* Metastatic carcinoma from the outset
* Contraindication to performing a TAP CT with injection of contrast product
* Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.)
* Subject under legal protection
* Subject under tutorship or curatorship
* Pregnancy
* Feeding with milk | University Hospital, Strasbourg, France | OTHER | {
"id": "7349",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-06-22T00:00:00 | {
"date": "2022-01-05",
"type": "ACTUAL"
} | {
"date": "2021-06-30",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patient with localized kidney tumors | PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Kidney Cancer"
] | null | null | [
{
"city": "Strasbourg",
"country": "France",
"facility": "Les Hôpitaux Universitaires de Strasbourg",
"geoPoint": {
"lat": 48.58392,
"lon": 7.74553
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Expression of MFI2-AS1",
"timeFrame": "36 month"
}
],
"secondary": null
} | [
{
"affiliation": "les Hôpitaux Universitaires de Strasbourg",
"name": "TRICARD Thibault",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014571",
"term": "Urologic Neoplasms"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D007674",
"term": "Kidney Diseases"
},
{
"id": "D014570",
"term": "Urologic Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
},
{
"id": "D000230",
"term": "Adenocarcinoma"
},
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
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],
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{
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"id": "M10703",
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{
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},
{
"asFound": null,
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},
{
"asFound": null,
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},
{
"asFound": null,
"id": "M27093",
"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14127",
"name": "Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8399",
"name": "Female Urogenital Diseases and Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10698",
"name": "Kidney Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17319",
"name": "Urologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27095",
"name": "Male Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3585",
"name": "Adenocarcinoma",
"relevance": "LOW"
},
{
"asFound": null,
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},
{
"asFound": null,
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},
{
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"id": "T4906",
"name": "Renal Cell Carcinoma",
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}
],
"meshes": [
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"id": "D007680",
"term": "Kidney Neoplasms"
},
{
"id": "D002292",
"term": "Carcinoma, Renal Cell"
}
]
} | null | {
"conditions": [
{
"id": "D007680",
"term": "Kidney Neoplasms"
},
{
"id": "D002292",
"term": "Carcinoma, Renal Cell"
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],
"interventions": null
} |
NCT06898866 | null | Functional and Occupational Rehabilitation of Troops | An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel | FORT | OBSERVATIONAL | NOT_YET_RECRUITING | 2025-03-18T00:00:00 | null | null | null | null | 480 | null | null | ALL | false | The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel. | This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual. | Inclusion Criteria:
"patient referred to functional restoration program by provider"
Exclusion Criteria:
"patient not referred to functional restoration program by provider" | The University of Texas Health Science Center at San Antonio | OTHER | {
"id": "STUDY00001264",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-03-25T00:00:00 | {
"date": "2025-03-27",
"type": "ACTUAL"
} | {
"date": "2025-03-27",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Active duty military personnel diagnosed with chronic musculoskeletal pain. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Chronic Musculoskeletal Pain"
] | null | null | null | [
{
"class": "FED",
"name": "United States Department of Defense"
},
{
"class": "OTHER",
"name": "University of Washington"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pain Impact Score (PIS)",
"timeFrame": "Baseline to 13 months"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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NCT05827666 | null | The Effect of Dairy and Dairy-Free Alternative Beverages on Post-Exercise Anabolism in Active Youth | The Effect of Dairy and Dairy-Free Alternative Beverages on Post-Exercise Anabolism in Active Youth | PBS | INTERVENTIONAL | UNKNOWN | 2023-03-30T00:00:00 | null | null | null | [
"NA"
] | 24 | 8 | 16 | ALL | true | The growth and development of lean body mass (i.e., muscle and bone) is instrumental to health and performance across the lifespan, especially in youth, as they actively experience growth. Thus, it is important to capitalize on physical activity and nutrition (especially dietary protein), to support the accretion of lean tissues. Eating a protein-rich meal or performing physical activity can stimulate protein synthesis, and when repeated over time, lean body mass accretion. There is currently an increasing market demand for non-dairy alternatives, due to multiple reasons including environmental, ethical, or taste preferences. However, it is important to understand how different beverages may support 'growth' (anabolism) of lean tissues after exercise. Research in adults has shown that dairy milk is superior to non-dairy milk beverages for supporting post-exercise recovery and muscle protein synthesis. However, the impact of dairy and non-dairy milk alternatives on recovery from exercise is not well understood in children. By understanding the milk beverage that best supports post-exercise recovery, the investigators can determine the optimal nutritional environment to facilitate the growth of lean tissues in the body. | The growth and development of lean body mass (LBM) (e.g., muscle and bone) is vital to not only support health and performance across the lifespan but also, reduce the prevalence of metabolic disorders later in life, such as osteoporosis and sarcopenia. Active youth who regularly perform moderate-to-vigorous physical activity (MVPA) have superior increases LBM and muscle strength compared to their sedentary counterparts. LBM is regulated by the process of protein breakdown (PB), where old or damaged proteins are broken down releasing their constituent amino acids (AA), as well as protein synthesis (PS), a process by which new proteins are made by linking constituent AAs together. When rates of PS exceed rates of PB (PS\>PB), a positive net protein balance is achieved, ultimately facilitating the accretion of LBM. Contrarily, if PB\>PS, net protein balance is negative, leading to the loss of LBM.
Assuming total energy intakes are met, to meet the metabolic demands of an active lifestyle, dietary protein is a prime anabolic stimulus. This macronutrient facilitates the growth of lean tissues by providing the AA 'building blocks' to support the synthesis of muscle and other body proteins. Physical activity (PA) is a second pre-eminent factor contributing to the growth of LBM. Following exercise, in the absence of dietary protein ingestion, net protein balance is negative. However, post-exercise protein consumption facilitates a positive net protein balance, which when repeated over time, can contribute to the accretion of LBM. Youth who engage in high levels of PA have greater LBM compared to their sedentary counterparts. Thus, it is important to capitalize on the optimal nutritional and exercise interventions to support a positive net protein balance, an acute marker of growth, especially in vulnerable populations, such as children.
In children, milk protein ingestion has been shown to stimulate whole-body PS, resulting in a positive whole-body net protein balance. In adults, dairy proteins lead to superior post-exercise recovery and PS compared to non-dairy alternatives. Most research to date examining the post-prandial protein synthesis responses to plant-based protein sources have encompassed isolated protein sources. However, there is currently a paucity of research examining the effect of the whole-food matrix of plant-based protein sources on whole-body protein metabolism in active youth. Furthermore, the pubertal growth spurt is characterized by rapid accumulation of LBM that is only surpassed by the first year of life. This LBM, which is enhanced by an active lifestyle, must be supported by adequate energy and protein ingestion. Therefore, it is necessary to determine the post-exercise anabolic effect of dairy and non-dairy whole foods on markers of LBM growth and whole-body protein metabolism, especially in children, an under-researched population.
The current project will employ the indicator amino acid oxidation (IAAO) methodology to determine the protein/AA intake that minimizes oxidation of the indicator AA, while maximizing PS. The oxidation of the indicator AA is minimized by ingesting an adequate proportion of AA, and/or consuming nutritionally complete protein sources. The main objective of the present study is to determine the effect of energy-matched dairy and non-dairy milk alternatives on whole-body protein synthesis in active youth following exercise.
Aim 1: To determine the effect of dairy (2% milk) and non-dairy milk alternatives (soy, rice, and almond 'milk' beverages) on whole-body PS following a bout of intermittent exercise in children, adolescent males, and adolescent females.
Hypothesis 1: Whole body PS will be greatest after ingestion of dairy milk compared to isocaloric (i.e., equal energy amount) non-dairy alternatives, due to the greater and/or higher amount of quality dietary protein. Regardless of sex, adolescents are expected to have greater PS due to their heightened anabolic sensitivity, compared to children. | Inclusion Criteria:
* Between the ages of 8-16 years
* Children: \>-1 y age from peak height velocity\* (aPHV)
* Adolescents: -0.5 to 1.5 aPHV
* An age and sex-specific minimum of 75th percentile Beep Test level
* Considered healthy based on responses to the PAR-Q+ and a medical history form \*NOTE: age from peak height velocity (aPHV): sitting/standing height
Exclusion Criteria:
* Almond or soy allergy
* Lactose intolerance
* If enrolled as a child participant: biological age outside of \>-1 years from aPHV
* If enrolled as an adolescent participant: biological age outside -0.5 to 1.5 aPHV
* Inability to perform physical activity as determined by the PAR-Q+ and iPAQ
* Inability to adhere to protocol guidelines (e.g., 2-day controlled diet)
* Diagnosed medical condition under the care of a physician (e.g., type 1 diabetes)
* Consuming any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories)
* Failure to complete all four metabolic trials within four months | University of Toronto | OTHER | {
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"type": null
} | Unknown | {
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} | 2023-04-11T00:00:00 | {
"date": "2023-04-25",
"type": "ACTUAL"
} | {
"date": "2023-04-25",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Using a single-blind randomized counterbalanced crossover design, participants will complete four metabolic trials providing one of the four isoenergetic (equal calories) beverages: 2% milk (MILK), soy 'milk,' (SOY), almond 'milk,' (ALMOND), or rice 'milk' (RICE) following a bout of variable-intensity exercise. The caloric content of the beverages is based on 0.3 g/kg FFM 2% milk.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "As the study is a single-blind crossover design, the randomization of the protein type will be blinded to the participants only. For each liquid meal, beverages will be provided in opaque bottles, and the caloric content of the beverages will be the same.",
"whoMasked": [
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]
},
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"primaryPurpose": "OTHER",
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} | [
"Dietary Proteins",
"Indicator Amino Acid Oxidation"
] | ["Nutrition in Youth", "Growth", "Active youth", "Protein metabolism", "Lean body mass", "Whole food matrix", "Protein beverage", "Children", "Adolescent", "Indicator Amino Acid Oxidation"] | null | [
{
"city": "Toronto",
"country": "Canada",
"facility": "Goldring Centre for High Performance and Sport",
"geoPoint": {
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"state": "Ontario"
}
] | [
{
"class": "INDUSTRY",
"name": "Dairy Management Inc."
}
] | null | {
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"primary": [
{
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"measure": "F13CO2",
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}
],
"secondary": [
{
"description": null,
"measure": "Whole-Body Net Protein Balance",
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]
} | [
{
"affiliation": "University of Toronto",
"name": "Nicki Pourhashemi, BSc",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
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NCT03618966 | null | Neuromuscular Magnetic Stimulation in ALS Patients | Neuromuscular Magnetic Stimulation Counteracts Muscle Decline in ALS Patients | NMS-ALS | INTERVENTIONAL | COMPLETED | 2018-07-23T00:00:00 | null | 2016-05-01T00:00:00 | 2017-11-01T00:00:00 | [
"PHASE2"
] | 22 | null | null | ALL | false | Aim of the study is to verify whether neuromuscular magnetic stimulation can improve muscle function in spinal-onset Amyotrophic Lateral Sclerosis (ALS) patients. | Background: Amyotrophic lateral sclerosis (ALS) is a multi-factorial and multi-systemic pathology associated with motor neuron degeneration, muscle atrophy and paralysis. Mounting evidence suggests that the earliest presymptomatic functional and pathological changes are occurring distally in axons and at the neuromuscular junction (NMJ). These changes precede, and can be independent of the loss of cell bodies or alterations in other cell types already linked to the ALS disease process. In line with these studies, we found that in human ALS muscles the acetylcholine receptors (AChRs) are less sensitive to ACh than denervated non-ALS muscles. It has been also reported that muscle specific expression of mutant superoxide dismutase (SOD1) gene induces muscle atrophy, significant reduction in muscle strength, mitochondrial dysfunction, microgliosis, and neuronal degeneration, suggesting that retrograde signals from muscle to nerve may contribute to synapse and axon damage. This suggests that skeletal muscle is an important target for therapeutic intervention. Neuromuscular system may be artificially stimulated either by an electrical stimulation (ES) or by time-varying electromagnetic fields. Neuromuscular magnetic stimulation (NMMS) has been proposed as an alternative, non-invasive, stimulation technique.
Objective: aim of the study is to verify whether neuromuscular magnetic stimulation can improve muscle function in spinal-onset Amyotrophic Lateral Sclerosis (ALS) patients. We will study if neuromuscular magnetic stimulation can counteract muscle atrophy by promoting the modulation of factors associated with muscle catabolism and/or increasing the efficacy of nicotinic acetylcholine receptors.
Methods: At the baseline visit, ALS patients will be randomized in two groups to receive daily real neuromuscular magnetic stimulation in one arm and sham neuromuscular magnetic stimulation in the opposite arm for two weeks. All patients will undergo median nerve conduction study and a clinical examination, including handgrip strength test and evaluation of upper limbs muscle strength by Medical Research Council Muscle Scale. At the end of the stimulation procedures, a needle muscle biopsy will be performed bilaterally from flexor carpi radialis muscle. Muscle samples will be used to perform histomorphometric and molecular analysis and electrophysiological recordings of acetylcholine evoked currents. | Inclusion Criteria:
* diagnosis of probable or definite ALS with spinal-onset
* right-handed patients
* a bilateral symmetric muscular deficit in flexor carpi radialis muscle or flexor digitorum profundus muscle (defined by a MRC Muscle Scale score of 3-4/5)
Exclusion Criteria:
* history of epilepsy or severe headaches,
* pregnancy or breast-feeding
* patients with implanted cardiac pacemaker, neurostimulators, surgical clips or medical pumps
* presenting any other comorbid condition affecting the possibility of completing the study | University of Roma La Sapienza | OTHER | {
"id": "2174",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2018-08-01T00:00:00 | {
"date": "2018-08-07",
"type": "ACTUAL"
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"date": "2018-08-07",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients will be randomized in two groups by receiving a sequential number according to a from a computer-generated random list. A first group will receive a real stimulation (rNMMS) of the right arm and a sham stimulation (sNMMS) of the left arm; a second group received a rNMMS of the left arm and a sNMMS of the right arm. Every cycle of stimulation will last two weeks. All patients will undergo a medial nerve conduction study (NCS) and a clinical evaluation before and at the end of the treatment and another evaluation after two weeks after the end of treatment. Clinical examination will include i) handgrip strength test for the measure of maximal isometric strength of hand and flexor forearm muscles; ii) MRC Muscle Scale for manual muscular testing of the upper limbs. At the end of the stimulation procedure, a needle muscle biopsy under a local anesthetic will be performed bilaterally from flexor carpi radialis muscle for histological, physiological and molecular studies.",
"maskingInfo": {
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} | [
"Amyotrophic Lateral Sclerosis"
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"other": null,
"primary": [
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"description": null,
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"timeFrame": "Baseline to Week 2"
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],
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"description": null,
"measure": "Change from baseline to Week 2 in the muscle strength measured by handgrip dynamometry",
"timeFrame": "Baseline to Week 2"
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"description": null,
"measure": "Change from baseline to Week 2 in the Compound Muscle Action Potential (CMAP) amplitude from flexor carpi radialis",
"timeFrame": "Baseline to Week 2"
},
{
"description": null,
"measure": "Change from baseline to Week 2 in the amplitude of the ACh-evoked currents (IACh) for nicotinic acetylcholine receptors",
"timeFrame": "Baseline to Week 2"
},
{
"description": null,
"measure": "Change from baseline to Week 2 on levels of insulin-like growth factor-1 (IGF-1) and Myostatin",
"timeFrame": "Baseline to Week 2"
},
{
"description": null,
"measure": "Change from baseline to Week 2 on the diameter size of muscle fibers",
"timeFrame": "Baseline to Week 2"
},
{
"description": null,
"measure": "Change from baseline to Week 2 on levels of Muscle Atrophy F-box (MAFbx)/Atrogin-1 and Muscle Ring-Finger Protein 1 (MuRF-1)",
"timeFrame": "Baseline to Week 2"
}
]
} | [
{
"affiliation": "Department of Human Neuroscience, Umberto I Hospital-University of Rome Sapienza",
"name": "Maurizio Inghilleri, Prof",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "23217177", "type": "BACKGROUND", "citation": "Musaro A. Understanding ALS: new therapeutic approaches. FEBS J. 2013 Sep;280(17):4315-22. doi: 10.1111/febs.12087. Epub 2013 Jan 3."}, {"pmid": "27830784", "type": "BACKGROUND", "citation": "Taylor JP, Brown RH Jr, Cleveland DW. Decoding ALS: from genes to mechanism. Nature. 2016 Nov 10;539(7628):197-206. doi: 10.1038/nature20413."}, {"pmid": "21057983", "type": "BACKGROUND", "citation": "Dadon-Nachum M, Melamed E, Offen D. The \"dying-back\" phenomenon of motor neurons in ALS. J Mol Neurosci. 2011 Mar;43(3):470-7. doi: 10.1007/s12031-010-9467-1. Epub 2010 Nov 7."}, {"pmid": "19386549", "type": "BACKGROUND", "citation": "Dupuis L, Loeffler JP. Neuromuscular junction destruction during amyotrophic lateral sclerosis: insights from transgenic models. Curr Opin Pharmacol. 2009 Jun;9(3):341-6. doi: 10.1016/j.coph.2009.03.007. Epub 2009 Apr 20."}, {"pmid": "19046573", "type": "BACKGROUND", "citation": "Dobrowolny G, Aucello M, Rizzuto E, Beccafico S, Mammucari C, Boncompagni S, Belia S, Wannenes F, Nicoletti C, Del Prete Z, Rosenthal N, Molinaro M, Protasi F, Fano G, Sandri M, Musaro A. Skeletal muscle is a primary target of SOD1G93A-mediated toxicity. Cell Metab. 2008 Nov;8(5):425-36. doi: 10.1016/j.cmet.2008.09.002."}, {"pmid": "26780251", "type": "BACKGROUND", "citation": "Loeffler JP, Picchiarelli G, Dupuis L, Gonzalez De Aguilar JL. The Role of Skeletal Muscle in Amyotrophic Lateral Sclerosis. Brain Pathol. 2016 Mar;26(2):227-36. doi: 10.1111/bpa.12350."}, {"pmid": "22128328", "type": "BACKGROUND", "citation": "Palma E, Inghilleri M, Conti L, Deflorio C, Frasca V, Manteca A, Pichiorri F, Roseti C, Torchia G, Limatola C, Grassi F, Miledi R. Physiological characterization of human muscle acetylcholine receptors from ALS patients. Proc Natl Acad Sci U S A. 2011 Dec 13;108(50):20184-8. doi: 10.1073/pnas.1117975108. Epub 2011 Nov 29."}, {"pmid": "26929355", "type": "BACKGROUND", "citation": "Palma E, Reyes-Ruiz JM, Lopergolo D, Roseti C, Bertollini C, Ruffolo G, Cifelli P, Onesti E, Limatola C, Miledi R, Inghilleri M. Acetylcholine receptors from human muscle as pharmacological targets for ALS therapy. Proc Natl Acad Sci U S A. 2016 Mar 15;113(11):3060-5. doi: 10.1073/pnas.1600251113. Epub 2016 Feb 29."}, {"pmid": "25104935", "type": "BACKGROUND", "citation": "Kern H, Barberi L, Lofler S, Sbardella S, Burggraf S, Fruhmann H, Carraro U, Mosole S, Sarabon N, Vogelauer M, Mayr W, Krenn M, Cvecka J, Romanello V, Pietrangelo L, Protasi F, Sandri M, Zampieri S, Musaro A. Electrical stimulation counteracts muscle decline in seniors. Front Aging Neurosci. 2014 Jul 24;6:189. doi: 10.3389/fnagi.2014.00189. eCollection 2014."}, {"pmid": "19428960", "type": "BACKGROUND", "citation": "Eusebi F, Palma E, Amici M, Miledi R. Microtransplantation of ligand-gated receptor-channels from fresh or frozen nervous tissue into Xenopus oocytes: a potent tool for expanding functional information. Prog Neurobiol. 2009 May;88(1):32-40. doi: 10.1016/j.pneurobio.2009.01.008. Epub 2009 Feb 7."}, {"pmid": "11175789", "type": "BACKGROUND", "citation": "Musaro A, McCullagh K, Paul A, Houghton L, Dobrowolny G, Molinaro M, Barton ER, Sweeney HL, Rosenthal N. Localized Igf-1 transgene expression sustains hypertrophy and regeneration in senescent skeletal muscle. Nat Genet. 2001 Feb;27(2):195-200. doi: 10.1038/84839."}, {"pmid": "20157530", "type": "BACKGROUND", "citation": "Scicchitano BM, Rizzuto E, Musaro A. Counteracting muscle wasting in aging and neuromuscular diseases: the critical role of IGF-1. Aging (Albany NY). 2009 May 13;1(5):451-7. doi: 10.18632/aging.100050."}, {"pmid": "19357233", "type": "BACKGROUND", "citation": "Trendelenburg AU, Meyer A, Rohner D, Boyle J, Hatakeyama S, Glass DJ. Myostatin reduces Akt/TORC1/p70S6K signaling, inhibiting myoblast differentiation and myotube size. Am J Physiol Cell Physiol. 2009 Jun;296(6):C1258-70. doi: 10.1152/ajpcell.00105.2009. Epub 2009 Apr 8."}] | {"versionHolder": "2025-06-18"} | {
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NCT02569866 | null | Antibiotics After Breast Reduction:Clinical Trial With Randomization | Antibiotics After Breast Reduction:Clinical Trial With Randomization | None | INTERVENTIONAL | COMPLETED | 2015-10-04T00:00:00 | null | null | null | [
"PHASE2"
] | 124 | 18 | 60 | FEMALE | true | This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates. | Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.
Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.
The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.
Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty. | Inclusion Criteria:
* Breast hypertrophy
* Body mass index between 19 to 30 kg/m2
Exclusion Criteria:
* Patients undergoing a surgical procedure in the breast
* Diagnosis of breast pathology
* Smoking
* Childbirth or lactation less than a year
* Uncontrolled comorbidities
* Use of immunosuppressive drugs
* Misuse of capsules supplied
* Absence during the weekly follow-up | Federal University of São Paulo | OTHER | {
"id": "ESG180402",
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"date": "2018-04-20",
"type": "ACTUAL"
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"name": "Universidade do Vale do Sapucai"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Surgical site infection in the postoperative of reduction mammaplasty.",
"timeFrame": "30 days postoperatively"
}
],
"secondary": null
} | [
{
"affiliation": "Federal University of São Paulo",
"name": "Lydia M Ferreira, PhD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "20585232", "type": "BACKGROUND", "citation": "Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88."}, {"pmid": "27899130", "type": "DERIVED", "citation": "Garcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D014946",
"term": "Wound Infection"
},
{
"id": "D011183",
"term": "Postoperative Complications"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
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"abbrev": "BC26",
"name": "Wounds and Injuries"
},
{
"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"id": "M17685",
"name": "Wounds and Injuries",
"relevance": "LOW"
},
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"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
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"id": "M16310",
"name": "Surgical Wound Infection",
"relevance": "HIGH"
},
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"id": "M17684",
"name": "Wound Infection",
"relevance": "LOW"
},
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"id": "M1112",
"name": "Surgical Wound",
"relevance": "LOW"
},
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"id": "M14065",
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"relevance": "LOW"
}
],
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{
"id": "D013530",
"term": "Surgical Wound Infection"
}
]
} | {
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"term": "Anti-Bacterial Agents"
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"term": "Anti-Infective Agents"
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],
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"name": "Anti-Infective Agents"
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],
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"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
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"name": "Antibiotics, Antitubercular",
"relevance": "LOW"
},
{
"asFound": "Altered",
"id": "M5755",
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"relevance": "HIGH"
},
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002506",
"term": "Cephalexin"
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]
} | {
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],
"interventions": [
{
"id": "D002506",
"term": "Cephalexin"
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} |
NCT04662866 | null | Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose | Glucose Metabolism in South Asian Women With IGT or IFG. DIAbetes in South Asians - DIASA 3: A 12-week Intervention Trial With Oral Antidiabetic Medication to Improve Hepatic and Whole Body Insulin Sensitivity | DIASA3 | INTERVENTIONAL | UNKNOWN | 2020-11-16T00:00:00 | null | null | null | [
"PHASE2"
] | 64 | 18 | 60 | FEMALE | false | This study will test the effect of four common oral anti-diabetic agents on hepatic insulin sensitivity in South Asian women with impaired glucose tolerance or impaired fasting glucose. In a 12-week, double-blind, randomized controlled intervention trial, the following drugs will be tested head-to-head: Metformin, Pioglitazone, Empagliflozin and Linagliptin. Additional, exploratory outcomes include whole body insulin sensitivity, insulin secretion and other markers of glucose and lipid metabolism, measured by the euglycemic clamp with stable isotope tracer dilution, indirect calorimetry and CT-measurements of abdominal adipose tissue compartment volumes and hepatic and pancreatic volume and attenuation.
The study is part of the DIASA - DIAbetes in South Asians - Research Programme, which aims to find ways to improve both prevention and treatment of type 2 diabetes in people of South Asian ethnicity. | Background: South Asians (SA) have a high prevalence of type 2 diabetes (T2D). SA i Norway develop T2D approximately 10 years earlier than Nordic subjects (NO).T2D in SA is often poorly regulated with increased risk of complications.
Research hypothesis: South Asian subjects with Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) have a high degree of hepatic insulin resistance. Treatment with certain oral antidiabetic drugs will improve hepatic insulin sensitivity more than others.
Primary objective: To assess which of four oral antidiabetic medications is most effective in improving hepatic insulin sensitivity in women of South Asian origin with IFG/IGT.
Study design: Single-center, randomized, double-blind intervention trial with 4 parallel treatment arms: 1) Metformin 2) Pioglitazone 3) Empagliflozin 4) Linagliptin.
Endogenous glucose production (EGP) and hepatic and whole body insulin sensitivity will be assessed by a 2-step euglycemic, hyperinsulinemic clamp with deuterated glucose tracer. In addition, glucose and lipid metabolism will be assessed by indirect calorimetry (IC), insulin secretion by an oral glucose tolerance test (OGTT), and fatty infiltration in liver by computer tomography (CT).
Recruitment: From South Asian women with IFG/IGT who participated in DIASA 1.
Duration of study: 14 weeks, with a total of four study visits, every 4 weeks, plus two CT scans, at baseline and 12 weeks, and one end of study follow-up telephone visit at 14 weeks. The project is expected to last a maximum of 3 years.
Study population: Women ≥ 18 years of age of South Asian ethnicity with IGT/IFG.
Criteria for evaluation: Efficacy outcome will include evaluation of change in EGP from baseline to 12 weeks. Laboratory parameters of glucose and lipid metabolism. Questionnaires with physical activity and food frequency. Safety and tolerability will be assessed by clinical adverse events and laboratory measurements from randomization to 14 weeks.
Primary outcome: Difference between treatment arms in change in EGP from baseline to 12 weeks.
Explorative outcomes: Difference between treatment arms in change from randomisation to 12 weeks in:
* whole body insulin sensitivity
* HbA1c
* glucose and lipid metabolism measured by IC
* fatty infiltration in liver and visceral adipose tissue.
Statistical Methods: One-way ANOVA, Multiple regression analyses, Paired samples t-tests, longitudinal analyses. | Inclusion Criteria:
1. Able and willing to give informed consent
2. Woman ≥ 18 years of age
3. Of South Asian origin
4. Participated in the DIASA 1 study (i.e. has had previous gestational diabetes (GDM) in last pregnancy). A period of 3 months after the 3-year limit since childbirth after GDM is seen as acceptable for inclusion.
5. Impaired glucose tolerance (2-hour glucose value ≥7.8 and \< 11.1 mmol/l) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and \< 7.0 mmol/l) diagnosed in DIASA 1
Exclusion Criteria:
1. Known type 2 diabetes
2. Known type 1 diabetes
3. Fasting or 2-hour glucose values outside the inclusion criteria if the subject according to protocol needs to undergo an OGTT at baseline in DIASA 3
4. Pregnant or fully lactating at randomisation or planned during study period.
5. Not willing to practice a highly effective birth control method\* prior to initial dose, during study and for 2 weeks after the last administration of study drug.
6. Concomitant use of any antidiabetic medication
7. Concomitant use of fibrates or rifampicin
8. Radiological examinations iodine containing contrast the previous week before randomisation, or planned during the study period.
9. Known serious illness such as cancer (except in situ carcinoma) during past 5 years.
10. Previous radiation therapy directed towards the pelvic area.
11. Heart failure New York Heart Association (NYHA) class I-IV.
12. Estimated glomerulus filtration rate (eGFR) \< 60 ml/min/1,73m2
13. Chronic liver disease with serum levels of aspartate aminotransferase (ASAT) or alanine amino transferase (ALAT) \> 5 x upper limit of normal (ULN) or known impaired liver function (INR \> 1.5, Albumin \< 20 g/l, Bilirubin \> 20 g/l.
14. Active infectious disease at inclusion
15. Use of systemic corticosteroids \> 14 days within last 3 months before inclusion
16. Hypothyroidism where substitution with levothyroxine has not been stable for the last 3 months or with thyroid stimulating hormone (TSH) outside normal limits.
17. A history of bullous pemphigoid
18. A history of acute or chronic pancreatitis
19. Previous or present acute metabolic acidosis.
20. Known hypersensitivity to any of the active ingredients or additives in the study medication or placebo capsules.
21. Macroscopic haematuria not previously examined
22. History of major surgical procedures within 3 months prior to inclusion or planned during study period.
23. Any condition which in the investigator's opinion would jeopardize the subject's safety or compliance with the protocol.
* Birth control methods which may be considered as highly effective: Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence. | Oslo University Hospital | OTHER | {
"id": "24993",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-12-04T00:00:00 | {
"date": "2021-04-08",
"type": "ACTUAL"
} | {
"date": "2020-12-10",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomised controlled trial (RCT), 4 parallel groups",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Blinded medication",
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Impaired Glucose Tolerance",
"Insulin Sensitivity",
"Glucose Metabolism Disorders"
] | null | null | [
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"city": "Oslo",
"country": "Norway",
"facility": "Oslo University Hospital, Aker Hospital",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null
}
] | [
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"class": "OTHER",
"name": "The Research Council of Norway"
},
{
"class": "OTHER",
"name": "Norwegian Diabetes Association"
},
{
"class": "OTHER",
"name": "South-Eastern Norway Regional Health Authority"
},
{
"class": "OTHER",
"name": "University of Oslo"
},
{
"class": "OTHER",
"name": "University Hospital, Akershus"
},
{
"class": "OTHER",
"name": "Vestre Viken Hospital Trust"
},
{
"class": "OTHER",
"name": "University of Glasgow"
}
] | null | {
"other": [
{
"description": null,
"measure": "Endogenous glucose production during hyperinsulinemia",
"timeFrame": "After 12 weeks on respective drugs"
},
{
"description": null,
"measure": "Whole body insulin sensitivity",
"timeFrame": "After 12 weeks on respective drugs"
},
{
"description": null,
"measure": "Insulin secretion",
"timeFrame": "After 12 weeks on respective drugs"
},
{
"description": null,
"measure": "Liver fat",
"timeFrame": "After 12 weeks on respective drugs"
},
{
"description": null,
"measure": "Glycemia",
"timeFrame": "After 12 weeks on respective drugs"
},
{
"description": null,
"measure": "Pancreatic fat",
"timeFrame": "After 12 weeks on respective drugs"
},
{
"description": null,
"measure": "Intraabdominal fat",
"timeFrame": "After 12 weeks on respective drugs"
}
],
"primary": [
{
"description": null,
"measure": "Endogenous glucose production during fasting",
"timeFrame": "After 12 weeks on respective drugs"
}
],
"secondary": null
} | [
{
"affiliation": "Professor",
"name": "Kåre I Birkeland, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Immune System Diseases"
},
{
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"term": "Hyperglycemia"
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],
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],
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"term": "Glucose Metabolism Disorders"
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{
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]
} | {
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{
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"term": "Physiological Effects of Drugs"
},
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},
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"term": "Molecular Mechanisms of Pharmacological Action"
},
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},
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"term": "Hormones"
},
{
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"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
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"term": "Dipeptidyl-Peptidase IV Inhibitors"
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],
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"abbrev": "Hypo",
"name": "Hypoglycemic Agents"
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],
"browseLeaves": [
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"relevance": "HIGH"
},
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"name": "Insulin",
"relevance": "LOW"
},
{
"asFound": "Stretch",
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"asFound": "Immediately",
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"relevance": "LOW"
},
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"id": "M173166",
"name": "Insulin, Globin Zinc",
"relevance": "LOW"
},
{
"asFound": "Jevity",
"id": "M14343",
"name": "Protease Inhibitors",
"relevance": "HIGH"
},
{
"asFound": "Endoscopic Retrograde Cholangiopancreatography",
"id": "M4931",
"name": "Biguanides",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M19609",
"name": "HIV Protease Inhibitors",
"relevance": "LOW"
},
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"name": "Sodium-Glucose Transporter 2 Inhibitors",
"relevance": "LOW"
},
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"relevance": "LOW"
},
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"name": "Hormones",
"relevance": "LOW"
},
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"name": "Hormone Antagonists",
"relevance": "LOW"
},
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"name": "Dipeptidyl-Peptidase IV Inhibitors",
"relevance": "LOW"
},
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"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
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"id": "D008687",
"term": "Metformin"
},
{
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"term": "Pioglitazone"
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{
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"term": "Empagliflozin"
},
{
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"term": "Linagliptin"
},
{
"id": "D001645",
"term": "Biguanides"
},
{
"id": "D011480",
"term": "Protease Inhibitors"
}
]
} | {
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"term": "Metabolic Diseases"
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],
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"term": "Metformin"
},
{
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"term": "Pioglitazone"
},
{
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"term": "Empagliflozin"
},
{
"id": "D000069476",
"term": "Linagliptin"
},
{
"id": "D001645",
"term": "Biguanides"
},
{
"id": "D011480",
"term": "Protease Inhibitors"
}
]
} |
NCT06692166 | null | A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer | A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 vs Treatment of Physician's Choice in Subjects With Recurrent or Metastatic Cervical Cancer Who Progressed on or After Platinum-based Chemotherapy | None | INTERVENTIONAL | RECRUITING | 2024-11-14T00:00:00 | null | 2027-12-09T00:00:00 | 2029-12-31T00:00:00 | [
"PHASE3"
] | 420 | 18 | 75 | FEMALE | false | The purpose of this study is to compare the efficacy and safety of 9MW2821 and chemotherapy in participants with recurrent or metastatic cervical cancer who progressed on or after platinum-based chemotherapy. | null | Inclusion Criteria:
1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
2. Female subjects aged 18 to 75 years (including 18 and 75 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent.
5. Subject must have received a platinum-based chemotherapy with or without bevacizumab and received no more than 2 prior systemic therapy in the metastatic/recurrent setting. Subject must have experienced radiographic progression during or after the last treatment regimen.
6. An archival tumor tissue sample or a fresh tissue sample should be provided.
7. Life expectancy of ≥ 12 weeks.
8. Subjects must have measurable disease according to RECIST (version 1.1).
9. Adequate to receive one of the chemotherapy regimens in the control group (gemcitabine, pemetrexed, topotecan);
10. Adequate organ functions.
11. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
12. Subjects are willing to follow study procedures.
Exclusion Criteria:
1. Has other histologies not mentioned as part of the inclusion criteria above, i.e. HPV-independent adenocarcinoma or primary neuroendocrine.
2. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
3. Preexisting treatment related toxicity Grade ≥ 2. Subjects experienced Grade ≥ 3 immune related adverse events during or after immunotherapy.
4. Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
5. Major surgery within 28 days prior to first dose of study drug.
6. Hemoglobin A1C (HbA1c) ≥ 8%.
7. Preexisting peripheral neuropathy Grade ≥ 2.
8. Any live vaccines within 28 days before first dose of study drug or during the study.
9. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
10. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
11. Central nervous system metastases.
12. History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.
13. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
14. Has ocular conditions that may increase the risk of corneal epithelium damage.
15. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
16. Uncontrolled tumor-related bone pain or spinal cord compression.
17. Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.
18. Condition or situation which may put the subject at significant risk. | Mabwell (Shanghai) Bioscience Co., Ltd. | INDUSTRY | {
"id": "9MW2821-CP304",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-11-14T00:00:00 | {
"date": "2024-11-22",
"type": "ACTUAL"
} | {
"date": "2024-11-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Cervical Cancer"
] | ["Uterine Neoplasms", "Genital Neoplasms, Female", "Urogenital Neoplasms", "Neoplasms by Site", "Neoplasms", "Uterine Cervical Diseases", "Uterine Diseases", "Uterine Cervical Neoplasms"] | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Cancer Hospital Chinese Academy of Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null
},
{
"city": "Shanghai",
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null
}
] | null | null | {
"other": [
{
"description": null,
"measure": "Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores",
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},
{
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}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT06675266 | null | AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan | Development of an Artificial Intelligence Algorithm to Recognize Abnormal Findings at Routine Fetal Brain Ultrasound. AIRFRAME (Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs) | AIRFRAME | OBSERVATIONAL | RECRUITING | 2024-11-04T00:00:00 | null | 2024-12-30T00:00:00 | 2026-12-30T00:00:00 | null | 10,000 | 18 | 60 | FEMALE | true | Obstetric ultrasound represents the standard of care for the screening of the fetal anomalies. However, its performance is dependent upon several parameters including type of anomaly, gestational age, maternal habitus and skills of the examiner. The use of Artificial Intelligence (AI) in medical diagnostics has been suggested not only to reduce the inter- and intra-operator variability, but also to compress the required time necessary to perform routine tasks, hence optimizing healthcare resources. Fetal brain abnormalities are among the most challenging fetal congenital anomalies in terms of ultrasound diagnosis, prenatal counseling and management. The access to new sources of technology, i.e. AI, has the potential to improve recognition, detection and localization of brain malformations. Therefore, we propose to develop an AI-based software, which would be capable to recognize the brain structures at antenatal ultrasound and discriminate between normal and abnormal fetal brain anatomy through fully automatic data processing. | The application of AI in obstetric ultrasound includes three aspects: structure identification, automatic and standardized measurements, and classification diagnosis. Since obstetric ultrasound is time-consuming, the use of AI could also reduce examination time and improve workflow.
Study design: this is a multicenter retrospective observational cohort study and subsequent prospective cohort study. The study design will be organized in two different phases.
The first phase, the feasibility retrospective study, has the objective to develop and train AI-Algorithm with normal and abnormal images retrospectively acquired during second trimester ultrasound scan from various international fetal medicine centers.
The second phase, a prospective clinical validation, has the objective to test the AI-Algorithm in the assessment of basic fetal brain anatomy in a real clinic setting with real patients from each of the participating fetal medicine centers.
Setting: Three (3) fetal medicine centers.
Participants: singleton pregnant population who underwent ultrasound examination between 19 - 22 weeks of gestation in the participating centers.
Primary endpoint: to validate a novel AI-based technology for the automated assessment of the basic anatomy of the fetal brain which could potentially be used to support second trimester screening scan.
Secondary endpoints:
To improve the performance of the standard second trimester screening of fetal brain anatomy ensuring its reliable sonographic assessment within a shorter time of execution.
To detect higher repeatability and reproducibility, allowing to implement the ultrasound screening also in terms of efficiency on a vast scale, optimizing healthcare resources In the first phase of the study, participating fetal medicine centers will search their electronic databases for images of singleton pregnant women who underwent ultrasound imaging at 19+0 - 22+6 weeks of gestation with any fetal brain anomaly. Normal images of the fetal brain at the same gestational age will be provided by the promoting centers - i.e., Fondazione Policlinico A. Gemelli, IRCCS and University of Parma. Clinical, ultrasound, prenatal and postnatal information of each case will be retrieved from patient's medical records and entered an electronic database collection file by the principal investigator from each participating center. The acquired images will be anonymized, saved as DICOM and shared through a dedicated cloud storage system which will be set up by the bioengineering team. Each center will be able to access the web system using a personal ID and password.
In the second phase of the study, the algorithm will be prospectively tested and validated in a real clinical setting with real patients from each of the participating fetal medicine centers. Inclusion and exclusion criteria, imaging protocol and data collection will be the same carried out during the retrospective phase. | Inclusion Criteria:
* Women with singleton pregnancies undergoing ultrasound examination between 19+0 - 22+6 weeks of gestation
Exclusion Criteria:
* Women who did not have the second trimester screening scan at the settled gestational age.
* Women in which a good visualization of the transventricular, transthalamic and transcerebellar plane of the fetal head was not technically possible.
* Women who are not able to give the informed consent. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER | {
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] | ["Fetal Brain Anomaly", "Brain Malformation", "Second trimester ultrasound Scan"] | null | [
{
"city": "Rome",
"country": "Italy",
"facility": "Fondazione Policlinico Universitario Agostino Gemelli",
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] | null | {
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],
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"timeFrame": "1 year"
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} | [
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"affiliation": "Fondazione Policlinico Universitario A. Gemelli, IRCCS",
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] | [{"pmid": "28371793", "type": "RESULT", "citation": "Chen H, Wu L, Dou Q, Qin J, Li S, Cheng JZ, Ni D, Heng PA. Ultrasound Standard Plane Detection Using a Composite Neural Network Framework. IEEE Trans Cybern. 2017 Jun;47(6):1576-1586. doi: 10.1109/TCYB.2017.2685080. Epub 2017 Mar 30."}, {"pmid": "28534800", "type": "RESULT", "citation": "Yu Z, Tan EL, Ni D, Qin J, Chen S, Li S, Lei B, Wang T. A Deep Convolutional Neural Network-Based Framework for Automatic Fetal Facial Standard Plane Recognition. IEEE J Biomed Health Inform. 2018 May;22(3):874-885. doi: 10.1109/JBHI.2017.2705031. Epub 2017 May 17."}, {"pmid": "28958729", "type": "RESULT", "citation": "Yaqub M, Kelly B, Papageorghiou AT, Noble JA. A Deep Learning Solution for Automatic Fetal Neurosonographic Diagnostic Plane Verification Using Clinical Standard Constraints. Ultrasound Med Biol. 2017 Dec;43(12):2925-2933. doi: 10.1016/j.ultrasmedbio.2017.07.013. Epub 2017 Sep 28."}, {"pmid": "30177447", "type": "RESULT", "citation": "Ambroise Grandjean G, Hossu G, Bertholdt C, Noble P, Morel O, Grange G. Artificial intelligence assistance for fetal head biometry: Assessment of automated measurement software. Diagn Interv Imaging. 2018 Nov;99(11):709-716. doi: 10.1016/j.diii.2018.08.001. Epub 2018 Sep 1."}, {"pmid": "27714775", "type": "RESULT", "citation": "Rydberg C, Tunon K. Detection of fetal abnormalities by second-trimester ultrasound screening in a non-selected population. Acta Obstet Gynecol Scand. 2017 Feb;96(2):176-182. doi: 10.1111/aogs.13037. Epub 2016 Nov 22."}, {"pmid": "10369506", "type": "RESULT", "citation": "Hendricks KA, Simpson JS, Larsen RD. Neural tube defects along the Texas-Mexico border, 1993-1995. Am J Epidemiol. 1999 Jun 15;149(12):1119-27. doi: 10.1093/oxfordjournals.aje.a009766."}, {"pmid": "16303691", "type": "RESULT", "citation": "Klusmann A, Heinrich B, Stopler H, Gartner J, Mayatepek E, Von Kries R. A decreasing rate of neural tube defects following the recommendations for periconceptional folic acid supplementation. Acta Paediatr. 2005 Nov;94(11):1538-42. doi: 10.1080/08035250500340396."}, {"pmid": "14745929", "type": "RESULT", "citation": "De Wals P, Rusen ID, Lee NS, Morin P, Niyonsenga T. Trend in prevalence of neural tube defects in Quebec. Birth Defects Res A Clin Mol Teratol. 2003 Nov;67(11):919-23. doi: 10.1002/bdra.10124."}] | {"versionHolder": "2025-06-18"} | {
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NCT04372966 | null | Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures | Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures | None | INTERVENTIONAL | TERMINATED | 2020-04-27T00:00:00 | null | 2011-12-29T00:00:00 | 2016-12-29T00:00:00 | [
"NA"
] | 50 | 60 | null | ALL | false | Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures. | Hip fractures account for 20% of all fractures and displaced subcapital fractures represent 45% of the hip fracture workload. All of these patients are treated with some form of hip replacement. Recent randomised trials have confirmed that total hip replacement is probably the best choice of treatment in a fit older patient and is better than partial hip replacement or repair of the fracture with screws which are the other most commonly used treatments. Hip replacements may be cemented or uncemented. The uncemented type of hip replacement has not been commonly used in this group of patients but may have some advantages. The uncemented hip replacement is a shorter operation and this may be advantageous in the hip fracture population group since these are older patients, many of whom have other medical problems. The use of cement is occasionally associated with development of heart problems during anaesthesia.
Participants: The original aim was to recruit 200 patients who have been admitted with a displaced subcapital hip fracture to the New Royal Infirmary and will undergo total hip replacement surgery within 48 hours of admission. Patients fitting the inclusion criteria will be given a patient information sheet and will be given between 24-48 hours to decide whether they give consent to participate in the trial. Patients who have given their consent will be randomly allocated to one of two groups i.e.. allocation to one of the two groups will entirely by chance. Each group will have 100 patients.
Intervention Both groups will received a total hip replacement. The only difference between the two groups is the type of hip replacement and the way it is fixed in the thigh bone. One type of hip replacement requires cement ('Exeter'), the other ('CORAIL' from DePuy) doesn't. Other surgical protocols and care after the surgery will be exactly the same for both groups.
Purpose The purpose of this research is to compare the clinical outcome (i.e. complications, revisions etc.) and the function of the patients between the two groups at several different time points: around 8 weeks, 4 months, 12 months and 24 months post surgery.
Outcome measures Clinical: Surgery complications, duration of surgery, readmissions, revision surgery, duration of hospital stay. | Inclusion Criteria:
* patients over the age of 60 years with a displaced intracapsular hip fracture and are admitted to the study centre and are under the care of four orthopaedic trauma surgeons
* patients who were independently mobile before their hip fracture
* patients without cognitive impairment (mini-mental score \>6) and able to give informed consent
* patients without serious concomitant disease
Exclusion Criteria:
* those not meeting the inclusion criteria
* patients who are not independently mobile outside the home
* unable to give informed consent
* serious concomitant disease with anaesthetic risk too great for Tsurgery | NHS Lothian | OTHER_GOV | {
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} | The Chief Investigator (John Keating) | {
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"date": "2020-05-04",
"type": "ACTUAL"
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},
{
"description": null,
"measure": "Subjective patient hip pain",
"timeFrame": "6, 12 and 72 months"
},
{
"description": null,
"measure": "Operative time",
"timeFrame": "At time of index surgery"
},
{
"description": null,
"measure": "Intraoperative blood loss",
"timeFrame": "At time of of surgery"
},
{
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"timeFrame": "6, 12 and 72 months"
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{
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"timeFrame": "Time of surgery until one year following surgery"
},
{
"description": null,
"measure": "Survival",
"timeFrame": "Time of index surgery until final follow up (72 months), revision or death"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT01299766 | null | Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment | Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment | None | INTERVENTIONAL | COMPLETED | 2011-02-16T00:00:00 | null | 2016-12-13T00:00:00 | 2016-12-13T00:00:00 | [
"PHASE3"
] | 221 | 65 | null | ALL | false | The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months. | The goal of this study is to determine whether increasing participation in activities prevents cognitive decline in older African Americans with Mild Cognitive Impairment (MCI). We will attempt to increase activities with Behavioral Activation (BA). BA is a manual-based, behavioral treatment to increase activities as a way to improve function and mood. As patients do more (through activation) and perceive the benefit (i.e., feel better), their activity levels increase. BA promotes activities that reflect an individual's preferences and goals by structuring, scheduling, and reinforcing daily activities. This increases participation in activities with strong personal value, such as social engagement or normative role function, which in turn enhances mood and motivation to remain active.
The control treatment is Supportive Therapy, which is a non-directive, supportive therapy that is based on empathy, reflection, and support.
This study is specifically targeting older African Americans (AAs). Most clinical trials for MCI have tested pharmacologic treatments and have enrolled mostly Whites; their results may not apply to AAs whose life experiences and medical and genetic characteristics may exert unique effects. Those with MCI are a high-risk population for whom interventions to prevent cognitive decline are particularly important. Because AAs comprise one of the largest minority groups in the U.S., suffer disparities in health outcomes, and are unlikely to seek pharmacologic treatments or participate in clinical drug trials, there is an urgent need to enroll older AAs in non-pharmacologic intervention studies of cognition.
We will recruit 200 AA subjects aged 65 and older who have amnestic Mild Cognitive Impairment (MCI) - Multiple Domain subtype of MCI (aMCI-MD). One of the inclusion criteria is for participants to have a Knowledgeable Informant (KI) who is willing to participate in the study (with the subject's permission as documented in the informed consent form). A KI is defined as a family member or friend who is identified by the subject as someone who has regular and frequent contact with the subject (at least twice per week) in-person or by phone. The KI will be asked to provide information regarding the subject's functioning. | Inclusion Criteria:
* Age 65 years and older
* Having a friend/relative willing to serve as a Knowledgeable Informant (KI)
* Diagnosis of aMCI-MD
* Self-identified as African American
Exclusion Criteria:
* Psychiatric diagnosis, including dementia and major depression
* Sensory deficits that preclude neuropsychological testing
* Institutional residence
* Reduced life expectancy due to known terminal illness | Thomas Jefferson University | OTHER | {
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"description": null,
"measure": "Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)",
"timeFrame": "24 months"
}
],
"secondary": [
{
"description": null,
"measure": "Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year",
"timeFrame": "24 months"
}
]
} | [
{
"affiliation": "Thomas Jefferson University",
"name": "Robin J Casten, PhD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "31087388", "type": "DERIVED", "citation": "Rovner BW, Casten RJ, Leiby B. Memory improvement in African Americans with amnestic mild cognitive impairment. Int J Geriatr Psychiatry. 2019 Oct;34(10):1447-1454. doi: 10.1002/gps.5141. Epub 2019 Jun 18."}, {"pmid": "30208380", "type": "DERIVED", "citation": "Rovner BW, Casten RJ, Hegel MT, Leiby B. Preventing Cognitive Decline in Black Individuals With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1487-1493. doi: 10.1001/jamaneurol.2018.2513."}, {"pmid": "27000348", "type": "DERIVED", "citation": "Rovner BW, Casten RJ. Preserving Cognition in Older African Americans with Mild Cognitive Impairment. J Am Geriatr Soc. 2016 Mar;64(3):659-61. doi: 10.1111/jgs.14012. No abstract available."}, {"pmid": "25811797", "type": "DERIVED", "citation": "Rovner BW, Casten RJ, Leiby BE. Determinants of Activity Levels in African Americans With Mild Cognitive Impairment. Alzheimer Dis Assoc Disord. 2016 Jan-Mar;30(1):41-6. doi: 10.1097/WAD.0000000000000096."}, {"pmid": "22406101", "type": "DERIVED", "citation": "Rovner BW, Casten RJ, Hegel MT, Leiby BE. Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial. Contemp Clin Trials. 2012 Jul;33(4):712-20. doi: 10.1016/j.cct.2012.02.016. Epub 2012 Mar 2."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003072",
"term": "Cognition Disorders"
},
{
"id": "D019965",
"term": "Neurocognitive Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
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"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
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"name": "All Conditions"
}
],
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},
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},
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},
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D060825",
"term": "Cognitive Dysfunction"
}
]
} | null | {
"conditions": [
{
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}
],
"interventions": null
} |
NCT03494166 | null | Post-chemotherapy Symptom Management SMART | Post-chemotherapy Symptom Management: Testing Intervention Sequences in a SMART Design | None | INTERVENTIONAL | COMPLETED | 2018-03-30T00:00:00 | null | 2022-06-03T00:00:00 | 2022-06-03T00:00:00 | [
"NA"
] | 498 | 18 | null | ALL | false | Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms.
High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N=282) or 12-week SMSH Telephone Interpersonal Counseling (TIPC, N=93) added during weeks 1-8. After 4 weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N=30) or add TIPC (N=31). | Nearly 15.5 million Americans have survived cancer and virtually all have experienced symptoms from cancer treatment. Numerous symptom management interventions have been tested during active treatment, yet few have addressed the continuing fatigue, pain, depression, etc. that endure following the end of treatment.
Existing post-treatment symptom management research has targeted survivors months after the end of active treatment, overlooking the immediate post-treatment period. During this period, some survivors have their symptoms resolve naturally (low need for intervention), while others suffer from high symptom burden (high need for intervention), with 30% experiencing depression. Sample: Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years.
Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding Telephone Interpersonal Counselling (TIPC) to the SMSH. After 4 weeks, non-responders to SMSH alone on depression were re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIPC added for the remaining 8 weeks.
The primary outcome was symptom severity index, secondary outcome was depressive symptoms. The hypotheses tests included comparisons of primary and secondary outcomes according tp first randomization and second randomization for non-responders. | Inclusion Criteria:
* Survivors must have a new diagnosis or localized recurrence of solid tumor cancer
* Be finishing curative intent adjuvant chemotherapy or chemoradiation, and do not have any subsequent cancer treatments planned, except for radiation therapy, hormonal therapy or trastuzumab for breast cancer.
* 18 years of age or older
* Have access to a telephone
* Understand English or Spanish
* Are not currently receiving counseling and/or psychotherapy
Exclusion Criteria:
* Diagnosis of a psychotic disorder in medical record verified by the recruiter
* Nursing home resident
* Bedridden
* Currently receiving counseling and/or psychotherapy. | University of Arizona | OTHER | {
"id": "1711069340",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-04-03T00:00:00 | {
"date": "2023-10-19",
"type": "ACTUAL"
} | {
"date": "2018-04-11",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Following baseline, symptom management need (high versus low need) will be determined. The low need group will not receive interventions, but will be followed at week 4 for a brief symptom assessment and at week 13. The high need group will be randomly assigned to either: 1) SMSH alone or 2) TIP-C+SMSH for 8 weeks followed by continued 4 weeks of SMSH alone. We will mail the SMSH, printed in the survivor's preferred language, following randomization. All high need participants will receive weekly telephone contacts during weeks 1-12 to assess symptoms, deliver the assigned intervention, and assess intervention enactment and fidelity. After the initial 4 weeks, responders on depression will continue with the SMSH only. Non-responders will re-randomized to either continue with the SMSH alone or add TIP-C. Those initially randomized to TIP-C+SMSH will not be re-randomized. Total duration of each of the three intervention sequences is 12 weeks.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Data collectors will be blinded to the arm of the study.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Cancer"
] | ["Chemotherapy, symptom management"] | null | [
{
"city": "Phoenix",
"country": "United States",
"facility": "Cancer Center at St. Joseph's",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona"
},
{
"city": "Tucson",
"country": "United States",
"facility": "University of Arizona",
"geoPoint": {
"lat": 32.22174,
"lon": -110.92648
},
"state": "Arizona"
}
] | [
{
"class": "OTHER",
"name": "Michigan State University"
},
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Symptom Severity Index- Comparison of Two Groups Created by First Randomization",
"timeFrame": "Weeks 1-13"
},
{
"description": null,
"measure": "Symptom Severity Index- Comparison of Two Groups Created by Second Randomization",
"timeFrame": "Weeks 5-13"
}
],
"secondary": [
{
"description": null,
"measure": "Depressive Symptoms- Comparison of Two Groups Created by First Randomization.",
"timeFrame": "Week 13"
},
{
"description": null,
"measure": "Depressive Symptoms - Comparison of Two Groups Created by Second Randomization",
"timeFrame": "Week 13"
}
]
} | [
{
"affiliation": "University of Arizona",
"name": "Terry Badger, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "36801353", "type": "RESULT", "citation": "Sikorskii A, Badger T, Segrin C, Crane TE, Chalasani P, Arslan W, Hadeed M, Morrill KE, Given C. A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy. J Pain Symptom Manage. 2023 Jun;65(6):541-552.e2. doi: 10.1016/j.jpainsymman.2023.02.005. Epub 2023 Feb 17."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00492466 | null | Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies | A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies | RECOVER | INTERVENTIONAL | COMPLETED | 2007-06-25T00:00:00 | null | null | null | [
"PHASE4"
] | 14 | 18 | 55 | ALL | false | This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta. | This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.
In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.
The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.
Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months. | Inclusion Criteria:
* Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
* Disability equivalent to EDSS of 6.0 or less
* Clinical activity defined as at least one relapse rate within the last 12 months
* NAb titre \>20 (measured at least 48 hours after last interferon-beta injection
* has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment
Exclusion Criteria:
* Any condition that might give rise to similar symptoms as MS
* Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
* Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
* History of major depression
* Alcohol or drug dependency
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
* hypertension (BP \> 180/110 mmHg)
* Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
* Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
* Gastro-intestinal ulcers, gastritis, or dyspepsia
* Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives | Biogen | INDUSTRY | {
"id": "RECOVER",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-06-26T00:00:00 | {
"date": "2008-01-30",
"type": "ESTIMATED"
} | {
"date": "2007-06-27",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Relapsing-Remitting Multiple Sclerosis"
] | ["Multiple Sclerosis", "antibody", "Neutralizing antibody", "Binding antibody", "MxA protein"] | null | [
{
"city": "Turku",
"country": "Finland",
"facility": "Coordinating Research Site",
"geoPoint": {
"lat": 60.45148,
"lon": 22.26869
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)",
"timeFrame": "Month -1 and after 3, 6, 9, 12, and 15 months"
}
],
"secondary": [
{
"description": null,
"measure": "Change in MxA protein values",
"timeFrame": "Month -1 and after 3, 6, 9, 12, and 15 months"
},
{
"description": null,
"measure": "Change in binding antibody (Bab) tires",
"timeFrame": "Month -1 and after 3, 6, 9, 12, and 15 months"
},
{
"description": null,
"measure": "Proportion of patients with NAb positive titre <5",
"timeFrame": "Month -1 and after 3, 6, 9, 12, and 15 months"
},
{
"description": null,
"measure": "Change in annualised relapse rate",
"timeFrame": "at 3, 6, 9, 12, and 15 months"
},
{
"description": null,
"measure": "The number of relapse-free patients",
"timeFrame": "at 3, 6, 9, 12, and 15 months"
}
]
} | [
{
"affiliation": "[email protected]",
"name": "Biogen-Idec Investigator",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D020278",
"term": "Demyelinating Autoimmune Diseases, CNS"
},
{
"id": "D020274",
"term": "Autoimmune Diseases of the Nervous System"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D003711",
"term": "Demyelinating Diseases"
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{
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"term": "Autoimmune Diseases"
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{
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"term": "Immune System Diseases"
}
],
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"abbrev": "BC10",
"name": "Nervous System Diseases"
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"name": "All Conditions"
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"abbrev": "BC23",
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],
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"name": "Sclerosis",
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},
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},
{
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"id": "M4629",
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},
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},
{
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"id": "M10200",
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}
],
"meshes": [
{
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"term": "Multiple Sclerosis"
},
{
"id": "D020529",
"term": "Multiple Sclerosis, Relapsing-Remitting"
},
{
"id": "D012598",
"term": "Sclerosis"
}
]
} | {
"ancestors": [
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},
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},
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{
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{
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{
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{
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},
{
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"term": "Adjuvants, Immunologic"
}
],
"browseBranches": [
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"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
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},
{
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{
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{
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{
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],
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"relevance": "LOW"
},
{
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"relevance": "HIGH"
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{
"asFound": "Operative",
"id": "M11749",
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"relevance": "HIGH"
},
{
"asFound": null,
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"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": "Gene Expression",
"id": "M272",
"name": "Interferon beta-1a",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10537",
"name": "Iron-Dextran Complex",
"relevance": "LOW"
},
{
"asFound": "Fluticasone",
"id": "M19244",
"name": "Interferon-beta",
"relevance": "HIGH"
},
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"relevance": "LOW"
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"relevance": "LOW"
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"id": "M4251",
"name": "Antiemetics",
"relevance": "LOW"
},
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"name": "Gastrointestinal Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9047",
"name": "Glucocorticoids",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9788",
"name": "Hormone Antagonists",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20773",
"name": "Neuroprotective Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21869",
"name": "Protective Agents",
"relevance": "LOW"
},
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"asFound": null,
"id": "M10201",
"name": "Immunologic Factors",
"relevance": "LOW"
},
{
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"relevance": "LOW"
}
],
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"id": "D007372",
"term": "Interferons"
},
{
"id": "D016899",
"term": "Interferon-beta"
},
{
"id": "D000068556",
"term": "Interferon beta-1a"
},
{
"id": "D008775",
"term": "Methylprednisolone"
}
]
} | {
"conditions": [
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"term": "Multiple Sclerosis"
},
{
"id": "D020529",
"term": "Multiple Sclerosis, Relapsing-Remitting"
},
{
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"term": "Sclerosis"
}
],
"interventions": [
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"term": "Interferons"
},
{
"id": "D016899",
"term": "Interferon-beta"
},
{
"id": "D000068556",
"term": "Interferon beta-1a"
},
{
"id": "D008775",
"term": "Methylprednisolone"
}
]
} |
NCT02455466 | null | Altered PSA Test Due to Possible Suspected Heterophilic Antibodies | Altered PSA Test Due to Possible Suspected Heterophilic Antibodies | None | OBSERVATIONAL | TERMINATED | 2015-05-11T00:00:00 | null | 2016-12-31T00:00:00 | 2016-12-31T00:00:00 | null | 50 | 40 | 90 | MALE | false | The purpose of this study is to investigate if clinically non explainable high or low Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the serum of participants. The investigators will examine if heterophilic antibodies are the reasons of altered PSA levels. | null | Inclusion Criteria:
* Male, with a a clinically high or low unexplainable PSA measurement
* Age between 40 and 90 years
* Written informed consent
Exclusion Criteria:
* Female
* No PSA measurement available or planned
* Age over 90 or under 40 years | University of Zurich | OTHER | {
"id": "2014-0652",
"link": null,
"type": null
} | not enough recruitment | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-05-26T00:00:00 | {
"date": "2017-05-31",
"type": "ACTUAL"
} | {
"date": "2015-05-27",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Male, where a PSA measurement is planned | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"PSA"
] | null | null | [
{
"city": "Zürich",
"country": "Switzerland",
"facility": "University Hospital Zürich",
"geoPoint": {
"lat": 47.36667,
"lon": 8.54999
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Presence of heterophilic antibodies in the serum of participants",
"timeFrame": "1.5 years"
},
{
"description": null,
"measure": "Altered PSA levels due to the Presence of Heterophilic antibodies",
"timeFrame": "1.5 years"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | null | {
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"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
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"relevance": "LOW"
}
],
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} | {
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} |
NCT06797466 | null | Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy | Investigation of the Effect of Three Dimensional Virtual Reconstruction (3D) on Percutaneous Nephrolithotomy Learning Curve in Specialist Training | None | INTERVENTIONAL | RECRUITING | 2025-01-21T00:00:00 | null | 2025-01-21T00:00:00 | 2025-10-31T00:00:00 | [
"NA"
] | 100 | 18 | null | ALL | false | The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training. | null | Inclusion Criteria:
* Patients with kidney stones larger than 2 cm and those with PCNL indication.
Exclusion Criteria:
* Patients with missing CT images, missing clinical information, or inaccessible | Adiyaman University | OTHER | {
"id": "HRÜ/24.21.44",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-01-27T00:00:00 | {
"date": "2025-05-09",
"type": "ACTUAL"
} | {
"date": "2025-01-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
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},
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"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"PNL",
"Stone, Kidney"
] | null | null | [
{
"city": "Adıyaman",
"country": "Turkey",
"facility": "Adıyaman University",
"geoPoint": {
"lat": 37.76441,
"lon": 38.27629
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of Participants with perioperative Bleeding.",
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},
{
"description": null,
"measure": "Number of Participants with stone free",
"timeFrame": "1 month after the intervention/procedure/surgery"
},
{
"description": null,
"measure": "leng of the hospital stay",
"timeFrame": "immediately after the intervention/procedure/surgery"
}
],
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{
"description": null,
"measure": "Number of Participants with Complication",
"timeFrame": "immediately after the intervention/procedure/surgery"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D007674",
"term": "Kidney Diseases"
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{
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"term": "Female Urogenital Diseases and Pregnancy Complications"
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{
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"term": "Urogenital Diseases"
},
{
"id": "D052878",
"term": "Urolithiasis"
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{
"id": "D014545",
"term": "Urinary Calculi"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
},
{
"id": "D002137",
"term": "Calculi"
},
{
"id": "D020763",
"term": "Pathological Conditions, Anatomical"
}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
}
],
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"relevance": "HIGH"
},
{
"asFound": "Stone, Kidney",
"id": "M27126",
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},
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"id": "M27093",
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},
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},
{
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},
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"id": "D007669",
"term": "Kidney Calculi"
},
{
"id": "D053040",
"term": "Nephrolithiasis"
}
]
} | null | {
"conditions": [
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{
"id": "D053040",
"term": "Nephrolithiasis"
}
],
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} |
NCT05216666 | null | The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty | Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis | HSS | INTERVENTIONAL | RECRUITING | 2022-01-15T00:00:00 | null | null | null | [
"NA"
] | 580 | 40 | 80 | ALL | false | Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach. | The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty.
580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated. | Inclusion Criteria:
* Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
* Ability to understand and write swedish.
Exclusion Criteria:
* Impaired funktion of the contralateral hip or knees causing limping.
* Neuromuscular diseases
* Postoperative leg length discrepancy excceding 1 cm
* Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip. | Sahlgrenska University Hospital | OTHER | {
"id": "277461",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2022-01-27T00:00:00 | {
"date": "2025-04-09",
"type": "ACTUAL"
} | {
"date": "2022-01-31",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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} | [
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"Muscle Weakness",
"Muscle Atrophy",
"Muscle Injury",
"Arthroplasty Complications"
] | ["abductor", "approach", "limp", "Trendelenburg", "gluteus medius"] | null | [
{
"city": "Mölndal",
"country": "Sweden",
"facility": "Sahlgrenska University Hospital",
"geoPoint": {
"lat": 57.6554,
"lon": 12.01378
},
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}
] | [
{
"class": "OTHER_GOV",
"name": "Vastra Gotaland Region"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Trendelenburg sign as binary variable (positive/negative)",
"timeFrame": "At 12 months after intervention"
}
],
"secondary": [
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"description": null,
"measure": "Dislocation",
"timeFrame": "Within 12 months from intervention"
},
{
"description": null,
"measure": "Intraoperative blood loss",
"timeFrame": "Intraoperative"
},
{
"description": null,
"measure": "Periprosthetic infection",
"timeFrame": "Within 12 months from intervention"
},
{
"description": null,
"measure": "Oxford Hip Score",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "Oxford Hip Score",
"timeFrame": "At 12 months after intervention"
},
{
"description": null,
"measure": "Euroqol 5 dimension 5 level index (EQ5D-5L)",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "Euroqol 5 dimension 5 level index (EQ5D-5L)",
"timeFrame": "At 12 months after intervention"
},
{
"description": null,
"measure": "Euroqol visual analog scale (EQVAS)",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "Euroqol visual analog scale (EQVAS)",
"timeFrame": "At 12 months after intervention"
},
{
"description": null,
"measure": "University of California Activity Level (UCLA)",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "University of California Activity Level (UCLA)",
"timeFrame": "At 12 months after intervention"
},
{
"description": null,
"measure": "Gluteus medius avulsion in ultrasound",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "Gluteus medius atrophy in Magnetic Resonance Imaging",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "Hip abuction torque",
"timeFrame": "At 3 months after intervention"
},
{
"description": null,
"measure": "Trendelenburg sign as binary variable (positive/negative)",
"timeFrame": "At 3 months after intervention"
}
]
} | [
{
"affiliation": "Sahlgrenska University Hospital",
"name": "Georgios Tsikandylakis, MD PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "23039167", "type": "BACKGROUND", "citation": "Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8."}, {"pmid": "28440704", "type": "BACKGROUND", "citation": "Zijlstra WP, De Hartog B, Van Steenbergen LN, Scheurs BW, Nelissen RGHH. Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty. Acta Orthop. 2017 Aug;88(4):395-401. doi: 10.1080/17453674.2017.1317515. Epub 2017 Apr 25."}, {"pmid": "31060427", "type": "BACKGROUND", "citation": "Skoogh O, Tsikandylakis G, Mohaddes M, Nemes S, Odin D, Grant P, Rolfson O. Contemporary posterior surgical approach in total hip replacement: still more reoperations due to dislocation compared with direct lateral approach? An observational study of the Swedish Hip Arthroplasty Register including 156,979 hips. Acta Orthop. 2019 Oct;90(5):411-416. doi: 10.1080/17453674.2019.1610269. Epub 2019 May 7."}, {"pmid": "30080985", "type": "BACKGROUND", "citation": "Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6."}, {"pmid": "31146555", "type": "BACKGROUND", "citation": "Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1."}, {"pmid": "22410129", "type": "BACKGROUND", "citation": "Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10."}] | {"versionHolder": "2025-06-18"} | {
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{
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"term": "Osteoarthritis, Hip"
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{
"id": "D009133",
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],
"interventions": null
} |
NCT02715466 | null | Gelatin in ICU and Sepsis | Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis | GENIUS | INTERVENTIONAL | TERMINATED | 2016-03-17T00:00:00 | null | 2021-12-08T00:00:00 | 2021-12-08T00:00:00 | [
"PHASE4"
] | 167 | 18 | 85 | ALL | false | This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock. | null | Inclusion Criteria:
* Male or female patients ≥ 18 years of age
* Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
* Patients with body weight ≤ 140 kg
* Patients diagnosed severe sepsis / septic shock at admission on Intensive Care Unit who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during Intensive Care Unit stay who can be enrolled within 90 min after diagnosis
* Patients where antibiotic therapy has already been started (prior to randomization)
* Patient who are fluid responsive. Fluid responsiveness is defined as increase of \> 10% in mean arterial pressure (MAP) after passive leg raising (PLR)
* Signed informed consent by patient, legal representative or authorized person or deferred consent
Exclusion Criteria:
* Administration of HES, dextrane solutions or \> 500 ml of Gelatin solutions within the 24 h prior to randomization
* Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
* Patients for whom the need of pressure infusions are expected
* Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
* Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
* Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e. partial thromboplastin time \> 60 sec)
* Acutely burned patients
* Contraindications according to summary of product characteristics of investigational test and reference product
* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) | B. Braun Melsungen AG | INDUSTRY | {
"id": "HC-G-H-1209",
"link": null,
"type": null
} | recommended by DSMB | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2016-03-21T00:00:00 | {
"date": "2024-08-22",
"type": "ACTUAL"
} | {
"date": "2016-03-22",
"type": "ESTIMATED"
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} | [
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"facility": "Medizinische Universität Innsbruck",
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"facility": "Hospital Universitario La Paz",
"geoPoint": {
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] | null | null | {
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],
"secondary": [
{
"description": null,
"measure": "Length of stay (LOS) in the intensive care unit (ICU)",
"timeFrame": "Intensive care unit (ICU) discharge or day 28"
}
]
} | [
{
"affiliation": "Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin",
"name": "Gernot Marx, Prof. Dr. med.",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "34078421", "type": "DERIVED", "citation": "Marx G, Zacharowski K, Ichai C, Asehnoune K, Cerny V, Dembinski R, Ferrer Roca R, Fries D, Molnar Z, Rosenberger P, Sanchez-Sanchez M, Schurholz T, Dehnhardt T, Schmier S, von Kleist E, Brauer U, Simon TP. Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis. Trials. 2021 Jun 2;22(1):376. doi: 10.1186/s13063-021-05311-8."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D010335",
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],
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}
],
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{
"id": "D020896",
"term": "Hypovolemia"
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]
} | {
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"abbrev": "PhSol",
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],
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"id": "D019999",
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}
]
} |
NCT00417066 | null | Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders | The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders | None | INTERVENTIONAL | COMPLETED | 2006-12-22T00:00:00 | null | null | null | [
"PHASE4"
] | 270 | 18 | 50 | FEMALE | true | The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients. | Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients.
Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups. | Inclusion Criteria:
* regular menstrual cycle
* 1 or more failed IVF attempts with poor response
* 5 or fewer oocytes retrieved
* FSH\>12 IU/l on day 3
Exclusion Criteria:
* PCOS
* Normal responders | Eugonia | OTHER | {
"id": "poor responders",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-12-28T00:00:00 | {
"date": "2013-12-16",
"type": "ESTIMATED"
} | {
"date": "2006-12-29",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Infertility",
"Premature Ovarian Failure"
] | ["poor responders", "GnRH antagonist", "GnRH agonist", "flare up", "short protocol"] | null | [
{
"city": "Athens",
"country": "Greece",
"facility": "Eugonia",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Ongoing pregnancy rate per embryo transfer",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.",
"timeFrame": null
},
{
"description": null,
"measure": "Number of mature oocytes retrieved.",
"timeFrame": null
},
{
"description": null,
"measure": "Number of fertilised oocytes.",
"timeFrame": null
}
]
} | [
{
"affiliation": "Eugonia",
"name": "Tryfon Lainas, PhD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "12638782", "type": "BACKGROUND", "citation": "Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007."}, {"pmid": "18403419", "type": "DERIVED", "citation": "Lainas TG, Sfontouris IA, Papanikolaou EG, Zorzovilis JZ, Petsas GK, Lainas GT, Kolibianakis EM. Flexible GnRH antagonist versus flare-up GnRH agonist protocol in poor responders treated by IVF: a randomized controlled trial. Hum Reprod. 2008 Jun;23(6):1355-8. doi: 10.1093/humrep/den107. Epub 2008 Apr 10."}] | {"versionHolder": "2025-06-18"} | {
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{
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}
]
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"term": "Triptorelin Pamoate"
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{
"id": "C061018",
"term": "Ganirelix"
}
]
} | {
"conditions": [
{
"id": "D007246",
"term": "Infertility"
},
{
"id": "D016649",
"term": "Primary Ovarian Insufficiency"
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{
"id": "D008594",
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],
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"term": "Triptorelin Pamoate"
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"id": "C061018",
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]
} |
NCT06066866 | null | Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment | Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2023-09-27T00:00:00 | null | 2026-01-01T00:00:00 | 2028-01-01T00:00:00 | null | 150 | 18 | 100 | ALL | true | GI disorders are influenced by the gut microbiome. To date, sampling of the small intestine in GI disorders has been limited. The investigators plan to sample the small intestinal contents during endoscopy for research purposes. | Current guidelines (AGA Clinical Practice Update, 2020) report the definition of SIBO as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine. To date, there is unlimited knowledge regarding the diagnostic criterion which has been limited by nonspecific and nonsensitive testing such as breath tests. Breath tests have a limited use in patients with IBS-D who inherently have increased gut transit time rendering the testing invalid for accurately measuring small intestinal bacteria. Additionally, the relationship between SIBO and symptoms in patients without obvious risk factors (such as anatomical changes due to surgery) is unknown. The investigators study aims to investigate the microbial landscape of the small intestine in healthy patients and those with GI disease (suspected or diagnosed) undergoing an upper endoscopy by collecting an aspirate of patient small intestinal fluid and studying it. | Inclusion Criteria:
* Age \>18years
* Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care
Exclusion Criteria:
Children (under age 18years) Pregnant Women and Fetuses Neonates (0 - 28 days) Impaired Decision Making Capacity | Stanford University | OTHER | {
"id": "71429",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-09-27T00:00:00 | {
"date": "2023-10-06",
"type": "ACTUAL"
} | {
"date": "2023-10-04",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care | NON_PROBABILITY_SAMPLE | false | {
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"timePerspective": "PROSPECTIVE"
} | [
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"IBS - Irritable Bowel Syndrome",
"Inflammatory Bowel Diseases"
] | null | null | null | null | null | {
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"primary": [
{
"description": null,
"measure": "Ability to isolate live bacteria from 95% of samples",
"timeFrame": "1-4 years"
}
],
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"description": null,
"measure": "Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples",
"timeFrame": "1-4 years"
}
]
} | [
{
"affiliation": "Stanford University",
"name": "Sean P Spencer, MD,PhD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Stanford University",
"name": "Linda A Nguyen, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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},
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},
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"term": "Gastroenteritis"
},
{
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"term": "Colonic Diseases, Functional"
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{
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"abbrev": "BC23",
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},
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},
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"name": "Colonic Diseases, Functional",
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}
],
"meshes": [
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"term": "Inflammatory Bowel Diseases"
},
{
"id": "D043183",
"term": "Irritable Bowel Syndrome"
}
]
} | {
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{
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"term": "Central Nervous System Depressants"
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{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
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"id": "D018691",
"term": "Excitatory Amino Acid Antagonists"
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"id": "D010634",
"term": "Phenobarbital"
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} |
NCT00289666 | null | The Effect of Positive Airway Pressure on Heart Rate Variability | A Prospective Study to Determine the Effect of Positive Airway Pressure on Heart Rate Variability in Individuals With Obstructive Sleep Apnea | None | OBSERVATIONAL | COMPLETED | 2006-02-09T00:00:00 | null | null | null | null | 38 | 18 | 75 | ALL | false | This study is designed to determine the effect of continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) on heart rate variability (HRV) in patients with obstructive sleep apnea (OSA). | Visit 1: You will come to the Diabetes and Metabolic Research Center having refrained from taking your routine medications and having not eaten in the last 8 hours, avoided using caffeine-containing beverages and tobacco products in the last 10 hours, and having had no alcoholic beverages in the last 24 hours. In addition, you should refrain from taking any nonprescription drugs and avoid engaging in any vigorous exercise for 48 hours before testing.
For those individuals who have diabetes, a letter or direct verbal permission will be obtained, prior to coming to this study visit, from your eye doctor indicating that you can take part in one of the tests listed below. During this visit, an electrocardiogram (EKG, usual heart rhythm test performed in a doctor's office) will be performed. Your heart rate will also be measured for six minutes with an EKG machine while breathing as deeply as possible. This test, which will be performed twice, will tell whether or not the nerves that go to the heart are normal. You will be asked to blow into a plastic tube for 15 seconds (this is the test for which we will obtain the eye doctor's permission for individuals with diabetes). Your heart rate will be measured during and for 60 seconds after you have finished blowing. This test, which will be performed twice, will tell if the nerves that go to blood vessels are normal. Your blood pressure will be measured four times, one minute apart, while you are lying down. You will then be asked to stand up and your blood pressure will again be measured four more times, each time one minute apart. Change in your heart rate will also be determined as you go from lying down to standing. All individuals will have a fingerstick blood sugar level performed prior to the performance of the tests describe above.
You will have about 2 tablespoons of blood drawn. This blood will be stored (frozen) in case possible risk factors of reduced heart rate variability are discovered in the future. A random urine sample will be stored (frozen) for potential examination for microalbuminuria (protein in the urine) or other possible risk factors. At this visit, we will give you a container with instructions for collecting urine for 24-hours. You will also be given some dietary suggestions (e.g., eating a liberal salt diet) that we would like you to follow for 3-days prior to the 24-hour collection of urine. For individuals with diabetes, a small portion of blood will be checked to determine your blood sugar control level.
Standard medical history questions will be asked during this visit along with questions that assess the likelihood of you falling asleep in various situations. Your medical records from your pulmonary doctor will be reviewed for information about the results of the sleep study you had that determined you have a sleep disorder. You will be asked to keep a diary everyday, for the first six weeks, of how many hours per night you use the treatment for your sleep disorder. This visit will last approximately 1-1 ½ hours.
Visit 2: Within 1-48 hours of completion of the 24-hour urine collection and before you begin treatment for your sleep disorder, you will need to bring the urine specimen to the Diabetes and Metabolic Research Center. A part of this urine will be stored (frozen) for possible testing of a hormone called aldosterone, substances filtered by the kidneys (salt and creatinine), and other potential risk factors. Also at this visit, about 2 tablespoons of blood will be drawn and stored for potential testing of a protein in the blood called renin. You should continue the dietary suggestions (e.g., liberal salt diet) given for the collection of the 24-hour urine until the blood is collected. A part of the blood drawn during this visit will also be stored (frozen) in case potential risk factors of heart rate variability are discovered in the future. This visit will last approximately 15 minutes.
Since some drugs can affect how much your heart speeds up and slows down, if your doctor adds a new drug or changes the dosage of any current drugs you may not be able to continue in this study. Please inform a member of the research staff when your doctor makes any change in your medications.
Before coming to the Diabetes and Metabolic Research Center for visit 3, we will need to determine if you have used your device for the treatment of your sleep disorder enough during the six week period. Therefore, a member of the research staff will call you on a weekly basis to ask you to tell us the information that you have recorded in your diary with regard to how often you used the device for the treatment of your sleep disorder.
Visit 3 (approximately six weeks after you begin treatment for your sleep disorder): If you have used the device that is being used to treat your sleep disorder enough, you will be invited to come for visit 3. All of the tests performed during the first visit will be performed again during visit 3. Thus, you will need to follow the same instructions about food, medicine, and exercise as described under visit 1 before coming to visit 3. You will again have a fingerstick blood sugar level performed. In addition, about 2 tablespoons of blood will be drawn. This blood and a random urine sample will be stored (frozen) in case possible risk factors of reduced heart rate variability are discovered in the future and in case these factors need to be examined before and after treatment for a sleep disorder. The same questions asked with regard to the likelihood of you falling asleep in various situations will be asked. This visit will last approximately 1-1 ½ hours.
Visit 4 (approximately 18-months after you begin treatment for your sleep disorder): If you continue to use the device that is being used to treat your sleep disorder for 18-months, you will be invited to come for visit 4. All of the tests performed during the first visit will be performed again during visit 4. Thus, you will need to follow the same instructions about food, medicine, and exercise as described under visit 1 before coming to visit 4. You will again have a fingerstick blood sugar level performed. In addition, about 2 tablespoons of blood will be drawn. This blood and a random urine sample will be stored (frozen) in case possible risk factors of reduced heart rate variability are discovered in the future and in case these factors need to be examined before and after treatment for a sleep disorder. For individuals with diabetes, a small portion of blood will be checked to determine your blood sugar control level. The same questions asked with regard to the likelihood of you falling asleep in various situations will be asked again. This visit will last approximately 1-1 ½ hours. | Inclusion Criteria:
* Individuals aged 18-75 years old.
* Individuals with diagnosed OSA.
Exclusion Criteria:
* 1. Individuals who are receiving treatment for OSA, excluding those being treated by weight loss.
2. Individuals who have had pharyngeal surgery (i.e., uvulopalatopharyngoplasty).
3. Individuals who have arterial oxygen desaturation episodes or apneic episodes not felt to be due to OSA.
4. Individuals whose treatment dosage changes 2 months prior to, or during, the study for antihypertensive and antidiabetic medications and the following medications that may affect the autonomic nervous system: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, cordarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic drugs, antiparkinsonism drugs, and nitrated drugs. | Christiana Care Health Services | OTHER | {
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"affiliation": "University of Delaware",
"name": "Raelene E Maser, PhD",
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] | [{"pmid": "17951618", "type": "RESULT", "citation": "Maser RE, Lenhard MJ, Rizzo AA, Vasile AA. Continuous positive airway pressure therapy improves cardiovascular autonomic function for persons with sleep-disordered breathing. Chest. 2008 Jan;133(1):86-91. doi: 10.1378/chest.07-1580. Epub 2007 Oct 20."}] | {"versionHolder": "2025-06-18"} | {
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NCT06124066 | null | THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS | THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS | None | INTERVENTIONAL | COMPLETED | 2023-09-02T00:00:00 | null | 2022-09-30T00:00:00 | 2022-10-30T00:00:00 | [
"PHASE4"
] | 42 | 18 | null | ALL | false | Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of urine into the ureter. Complaints often appear in patients, especially lower urinary tract symptoms (LUTS), pain in the waist when urinating due to reflux of urine, sexual dysfunction, and hematuria.
Currently, to assess complaints after ureteral stent placement, the Ureteral Stent Symptom Questionnaire instrument consists of 6 topics: urinary complaints, pain, general health, work, sexual problems, and other things.
Interleukin-6 is an important inflammatory cytokine when irritation occurs after ureteral stent placement. Interleukin 10 is a cytokine with potent anti-inflammatory properties that plays a central role in limiting the host's immune response to pathogens, thereby preventing host damage and maintaining normal tissue homeostasis. The profile of these biomarkers has the potential to determine the correct prognosis and therapy.
Mirabegron is a β3 adrenergic receptor agonist that has a dual antioxidant effect that plays a key role in the first step of the antimicrobial response and early resolution of inflammation so that post-stent complaints similar to overactive bladder complaints can be resolved. Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter, thereby reducing the inflammatory reaction and improving oxidative stress by reducing the formation of reactive oxidative stress. | The research design used was experimental with randomized sampling, double-blinded, in men and women with ureteral stents. The patient signed informed consent regarding blood and urine sampling, bladder mucosal biopsy, placement and removal of ureteral stents, drug administration, and side effects of therapy. The history and physical examination of the patient were recorded including age, height, weight, and body mass index (BMI). Investigation procedures for urinalysis, routine blood, SGOT/SGPT, urea/creatinine, blood sugar during, ultrasonography, plain abdominal photos, and CT scan urography were performed on patients before surgery. The patient's largest stone size is used as a benchmark to record the patient's stone size.
All patients who underwent routine post-ureterorenoscopy lithotripsy (URSL) ureteral stent procedures and met the inclusion and exclusion criteria were included in the study evaluation. The ureteral stent used was 4.7 Fr in size with a length of 24-26 cm, made from polyurethane used in all patients.
Blood and urine samples will be taken before drug administration begins, and when the ureteral stent is removed or replaced. Bladder mucosal biopsy was performed in the trigone vesicae around the contralateral ureteral opening during cystoscopy before ureteral stent placement, and on the ipsilateral side when the ureteral stent was to be removed or replaced in the 6th week after ureteral stent placement.
A plain photo of the abdomen or ultrasound is done postoperatively to see the remaining stone fragments and the position of the ureteral stent. Urethral catheters were removed on the 2nd postoperative day in all patients before the patients were discharged and given oral antibiotics (cefadroxil) for 5 days. During the observation phase, the patient was given the same analgesic (paracetamol 500 mg every 8 hours/24 hours and if needed can be given every 6 hours/24 hours). The total amount of analgesics consumed by the patient will be recorded in filling out the final questionnaire.
Patients were asked to come to the urology clinic at the hospital for control on the seventh day. The patient will be given a questionnaire format that will measure the presence or absence and severity of side effects experienced by the patient for 7 days after ureteral stent placement.
Patients will be divided into 3 groups of drug administration. The double-blinded method is used to minimize bias. All medicines were placed in the same 3 boxes, which were held by the paramedics so that the patients and researchers did not know the allocation of the types of drugs given. All patients have been informed about the side effects of the drug.
Administration of mirabegron 50 mg/day compared to tamsulosin 0.4 mg and placebo began on the third day before insertion of the ureteral stent. Completion of the questionnaire began on the seventh day after ureteral stent insertion, then it was measured every 7 days (7th, 14th, 21st, 28th, 35th, and 42nd day) after ureteral stent insertion. Filling out the questionnaire can be done by in-person interview at the clinic or by telephone. | Inclusion Criteria:
* Age \> 18 years
* Patient with first ureterorenoscopy and ureteral stent placement
* Using a semi-rigid (rigid) retrograde or flexible (flexible) ureteroscope
* Stent placement on one side
* Stent installation size 4.7 Fr, length 24-26cm hydrophilic coated ureteric stent
* Patients who can read and understand Indonesia language (Bahasa Indonesia)
Exclusion Criteria:
* Patients with or who have a history of malignancy of the urinary tract
* Patients with LUTS caused by benign prostatic enlargement, bladder stones, or urethral strictures
* Catheterized patients or on self-catheter therapy regularly and patients with urinary diversion
* Patients with Post void residual volume \> 350 mL
* Patients with neurogenic bladder and/or OAB syndrome, stress incontinence, or mixed stress/urge incontinence
* Patients with chronic pain that is not controlled or on therapy to manage chronic pain
* Patients with symptomatic UTI
* Patients with a prior history of sexual dysfunction
* Have or are currently undergoing radiation therapy/hormonal therapy and/or surgical procedures in the minor pelvis, ureteral reconstructive surgery.
* Patients with primary neurological disorders, such as multiple sclerosis, Parkinson's disease, diabetic nephropathy, or other neurological diseases that affect bladder function.
* Patients who are hypersensitive to mirabegron and tamsulosin or their derivatives and patients with mirabegron and tamsulosin contraindications.
* The patient could not follow the research protocol due to an organic brain disorder or psychiatric disorder
* Patients with autoimmune diseases and other inflammatory diseases, as well as patients taking immunosuppressant drugs | Hasanuddin University | OTHER | {
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"country": "Indonesia",
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NCT01230866 | null | Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer | A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2010-10-27T00:00:00 | null | null | null | [
"PHASE3"
] | 150 | 18 | null | MALE | false | The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better. | null | Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
* History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. \> 6 cores are strongly recommended.
* PSA values \< 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
* Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
* No pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
* Patients must be at least 18 years old.
* ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
* IPSS score \<= 16.
* Patients must give IRB approved, study specific, informed consent.
* Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.
Exclusion Criteria:
* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
* Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.
* Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed). | Proton Collaborative Group | NETWORK | {
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Prostate Cancer"
] | ["Proton Radiation Prostate Cancer"] | null | [
{
"city": "Phoenix",
"country": "United States",
"facility": "Mayo Clinic Cancer Center",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona"
},
{
"city": "Warrenville",
"country": "United States",
"facility": "Northwestern Medicine Chicago Proton Center",
"geoPoint": {
"lat": 41.81781,
"lon": -88.1734
},
"state": "Illinois"
},
{
"city": "Baltimore",
"country": "United States",
"facility": "Maryland Proton Treatment Center",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
},
{
"city": "Oklahoma City",
"country": "United States",
"facility": "Oklahoma Proton Center",
"geoPoint": {
"lat": 35.46756,
"lon": -97.51643
},
"state": "Oklahoma"
},
{
"city": "Hampton",
"country": "United States",
"facility": "Hampton University Proton Therapy Institute",
"geoPoint": {
"lat": 37.02987,
"lon": -76.34522
},
"state": "Virginia"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.",
"timeFrame": "At 5 years post treatment completion +/- 90 days"
}
],
"secondary": [
{
"description": null,
"measure": "To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.",
"timeFrame": "At 6 months and 2 years post randomization"
}
]
} | [
{
"affiliation": "Proton Collaborative Group",
"name": "Carlos Vargas, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005834",
"term": "Genital Neoplasms, Male"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D005832",
"term": "Genital Diseases, Male"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D011469",
"term": "Prostatic Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
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},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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},
{
"asFound": null,
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"name": "Adenocarcinoma",
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},
{
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},
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},
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},
{
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"relevance": "LOW"
},
{
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},
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},
{
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
],
"interventions": null
} |
NCT02450266 | null | Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy | Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy | PROFUSE | INTERVENTIONAL | UNKNOWN | 2015-05-19T00:00:00 | null | null | null | [
"NA"
] | 586 | 18 | null | MALE | true | Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. | In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of significant prostate cancers compared with systematic transrectal ultrasound-guided prostate biopsy.
Men with at least one previously negative transrectal ultrasound-guided biopsy and persistently elevated PSA values (\> 3 ng/ml) or PSA velocity \>0.75 ng/ml/p.a. will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound--guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI/ultrasound fusion-guided. | Inclusion Criteria:
* At least one negative transrectal ultrasound-guided prostate biopsy
* PSA \> 3.0 ng/ml or PSA velocity \>0.75 ng/ml/p.a.
Exclusion Criteria:
* Known prostate cancer
* PSA \>50 ng/ml
* Previous MRI-targeted prostate biopsy | Heinrich-Heine University, Duesseldorf | OTHER | {
"id": "004",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-05-20T00:00:00 | {
"date": "2015-05-21",
"type": "ESTIMATED"
} | {
"date": "2015-05-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Prostate Cancer"
] | ["Primary disease", "multiparametric MRI", "targeted prostate biopsy", "MRI/ultrasound fusion-guided prostate biopsy", "systematic transrectal ultrasound-guided prostate biopsy"] | null | [
{
"city": "Berlin",
"country": "Germany",
"facility": "Department of Urology, Charité-Universitätsmedizin",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null
},
{
"city": "Düsseldorf",
"country": "Germany",
"facility": "Department of Urology, University Hospital Düsseldorf",
"geoPoint": {
"lat": 51.22172,
"lon": 6.77616
},
"state": null
},
{
"city": "Jena",
"country": "Germany",
"facility": "Department of Urology, University Hospital Jena",
"geoPoint": {
"lat": 50.92878,
"lon": 11.5899
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "German Cancer Research Center"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Detection rate of significant prostate cancers",
"timeFrame": "One week after biopsy"
}
],
"secondary": [
{
"description": null,
"measure": "Overall detection rate of prostate cancers",
"timeFrame": "One week after biopsy"
}
]
} | [
{
"affiliation": "Department of Urology, University Hospital Düsseldorf",
"name": "Christian Arsov, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D005834",
"term": "Genital Neoplasms, Male"
},
{
"id": "D014565",
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},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D005832",
"term": "Genital Diseases, Male"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D011469",
"term": "Prostatic Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"relevance": "HIGH"
},
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"id": "M8946",
"name": "Genital Neoplasms, Male",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17315",
"name": "Urogenital Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8944",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
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"relevance": "LOW"
},
{
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"id": "M14333",
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},
{
"asFound": null,
"id": "M27095",
"name": "Male Urogenital Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D011471",
"term": "Prostatic Neoplasms"
}
],
"interventions": null
} |
NCT04534166 | null | A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis | A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis | None | OBSERVATIONAL | UNKNOWN | 2020-08-26T00:00:00 | null | 2022-09-30T00:00:00 | 2022-09-30T00:00:00 | null | null | null | null | ALL | false | The fracture risk of diabetic patients proves to be higher than those without diabetesdue to thehyperglycemia, usage of diabetes drugs, the changes in insulin levels and excretion, and this risk begins as early as adolescence.Many factors may be related to bone metabolism in patients with diabetes, including demographic data (e.g. age, height, weight, gender), medical history (e.g. smoking, drinking, menopause) and examination (e.g. bone mineral density, blood routine), urine routine).However, most of existing methods are qualitative assessments and do not take the interactions of the physiological factors of humans into consideration. In addition, the fracture risk of diabetic patients with osteoporosis has not been further studied before. In order to investigate the effect of patients' physiological factors on fracture risk, in the paper, we used a hybrid model combining XGBoost with deep neural network to predict the fracture risk of diabetic patients with osteoporosis. | null | Inclusion Criteria:
* Patients in Hospital's outpatient and inpatient His database between July 2012 and November 2022, diabetic patients were combined with osteoporosis.
Exclusion Criteria:
* Patients with fractures before diagnosis of diabetes; patients with fractures before diagnosis of osteoporosis; patients with hyroid disease and other diseases that seriously affect bone metabolism. | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER | {
"id": "XH-20-020",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-08-26T00:00:00 | {
"date": "2020-09-01",
"type": "ACTUAL"
} | {
"date": "2020-09-01",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Chinese | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "ECOLOGIC_OR_COMMUNITY",
"primaryPurpose": null,
"timePerspective": "OTHER"
} | [
"Healthcare; Risk Prediction; Diabetic Patients With Osteoporosis"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Fracture",
"timeFrame": "2-10 year"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001851",
"term": "Bone Diseases, Metabolic"
},
{
"id": "D001847",
"term": "Bone Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC26",
"name": "Wounds and Injuries"
}
],
"browseLeaves": [
{
"asFound": "Osteoporosis",
"id": "M12947",
"name": "Osteoporosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M26370",
"name": "Fractures, Bone",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5130",
"name": "Bone Diseases, Metabolic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5126",
"name": "Bone Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010024",
"term": "Osteoporosis"
}
]
} | null | {
"conditions": [
{
"id": "D010024",
"term": "Osteoporosis"
}
],
"interventions": null
} |
NCT03416166 | null | International Multisite Transcatheter Tricuspid Valve Therapies Registry | International Multisite Transcatheter Tricuspid Valve Therapies Registry | TriValve | OBSERVATIONAL | RECRUITING | 2018-01-23T00:00:00 | null | 2017-05-15T00:00:00 | 2026-11-01T00:00:00 | null | 269 | 18 | 99 | ALL | null | For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).
Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.
The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease. | null | Inclusion Criteria:
* All the patients undergoing transcatheter tricuspid valve intervention.
General inclusion criteria:
* Minimal age: 18 years
* Patient is able to give written informed consent to the procedure
Exclusion Criteria:
* Patients not fulfilling the indications for transcatheter tricuspid intervention | University of Zurich | OTHER | {
"id": "2016-01753",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-01-29T00:00:00 | {
"date": "2018-01-30",
"type": "ACTUAL"
} | {
"date": "2018-01-30",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with severe symptomatic tricuspid regurgitation | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Severe Tricuspid Regurgitation"
] | ["Tricuspid Valve", "tricuspid regurgitation", "transcatheter tricuspid regurgitation"] | null | [
{
"city": "Zürich",
"country": "Switzerland",
"facility": "University Hospital Zurich",
"geoPoint": {
"lat": 47.36667,
"lon": 8.54999
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Cardiovascular Death",
"timeFrame": "30 days"
}
],
"secondary": [
{
"description": null,
"measure": "NYHA Class",
"timeFrame": "30 days, 1 year"
},
{
"description": null,
"measure": "TR Reduction",
"timeFrame": "30 days, 1 year"
}
]
} | null | [{"pmid": "33541097", "type": "DERIVED", "citation": "Muntane-Carol G, Taramasso M, Miura M, Gavazzoni M, Pozzoli A, Alessandrini H, Latib A, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Harr C, Lauten A, Lurz J, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Philippon F, Praz F, Puri R, Schafer U, Schofer J, Sievert H, Tang GHL, Khattab AA, Andreas M, Russo M, Thiele H, Unterhuber M, Himbert D, Urena M, von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, Rodes-Cabau J. Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry. Circ Cardiovasc Interv. 2021 Feb;14(2):e009685. doi: 10.1161/CIRCINTERVENTIONS.120.009685. Epub 2021 Feb 5."}, {"pmid": "32912460", "type": "DERIVED", "citation": "Miura M, Alessandrini H, Alkhodair A, Attinger-Toller A, Biasco L, Lurz P, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Estevez-Loureiro R, Fam N, Frerker C, Gavazzoni M, Hausleiter J, Himbert D, Ho E, Juliard JM, Kaple R, Besler C, Kodali S, Kreidel F, Kuck KH, Latib A, Lauten A, Monivas V, Mehr M, Muntane-Carol G, Nazif T, Nickenig G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodes-Cabau J, Schafer U, Schofer J, Sievert H, Tang GHL, Thiele H, Rommel KP, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Maisano F, Hahn RT, Taramasso M; TriValve Investigators. Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1999-2009. doi: 10.1016/j.jcin.2020.05.011."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006349",
"term": "Heart Valve Diseases"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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},
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},
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}
],
"meshes": [
{
"id": "D014262",
"term": "Tricuspid Valve Insufficiency"
}
]
} | null | {
"conditions": [
{
"id": "D014262",
"term": "Tricuspid Valve Insufficiency"
}
],
"interventions": null
} |
NCT04670666 | null | Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus | National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus. | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2020-12-11T00:00:00 | null | null | null | [
"PHASE3"
] | 270 | 18 | null | ALL | false | The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus. | null | Inclusion Criteria:
* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants with 18 years of age or greater;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy);
* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \> 100 mg/dL at the screening visit;
* BMI (body mass index) \> 19 Kg/m2 and ≤ 45 Kg/m2.
Exclusion Criteria:
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to the formula components used during the clinical trial;
* Type 1 diabetes mellitus;
* Fasting blood glucose \> 300 mg/dL;
* Risk factors for volume depletion;
* Impaired renal function and end-stage renal disease;
* Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;
* Impaired hepatic function;
* Medical history of pancreatic diseases that may suggest insulin deficiency;
* Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;
* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;
* Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;
* Current medical history of cancer and/ or cancer treatment in the last 5 years;
* Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;
* Medical history of blood dyscrasia or any other hemolytic disorders;
* Participants using sulfonylureas and/or insulin therapy;
* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months. | EMS | INDUSTRY | {
"id": "EMS1419 - MADALENA",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-12-11T00:00:00 | {
"date": "2024-02-16",
"type": "ACTUAL"
} | {
"date": "2020-12-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Type 2 Diabetes Mellitus"
] | ["Type 2 Diabetes Mellitus"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline in glycated hemoglobin (HbA1c) levels.",
"timeFrame": "120 days"
}
],
"secondary": [
{
"description": null,
"measure": "Incidence and severity of adverse events recorded during the study.",
"timeFrame": "150 days"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D044882",
"term": "Glucose Metabolism Disorders"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
},
{
"id": "D004700",
"term": "Endocrine System Diseases"
}
],
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
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"abbrev": "BC19",
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"abbrev": "All",
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],
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"id": "M7119",
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"relevance": "HIGH"
},
{
"asFound": null,
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"relevance": "LOW"
},
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"name": "Glucose Metabolism Disorders",
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},
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"relevance": "LOW"
}
],
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{
"id": "D003920",
"term": "Diabetes Mellitus"
},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
]
} | {
"ancestors": [
{
"id": "D007004",
"term": "Hypoglycemic Agents"
},
{
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"term": "Physiological Effects of Drugs"
},
{
"id": "D000077203",
"term": "Sodium-Glucose Transporter 2 Inhibitors"
},
{
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"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D054795",
"term": "Incretins"
},
{
"id": "D006728",
"term": "Hormones"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D054873",
"term": "Dipeptidyl-Peptidase IV Inhibitors"
},
{
"id": "D011480",
"term": "Protease Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
}
],
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"abbrev": "Hypo",
"name": "Hypoglycemic Agents"
},
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"abbrev": "All",
"name": "All Drugs and Chemicals"
},
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"abbrev": "Infe",
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}
],
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"id": "M445",
"name": "Linagliptin",
"relevance": "HIGH"
},
{
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"id": "M258082",
"name": "Empagliflozin",
"relevance": "HIGH"
},
{
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"name": "Hypoglycemic Agents",
"relevance": "LOW"
},
{
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"name": "Sodium-Glucose Transporter 2 Inhibitors",
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},
{
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"name": "Incretins",
"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
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"id": "M9788",
"name": "Hormone Antagonists",
"relevance": "LOW"
},
{
"asFound": null,
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"name": "Dipeptidyl-Peptidase IV Inhibitors",
"relevance": "LOW"
},
{
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"id": "M19609",
"name": "HIV Protease Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
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"name": "Protease Inhibitors",
"relevance": "LOW"
},
{
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"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
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{
"id": "D008687",
"term": "Metformin"
},
{
"id": "C570240",
"term": "Empagliflozin"
},
{
"id": "D000069476",
"term": "Linagliptin"
}
]
} | {
"conditions": [
{
"id": "D003920",
"term": "Diabetes Mellitus"
},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
],
"interventions": [
{
"id": "D008687",
"term": "Metformin"
},
{
"id": "C570240",
"term": "Empagliflozin"
},
{
"id": "D000069476",
"term": "Linagliptin"
}
]
} |
NCT06408766 | null | Investigating the Effects of Smartphone Use on the Masseter Muscle | Investigating the Short and Long-term Effects of Smartphone Use on the Masseter Muscle | None | OBSERVATIONAL | COMPLETED | 2024-05-07T00:00:00 | null | 2025-01-01T00:00:00 | 2025-01-15T00:00:00 | null | 105 | 18 | 30 | ALL | true | The aim of this study was to determine the short- and long-term effects of smartphone use on the masseter muscle. In the short term, to investigate whether repetitive thumb movements during phone use will cause a spontaneous muscle activation and/or tenderness in the masseter muscle; in the long term, to investigate the relationship between strength change and tenderness of the tenar and masseter muscles depending on the intensity and duration of phone use. | A total of 120 healthy university students aged 18-30 years at Bandırma Onyedi Eylül University will be included in our study. Descriptive data form, Smartphone Addiction Scale - Short Form, Edinburg Hand Preference Inventory, pressure pain threshold, muscle activity, lateral grip strength, hand grip strength will be evaluated in the participant students. | Inclusion Criteria:
* Smartphone users students between the ages of 18-30 years
* Students whose voluntary informed consent was obtained
Exclusion Criteria:
* Individuals undergoing masseter botox application
* Individuals diagnosed with TMJ disorder and/or bruxism
* Individuals with musculoskeletal problems with evidence of a systemic, specific pathologic condition such as fracture of the hand, finger, upper extremity and/or TMJ, rheumatoid disease
* Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
* Individuals with less than 6 months of physiotherapy and rehabilitation services related to hand, finger, upper extremity and/or TMJ
* Individuals with facial paralysis
* Individuals with diagnosed psychiatric illness. | Bandırma Onyedi Eylül University | OTHER | {
"id": "2024-26",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-05-07T00:00:00 | {
"date": "2025-06-06",
"type": "ACTUAL"
} | {
"date": "2024-05-10",
"type": "ACTUAL"
} | [
"ADULT"
] | University students | PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Smartphone Addiction",
"Masseter Muscle Hypertrophy",
"Masseter Muscle Spasm"
] | ["Smartphone Addiction", "masseter", "thenar"] | null | [
{
"city": "Balikesir",
"country": "Turkey",
"facility": "Bandirma Onyedi Eylul University",
"geoPoint": {
"lat": 39.64917,
"lon": 27.88611
},
"state": "Bandirma"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Smartphone Addiction Scale-Short Form",
"timeFrame": "4 months"
},
{
"description": null,
"measure": "Edinburg Hand Preference Inventory",
"timeFrame": "4 months"
},
{
"description": null,
"measure": "Pressure Pain Threshold Assessment",
"timeFrame": "4 months"
},
{
"description": null,
"measure": "Muscle Activation Measurement",
"timeFrame": "4 months"
},
{
"description": null,
"measure": "Hand Grip Strength Assessment",
"timeFrame": "4 months"
},
{
"description": null,
"measure": "Finger Lateral Grip Strength Assessment",
"timeFrame": "4 months"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003192",
"term": "Compulsive Behavior"
},
{
"id": "D007175",
"term": "Impulsive Behavior"
},
{
"id": "D020763",
"term": "Pathological Conditions, Anatomical"
},
{
"id": "D000088942",
"term": "Technology Addiction"
},
{
"id": "D020879",
"term": "Neuromuscular Manifestations"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
}
],
"browseLeaves": [
{
"asFound": "Hypertrophy",
"id": "M10035",
"name": "Hypertrophy",
"relevance": "HIGH"
},
{
"asFound": "Addiction",
"id": "M19100",
"name": "Behavior, Addictive",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9999",
"name": "Hyperkinesis",
"relevance": "LOW"
},
{
"asFound": "Muscle Spasm",
"id": "M15837",
"name": "Spasm",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12077",
"name": "Muscle Cramp",
"relevance": "LOW"
},
{
"asFound": "Masseter Muscle Spasm",
"id": "M17065",
"name": "Trismus",
"relevance": "HIGH"
},
{
"asFound": "Smartphone Addiction",
"id": "M2355",
"name": "Internet Addiction Disorder",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6418",
"name": "Compulsive Behavior",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10220",
"name": "Impulsive Behavior",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22519",
"name": "Pathological Conditions, Anatomical",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2684",
"name": "Technology Addiction",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22619",
"name": "Neuromuscular Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D013035",
"term": "Spasm"
},
{
"id": "D014313",
"term": "Trismus"
},
{
"id": "D006984",
"term": "Hypertrophy"
},
{
"id": "D016739",
"term": "Behavior, Addictive"
},
{
"id": "D000082424",
"term": "Internet Addiction Disorder"
}
]
} | null | {
"conditions": [
{
"id": "D013035",
"term": "Spasm"
},
{
"id": "D014313",
"term": "Trismus"
},
{
"id": "D006984",
"term": "Hypertrophy"
},
{
"id": "D016739",
"term": "Behavior, Addictive"
},
{
"id": "D000082424",
"term": "Internet Addiction Disorder"
}
],
"interventions": null
} |
NCT01280266 | null | Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon | Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial | None | INTERVENTIONAL | COMPLETED | 2011-01-14T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 29 | 18 | 75 | ALL | false | The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.
Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients. | null | Inclusion Criteria:
* secondary Raynaud's phenomenon
Exclusion Criteria:
* primary raynaud phenomenon
* active infection
* hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)
* elevated AST/ALT (3 times above the upper normal limit)
* severe renal failure
* patients on nitrite or nitric oxide (NO) donor treatment
* recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery
* hypotension (less than 90/50 mmHg) or uncontrolled hypertension | Seoul National University Hospital | OTHER | {
"id": "RaynaudSNUH",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-01-19T00:00:00 | {
"date": "2012-12-11",
"type": "ESTIMATED"
} | {
"date": "2011-01-20",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Raynaud Phenomenon"
] | ["Pathological Conditions", "Signs and Symptoms", "Blood circulation"] | null | [
{
"city": "Seoul",
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null
}
] | [
{
"class": "INDUSTRY",
"name": "Dong-A Pharmaceutical Co., Ltd."
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "RP Attacks Per Day",
"timeFrame": "baselin and 4 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Change in Raynaud's Condition Score (RCS)",
"timeFrame": "baseline and 4 weeks"
},
{
"description": null,
"measure": "Change in the RP Duration",
"timeFrame": "baseline and 4 weeks"
},
{
"description": null,
"measure": "Change in Health Assessment Questionnaire (HAQ)",
"timeFrame": "0 and 4 weeks"
},
{
"description": null,
"measure": "Change in Physician's Global Assessment on Visual Analogue Scale (VAS)",
"timeFrame": "at 0 (baseline) and 4 weeks (after treatment)"
},
{
"description": null,
"measure": "Change in Digital Ulcer Number",
"timeFrame": "baseline and 4 weeks"
},
{
"description": null,
"measure": "Change in Peak Systolic Flow (cm/Sec)",
"timeFrame": "baseline and 4 weeks"
},
{
"description": null,
"measure": "Time-averaged Peak Velocity (cm/Sec)",
"timeFrame": "baseline and 4 weeks"
},
{
"description": null,
"measure": "Dorsal-digital-difference.",
"timeFrame": "baseline and 4 weeks"
}
]
} | [
{
"affiliation": "professor of Seoul National University College of Medicine",
"name": "Eun Bong Lee, MD PhD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Assistant professor, Seoul National University College of Medicine",
"name": "Eun Young Lee, MD PhD",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "Seoul National University Hospital",
"name": "Jin Kyun Park, MD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "24352340", "type": "DERIVED", "citation": "Lee EY, Park JK, Lee W, Kim YK, Park CS, Giles JT, Park JW, Shin K, Lee JS, Song YW, Lee EB. Head-to-head comparison of udenafil vs amlodipine in the treatment of secondary Raynaud's phenomenon: a double-blind, randomized, cross-over study. Rheumatology (Oxford). 2014 Apr;53(4):658-64. doi: 10.1093/rheumatology/ket417. Epub 2013 Dec 17."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D000090122",
"term": "Livedoid Vasculopathy"
},
{
"id": "D013927",
"term": "Thrombosis"
},
{
"id": "D016769",
"term": "Embolism and Thrombosis"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D016491",
"term": "Peripheral Vascular Diseases"
},
{
"id": "D017445",
"term": "Skin Diseases, Vascular"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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},
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"id": "M14772",
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"relevance": "HIGH"
},
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"asFound": null,
"id": "M17400",
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},
{
"asFound": null,
"id": "M2750",
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},
{
"asFound": null,
"id": "M16686",
"name": "Thrombosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7784",
"name": "Embolism",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19128",
"name": "Embolism and Thrombosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M29213",
"name": "Peripheral Arterial Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18894",
"name": "Peripheral Vascular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19714",
"name": "Skin Diseases, Vascular",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T4202",
"name": "Oculocerebral Syndrome With Hypopigmentation",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T3486",
"name": "Livedoid Vasculopathy",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011928",
"term": "Raynaud Disease"
}
]
} | {
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"id": "D000959",
"term": "Antihypertensive Agents"
},
{
"id": "D002121",
"term": "Calcium Channel Blockers"
},
{
"id": "D049990",
"term": "Membrane Transport Modulators"
},
{
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"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D000077264",
"term": "Calcium-Regulating Hormones and Agents"
},
{
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"term": "Physiological Effects of Drugs"
},
{
"id": "D014665",
"term": "Vasodilator Agents"
},
{
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"term": "Phosphodiesterase 5 Inhibitors"
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},
{
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}
],
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "BDCA",
"name": "Bone Density Conservation Agents"
},
{
"abbrev": "AnAg",
"name": "Antihypertensive Agents"
},
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
},
{
"abbrev": "VaDiAg",
"name": "Vasodilator Agents"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M5381",
"name": "Calcium",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5398",
"name": "Calcium, Dietary",
"relevance": "LOW"
},
{
"asFound": "Clinical Study",
"id": "M19600",
"name": "Amlodipine",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M29332",
"name": "Phosphodiesterase 5 Inhibitors",
"relevance": "LOW"
},
{
"asFound": "Money",
"id": "M351268",
"name": "Udenafil",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4277",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M5384",
"name": "Calcium Channel Blockers",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17412",
"name": "Vasodilator Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13629",
"name": "Phosphodiesterase Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D017311",
"term": "Amlodipine"
},
{
"id": "C419664",
"term": "Udenafil"
}
]
} | {
"conditions": [
{
"id": "D011928",
"term": "Raynaud Disease"
}
],
"interventions": [
{
"id": "D017311",
"term": "Amlodipine"
},
{
"id": "C419664",
"term": "Udenafil"
}
]
} |
NCT05280366 | null | STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma | A Prospective, Randomized, Multi-center Evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma | VENICE | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2021-12-29T00:00:00 | null | 2026-06-30T00:00:00 | 2026-06-30T00:00:00 | [
"NA"
] | 150 | 22 | null | ALL | false | A study of the Streamline Surgical System versus competitor | null | Inclusion Criteria:
Diagnosis of Mild to Moderate Primary Open Angle Glaucomma
Exclusion Criteria:
* Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma. Ocular hypertension. | New World Medical, Inc. | INDUSTRY | {
"id": "DF6-CL-21-02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-03-14T00:00:00 | {
"date": "2024-11-12",
"type": "ACTUAL"
} | {
"date": "2022-03-15",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Open Angle Glaucoma"
] | ["glaucoma", "Goniotomy", "MIGS"] | null | [
{
"city": "Fayetteville",
"country": "United States",
"facility": "Vold Vision",
"geoPoint": {
"lat": 36.06258,
"lon": -94.15743
},
"state": "Arkansas"
},
{
"city": "Newport Beach",
"country": "United States",
"facility": "Visionary Research Institute",
"geoPoint": {
"lat": 33.61891,
"lon": -117.92895
},
"state": "California"
},
{
"city": "Torrance",
"country": "United States",
"facility": "Wolstan and Goldberg Eye Associates",
"geoPoint": {
"lat": 33.83585,
"lon": -118.34063
},
"state": "California"
},
{
"city": "Aurora",
"country": "United States",
"facility": "University of Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado"
},
{
"city": "Ocala",
"country": "United States",
"facility": "Ocala Eye",
"geoPoint": {
"lat": 29.1872,
"lon": -82.14009
},
"state": "Florida"
},
{
"city": "Atlanta",
"country": "United States",
"facility": "Georgia Eye Partners",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia"
},
{
"city": "Louisville",
"country": "United States",
"facility": "The Eye Institute",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky"
},
{
"city": "Saint Louis",
"country": "United States",
"facility": "Ophthalmology Associates",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri"
},
{
"city": "Dover",
"country": "United States",
"facility": "Eye Associates of North New Jersey",
"geoPoint": {
"lat": 40.88399,
"lon": -74.5621
},
"state": "New Jersey"
},
{
"city": "Vineland",
"country": "United States",
"facility": "Eye Associates Surgical Center",
"geoPoint": {
"lat": 39.48623,
"lon": -75.02573
},
"state": "New Jersey"
},
{
"city": "Orchard Park",
"country": "United States",
"facility": "Ross Eye Institute",
"geoPoint": {
"lat": 42.76756,
"lon": -78.74392
},
"state": "New York"
},
{
"city": "Rapid City",
"country": "United States",
"facility": "Black Hills Regional Eye Institute",
"geoPoint": {
"lat": 44.08054,
"lon": -103.23101
},
"state": "South Dakota"
},
{
"city": "Maryville",
"country": "United States",
"facility": "University Eye Specialists",
"geoPoint": {
"lat": 35.75647,
"lon": -83.97046
},
"state": "Tennessee"
},
{
"city": "Fort Worth",
"country": "United States",
"facility": "Ophthalmology Associates",
"geoPoint": {
"lat": 32.72541,
"lon": -97.32085
},
"state": "Texas"
},
{
"city": "Houston",
"country": "United States",
"facility": "Berkely Eye Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
},
{
"city": "San Antonio",
"country": "United States",
"facility": "R & R Eye Research",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas"
},
{
"city": "Lynchburg",
"country": "United States",
"facility": "Piedmont Eye Center",
"geoPoint": {
"lat": 37.41375,
"lon": -79.14225
},
"state": "Virginia"
},
{
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"country": "United States",
"facility": "Eye Centers of Racine and Kenosha",
"geoPoint": {
"lat": 42.72613,
"lon": -87.78285
},
"state": "Wisconsin"
},
{
"city": "San José",
"country": "Costa Rica",
"facility": "Clinica 20/20",
"geoPoint": {
"lat": 9.93333,
"lon": -84.08333
},
"state": null
},
{
"city": "Puebla",
"country": "Mexico",
"facility": "Clinica Laser y Ultrasonido Ocular",
"geoPoint": {
"lat": 19.03793,
"lon": -98.20346
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in mean unmedicated diurnal Intraocular Pressure (IOP)",
"timeFrame": "24 months"
}
],
"secondary": null
} | [
{
"affiliation": "New World Medical, Inc.",
"name": "Elysia Ison, OD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009798",
"term": "Ocular Hypertension"
},
{
"id": "D005128",
"term": "Eye Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC11",
"name": "Eye Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
}
],
"browseLeaves": [
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"asFound": "Glaucoma",
"id": "M9013",
"name": "Glaucoma",
"relevance": "HIGH"
},
{
"asFound": "Open Angle Glaucoma",
"id": "M9014",
"name": "Glaucoma, Open-Angle",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10024",
"name": "Hypertension",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12731",
"name": "Ocular Hypertension",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005901",
"term": "Glaucoma"
},
{
"id": "D005902",
"term": "Glaucoma, Open-Angle"
}
]
} | null | {
"conditions": [
{
"id": "D005901",
"term": "Glaucoma"
},
{
"id": "D005902",
"term": "Glaucoma, Open-Angle"
}
],
"interventions": null
} |
NCT01882166 | null | Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment | Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment | None | INTERVENTIONAL | TERMINATED | 2013-06-17T00:00:00 | null | 2015-01-01T00:00:00 | 2015-01-01T00:00:00 | [
"NA"
] | 20 | 18 | 38 | FEMALE | false | The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short "time to pregnancy" with impact on both economical aspects for the society and medical and psychological aspects for the couple. During treatment, success relies on 1) optimal stimulation of growth and maturation of multiple follicles by administration of exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo with the highest potential of implantation to be transferred to the mother. In the present project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared. To this end early embryo development and kinetics after fertilization will be evaluated. The system to be used is time-lapse recording of embryo morphology during the first days of embryo development by means of an embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have different effect on embryo quality. The hypothesis of the study is that stimulation of egg production by these two types of follicle stimulating hormone does not have the same effect on early embryo quality. | null | Inclusion Criteria:
* First or second intracytoplasmic sperm injection (ICSI) treatment
* BMI 18-32 kg/m²
* No previous ovarian hyperstimulation syndrome (OHSS)
* Regular menstrual cycle (cycle length 28 ± 3 days
* Less than 20 antral follicles evaluated by vaginal ultrasound
* S- Anti-Müller Hormone (AMH) 10 - 40 pmol/L
* has given informed consent | St. Olavs Hospital | OTHER | {
"id": "2013/600",
"link": null,
"type": null
} | principal investigator left for another job, project leader retired | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-06-17T00:00:00 | {
"date": "2018-09-14",
"type": "ACTUAL"
} | {
"date": "2013-06-20",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Infertility, Female"
] | ["Fertilization in Vitro", "Sperm Injections, Intracytoplasmic", "Follicle Stimulating Hormone", "Embryonic Development"] | null | [
{
"city": "Trondheim",
"country": "Norway",
"facility": "IVF Unit, St. Olavs Hospital",
"geoPoint": {
"lat": 63.43049,
"lon": 10.39506
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Embryo quality",
"timeFrame": "2 days"
}
],
"secondary": null
} | [
{
"affiliation": "St. Olavs Hospital",
"name": "Arne Sunde, phd",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D005831",
"term": "Genital Diseases, Female"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
}
],
"browseBranches": [
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Infertility",
"id": "M10290",
"name": "Infertility",
"relevance": "HIGH"
},
{
"asFound": "Infertility, Female",
"id": "M10291",
"name": "Infertility, Female",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8943",
"name": "Genital Diseases, Female",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27093",
"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14127",
"name": "Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8399",
"name": "Female Urogenital Diseases and Pregnancy Complications",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007246",
"term": "Infertility"
},
{
"id": "D007247",
"term": "Infertility, Female"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Repr",
"name": "Reproductive Control Agents"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8759",
"name": "Follicle Stimulating Hormone",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9168",
"name": "Chorionic Gonadotropin",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D007246",
"term": "Infertility"
},
{
"id": "D007247",
"term": "Infertility, Female"
}
],
"interventions": []
} |
NCT03153566 | null | Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients | Comparison Between Tuberculin Vaccine and Cryotherapy in the Treatment of Genital Wart Patients | None | INTERVENTIONAL | UNKNOWN | 2017-05-12T00:00:00 | null | null | null | [
"PHASE3"
] | 45 | 20 | 60 | ALL | false | Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma Virus. Although it is a benign condition it causes disfigurement, has tendency to collect, can be transmitted to others, this makes adequate and timely treatment important, while many warts are resolve spontaneously over several years, most patients seek treatment because the warts are unsightly and often tender or painful. | Genital warts are highly contagious sexually transmitted diseases (STD) caused by infection of Human Papilloma Virus and, as the most common STD in developed countries, can currently be considered to be globally epidemic.
It is estimated that the frequency of Human Papilloma Virus infection among women in the world ranges from 2% to 44%.
The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and laser, antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, 5 fluorouracil and antiviral agents such as cidofovir and retinoids.
There are different mechanisms have been proposed for the resolution of warts with skin test antigens such as mumps, candida, trichophyton both at the injected as well as distant sites.
Tuberculin:
Purified protein derivative or tuberculin stimulates the cell mediated immunity non specifically by activating T helper 1 cells, Natural Killer cells, and cytokine production an increase in interleukin-12 as a process in boosting the cell-mediated immunity contributes to the mechanism of action. | Inclusion Criteria:
* All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size
Exclusion Criteria:
* Patients with immunodeficient diseases or receiving any immunosuppressive drugs
* Pregnancy and lactation | Assiut University | OTHER | {
"id": "PPDG",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-05-12T00:00:00 | {
"date": "2017-05-17",
"type": "ACTUAL"
} | {
"date": "2017-05-15",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Genital Wart"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "number of patients with complete resolution of genital warts",
"timeFrame": "4 months"
}
],
"secondary": null
} | null | [{"pmid": "11238198", "type": "RESULT", "citation": "Scott M, Nakagawa M, Moscicki AB. Cell-mediated immune response to human papillomavirus infection. Clin Diagn Lab Immunol. 2001 Mar;8(2):209-20. doi: 10.1128/CDLI.8.2.209-220.2001. No abstract available."}, {"pmid": "16973081", "type": "RESULT", "citation": "Buck HW Jr. Genital warts. Clin Evid. 2006 Jun;(15):2149-61. No abstract available."}, {"pmid": "12807939", "type": "RESULT", "citation": "Bosch FX, de Sanjose S. Chapter 1: Human papillomavirus and cervical cancer--burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;(31):3-13. doi: 10.1093/oxfordjournals.jncimonographs.a003479."}, {"pmid": "25273231", "type": "RESULT", "citation": "Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available."}, {"pmid": "15897380", "type": "RESULT", "citation": "Horn TD, Johnson SM, Helm RM, Roberson PK. Intralesional immunotherapy of warts with mumps, Candida, and Trichophyton skin test antigens: a single-blinded, randomized, and controlled trial. Arch Dermatol. 2005 May;141(5):589-94. doi: 10.1001/archderm.141.5.589."}, {"pmid": "23336207", "type": "RESULT", "citation": "Abd-Elazeim FM, Mohammed GF, Fathy A, Mohamed RW. Evaluation of IL-12 serum level in patients with recalcitrant multiple common warts, treated by intralesional tuberculin antigen. J Dermatolog Treat. 2014 Jun;25(3):264-7. doi: 10.3109/09546634.2013.768760. Epub 2013 May 6."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D030361",
"term": "Papillomavirus Infections"
},
{
"id": "D004266",
"term": "DNA Virus Infections"
},
{
"id": "D014777",
"term": "Virus Diseases"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D017193",
"term": "Skin Diseases, Viral"
},
{
"id": "D014412",
"term": "Tumor Virus Infections"
},
{
"id": "D012874",
"term": "Skin Diseases, Infectious"
},
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D015229",
"term": "Sexually Transmitted Diseases, Viral"
},
{
"id": "D012749",
"term": "Sexually Transmitted Diseases"
},
{
"id": "D003141",
"term": "Communicable Diseases"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"id": "M17603",
"name": "Warts",
"relevance": "HIGH"
},
{
"asFound": "Genital Warts",
"id": "M6443",
"name": "Condylomata Acuminata",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23687",
"name": "Papillomavirus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17522",
"name": "Virus Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7442",
"name": "DNA Virus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19501",
"name": "Skin Diseases, Viral",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17162",
"name": "Tumor Virus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15677",
"name": "Skin Diseases, Infectious",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15558",
"name": "Sexually Transmitted Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17933",
"name": "Sexually Transmitted Diseases, Viral",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D014860",
"term": "Warts"
},
{
"id": "D003218",
"term": "Condylomata Acuminata"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M17360",
"name": "Vaccines",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D014860",
"term": "Warts"
},
{
"id": "D003218",
"term": "Condylomata Acuminata"
}
],
"interventions": []
} |
NCT00901966 | null | Sun Exposure and Melanoma in Agricultural Workers | Sun Exposure and Melanoma in Agricultural Workers | None | OBSERVATIONAL | COMPLETED | 2009-05-13T00:00:00 | null | 2010-10-31T00:00:00 | 2013-02-13T00:00:00 | null | 447 | 18 | 100 | ALL | false | This K07 Career Development Award application is designed to expand Dr. Dennis career development from cancer etiology to cancer prevention and control. The career development plan rests on mentoring directed by experts in cancer prevention research and protected time to foster my professional development as an independent cancer control researcher. A unique population, the Agricultural Health Study (AHS) cohort, will be used to examine sun exposure, sun protection behavior, and factors affecting these behaviors regarding the risk of melanoma in private pesticide applicators (farmers) and their spouses.
The research plan proposed to examine skin melanoma within this prospective cohort of private applicators (mostly farmers) and their spouses in Iowa and North Carolina (the AHS) in association with environmental factors. Specific aim 1 examined the risk of melanoma in the AHS cohort using various existing measures of sun exposure adjusted for skin sensitivity and sun protection. Subsequently (for aim 2) qualitative research methods were used to design appropriate measures of sun exposure, sun protection behavior, and factors affecting these behaviors in private applicators and their spouses within the AHS based on the cohort analyses.
Now Aim 3 will be completed by conducting a nested case-control study of melanoma within the AHS cohort to examine in more detail sun exposure histories and protective behavior. The questionnaire was designed based on findings from the cohort analyses (aim 1) and qualitative methods (aim 2). The risk of melanoma will be examined regarding: a) the complex relationship of cumulative (sun exposure during each decade of life) and intermittent sun exposure (sunburns and sunny vacations), b) factors affecting behavior including attitudes about sun exposure and prevention, and c) the use of tanning salons and sunless tanning creams, particularly in spouses (expected to be rare overall).
The final aim is to use the results from the cohort and nested case-control studies to design a behavioral intervention, along with short computer automated telephone interview (CATI) that can be used in the whole AHS cohort or other farming populations. Funding for such studies will be sought through the R01) mechanism as an independent cancer control researcher. The behavioral intervention will be based on those factors that are the strongest risk factors for melanoma, highly prevalent, and easily modifiable. The behavioral intervention will be designed based on knowledge and skill gained from the Career Development Plan goals. | This K07 Career Development Award application is designed to expand Dr. Dennis career development from cancer etiology to cancer prevention and control. The career development plan rests on mentoring directed by experts in cancer prevention research and "protected time" to foster my professional development as an independent cancer control researcher. A unique population, the Agricultural Health Study (AHS) cohort, will be used to examine sun exposure, sun protection behavior, and factors affecting these behaviors regarding the risk of melanoma in private pesticide applicators (farmers) and their spouses. The research plan proposed to examine skin melanoma within this prospective cohort of private applicators (mostly farmers) and their spouses in Iowa and North Carolina (the AHS) in association with environmental factors. Specific aim 1 examined the risk of melanoma in the AHS cohort using various existing measures of sun exposure adjusted for skin sensitivity and sun protection. Subsequently (for aim 2), qualitative research methods were used to design appropriate measures of sun exposure, sun protection behavior, and factors affecting these behaviors in private applicators and their spouses within the AHS based on the cohort analyses. Now Aim 3 will be completed by conducting a nested case-control study of melanoma within the AHS cohort to examine in more detail sun exposure histories and protective behavior. The questionnaire was designed based on findings from the cohort analyses (aim 1) and qualitative methods (aim 2). The risk of melanoma will be examined regarding: a) the complex relationship of cumulative (sun exposure during each decade of life) and intermittent sun exposure (sunburns and sunny vacations), b) factors affecting behavior including attitudes about sun exposure and prevention, and c) the use of tanning salons and sunless tanning creams, particularly in spouses (expected to be rare overall). The final aim is to use the results from the cohort and nested case-control studies to design a behavioral intervention, along with a short computer automated telephone interview (CATI) that can be used in the whole AHS cohort or other farming populations. Funding for such studies will be sought through the R01 mechanism as an independent cancer control researcher. The behavioral intervention will be based on those factors that are the strongest risk factors for melanoma, highly prevalent, and easily modifiable. The behavioral intervention will be designed based on knowledge and skill gained from the Career Development Plan goals. | * INCLUSION CRITERIA:
* Registered Agricultural Health Study (AHS) participants in Iowa
EXCLUSION CRITERIA:
* prior cancer diagnosis other than melanoma
* surrogates will not be used if a case has died before they are interviewed
* participants under 18 will not be included. | National Institutes of Health Clinical Center (CC) | NIH | {
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"Melanoma"
] | ["Melanoma", "Sun Exposure History", "Agricultural Health Study", "Sun Exposure"] | null | [
{
"city": "Bethesda",
"country": "United States",
"facility": "National Cancer Institute (NCI), 9000 Rockville Pike",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland"
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"other": null,
"primary": [
{
"description": null,
"measure": "Prevalence of melanoma",
"timeFrame": "After enrollment"
}
],
"secondary": null
} | [
{
"affiliation": "National Cancer Institute (NCI)",
"name": "Laura Beane-Freeman",
"role": "PRINCIPAL_INVESTIGATOR"
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] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D009373",
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"term": "Neoplasms by Histologic Type"
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"id": "D009369",
"term": "Neoplasms"
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"term": "Neoplasms, Nerve Tissue"
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"term": "Skin Neoplasms"
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NCT03680066 | null | Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children. | Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children. | None | INTERVENTIONAL | TERMINATED | 2018-07-25T00:00:00 | null | 2023-11-28T00:00:00 | 2023-11-28T00:00:00 | [
"NA"
] | 15 | 2 | 18 | ALL | true | This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling. | Visit 1 (V1): During this visit at the Pediatric Research Platform at the Children's Hospital, subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces" by following safety and accuracy guidelines for food challenges (7). The following foods (similar for all patients) will be given in one dose in the size of a regular serving:
* cookies, max 30 g;
* chocolate, max 30 g;
* breakfast cereals, max 50 g.
Each meal will be administered with a 1 hour observation period in between and at the end.
If the patient does not react to any of the foods or has only oral itching (mild symptoms), he/she will be instructed to stop the ban on "may contain" foods and eat them regularly. If the patient has more than mild symptoms, the study will be stopped and the patient will be banned from eating foods with traces. The study subjects with a negative challenge and instructed to eat foods with the "may contain" label will be provided emergency medications and instruction on when and how to use them according to current guidelines (8).
An age appropriate quality of life questionnaire will be filled out by the parents/patient during the visit.
For the following 3 months after "may contain food" challenges, the patients will be invited to eat on a regular basis any foods labeled as "may contain" tree nuts and/or peanuts and record the consumption on a diary. Such foods will only be eaten in presence of a family member instructed for the measures to be taken in case of a reaction. They will record any history of reaction and contact the study team. The brand name of the food, and if available the batch will be recorded. The participants will store the study food and its packaging safely in a box and bring it along at V2 for allergen content analysis.
If a reaction occurs, the food will be analyzed for allergen content by immunoaffinity capillary elecrophoresis-matrix assisted laser desorption/ionization mass spectrometry, as well as a simplified version of this technique, the immunomagnetic separation -matrix-assisted laser desorption/ionization mass spectrometry.
Visit 2 (V2): During this visit, the parents/patients will report on the brand, the frequency and the amount of "may contain" foods eaten since V1.
The quality of life questionnaire will be filled out again by the parents/patient. | Inclusion Criteria:
* Children aged 2-18 years at time of inclusion
* Tree nut or peanut allergy documented by:
* Positive skin prick tests (SPTs) to peanut and/or tree nuts
* Positive specific IgE (sIgE) to peanut and/or tree nuts ( ≥0.35 kU/L)
* A recent (\< 1 year) positive food challenge, reacting to the dose of 30 mg of proteins or below.
* Parent/Legal guardian has been informed about the study and has signed Informed Consent Form
Exclusion Criteria:
* History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.
* Expected non-adherence to the study protocol.
* Severe or uncontrolled asthma. | University Hospital, Geneva | OTHER | {
"id": "CCER 2017-01413",
"link": null,
"type": null
} | recruitment stopped due to low number of subjects | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-09-20T00:00:00 | {
"date": "2023-12-05",
"type": "ACTUAL"
} | {
"date": "2018-09-21",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Food Allergy",
"Peanut Allergy",
"Tree Nut Allergy"
] | ["Peanut allergy", "Tree Nut allergy", "Precautionary allergen labeling", "May contain traces", "Allergen threshold"] | null | [
{
"city": "Geneva",
"country": "Switzerland",
"facility": "Pediatric Allergy Unit - University Hospitals of Geneva",
"geoPoint": {
"lat": 46.20222,
"lon": 6.14569
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Result of the food challenges with foods labelled with \"may contain traces\" (tolerated or reacted).",
"timeFrame": "At study entry"
}
],
"secondary": [
{
"description": null,
"measure": "Tolerance to foods labelled with \"may contain traces\" eaten normally during a 3 months follow-up.",
"timeFrame": "During 3 months follow-up"
},
{
"description": null,
"measure": "Frequency of reactions to foods labelled with \"may contain traces\" eaten normally during a 3 months follow-up.",
"timeFrame": "During 3 months follow-up"
},
{
"description": null,
"measure": "Severity of reactions to foods labelled with \"may contain traces\" eaten normally during a 3 months follow-up.",
"timeFrame": "During 3 months follow-up"
},
{
"description": null,
"measure": "Changes of quality of life after 3 months without restriction of foods labelled with \"may contain traces\", compared to baseline when restricting.",
"timeFrame": "At entry and after 3 months"
}
]
} | [
{
"affiliation": "University Hospitals of Geneva",
"name": "Philippe Eigenmann, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D007154",
"term": "Immune System Diseases"
},
{
"id": "D006969",
"term": "Hypersensitivity, Immediate"
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"id": "D000074924",
"term": "Nut and Peanut Hypersensitivity"
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],
"browseBranches": [
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"abbrev": "BC20",
"name": "Immune System Diseases"
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},
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"meshes": [
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"term": "Hypersensitivity"
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"term": "Food Hypersensitivity"
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"id": "D021183",
"term": "Peanut Hypersensitivity"
},
{
"id": "D021184",
"term": "Nut Hypersensitivity"
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]
} | null | {
"conditions": [
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"term": "Hypersensitivity"
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NCT05635266 | null | Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives | A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives | None | OBSERVATIONAL | RECRUITING | 2022-11-22T00:00:00 | null | null | null | null | 20,000 | 18 | 85 | ALL | true | To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions. | null | Inclusion Criteria:
* Persons 18 to 85 years of age at the date of informed consent.
* If presenting with a history of a specific condition, the diagnosis is confirmable in the medical record or may be confirmed using other forms of verification including self-reporting.
* Understands the procedures and requirements of the study by providing written informed consent (or verbal assent if a legally authorized representative will sign the ICF), including consent for authorization for protected health information disclosure.
Exclusion Criteria:
* Persons younger than 18 years of age or older than 85 years of age at the date of informed consent.
* Receipt of blood products 30 days before the study blood draw.
* Receipt of an investigational (unapproved) drug 30 days before the study blood draw.
* A confirmable diagnosis of any medical condition that would increase potential phlebotomy risks.
* Has donated a unit of blood within the last 2 months at the date of informed consent. | Sanguine Biosciences | INDUSTRY | {
"id": "SAN-BB-02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-11-22T00:00:00 | {
"date": "2024-05-07",
"type": "ACTUAL"
} | {
"date": "2022-12-02",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Health condition, exceptive condition, and control participants will be recruited by one or any of the following resources, but not limited to:
* Use of online marketing where potential participants receive study information from the Sanguine's website or online participant referral program;
* In the site investigators (or PI's) clinic; and/or
* Through community advocacy programs.
* Participant Referral | PROBABILITY_SAMPLE | null | {
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"Allergies",
"Alpha-Gal Syndrome",
"Alzheimer Disease",
"Amyloidosis",
"Ankylosing Spondylitis",
"Arthritis",
"Alopecia Areata",
"Asthma",
"Atopic Dermatitis",
"Autism",
"Autoimmune Hepatitis",
"Behcet's Disease",
"Beta-Thalassemia",
"Cancer",
"Celiac Disease",
"Kidney Diseases",
"COPD",
"Crohn Disease",
"Cystic Fibrosis",
"Diabetes",
"Dravet Syndrome",
"DMD",
"Fibromyalgia",
"Graves Disease",
"Thyroid Diseases",
"Hepatitis",
"Hidradenitis Suppurativa",
"ITP",
"Leukemia",
"ALS",
"Lupus or SLE",
"Lymphoma",
"Multiple Sclerosis",
"Myasthenia Gravis",
"Heart Diseases",
"Parkinson Disease",
"Pemphigus Vulgaris",
"Cirrhosis",
"Psoriasis",
"Schizophrenia",
"Scleroderma",
"Sickle Cell Disease",
"Stroke",
"Ulcerative Colitis",
"Vasculitis",
"Vitiligo"
] | null | null | [
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"country": "United States",
"facility": "Sanguine Biosciences",
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{
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{
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{
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{
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{
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{
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{
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{
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},
{
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"term": "Mental Disorders"
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{
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"term": "Urologic Diseases"
},
{
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"term": "Female Urogenital Diseases"
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{
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"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
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"term": "Urogenital Diseases"
},
{
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"term": "Male Urogenital Diseases"
},
{
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"term": "Dementia"
},
{
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{
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{
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{
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{
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},
{
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},
{
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{
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{
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{
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{
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{
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{
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{
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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NCT02157766 | null | Wisconsin Center for the Neuroscience and Psychophysiology of Meditation | Wisconsin Center for the Neuroscience and Psychophysiology of Meditation | None | INTERVENTIONAL | COMPLETED | 2014-05-27T00:00:00 | null | null | 2019-04-14T00:00:00 | [
"NA"
] | 457 | 18 | 65 | ALL | true | The Wisconsin Center for the Neuroscience and Psychophysiology of Meditation will be a highly focused center dedicated to novel and cutting edge research on the mechanisms by which meditation works. The core set of hypotheses for this Center focus on the mechanisms of two common meditation practices: Mindfulness Meditation (MM) and Loving-Kindness/Compassion Meditation (LKM-CO), both taught in Mindfulness-Based Stress Reduction (MBSR). The investigators will study both Long-Term Meditators (LTMs) as well as meditation-naïve participants (MNPs). The latter group will be randomly assigned to MBSR, a rigorously matched comparison intervention called the Health Enhancement Program (HEP; MacCoon et al., 2012), or to a Wait List (WL) control group. This will give us a comprehensive view of changes that are produced by meditation practices per se, changes generically associated with interventions designed to promote well-being, and changes that might be effects of repeating testing protocols across multiple occasions. In addition, the inclusion of both novice and experienced meditators provides a wide range of practice experience that will provide critical information on dose-related effects, information that is lacking in the research literature today.
Each of the projects is focused on examining the brain mechanisms and peripheral biological correlates of meditation. Project 1 (Davidson) will examine the impact of the explicit use of mindfulness and loving-kindness/compassion strategies on emotion regulation, specifically neural, biobehavioral and hormonal indices of reactivity to and recovery from pictures of human suffering and flourishing. Project 2 (Rosenkranz) will investigate the brain to periphery pathways through which psychological factors contribute to the expression of asthma symptoms. In addition, it will examine the efficacy of meditation training in reducing the inflammatory response to an allergen in asthmatic individuals by reducing the reactivity of emotion-related neural circuitry. Project 3 (Tononi) will examine whether the previously reported increase in gamma oscillations during Non-REM (NREM) sleep in meditators is associated with changes in sleep mentation (Ferrarelli et al. 2013). In addition, project 3 will examine relations between meditation-induced changes in brain activity during sleep and brain activity and cognitive function during wakefulness. | null | Inclusion Criteria - MNP-A:
* Able to provide valid informed consent to participate by signing/dating a consent form.
* Fluent English speaker
* MRI safe - Not excluded based on magnetic resonance Screening Form
* 18-65 years old
* Pre-albuterol FEV1 ≥ 60% while holding meds
* Physician's diagnosis of asthma - via clinical assessment, reversibility or airway hyperresponsivity;
* Ability to provide blood samples with relatively easy vascular access
* Uses acceptable contraception
* Evidence of persistent, residual inflammation (≥2% sputum eosinophils OR peripheral blood eosinophils ≥ 150 OR eNO of 30+
* Must be US citizen, green card holder or have an F-1 or J-1 visa. This is required in order to be able to pay participants.
Exclusion Criteria - MNP-A:
* Pregnant, wanting to become pregnant, breast feeding or less than 6 months post-partum.
* Taking prescribed psychotropic or central nervous system altering medications (may be included with the PIs discretion).
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder. Diagnosed episode of Major Depression unless it was more than 1 year ago. Diagnosed eating disorder or anxiety disorder unless it was more than 1 year ago. (May be included with the PIs discretion).
* Excluded based upon the screening visit
* Some ongoing medical problems will be excluded based on team judgments about whether they will affect a participant's ability to participate in the study procedures or will affect one or more outcome measures.
* Unable to distinguish colors used in Stroop task
* Use of oral corticosteroids
* Inability or unwillingness to withhold medication as detailed below, before each set of laboratory assessments:
* Leukotriene Inhibitors - 2 days
* Zyrtec - 5 days
* Allegra/Claritin - 4 days
* Antihistamines - 2 days
* Nasal Steroids - 24h
* Albuterol - 6 h
* Inhaled corticosteroids - 12 h
* Use of \>1000 mcg Fluticasone or equivalent ICS per day.
* Use of monoclonal antibody that targets eosinophils
* Concurrent medications other than for allergies/asthma (must be approved by Dr.)
* Current smoker or has a smoking history exceeding 5 pack-years within the last 10 years (i.e. someone who has been a non-smoker for 10 or more years can be enrolled)
* Significant previous training or significant current practice in meditation
* Completed Mindfulness Based Stress Reduction (MBSR) in the past.
* Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include)).
* Significant daily practice with other mind-body techniques
* Daily Yoga or Tai Chi Practice - exclude
* Other daily practice - judgment.
Inclusion Criteria - MNP-NA:
* Able to provide valid informed consent to participate by signing/dating a consent form.
* Fluent English speaker
* MRI safe - Not excluded based on magnetic resonance Screening Form
* BMI under 35
* 25-65 years old
* Live within 50 miles of Madison, WI.
* Takes less than 30 minutes to fall asleep on average. Gets a good night of sleep regularly. Goes to bed before 12 a.m., able to sleep between 11 p.m. \& 6 a.m. and sleeps \>= 6 hours. (May be included at sleep doctor's discretion. In some cases, participants may not comply with these criteria but may be entirely safe to participate in the study. For example, a participant may indicate they do not get a good night of sleep due to a situational issue such as a waking baby or a pet as opposed to a chronic issue like insomnia. In these cases, there is no safety issue in having the participant included in the study)
* Participants assigned to HEP must have physician signature (on the Physician Authorization Form - PAF) indicating it is safe for them to participate in our interventions as some participant characteristics, such as a family history of coronary or atherosclerotic disease, represent risk factors that together may make the HEP intervention inadvisable; The process is consistent for ANY person who wishes to participate in any sort of physical activity class at the UW Health Research Park Clinic.
* Must be US citizen, green card holder or have an F-1 or J-1 visa. This is required in order to be able to pay participants.
Exclusion Criteria - MNP-NA:
* Pregnant, wanting to become pregnant, breast feeding or less than 6 months post-partum.
* Taking prescribed psychotropic or central nervous system altering medications (may be judged by PI in cases of periodic use (e.g. takes anti-anxiety med only when flying)
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder. Diagnosed episode of Major Depression unless it was more than 1 year ago. Diagnosed eating disorder or anxiety disorder unless it was more than 1 year ago.
* Excluded based upon the screening visit
* Some ongoing medical problems will be excluded based on team judgments about whether they will affect a participant's ability to participate in the study procedures or will affect one or more outcome measures.
* Unable to distinguish colors used in Stroop task
* Currently participating in another clinical trial
* Current diagnosis of asthma unless. History of asthma is not cause for exclusion.
* Taking prescribed sleeping medications (may be judged by sleep doctor in cases of periodic use (e.g. takes sleep med only when traveling internationally))
* Currently diagnosed sleep disorders. Past disorders are a judgment by a doctor from the sleep clinic.
* Regular night shift worker. (Participants may work periodic night shifts (e.g. one rotation per month) as long as they are able to sleep at normal times for the study)
* Epworth Sleepiness Scale - sleep lab will judge focusing on whether this a situational or chronic issue (e.g. dogs waking up vs. awake due to anxiety).
* Insomnia Severity Index - sleep lab will judge focusing on whether this a situational or chronic issue (e.g. dogs waking up vs. awake due to anxiety).
* STOP-BANG questionnaire - sleep lab will judge focusing on whether this is a situational or chronic issue (unless question 3 = yes in which case a score \>3 will be excluded).
* Cigarette smoker unless willing to go without a cigarette for 4 hours or more.
* Traveled across more than 3 time zones in the three weeks prior to each study visit.
* Expert in physical activity (e.g. physical therapist, personal trainer), music (music therapist) or nutrition (nutritionist).
* Significant daily practice with physical activity as scored by the web screen.
* Significant previous training or significant current practice in meditation
* Completed Mindfulness Based Stress Reduction (MBSR) in the past.
* Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include)).
* Significant daily practice with other mind-body techniques
* Daily Yoga or Tai Chi Practice - exclude
* Other daily practice - judgment.
Inclusion Criteria - LTM:
* Able to provide valid informed consent to participate by signing/dating a consent form.
* Fluent English speaker
* MRI safe - Not excluded based on magnetic resonance Screening Form
* BMI under 35
* 25-65 years old .
* Takes less than 30 minutes to fall asleep on average. Gets a good night of sleep regularly. Goes to bed before 12 a.m., able to sleep between 11 p.m. \& 6 a.m. and sleeps \>= 6 hours. Long-term practitioners may be judged on these last criteria because their sleep habits are sometimes very different than meditation naïve participants. (May be included at sleep doctor's discretion. In some cases, participants may not comply with these criteria but may be entirely safe to participate in the study. For example, a participant may indicate they do not get a good night of sleep due to a situational issue such as a waking baby or a pet as opposed to a chronic issue like insomnia. In these cases, there is no safety issue in having the participant included in the study)
* Meditation practice for a minimum of 5 years with an average practice of 200 minutes/week, that includes both mindfulness meditation and loving kindness and/or compassion meditation
* Significant retreat experience - a minimum of five weeks on retreat (with PI's discretion as financial means can make retreats impossible).
* Must be US citizen, green card holder or have an F-1 or J-1 visa. This is required in order to be able to pay participants.
Exclusion Criteria - LTM:
* Pregnant, wanting to become pregnant, breast feeding or less than 6 months post-partum.
* Taking prescribed psychotropic or central nervous system altering medications (may be judged by PI in cases of periodic use (e.g. takes anti-anxiety med only when flying)
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder. Diagnosed episode of Major Depression unless more than 1 year ago. Diagnosed eating disorder or anxiety disorder unless it was more than 1 year ago. Participants may be included with a history of these disorders with the PIs discretion.
* Excluded based upon the screening visit (Non-local LTMs will be excluded if they are not comfortable with the MRI however they may participate in the study if they are not comfortable with the electrical stimulation.)
* Some ongoing medical problems will be excluded based on team judgments about whether they will affect a participant's ability to participate in the study procedures or will affect one or more outcome measures.
* Unable to distinguish colors used in Stroop task
* Currently participating in another clinical trial
* Taking prescribed sleeping medications (may be judged by sleep doctor in cases of periodic use (e.g. takes sleep med only when traveling internationally))
* Currently diagnosed sleep disorders. Past disorders are a judgment by a doctor from the sleep clinic.
* Regular night shift worker. (Participants may work periodic night shifts (e.g. one rotation per month) as long as they are able to sleep at normal times for the study)
* Epworth Sleepiness Scale - sleep lab will judge focusing on whether this a situational or chronic issue (e.g. dogs waking up vs. awake due to anxiety).
* Insomnia Severity Index - sleep lab will judge focusing on whether this a situational or chronic issue (e.g. dogs waking up vs. awake due to anxiety).
* STOP-BANG questionnaire - sleep lab will judge focusing on whether this is a situational or chronic issue (unless question 3 = yes in which case a score \>3 will be excluded).
* Cigarette smoker unless willing to go without a cigarette for 4 hours or more.
* Traveled across more than 3 time zones in the three weeks prior to each study visit. | University of Wisconsin, Madison | OTHER | {
"id": "2014-0116",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-06-03T00:00:00 | {
"date": "2021-08-03",
"type": "ACTUAL"
} | {
"date": "2014-06-06",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
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},
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"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
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"Mindfulness",
"Compassion",
"Meditation",
"Mental Health",
"Asthma"
] | ["Mental Health", "Asthma", "Mindfulness", "Compassion", "Meditation"] | null | [
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] | [
{
"class": "NIH",
"name": "National Center for Complementary and Integrative Health (NCCIH)"
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] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in temporal dynamics of response to emotional anticipation task (fMRI) as a result of short term meditation practice OR 8 week training in meditation or health wellness interventions.",
"timeFrame": "baseline, 3 months, 10 months"
},
{
"description": null,
"measure": "Change in slope measure of diurnal cortisol following a well-being intervention relative to baseline.",
"timeFrame": "baseline (pre-intervention), 3 months (post-intervention), 10 months (follow-up)"
},
{
"description": null,
"measure": "Difference between groups (MBSR, WL) on change in lung function from pre-training to post-training",
"timeFrame": "baseline (pre), 3 months (post-intervention)"
}
],
"secondary": null
} | [
{
"affiliation": "UW-Madison, Center for Investigating Healthy Minds at the Waisman Center",
"name": "Richard J Davidson, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "36177306", "type": "DERIVED", "citation": "Higgins ET, Davidson RJ, Busse WW, Klaus DR, Bednarek GT, Goldman RI, Sachs J, Rosenkranz MA. Clinically relevant effects of Mindfulness-Based Stress Reduction in individuals with asthma. Brain Behav Immun Health. 2022 Sep 14;25:100509. doi: 10.1016/j.bbih.2022.100509. eCollection 2022 Nov."}] | {"versionHolder": "2025-06-18"} | {
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"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Asthma",
"id": "M4556",
"name": "Asthma",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5258",
"name": "Bronchial Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11170",
"name": "Lung Diseases, Obstructive",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10018",
"name": "Hypersensitivity",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14967",
"name": "Respiratory Hypersensitivity",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10020",
"name": "Hypersensitivity, Immediate",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001249",
"term": "Asthma"
}
]
} | null | {
"conditions": [
{
"id": "D001249",
"term": "Asthma"
}
],
"interventions": null
} |
NCT04799366 | null | Contractile Properties of Hypertrofic Muscles in Patients With Non-Dystrophic Myotonia | Contractile Properties of Hypertrofic Muscles in Patients With Non-Dystrophic Myotonia | None | OBSERVATIONAL | COMPLETED | 2021-03-11T00:00:00 | null | 2021-12-01T00:00:00 | 2021-12-01T00:00:00 | null | 36 | 18 | 80 | ALL | false | In myotonia congenita (MC), mutations in the CLCN1 gene coding a key chloride channel expressed in muscle cells cause myotonia. On examination, the myotonia can be demonstrated as delayed muscle relaxation of muscle contractions after mechanical stimulations. Existing literature describe no muscle weakness in MC patients, however a recent muscle MRI study in non-dystrophic myotonia patients found structural abnormalities in affected muscles when examined using T1 and STIR imaging. The question remains whether the signs of structural changes in the muscle are merely due to the myotonia, or long-term effects of elevated stress of the tissue, and if so, whether those changes lead to clinically significant loss of contractile properties of the muscle.
This study examines if the contractile properties of myotonic muscles are impaired in MC patients. 40 patients with Thomsens disease (n=20) and Beckers disease (n=20), respectively, will be included along with 20 healthy controls. Peak muscle torque is measured in the hand by hand dynamometer and in the thigh and calf muscles with a Biodex System 4 Pro Dynamometer and the cross-sectional area of the muscles are examined on T1-weighed and Dixon-MRI-scan. With the obtained data peak torque in strength tests, muscle hypertrophy, fat fraction in muscle tissue and contractility of the muscles, compared with healthy controls, will be assessed. | null | Inclusion Criteria:
* Age \<18 years
* Molecularly verified MC (Thomsens or Beckers disease)
Exclusion Criteria:
* Conditions that may impair results of the study, evaluated by the investigator
* Clausphobia
* Pregnancy or breastfeeding
* Metallic objects in and around the body that are not MR-compatible | Rigshospitalet, Denmark | OTHER | {
"id": "H-18023049-1",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-03-11T00:00:00 | {
"date": "2023-03-30",
"type": "ACTUAL"
} | {
"date": "2021-03-16",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | 40 patients (Thomsens MC, n=20; Beckers MC, n=20) will be included along with 20 healthy age- and gender-matched controls. Inclusion criteria are age \>18 years, verified MC diagnosis. Exclusion criteria areknown competing disorders that can interfere with the results (ie. muscular diseases or arthritis) or MRI contraindications.
Before participation patients are asked about medication status. Participants who are treated for their myotonic symptoms with either Mexiletin or Lamotrigin are asked to pause their medication four days prior to participation.
All patients will be asked to evaluate the severity of their myotonic symptoms using the MBS (Myotonic Behaviour Scale) rating from 1 (least severe) to 6 (most severe). | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Non-Dystrophic Myotonia",
"Myotonia Congenita"
] | null | null | [
{
"city": "Copenhagen",
"country": "Denmark",
"facility": "Rigshospitalet",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Contractile properties",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Measuring muscle hypertrophy in upper and lower limbs",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "Rigshospitalet, Denmark",
"name": "Laura Jacobsen, BSc",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020879",
"term": "Neuromuscular Manifestations"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D020967",
"term": "Myotonic Disorders"
},
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D020271",
"term": "Heredodegenerative Disorders, Nervous System"
},
{
"id": "D019636",
"term": "Neurodegenerative Diseases"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
}
],
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Myotonia",
"id": "M12174",
"name": "Myotonia",
"relevance": "HIGH"
},
{
"asFound": "Myotonia Congenita",
"id": "M12176",
"name": "Myotonia Congenita",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22619",
"name": "Neuromuscular Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22698",
"name": "Myotonic Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12092",
"name": "Muscular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22092",
"name": "Heredodegenerative Disorders, Nervous System",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21558",
"name": "Neurodegenerative Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12411",
"name": "Neuromuscular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": "Non-Dystrophic Myotonia",
"id": "T4158",
"name": "Nondystrophic Myotonia",
"relevance": "HIGH"
},
{
"asFound": "Myotonia Congenita",
"id": "T4023",
"name": "Myotonia Congenita",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009224",
"term": "Myotonia Congenita"
},
{
"id": "D009222",
"term": "Myotonia"
}
]
} | null | {
"conditions": [
{
"id": "D009224",
"term": "Myotonia Congenita"
},
{
"id": "D009222",
"term": "Myotonia"
}
],
"interventions": null
} |
NCT04357366 | null | suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE) | suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial | SAVE | INTERVENTIONAL | COMPLETED | 2020-04-20T00:00:00 | null | 2022-01-29T00:00:00 | 2022-04-15T00:00:00 | [
"PHASE2"
] | 1,000 | 18 | null | ALL | false | In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure. | The major hurdle of Coronavirus disease 2019 (COVID-19) is the early recognition of the patients at high risk for the development of severe respiratory failure (SRF). If this can be achieved early, then appropriate immunomodulatory treatment may be administered to prevent development of SRF. This scenario is extremely visionary since it prevents the development of the major fatal consequence of COVID-19 but also alleviates the heavy medical and financial burden of Intensive Care Unit (ICU) admission.
Current evidence suggests that SARS-CoV-2 activates endothelial function which leads to over-production of D-dimers. Urokinase plasminogen activator receptor (uPAR) is anchored to the cell membranes of the lung endothelial cells. As result of the activation of kallikrein, uPAR is cleaved and enters the systemic circulation as the soluble counterpart suPAR. Preliminary unpublished data from 57 Greek patients hospitalized after March 1st, 2020 in Greek hospitals due to pneumonia by confirmed SARS-CoV-2 infection showed that those with suPAR admission levels ≥ 6 ng/ml had greater risk for the development of SRF within 14 days than patients with suPAR less than 6ng/ml. The sensitivity of suPAR to detect these patients was 85.9% and the positive predictive value 85.9%. It needs to be underlined that all 21 Greek patients with suPAR≥ 6ng/ml were under treatment with hydroxychloroquine and azithromycin. These data were confirmed in 15 patients hospitalized for pneumonia by SARS-CoV-2 in Rush Medical Center at Chicago.
This prognostic ability of suPAR for unfavourable outcome is not presented for the first time; in the TRIAGE III trial that was conducted among 4,420 admissions in the emergency department in Denmark the interquartile range of suPAR was between 2.6 and 4.7 ng/ml in 30-day survivors and between 6.7 and 11.8 ng/ml in 30-day non-survivors. Previous data from the Hellenic Sepsis Study Group on 1,914 patients clearly shows a high prognostic utility of admission suPAR for 28-day mortality.
It is obvious that suPAR can early identify the start of such a type of inflammatory process in the lung parenchyma that has will soon be intensified. A recent publication has shown that this is due to the early release of interleukin-1α (IL-1α) from lung epithelial cells that are infected by the virus. This IL-1α acts as a promoting factor that stimulates the production of IL-1β and of a further cytokine storm from alveolar macrophages.
Anakinra is the only marketed product that inhibits both IL-1β and IL-1α and hence it is able to block an inflammatory response early on and to prevent the downstream inflammatory cascade. suPAR can be used as the biomarker tool to indicate patients with COVID-19 pneumonia in risk of SRF and for whom early start of anakinra may prevent development of SRF.
Anakinra is a safe drug that has been licensed for chronic subcutaneous administration in rheumatoid arthritis, refractory gout and chronic auto-inflammatory disorders. The safety profile was further proven when it was administered in two randomized clinical trials where more than 1,500 critically ill patients with severe sepsis were intravenously treated. | Inclusion Criteria:
* Age equal to or above 18 years
* Male or female gender
* In case of women, unwillingness to remain pregnant during the study period.
* Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent
* Confirmed infection by SARS-CoV-2 virus using molecular techniques as defined by the World Health Organization
* Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection
* Plasma suPAR ≥6ng/ml
Exclusion Criteria:
* Age below 18 years
* Denial for written informed consent
* Any stage IV malignancy
* Any do not resuscitate decision
* Any primary immunodeficiency
* Less than 1,500 neutrophils/mm3
* Known hypersensitivity to anakinra
* Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone for a greater period than the last 15 days.
* Any anti-cytokine biological treatment the last one month
* Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
* Severe hepatic failure
* Severe renal failure
* Any need for CPAP or mechanical ventilation
* Any pO2/FiO2 ratio less than 150 | Hellenic Institute for the Study of Sepsis | OTHER | {
"id": "SAVE",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-04-21T00:00:00 | {
"date": "2023-07-13",
"type": "ACTUAL"
} | {
"date": "2020-04-22",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Treatment with anakinra",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"COVID-19",
"Virus Diseases",
"Corona Virus Infection",
"Lower Respiratory Tract Infection Viral"
] | ["COVID-19", "SARS-CoV-2", "Anakinra", "suPAR"] | null | [
{
"city": "Marousi",
"country": "Greece",
"facility": "COVID-19 Department, General Hospital of Attica SISMANOGLEIO-AMALIA FLEMING",
"geoPoint": {
"lat": 38.05,
"lon": 23.8
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"state": "Athens"
},
{
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"facility": "2nd Department of Internal Medicine, University General Hospital of Alexandroupolis",
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"lon": 25.87644
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"lat": 37.97945,
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"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
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},
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"city": "Athens",
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"facility": "1st Department of Internal Medicine Amalia Fleming General Hospital",
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{
"city": "Athens",
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"state": null
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"geoPoint": {
"lat": 39.62069,
"lon": 19.91975
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"lat": 39.66486,
"lon": 20.85189
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"state": null
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"country": "Greece",
"facility": "Department of Internal Medicine, General Hospital of Katerini",
"geoPoint": {
"lat": 40.26956,
"lon": 22.50608
},
"state": null
},
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"city": "Larissa",
"country": "Greece",
"facility": "Department of Internal Medicine, University General Hospital of Larissa",
"geoPoint": {
"lat": 39.63689,
"lon": 22.41761
},
"state": null
},
{
"city": "Larissa",
"country": "Greece",
"facility": "Department of Internal Medicine, General Hospital of Larisa KOUTLIMBANEIO & ΤΡΙΑΝΤΑFΥLLΕΙΟ",
"geoPoint": {
"lat": 39.63689,
"lon": 22.41761
},
"state": null
},
{
"city": "Patra",
"country": "Greece",
"facility": "Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA",
"geoPoint": {
"lat": 38.24444,
"lon": 21.73444
},
"state": null
},
{
"city": "Piraeus",
"country": "Greece",
"facility": "2nd Department of Internal Medicine, General Hospital of Piraeus TZANEIO",
"geoPoint": {
"lat": 37.94745,
"lon": 23.63708
},
"state": null
},
{
"city": "Thessaloníki",
"country": "Greece",
"facility": "1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki",
"geoPoint": {
"lat": 40.64361,
"lon": 22.93086
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The ratio of patients who will develop serious respiratory failure (SRF)",
"timeFrame": "Visit study day 14"
}
],
"secondary": [
{
"description": null,
"measure": "Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment",
"timeFrame": "Visit study day 14"
},
{
"description": null,
"measure": "Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7",
"timeFrame": "Visit study day 1, visit study day 7"
},
{
"description": null,
"measure": "Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14",
"timeFrame": "Visit study day 1, visit study day 14"
},
{
"description": null,
"measure": "Change of SOFA score in enrolled subjects between days 1 and 7",
"timeFrame": "Visit study day 1, visit study day 7"
},
{
"description": null,
"measure": "Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14",
"timeFrame": "Visit study day 1, visit study day 14"
},
{
"description": null,
"measure": "Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7",
"timeFrame": "Visit study day 1, visit study day 7"
},
{
"description": null,
"measure": "Change of plasma inflammatory mediators levels between days 1 and 7",
"timeFrame": "Visit study day 1, visit study day 7"
},
{
"description": null,
"measure": "Rate of Mortality",
"timeFrame": "Visit study day 30"
},
{
"description": null,
"measure": "Rate of Mortality",
"timeFrame": "Visit study day 90"
},
{
"description": null,
"measure": "Change of gene expression between days 1 nad 7",
"timeFrame": "days 1 and 7"
},
{
"description": null,
"measure": "Safety of anakinra",
"timeFrame": "Last patients visit, Day 90"
},
{
"description": null,
"measure": "Association between the time interval from hospital admission until start of anakinra and the incidence of SRF",
"timeFrame": "Visit day 14"
},
{
"description": null,
"measure": "Correlation between time interval and the occurrence of SAA under treatment with anakinra",
"timeFrame": "Visit day 14"
},
{
"description": null,
"measure": "Association between radiological opacities in chest computed tomography and the incidence of SRF under anakinra treatment",
"timeFrame": "Visit day 14"
},
{
"description": null,
"measure": "Association of the efficacy of anakinra for subgroups of patients; the studied subgroups will be the quartiles of the respiratory ratio (pO2/FiO2) at admission; the main comorbidities; the WHO classification",
"timeFrame": "Visit day 14"
}
]
} | [
{
"affiliation": "Aristotle University of Thessaloniki, Medical School",
"name": "Simeon Metallidis, MD, PhD",
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NCT06611566 | null | VR-guided Exercise and Mindfulness Program for People with Chronic Pain | Virtual-reality-guided Exercise and Mindfulness Program for People with Chronic Pain Under Rehabilitation: a Randomised Controlled Cross-over Trial | VRalgia | INTERVENTIONAL | COMPLETED | 2024-09-09T00:00:00 | null | 2023-03-01T00:00:00 | 2023-03-01T00:00:00 | [
"NA"
] | 27 | 18 | null | ALL | false | In this study we assessed the feasibility of a VR-guided intervention seeking to improve physical fitness in individuals with chronic pain. In a randomised controlled trial with a cross-over design and participants in rehabilitation for chronic pain were asked to perform, in a counter-balanced order, five minutes of aerobic exercise following identical instructions given through either a VR headset or TV screen. The procedures were then repeated with mindfulness exercises. Heart rate (HR) was monitored throughout all four sessions and participants self-reported perceived exercise intensity, benefit, relaxation, and reward. Paired Student's t-test, Wilcoxon signed rank test and McNemar's test were performed to compare the outcome variables across sessions for individuals, as appropriate. | Participants: were recruited through partner patients' organizations, a local exercise group aimed at people living with rheumatological conditions, and an inpatient occupations rehabilitation centre.
The study was conducted according to the Helsinki declaration and approved by the Local committee for medical and health research ethics at the Inland Norway University of Applied Sciences (Ref. 20616405).
Study design The study was designed as a randomised controlled trial with a cross-over design.
Intervntion: Each participant underwent five exercise sessions in total. Firstly, all participants performed a six- minutes warm-up session following instructions projected on a TV screen. Subsequently, the participants performed two aerobic exercise sessions, identical in content and duration (five- minutes), once following the instructions from VR (VR-A) and once following the identical program that was displayed on a TV screen (TV-A). The allocation of the first aerobic exercise session as VR-A or TV-A was randomly assigned for each individual. After completing the first aerobic exercise session, the participants were subsequently asked to complete the second session guided through the opposite mode of delivery. After the exercise sessions the same randomised cross-over design was followed for two five- minute mindfulness sessions, with the participants undergoing, in a counter-balanced and random order, a guided mindfulness program, once delivered through VR (VR-M) and once displayed on a TV screen (TV-M).
Virtual environment and technology In the VR-A and VR-M, the participants wore a stand-alone HMD (Oculus Quest 2 with stock headstrap, Meta Platforms, Menlo Park, California, USA). The virtual environment was developed by Fynd Reality AS (Hamar, Norway), in line with general criteria outlined during the participatory process and consisted of a computer-generated replication of Hamar's town square (Norway). Each participant would enter this town square as a virtual avatar with virtual arms and body. The position of the arms was tracked by the hand-held controllers. A large screen would appear in the virtual town square, showing a video in which an instructor guided the exercises for the various sessions. This was the same video as shown on the TV screen.
Data collection at baseline Participant were assessed according to the Polysymptomatic Distress Scale (PDS). The Widespread Pain Index and Symptom Scale that together compose thePDS were completed by participants. The PDS is composed of variables used in the 2010 American College of Rheumatology (ACR) fibromyalgia criteria which were later modified for use in clinical research and self-evaluation in epidemiological surveys 17-19. The PSD is thus both a diagnostic aid and a measure of fibromyalgia severity. A diagnosis of fibromyalgia may be indicated by a PSD score of 12 or more in an epidemiological study1. The PDS has been translated and validated in Norwegian 20.
Outcome measures HR was registered throughout the sessions using a HR-monitors worn at the wrist (Garmin® Forerunner 55). The mean HRs for the last three minutes of each session were calculated for each individual. For the aerobic exercise sessions, HR was also categorised into HR-zones according to the ACSM recommendations based on the participants' predicted maximal HR (220 minus age) 4, with the proportion of time spent in " moderate-vigorous exercise intensity" (HR 65% of maximum heart rate or more) being calculated and used for further analysis.
Participants also completed questionnaires
Statistics We compared the mean HR values recorded within the last three minutes of the warm-up vs. all other sessions, as well between each aerobic exercise (VR-A vs. TV-A) and mindfulness sessions (VR-M vs. TV-M), using paired Student's t-test.
The time spent in each HR category was compared using the paired Wilcoxon signed rank test and time in the "moderate-vigorous" vs "low" ACSM zone in the VR-A vs. TV-A sessions using McNemar's test for dichotomised variables.
Comparisons between the self-reported measurements collected after the aerobic exercise (VR-A vs. TV-A) and mindfulness sessions (VR-M vs. TV-M) were performed using the paired Wilcoxon signed rank test for each session for ordinal data and McNemars test for dichotomised variables. | Inclusion Criteria:
* The inclusion criteria were adults (\>18 years of age) with chronic musculo-skeletal pain.
Exclusion Criteria:
* The exclusion criteria were inability to perform VR-delivered physical exercise | Inland Norway University of Applied Sciences | OTHER | {
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NCT00717366 | null | Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis | An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis | None | INTERVENTIONAL | COMPLETED | 2008-07-16T00:00:00 | null | null | null | [
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] | 64 | 5 | 17 | ALL | false | This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose. | null | Inclusion Criteria:
* Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
* Hemodialysis for greater than or equal to (\>=) 8 weeks
* Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for \>= 8 weeks before screening and with no weekly dose change \>= 25 percent (%) (increase or decrease) during the 2 weeks of screening
Exclusion Criteria:
* Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
* Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
* Active malignant disease
* Pure red cell aplasia (PRCA) or history of PRCA
* Pregnant or lactating females
* Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment | Hoffmann-La Roche | INDUSTRY | {
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},
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"lat": 55.75222,
"lon": 37.61556
},
"state": null
},
{
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"lon": 2.15899
},
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},
{
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},
"state": null
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{
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"lat": 37.38283,
"lon": -5.97317
},
"state": null
},
{
"city": "Valencia",
"country": "Spain",
"facility": "Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null
},
{
"city": "Bangkok",
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"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null
},
{
"city": "Bangkok",
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"geoPoint": {
"lat": 13.75398,
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},
"state": null
},
{
"city": "Kiev",
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"facility": "Kiev city childrens nephrological center of hospital #1; Nephrology and RRT",
"geoPoint": {
"lat": 50.45466,
"lon": 30.5238
},
"state": null
},
{
"city": "Zaporizhzhia",
"country": "Ukraine",
"facility": "Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic",
"geoPoint": {
"lat": 50.60727,
"lon": 31.78792
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in Average Hb Concentration Between Baseline and Evaluation Period",
"timeFrame": "Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)"
}
],
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{
"description": null,
"measure": "Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb",
"timeFrame": "Evaluation Period (Week 17 to Week 21)"
},
{
"description": null,
"measure": "Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL",
"timeFrame": "Evaluation Period (Week 17 to Week 21)"
},
{
"description": null,
"measure": "Number of Participants With Blood Transfusions",
"timeFrame": "Baseline to Week 20"
},
{
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"measure": "Change in Average Reticulocyte Count Between the Baseline and Evaluation Period",
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},
{
"description": null,
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},
{
"description": null,
"measure": "Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA",
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},
{
"description": null,
"measure": "Time to Reach Cmax (Tmax) of MIRCERA",
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},
{
"description": null,
"measure": "Apparent Terminal Phase Half-Life (t1/2) of MIRCERA",
"timeFrame": "Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13"
}
]
} | [
{
"affiliation": "Hoffmann-La Roche",
"name": "Clinical Trials",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D014570",
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{
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{
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{
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{
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{
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},
{
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{
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{
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"abbrev": "BXS",
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},
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"asFound": null,
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},
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"id": "M8399",
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"name": "Chronic Graft Versus Host Disease",
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"term": "Renal Insufficiency, Chronic"
},
{
"id": "D000740",
"term": "Anemia"
}
]
} | {
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"abbrev": "Hemat",
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],
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{
"id": "D000068817",
"term": "Epoetin Alfa"
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} |
NCT06569966 | null | The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure | The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure: A Single Center Prospective Randomized Controlled Study | None | INTERVENTIONAL | RECRUITING | 2024-08-20T00:00:00 | null | null | null | [
"NA"
] | 154 | 18 | 85 | ALL | false | This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure. | The patients in the experimental group collected the contents of the ileostomyand placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded.Patients in the control group received routine perioperative management. | Inclusion Criteria:
* aged 18-85 years old
* Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
* rectal cancer confirmed by preoperative pathology
* in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
* prophylactic ileostomy.
Exclusion Criteria:
* cannot complete treatment
* the history of the anorectal surgery
* preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
* postoperative anastomotic fistula and stricture
* during pregnancy or breastfeeding women
* with uncontrolled seizures, central nervous system disease or a history of mental disorders
* the last five years have other history of malignant disease cured except skin cancer and cervical carcinoma in situ
* clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association class II or worse 9) severe congestive heart failure or major arrhythmia requiring medical intervention, or myocardial infarction within the previous 6 months
* has a history of cerebral infarction or cerebral hemorrhage within the past 6 months
* organ transplantation requiring immunosuppressive therapy
* serious uncontrolled repeated infections, or other serious with disease of control;
* moderate or severe renal impairment creatinine clearance equal to or less than 50ml/min, or upper limit of normal (ULN)
* emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
* in screening the first 4 weeks received study medication or treatment (to participate in other test). | The Affiliated Hospital of Qingdao University | OTHER | {
"id": "Prehab-LARS2024",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-08-22T00:00:00 | {
"date": "2024-08-26",
"type": "ACTUAL"
} | {
"date": "2024-08-26",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Low Anterior Resection Syndrome"
] | null | null | [
{
"city": "Qingdao",
"country": "China",
"facility": "the Affiliated Hospital of Qingdao",
"geoPoint": {
"lat": 36.06488,
"lon": 120.38042
},
"state": "Shandong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The extent of low anterior resection syndrome",
"timeFrame": "1 month after discharge, and 3, 6, and 12 months after surgery"
}
],
"secondary": [
{
"description": null,
"measure": "the intestinal function recovery",
"timeFrame": "up to 10 days after surgery"
},
{
"description": null,
"measure": "Concentration of C-reactive protein",
"timeFrame": "up to 10 days after surgery"
},
{
"description": null,
"measure": "Quality of Life Questionnaire Core 30",
"timeFrame": "1 month after discharge, and 3, 6, and 12 months after surgery"
},
{
"description": null,
"measure": "fecal incontinence",
"timeFrame": "1 month after discharge, and 3, 6, and 12 months after surgery"
},
{
"description": null,
"measure": "Weight change after rehabilitation",
"timeFrame": "From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months"
},
{
"description": null,
"measure": "The number of emergency visits or rehospitalizations related to stoma closure",
"timeFrame": "1 year after surgery"
},
{
"description": null,
"measure": "the incidence of postoperative intestinal obstruction (POI)",
"timeFrame": "1 year after surgery"
}
]
} | [
{
"affiliation": "the Affiliated Hospital of Qingdao",
"name": "Yanbing Zhou",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003108",
"term": "Colonic Diseases"
},
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D012002",
"term": "Rectal Diseases"
},
{
"id": "D011183",
"term": "Postoperative Complications"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
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{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
}
],
"browseLeaves": [
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"name": "Syndrome",
"relevance": "LOW"
},
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"id": "M3018",
"name": "Low Anterior Resection Syndrome",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6336",
"name": "Colonic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
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"name": "Intestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14844",
"name": "Rectal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14065",
"name": "Postoperative Complications",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000094123",
"term": "Low Anterior Resection Syndrome"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "HB",
"name": "Herbal and Botanical"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "T120",
"name": "Cola",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D000094123",
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],
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NCT03963466 | null | A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma. | A Randomized Controlled Trial of the Efficacy and Safety of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma. | None | INTERVENTIONAL | COMPLETED | 2019-05-10T00:00:00 | null | 2020-02-01T00:00:00 | 2020-05-01T00:00:00 | [
"NA"
] | 30 | 20 | 60 | ALL | false | 1.Melasma is a common acquired condition of symmetric hyperpigmentation, typically occurring on the face, with higher prevalence in females and darker skin types. Treatments for melasma include topical, oral, procedural, and combination treatments.
2.1064-nm Q-Switched laser is one of the most widely used lasers for pigmented diseases in recent years. This wavelength laser can be effectively absorbed by pigment, which leads to damage of pigment and melanocyte. Previous 1064-nm Q-Switched laser treatment of melasma requires the use of large flare and low energy scanning repeatedly in the lesion area, and the terminal reaction is reddish and skin lesion temperature increased by 2℃. So the course of treatment is even longer and is closely related to the treatment of the doctor's subjective judgment. Current 1064-nm Q-Switched fractional laser is designed with focusing lens and can be scanned only once for skin lesions during treatment. Further more, the treatment energy of a single point is higher and it has stronger ability to destroy melanin. Finally, 1064-nm Q-Switched fractional laser promotes the expulsion of melanin particles from the superficial dermis and basal epidermis.
3.Tranexamic acid (TA) works by inhibiting the plasmin-plasminogen pathway. Increase in plasmin in keratinocytes leads to increase in production of arachidonic acid and alpha-melanocyte-stimulating hormone (alpha-MSH) production. Thus, by inhibiting the plasmin pathway, TA results in decreased melanogenesis. Studies support the use of oral TA as an adjuvant therapy for in refractory cases of melasma or as a second-line or third-line agent, and there is some early evidence supporting the utility of oral TA as monotherapy. Overall, randomized controlled trials have found that combination treatment regimens using oral TA as adjunct therapy results in greater reduction of melasma. | null | Inclusion Criteria:
.Subjects must be clinically diagnosed by the investigator to melasma and MASI score ≥24.
* no other treatment was performed for the skin lesions for half a year before the treatment
* (patients with a "no" in any of the above criteria are not eligible for inclusion) .Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Exclusion Criteria:
* subjects with a recent history of exposure to sunlight;
* subjects allergic to topical anesthesia;
* subjects with scar constitution;
* subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc.
* subjects who Pregnant or breast feeding;
* subjects with recent skin infections (such as viruses, bacteria, etc.);
* the methods are being used to treat subjects with similar diseases;
* subject who have taken isotretinoin A in the past year; .subject with facial dermatitis. | Xijing Hospital | OTHER | {
"id": "XijingH-PF-20190430",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-05-22T00:00:00 | {
"date": "2021-03-11",
"type": "ACTUAL"
} | {
"date": "2019-05-24",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Melasma"
] | ["Melasma", "1064-nm Q-Switched Fractional Laser", "Tranexamic acid (TA)", "Treatment"] | null | [
{
"city": "Xi'an",
"country": "China",
"facility": "Dermatology Derpartment of Xijing Hospital",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi"
}
] | [
{
"class": "OTHER_GOV",
"name": "Air Force General Hospital of the PLA"
},
{
"class": "OTHER",
"name": "First Hospital of China Medical University"
},
{
"class": "OTHER",
"name": "Chinese Academy of Medical Sciences"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Melasma area and severity index (MASI)",
"timeFrame": "From 0weeks to 36Weeks"
},
{
"description": null,
"measure": "Antera 3D skin test",
"timeFrame": "From 0weeks to 36Weeks"
},
{
"description": null,
"measure": "VISIA image analysis system",
"timeFrame": "From 0weeks to 36Weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Patient self-evaluation",
"timeFrame": "20Weeks，36Weeks"
}
]
} | [
{
"affiliation": "Dermatology Derpartment of Xijing Hospital",
"name": "Gang Wang, Prof",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D017495",
"term": "Hyperpigmentation"
},
{
"id": "D010859",
"term": "Pigmentation Disorders"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"asFound": "Melasma",
"id": "M11531",
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"relevance": "HIGH"
},
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"asFound": null,
"id": "M19760",
"name": "Hyperpigmentation",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13754",
"name": "Pigmentation Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008548",
"term": "Melanosis"
}
]
} | {
"ancestors": [
{
"id": "D000933",
"term": "Antifibrinolytic Agents"
},
{
"id": "D050299",
"term": "Fibrin Modulating Agents"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D006490",
"term": "Hemostatics"
},
{
"id": "D003029",
"term": "Coagulants"
}
],
"browseBranches": [
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"abbrev": "Coag",
"name": "Coagulants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Plan",
"id": "M16902",
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"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M6259",
"name": "Coagulants",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D014148",
"term": "Tranexamic Acid"
}
]
} | {
"conditions": [
{
"id": "D008548",
"term": "Melanosis"
}
],
"interventions": [
{
"id": "D014148",
"term": "Tranexamic Acid"
}
]
} |
NCT00283166 | null | Coaching to Improve Care of Cancer Pain | Coaching to Improve Care of Cancer Pain | None | INTERVENTIONAL | COMPLETED | 2006-01-25T00:00:00 | null | null | null | [
"NA"
] | 258 | 18 | 80 | ALL | false | An estimate of 90% of patients with cancer experience at least moderate pain at some point in their illness, and 42% of patients do not receive adequate palliation. The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers. The aims of the study are: 1) to compare the effects on pain, cancer-related symptoms, and health-related quality of life of a standard cancer pain leaflet versus face-to-face, tailored education and coaching; 2) to estimate the effect of tailored education and coaching on patients' self confidence for managing their pain and participating actively in care; and 3) to examine the mechanisms underlying the beneficial effects of the intervention. The proposed model will enhance research on pain management in that it is a pilot-tested intervention that is applicable in the outpatient setting, based on Social Cognitive Theory, and focused on patient activation and education. | Background: A small, randomized trial was conducted in 2001, that supplied preliminary evidence that a carefully structured, one-time individualized education and coaching intervention has the potential to provide important clinical benefits for patients suffering from cancer-related pain. The study did not explore the impact of the intervention in a larger, more diverse patient population; the duration of the intervention's benefits; or the pathway by which the benefits are achieved. This project will attempt to address these issues while building on the literature that exists in palliation and physician-patient communication.
Objective/Hypothesis: The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers.
Specific Aims: The aims of this study are: 1) to compare the effects on pain, cancer-related symptoms, and health-related quality of life of a standard educational intervention versus face-to-face, tailored education and coaching; 2) to estimate the effect of tailored education and coaching on self-efficacy for pain self-management and for participation in care; and 3) to examine the mechanisms underlying the beneficial effects of the intervention.
Study Design: The proposed study is a randomized, controlled trial comparing "education only" with tailored education and coaching for patient activation (TEC). Eligible patients scheduled to see their oncologist at any of the three participating health systems will be invited to participate in the study. Consenting patients will be randomly allocated to TEC or education only. The intervention will be applied during a brief session just before the scheduled oncology visit. Allocation will be concealed from physicians, interviewers, and data analysts. Patients assigned to the usual care group will review the content of a standard informational booklet on cancer pain. A health educator will review key learning points and be available to answer questions. Patients assigned to the TEC group will receive an intervention designed to improve self-efficacy for both pain self-management and participation in care. Data will be collected from patients in a private waiting alcove just prior to the index visit (personal interview); during the index visit (audio-taping); and then two, six, and 12 weeks after the visit (phone interview). In addition to assessing effectiveness of the intervention, the study is designed to measure potential mediators and intermediate outcomes (attitudes, beliefs, self-efficacy, patient participation, quality of care, and adherence) and to examine the mechanisms underlying the intervention's beneficial effects. The study will contribute to a test of Social Cognitive Theory by examining whether the benefit of the intervention is more powerfully attenuated by changes in attitudes and beliefs or by changes in self-efficacy.
Cancer Relevance: Uncontrolled cancer pain remains prevalent. An estimated 90% of patients with cancer experience at least moderate pain at some point in their illness, and 42% of patients do not receive adequate palliation. Aside from impairing quality of life, uncontrolled pain can contribute to depression, increase the likelihood of suicide, and decrease patient acceptance of potentially beneficial therapy. The proposed project is valuable in that it will confirm the benefit of patient coaching, elucidate its mechanisms, and test Social Cognitive Theory. The proposed model will enlarge existing research on pain management in that it is: a (1) pilot tested, easily implementable intervention that is (2) applicable in the outpatient setting, (3) based on strong theory that makes predictions about mechanisms of benefit, and (4) focused on patient activation as well as education. | Inclusion Criteria:
* Seen or scheduled to be seen at participating facility
* Diagnosis of locally advanced or disseminated lung, breast, prostate, head and neck, gynecologic (ovarian, uterine, cervical), esophageal, or colorectal cancer
* English speaking
* Worst pain past two weeks 4/10 or higher
Exclusion Criteria:
* Major surgical procedure scheduled within six weeks
* Enrolled in hospice
* Followed by pain management service (more than one visit made or scheduled)
* Already contacted for study
* Positive six-item dementia screen | University of California, Davis | OTHER | {
"id": "224690",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-01-25T00:00:00 | {
"date": "2017-06-09",
"type": "ACTUAL"
} | {
"date": "2006-01-27",
"type": "ESTIMATED"
} | [
"ADULT",
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] | null | null | true | {
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},
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} | [
"Pain"
] | ["Palliative Care"] | null | [
{
"city": "Mather",
"country": "United States",
"facility": "VA Northern California Health Care System",
"geoPoint": {
"lat": 37.88215,
"lon": -119.85573
},
"state": "California"
},
{
"city": "Oakland",
"country": "United States",
"facility": "Kaiser Permanente Northern California",
"geoPoint": {
"lat": 37.80437,
"lon": -122.2708
},
"state": "California"
},
{
"city": "Sacramento",
"country": "United States",
"facility": "UC Davis Cancer Center",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California"
}
] | [
{
"class": "OTHER",
"name": "Kaiser Permanente"
},
{
"class": "FED",
"name": "VA Northern California Health Care System"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pain control 2, 6, and 12 weeks after the index visit",
"timeFrame": "Baseline, 2, 6, and 12 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Pain self-efficacy",
"timeFrame": "Baseline, 2, 6, 12 weeks"
},
{
"description": null,
"measure": "Communication self-efficacy",
"timeFrame": "Baseline, 2, 6, 12 weeks"
}
]
} | [
{
"affiliation": "UC Davis Center for Health Services Research in Primary Care",
"name": "Richard L Kravitz, MD, MSPH",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "19737424", "type": "BACKGROUND", "citation": "Kravitz RL, Tancredi DJ, Street RL Jr, Kalauokalani D, Grennan T, Wun T, Slee C, Evans Dean D, Lewis L, Saito N, Franks P. Cancer Health Empowerment for Living without Pain (Ca-HELP): study design and rationale for a tailored education and coaching intervention to enhance care of cancer-related pain. BMC Cancer. 2009 Sep 9;9:319. doi: 10.1186/1471-2407-9-319."}, {"pmid": "19962845", "type": "RESULT", "citation": "Street RL Jr, Slee C, Kalauokalani DK, Dean DE, Tancredi DJ, Kravitz RL. Improving physician-patient communication about cancer pain with a tailored education-coaching intervention. Patient Educ Couns. 2010 Jul;80(1):42-7. doi: 10.1016/j.pec.2009.10.009. Epub 2009 Dec 4."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
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"abbrev": "BC23",
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],
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{
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"term": "Cancer Pain"
}
]
} | null | {
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],
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} |
NCT02069366 | null | Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder | Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder | None | INTERVENTIONAL | COMPLETED | 2014-02-18T00:00:00 | null | null | null | [
"NA"
] | 86 | 21 | 45 | ALL | true | The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders. | The total time that for each participant involved in this study is 4 visits, as outlined below:
Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential participant will learn about the study procedures, sign the informed consent documents, and fill out a packet of forms that ask about his or her race and ethnic background, use of drugs and alcohol and physical and mental health.
Visit 2: Behavioral Tests: During this visit the participant will complete several computer tasks, and the study staff will be measuring reaction time and psychophysiological measures.The tasks that the participant will perform will show three different images and an aversive stimulus (e.g. loud burst of noise or mild wrist shock) may follow one image most of the time, while the other images may never be followed by a noise or mild wrist shock. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown and will be asked to repeatedly rate on a scale how likely it is that he or she thinks a noise/shock will occur after each image. Lastly, during the session the participant will also be asked to report his or her level of anxiety on a scale from 0 to 100.
Visit 3: Behavioral Tests with Drug or Placebo and MRI scan: For safety reasons participant will not be allowed to take any drugs for at least 24 hours before this visit, and should not use marijuana for at least 2 weeks before. Participants will be required to pass a urine drug test (and pregnancy test for women) and breathalyzer test before being allowed to continue with this visit. The participant will also not be allowed to drive himself or herself home from this visit, so he or she should arrange a friend or family member to pick him or her up or a taxi can be called by our research staff.
The participant will view the same images he or she did on the previous day (Visit 2), and may experience the same aversive stimulus as during Visit 2. The participant will again be asked to rate how much he or she expects to experience the aversive stimulus after each image and he or she will also be asked to report his or her level of anxiety on a scale from 0 to 100. However, about 2 hours before the task begins, the participant will be asked to swallow a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill). Dronabinol is a Food \& Drug Administration (FDA) approved drug and the dose (7.5mg; one time) is unlikely to have any effects that last beyond the duration of the study visit. About every 30 minutes after taking the pill, the participant will fill out some questionnaires about mood and how he or she is feeling at the moment.
Visit 4: Behavioral Tests and MRI scan: This visit will be very similar to Visit 2. Participants will participate in the same type of task inside the MRI scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously, and may experience the same aversive stimulus as during Visit 2. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100. | Inclusion Criteria for All Participants:
* Able to give informed consent
* Physically and neurologically healthy \[confirmed by a comprehensive medical history\]
* Age between 21-45 years old
* Right-handed
Inclusion Criteria for Participants with PTSD:
* Current PTSD diagnosis \[related to civilian trauma\]
Inclusion Criteria for Trauma-Exposed Participants without PTSD:
* Experience with a civilian trauma without a PTSD diagnosis
* Free of a lifetime Axis I or Axis II diagnosis
Inclusion Criteria for Non-Trauma-Exposed Healthy Participants:
* Free of a lifetime Axis I or Axis II diagnosis
Exclusion Criteria for All Participants:
* Clinically significant medical or neurological condition
* Less than a high school education
* Lack of fluency in English
* Night shift work
* Currently pregnant; planning pregnancy; or lactating
* Unwilling/unable to sign informed consent document
* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia)
* Left-handed
* Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
* Under 21 or over 45 years of age
* Anticipation of a required drug test in the 4 weeks following study participation
* Positive urine drug screen and/or alcohol breathalyzer
* Current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances \[dronabinol/marijuana/cannabis/thc, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide\]
* Participation in an experiment involving white noise bursts or shocks in the last 6 months
Exclusion Criteria for Participants with PTSD:
* Primary comorbid anxiety disorder (defined by which disorder was the more debilitating and clinically salient)
* Life history of bipolar disorder, schizophrenia, or presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
* Current or in the past 6 months alcohol/drug abuse of dependence
* Current or in the past 6 months major depressive disorder
* Current suicidal ideation
* Diagnosis of an Axis II personality disorder
* Concomitant treatments with psychotropic/psychoactive medication \[including beta-adrenergic blockers, selective serotonin reuptake inhibitor (SSRI), benzodiazepines, tricyclic or monoamine oxidase inhibitor (MAOI) antidepressants, lithium, antiepileptic/anticonvulsants, neuroleptics/antipsychotics, etc.) or in the past two weeks \[8 weeks for fluoxetine and 4 weeks for MAOIs) before screening (Visit 1)
* currently receiving exposure-based therapy for PTSD
Exclusion Criteria for Trauma-Exposed Participants without PTSD and Non-Trauma Exposed Healthy Participants:
* Current or past Axis I psychiatric disorder \[including alcohol/substance abuse of dependence disorder\] | Wayne State University | OTHER | {
"id": "1K01MH101123-01A1",
"link": "https://reporter.nih.gov/quickSearch/1K01MH101123-01A1",
"type": "NIH"
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2014-02-19T00:00:00 | {
"date": "2022-09-09",
"type": "ACTUAL"
} | {
"date": "2014-02-24",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
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]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Post-Traumatic Stress Disorder"
] | ["Post-Traumatic Stress Disorders", "Dronabinol", "Extinction", "fMRI"] | null | [
{
"city": "Detroit",
"country": "United States",
"facility": "Eugene Applebaum College of Pharmacy and Health Sciences",
"geoPoint": {
"lat": 42.33143,
"lon": -83.04575
},
"state": "Michigan"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Brain Measures",
"timeFrame": "Brain measures are collected on Visit 3, 14 days from baseline (Visit 1) and Visit 4, 15 days from baseline (Visit 1), for approximately 1.5 hours each day"
},
{
"description": null,
"measure": "Expectancy Ratings",
"timeFrame": "Collected on Visit 2, 13 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), and Visit 4, 15 days from baseline, during the task. Each day the task lasted approximately 20 minutes."
}
],
"secondary": [
{
"description": null,
"measure": "Subjective Units of Distress (SUDS)",
"timeFrame": "SUDS ratings are collected at Visit 3, 14 days from baseline (Visit 1), and Visit 4, 15 days from baseline (Visit 1), at 3 timepoints within each visit: before the task begins (Pre), in the middle of the task (Mid), and at the end of the task (Post)."
}
]
} | [
{
"affiliation": "Wayne State University",
"name": "Christine A. Rabinak, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "35141873", "type": "DERIVED", "citation": "Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"term": "Trauma and Stressor Related Disorders"
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],
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"abbrev": "BXM",
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"name": "All Conditions"
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]
} | {
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},
{
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{
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{
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{
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"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
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],
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"abbrev": "Analg",
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},
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"name": "All Drugs and Chemicals"
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],
"browseLeaves": [
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],
"meshes": [
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} | {
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],
"interventions": [
{
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} |
NCT02473666 | null | Patient Blood Management - Use and Outcome | Patient Blood Management - Use and Outcome | PBM-USZ | OBSERVATIONAL | COMPLETED | 2015-05-11T00:00:00 | null | null | null | null | 250,000 | null | null | ALL | false | Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost. | At the University Hospital of Zurich, an in-house designed monitoring and feedback system was introduced which electronically registers each transfusion of any allogeneic blood product, be it red blood cells, plasma or platelets as well as corresponding laboratory data. Results are reported quarterly to Department heads. The investigator analyzes whether the introduction of this monitoring and feedback system as part of a patient blood management Program has a significant influence on use of allogeneic blood product transfusions and transfusion-related costs, without compromising patient outcome. | Inclusion Criteria:
* Only case records, all discharged patients of the University Hospital of Zürich
Exclusion Criteria:
* Not discharged from our Hospital. | University of Zurich | OTHER | {
"id": "KEK 2015-0175",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-06-11T00:00:00 | {
"date": "2020-11-12",
"type": "ACTUAL"
} | {
"date": "2015-06-16",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | All cases of all in hospital patients. Area of Focus: Transfusions of blood products. | PROBABILITY_SAMPLE | false | {
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"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
} | [
"Hemorrhage"
] | ["Patient Blood Management", "Red Blood Cells", "Platelet"] | null | [
{
"city": "Zurich",
"country": "Switzerland",
"facility": "University Hospital Zurich",
"geoPoint": {
"lat": 47.36667,
"lon": 8.54999
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"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Percentage of transfusions per participant",
"timeFrame": "participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years"
}
],
"secondary": [
{
"description": null,
"measure": "Percentage of transfusion of any blood product per participant",
"timeFrame": "participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years"
},
{
"description": null,
"measure": "Cost of any blood product per participant",
"timeFrame": "participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years"
},
{
"description": null,
"measure": "Survey of Patient Blood Management System",
"timeFrame": "participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years"
}
]
} | [
{
"affiliation": "IFA University Hospital Zurich",
"name": "Donat R Spahn, Prof",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
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],
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}
],
"meshes": [
{
"id": "D006470",
"term": "Hemorrhage"
}
]
} | null | {
"conditions": [
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"term": "Hemorrhage"
}
],
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} |
NCT01180166 | null | Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer | Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer | None | INTERVENTIONAL | UNKNOWN | 2010-08-03T00:00:00 | null | null | null | [
"PHASE2"
] | 30 | 18 | 75 | ALL | false | The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed. | There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed. | Inclusion Criteria:
* 18-75 years old, male or female
* Gastric cancer with measurable lesions, and the diameter is at least 1 cm
* Karnofsky score: at least 70
* Estimated survival: at least 6 months
* No prior target therapy or radiotherapy
* No severe hypertension, cardiac disease, or diabetes mellitus
* Normal blood routine and chemical tests
* Signed consent
Exclusion Criteria:
* Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
* Extensive distant metastases
* Pregnancy or in lactation
* Allergic to 5-Fluorouracil | ChineseAMS | UNKNOWN | {
"id": "CH-GI-010",
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"nctId": null,
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} | 2010-08-11T00:00:00 | {
"date": "2013-09-19",
"type": "ESTIMATED"
} | {
"date": "2010-08-12",
"type": "ESTIMATED"
} | [
"ADULT",
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] | null | null | true | {
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} | [
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"Concurrent Chemoradiotherapy"
] | ["Gastric cancer", "concurrent chemoradiotherapy", "target therapy"] | null | [
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"city": "Beijing",
"country": "China",
"facility": "Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | null | null | {
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"description": null,
"measure": "progression-free survival",
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"affiliation": "Chinese Acedemy of Medical Sciences",
"name": "jing jin, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D005770",
"term": "Gastrointestinal Neoplasms"
},
{
"id": "D004067",
"term": "Digestive System Neoplasms"
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NCT03238066 | null | Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy | A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy | Prostata-BT-HT | INTERVENTIONAL | UNKNOWN | 2015-12-01T00:00:00 | null | null | null | [
"NA"
] | 77 | 18 | null | MALE | false | Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy. | Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy:
Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22, 43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31) Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs should not exceed 43˚C | Inclusion Criteria:
* Histologically-confirmed locally recurrent prostate cancer - biopsy performed \< 6 months before registration;
* Histology: Adenocarcinoma, every Gleason score (2-10)
* Initial treatment (EBRT) completed \> 24 months prior to biopsy;
* Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration
* Staging performed within 12 weeks prior to registration:
* Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b);
* Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);
* Negative bone scan (M0);
* PSA-DT \> 6 months (PSA measurements taken of the 12 months prior to registration)
* Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) \< 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;
* Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
In TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows:
* Prostate/tumor volume \<60ml
* The distance rear prostate edge - rectal mucosa \>5mm
* Interference of pubic arch ruled out
* If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration
* Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas)
* The patient is suitable for spinal or general anesthesia
* Age \> 18 y.
* Life expectancy \> 5 years
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* The patient must sign a study-specific informed consent form before study registration
Exclusion Criteria:
* Severe, active comorbidities:
* Decompensated congestive heart disease
* Chronic obstructive pulmonary disease exacerbation, respiratory failure
* Hepatic insufficiency resulting in coagulation defects or clinical jaundice
* Other active malignancy or treatment of invasive or hematological malignancy
* Evidence of extraprostatic disease at local recurrence:
* Local stage T4
* Histologic or radiologic evidence of lymph node metastases (N1 or pN1)
* Presence of distant metastases (M1)
* Any of the following prior therapies:
* TURP within 6 months prior to registration
* Prostatic salvage cryosurgery performed at least 6 months before registration
* HIFU performed at least 6 months before registration
* Androgen deprivation therapy within 3 months prior to registration
* Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | University of Erlangen-Nürnberg Medical School | OTHER | {
"id": "Prostata-BT-HT",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2017-07-31T00:00:00 | {
"date": "2018-06-07",
"type": "ACTUAL"
} | {
"date": "2017-08-03",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
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] | null | null | [
{
"city": "Erlangen",
"country": "Germany",
"facility": "Strahlenklinik im Universitaetsklinikum Erlangen",
"geoPoint": {
"lat": 49.59099,
"lon": 11.00783
},
"state": null
},
{
"city": "Kraków",
"country": "Poland",
"facility": "Centrum Radiotherapii",
"geoPoint": {
"lat": 50.06143,
"lon": 19.93658
},
"state": null
},
{
"city": "Warszaw",
"country": "Poland",
"facility": "Maria Sklodowska-Curie Institute - Oncology Center",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Rate of late GI/GU grade 3 and more toxicities",
"timeFrame": "up to 60 Months in Follow up"
}
],
"secondary": [
{
"description": null,
"measure": "Rate of acute GI/GU treatment-related adverse events",
"timeFrame": "up to 24 months after start of recruitment"
},
{
"description": null,
"measure": "Time to biochemical failure",
"timeFrame": "up to 60 Months in Follow up"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "up to 60 Months in Follow up"
},
{
"description": null,
"measure": "Disease-free survival",
"timeFrame": "up to 60 Months in Follow up"
},
{
"description": null,
"measure": "Disease-specific survival",
"timeFrame": "up to 60 Months in Follow up"
},
{
"description": null,
"measure": "Clinical patterns of tumor recurrence",
"timeFrame": "up to 60 Months in Follow up"
}
]
} | [
{
"affiliation": "Assistant Medical Director of the Dept. of Radiooncology",
"name": "Vratislav Strnad, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Wounds and Injuries"
}
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},
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],
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NCT04487366 | null | Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve | Comparison of Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve for Anesthesia Residency Training on a Gelatin-based Phantom Model: a Prospective Randomized Controlled Study | None | INTERVENTIONAL | UNKNOWN | 2020-07-17T00:00:00 | null | 2020-09-15T00:00:00 | 2020-10-01T00:00:00 | [
"NA"
] | 50 | 24 | 40 | ALL | false | Aim of this study is to compare learning curves of single(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill) and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model. | Ultrasound-guided peripheral blocks are conventionaly performed by double operators. One operator controls both the ultrasound probe and peripheric block needle. Another assistant operator aspirate or injects local anesthetic. In this technique operator do not sense resistance in the syringe. Also this technique requires a well-done communication and coordination between operators.
In order to eliminate disadvantages of this technique several single-operator grip techniques of the needle and syringe have been described(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill). Single operator techniques allow the provider to perform independently.
Aim of this study is to compare learning curves of single and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model. | Inclusion Criteria:
- To be a junior resident of anesthesiology(\< 2 years )
Exclusion Criteria:
* Refusal of resident | Ankara City Hospital Bilkent | OTHER | {
"id": "E1/20-804",
"link": null,
"type": null
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"nctId": null,
"statusForNctId": null
} | 2020-07-22T00:00:00 | {
"date": "2020-07-27",
"type": "ACTUAL"
} | {
"date": "2020-07-27",
"type": "ACTUAL"
} | [
"ADULT"
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} | [
"Single-handed Ultrasound-guided Regional Anaesthesia Grip",
"Single-operator Ultrasound-guided Peripheric Nerve Block",
"Anesthesiology Training",
"Jedi Grip"
] | ["Jedi Grip", "single-operator ultrasound-guided regional anaesthesia grip", "Single-handed ultrasound-guided regional anaesthesia", "'On lock' grip", "Anesthesiology training"] | null | [
{
"city": "Ankara",
"country": "Turkey",
"facility": "Ankara City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"measure": "Time to correct grip1",
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},
{
"description": null,
"measure": "image quality1",
"timeFrame": "during implementation of procedure on phantom model(first session)"
},
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"description": null,
"measure": "number of attempts1",
"timeFrame": "during implementation of procedure on phantom model(first session)"
},
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"description": null,
"measure": "needling time 1",
"timeFrame": "during implementation of procedure on phantom model(first session)"
},
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"description": null,
"measure": "success of injection1",
"timeFrame": "during implementation of procedure on phantom model(first session)"
},
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"description": null,
"measure": "Time to correct grip2",
"timeFrame": "during implementation of procedure on phantom model(second session)"
},
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"description": null,
"measure": "Time to correct grip3",
"timeFrame": "during implementation of procedure on phantom model(third session)"
},
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"description": null,
"measure": "image quality2",
"timeFrame": "during implementation of procedure on phantom model(second session)"
},
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"description": null,
"measure": "image quality3",
"timeFrame": "during implementation of procedure on phantom model(third session)"
},
{
"description": null,
"measure": "number of attempts2",
"timeFrame": "during implementation of procedure on phantom model(second session)"
},
{
"description": null,
"measure": "number of attempts3",
"timeFrame": "during implementation of procedure on phantom model(third session)"
},
{
"description": null,
"measure": "needling time 2",
"timeFrame": "during implementation of procedure on phantom model(second session)"
},
{
"description": null,
"measure": "needling time 3",
"timeFrame": "during implementation of procedure on phantom model(third session)"
},
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"description": null,
"measure": "success of injection2",
"timeFrame": "during implementation of procedure on phantom model(second session)"
},
{
"description": null,
"measure": "success of injection3",
"timeFrame": "during implementation of procedure on phantom model(third session)"
}
],
"secondary": [
{
"description": null,
"measure": "NASA-TLX (NASA Task Load Index)",
"timeFrame": "during implementation of procedure on phantom model(third session)"
},
{
"description": null,
"measure": "Assesment of education",
"timeFrame": "during education of techniques"
}
]
} | [
{
"affiliation": "Ankara City Hospital Anesthesiology Department",
"name": "İsmail Aytac",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "21831086", "type": "BACKGROUND", "citation": "Pappin D, Christie I. The Jedi Grip: a novel technique for administering local anaesthetic in ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):845. doi: 10.1111/j.1365-2044.2011.06845.x. No abstract available."}, {"pmid": "28891057", "type": "BACKGROUND", "citation": "Gupta P, Berrill A. 'On lock' - a further single-operator ultrasound-guided regional anaesthesia grip. Anaesthesia. 2017 Oct;72(10):1289. doi: 10.1111/anae.14050. No abstract available."}, {"pmid": "21831088", "type": "BACKGROUND", "citation": "Bedforth N, Townsley P, Maybin J, Eisenberg E. Single-handed ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):846. doi: 10.1111/j.1365-2044.2011.06864.x. No abstract available."}, {"pmid": "9431583", "type": "BACKGROUND", "citation": "Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313."}, {"pmid": "36107586", "type": "DERIVED", "citation": "Guven Aytac B, Unal S, Aytac I. A randomized, controlled simulation study comparing single and double operator ultrasound-guided regional nerve block techniques using a gelatine-based home-made phantom. Medicine (Baltimore). 2022 Sep 2;101(35):e30368. doi: 10.1097/MD.0000000000030370."}] | {"versionHolder": "2025-06-18"} | {
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},
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"id": "M6368",
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},
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"id": "M12902",
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"relevance": "LOW"
},
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"id": "M17522",
"name": "Virus Diseases",
"relevance": "LOW"
},
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"name": "RNA Virus Infections",
"relevance": "LOW"
},
{
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"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007251",
"term": "Influenza, Human"
}
]
} | {
"ancestors": null,
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"abbrev": "PhSol",
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"abbrev": "CNSDep",
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NCT06623266 | null | Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC | Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial | None | INTERVENTIONAL | RECRUITING | 2024-09-29T00:00:00 | null | 2026-09-30T00:00:00 | 2028-09-30T00:00:00 | [
"NA"
] | 300 | 18 | 75 | ALL | false | To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only. | For the patients with cT1N0M0 oral squamous cell carcinoma (OSCC), surgical resection of primary lesion is the preferred treatment. However, there are still debates on the neck management, some surgeons suggest elective neck dissection (END), and some surgeons suggest neck observation (NOB). The advantage of elective neck dissection is to clear the potential occult neck lymph node metastasis (about 15%), which could not be detected by clinical examination and imaging examination, and the disadvantage of END is to cause neck deformity, large scars, stiff neck and shoulders, difficulty in raising shoulders, and increase medical costs. The disadvantage of NOB is the risk of lymph node metastasis and disease progression. However, recent retrospective studies show that END has no potential benefit in improving survival in cT1N0M0 patients. The aim of the present trial is to compare the clinical outcomes between the cT1N0M0 OSCC patients, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only, on the aspects of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life. A total number of 300 patients will be recruited, including 150 patients in the experimental arm and 150 patients in the control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Control arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection. A complete medical history will be obtained and tumor assessment will be performed at baseline. Patients will be followed-up by every three months in the first 2 years, every six months in the next 3-5 years, and once a year thereafter until death or data censoring. Two-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life will be collected and analyzed. | Inclusion Criteria:
* Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara
* Clinical stage is cT1N0M0 (AJCC 8th edition)
* Pathological diagnosis of squamous cell carcinoma
* Sign the informed consent form
Exclusion Criteria:
* More than 2 lesions found in the oral cavity
* Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)
* History of unilateral or bilateral neck dissection in the past
* History of previous head and neck radiotherapy
* Pregnant or lactating women
* Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation
* Participated in other clinical studies within 30 days before enrollment
* Other circumstances that the researcher considers unsuitable for participation in the study | Huashan Hospital | OTHER | {
"id": "Acromion",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-09-30T00:00:00 | {
"date": "2024-11-14",
"type": "ACTUAL"
} | {
"date": "2024-10-02",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized 1:1 to the experimental or control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion.\n\nControl arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection.",
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"Oral Cancer",
"Lymph Node Metastasis"
] | ["Oral squamous cell carcinoma", "Early stage", "Neck dissection", "Neck observation", "Lymph node metastasis rate"] | null | [
{
"city": "Shanghai",
"country": "China",
"facility": "Huashan Hospital, Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null
}
] | null | null | {
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"description": null,
"measure": "Rate of 2-year lymph node metastasis",
"timeFrame": "2 years"
}
],
"secondary": [
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"description": null,
"measure": "Rate of 2-year disease free survival",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Rate of 2-year overall survival",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Health-related quality of life",
"timeFrame": "2 years"
}
]
} | [
{
"affiliation": "Huashan Hospital",
"name": "Lai-ping Zhong, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"relevance": "HIGH"
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],
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} |
NCT06251466 | null | Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus. | A Monocenter, Randomized Controlled, Pilot Study of Telemonitoring for Gestational Diabetes Mellitus. | TEGEDIM | INTERVENTIONAL | RECRUITING | 2024-01-09T00:00:00 | null | null | null | [
"NA"
] | 40 | 18 | null | FEMALE | false | This interventional study examines the addition of telemonitoring (TM) in prenatal care for gestational diabetes mellitus (GDM). By incorporating TM into the prenatal care for GDM, it is expected to achieve faster and improved follow-up, resulting in faster reaction time in the detection of aberrant blood glucose levels. Therefore, the overarching aim is to improve maternal and newborn pregnancy outcomes through optimized monitoring strategies (TM). | Gestational diabetes mellitus (GDM) is characterized by the onset of spontaneous hyperglycemia, typically diagnosed in the second or third trimester of gestation. GDM can have short-term complications for both the mother and the unborn child, including neonates with macrosomia which can complicate delivery, necessitating a cesarean section. While GDM usually resolves following delivery, it can also have long-term consequences, including neonatal hypoglycemia, increased risk of developing maternal hypertension, and type 2 diabetes. Therefore, a proper follow-up, including monitoring of blood glucose values, plays a crucial role in preventing both the pregnant woman and the unborn child from potential complications.
The principal measures for blood glucose level regulation in GDM involve lifestyle modifications, comprising dietary adjustments and exercise, supplemented as necessary by intermittent insulin therapy. Together with these lifestyle modifications and/or insulin therapy, these pregnant women also need to measure their blood glucose values once a week at home at four different time points, including: before breakfast, two hours after breakfast, two hours after lunch, and two hours after dinner. These measurements are performed with a glucose meter and are called to the nurse of the endocrinology department. This medical information allows the endocrinologist to make treatment adjustments (low sugar diet or insulin therapy) when necessary, potentially preventing the need for hospitalization due to GDM-associated complications.
However, a limitation of this standard care lies in the potential oversight by pregnant women in monitoring and reporting their blood glucose values to the endocrinology department. Unfortunately, this may result in the delayed detection of alarming values. Additionally, it imposes an increased workload on nurses, as they are required to contact these patients on each occasion. Altogether, there is less effective follow-up, leading to an increased risk of developing GDM-complications for both the mother and neonate. This less effective follow-up may contribute to increased healthcare costs, particularly in situations where hospitalization is required due to GDM-related complications.
Adding telemonitoring (TM) to the standard care of pregnant women with GDM offers a viable solution to mitigate the limitation described above. TM can be defined as the use of telecommunication technologies to assist the transmission of medical information between the patient and the caregiver. Regarding the care of GDM, the pregnant women are expected to self-monitor their blood glucose levels at home. Subsequently, they will input these values directly into a smartphone application called iHealth Gluco-Smart. This application is coupled to a hospital-based platform where these values can be evaluated by the researcher and the endocrinology department. | Inclusion Criteria:
* Diagnosis of gestational diabetes mellitus
* Minimum 20 weeks of pregnancy
* Is proficient in Dutch
* Signing the Informed Consent
Exclusion Criteria:
* \<20 weeks of pregnancy
* Diagnosis of type 1 diabetes
* Congenital anomalies identified in the fetus
* Participant does not own a smartphone | Hasselt University | OTHER | {
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"interventionModelDescription": "Participants are randomized in either the control group or the telemonitoring group. The control group receives the standard care of gestational diabetes mellitus, meaning that the participants need to call their blood glucose levels weekly to the endocrinology department. The telemonitoring group receives telemonitoring, meaning that the participants need to register their blood glucose levels weekly in a smartphone application which is coupled to a platform in the hospital.",
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"Gestational Diabetes",
"Telemonitoring"
] | ["Gestational outcomes", "User-experience"] | null | [
{
"city": "Genk",
"country": "Belgium",
"facility": "Ziekenhuis Oost-Limburg",
"geoPoint": {
"lat": 50.965,
"lon": 5.50082
},
"state": "Limburg"
}
] | [
{
"class": "OTHER",
"name": "Ziekenhuis Oost-Limburg"
}
] | null | {
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"description": null,
"measure": "Satisfaction and usability of the modified care process through the administration of patient and staff questionnaires compared to the conventional follow-up approach.",
"timeFrame": "From diagnosis of gestational diabetes mellitus until birth"
}
],
"primary": [
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"description": null,
"measure": "Type of delivery (natural or cesarean delivery) in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "After gestation"
},
{
"description": null,
"measure": "Number of preterm deliveries in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "After gestation"
},
{
"description": null,
"measure": "Apgar-score of neonate in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "After gestation"
},
{
"description": null,
"measure": "Birth weight of neonate in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "After gestation"
},
{
"description": null,
"measure": "Admission to the neonatal intensive care (NIC) in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "After gestation"
}
],
"secondary": [
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"description": null,
"measure": "Number of prenatal consultations in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "From diagnosis of gestational diabetes mellitus until birth"
},
{
"description": null,
"measure": "Number of hospitalizations in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.",
"timeFrame": "From diagnosis of gestational diabetes mellitus until birth"
},
{
"description": null,
"measure": "Reaction time from measuring abnormal glucose values to performing an intervention in pregnancies in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care alone.",
"timeFrame": "From diagnosis of gestational diabetes mellitus until birth"
}
]
} | [
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"name": "Ine Lowyck",
"role": "PRINCIPAL_INVESTIGATOR"
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],
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}
],
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"term": "Diabetes, Gestational"
},
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} | {
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"name": "Hypoglycemic Agents"
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"relevance": "LOW"
}
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NCT01798966 | null | Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease | The Effects of Orbital Decompression Surgery on Intraocular Pressure Patterns in Patient With Thyroid Eye Disease Undergoing 24 Hour Continuous IOP Monitoring With the SENSIMED Triggerfish® | None | INTERVENTIONAL | COMPLETED | 2013-02-21T00:00:00 | null | null | null | [
"NA"
] | 10 | 18 | 90 | ALL | false | Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher orbital fat contents due to their disease process. The confined space of the orbit cannot hold the enlarged orbital contents creating a forward displacement and/or compression of the globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical decompression, a procedure that fractures orbital bones, in order to allow more space for the enlarged orbital contents to occupy. To date, there is no data that shows intraocular patterns over a 24-hour period in patients with mechanical compression on the globe as in TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns, glaucomatous patterns, or perhaps completely different then either. The goal of this project is to investigate patterns of IOP in patients requiring orbital decompression because of orbital congestion. Changes in IOP during a 24-hour period will be studied with a contact-lens embedded sensor that provides continuous data. This device has previously been investigated and shown to be safe and well-tolerated. Monitoring the pattern in these patients will allow us to compare Thyroid TED patterns of IOP with those of normal and glaucomatous patients. Also, testing these patients before and after orbital decompression surgery will allow characterization of how intraocular pressure changes once the mechanical compression on the globe is relieved. | null | Inclusion Criteria:
* Subject is able to comply with the study procedures
* 18-80 years old
* Subjects diagnosed with Thyroid Eye Disease based on both endocrinology studies showing autoimmune dysfunction consistent with Graves' Disease as well as orbital imaging studies manifesting characteristics consistent with Thyroid Eye Disease.
* Ability to understand the character and individual consequences of the study
* Subject has consented to be in the trial
Exclusion Criteria:
* Subjects with contraindications for wearing contact lenses
* Severe ocular surface disease
* Keratoconus or other corneal abnormality
* Severe ocular inflammation
* Full frame metal glasses during SENSIMED Triggerfish® monitoring
* Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
* Simultaneous participation in other clinical studies
* Diagnosis of glaucoma | Sensimed AG | INDUSTRY | {
"id": "TF-1111",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-02-22T00:00:00 | {
"date": "2016-03-11",
"type": "ESTIMATED"
} | {
"date": "2013-02-26",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Thyroid Eye Disease"
] | null | null | [
{
"city": "La Jolla",
"country": "United States",
"facility": "Shiley Eye Center, University of California, San Diego",
"geoPoint": {
"lat": 32.84727,
"lon": -117.2742
},
"state": "California"
}
] | [
{
"class": "OTHER",
"name": "University of California, San Diego"
}
] | null | {
"other": [
{
"description": null,
"measure": "Adverse Events and Serious Adverse Events",
"timeFrame": "4 days"
}
],
"primary": [
{
"description": null,
"measure": "Change in IOP Before and After Orbital Decompression Surgery",
"timeFrame": "24 hours"
}
],
"secondary": [
{
"description": null,
"measure": "IOP Patterns",
"timeFrame": "24 hours"
}
]
} | [
{
"affiliation": "University of California, San Diego",
"name": "Donald O Kikkawa, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Endocrine System Diseases"
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"term": "Graves Disease"
},
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"id": "D005094",
"term": "Exophthalmos"
},
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"id": "D009916",
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},
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NCT02519166 | null | Characterisation of Biofilm of the Chronic Wounds | null | Biofilm Plaie | INTERVENTIONAL | COMPLETED | 2015-07-28T00:00:00 | null | null | null | [
"NA"
] | 130 | 18 | null | ALL | false | In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations. | null | Inclusion Criteria:
* Patients with chronic wounds (period \> 6 weeks) \> 10 cm2
* Patient age \>18 for the 3 French centres
* Patient participation in a follow-up program for treatment of their wound \> 1 month
* Availability of patient information and written informed consent from them or their legal representative
Exclusion Criteria:
* Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
* Patients deprived of freedom or under guardianship | Institut Curie | OTHER | {
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"type": null
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NCT04826666 | null | Intraoperative Phlebotomies and Bleeding in Liver Transplantation | Intraoperative Phlebotomies and Bleeding in Liver Transplantation: a Retrospective Cohort Study and Causal Analysis Protocol | TOF_PHLEBO | OBSERVATIONAL | COMPLETED | 2021-03-30T00:00:00 | null | 2021-11-04T00:00:00 | 2021-11-04T00:00:00 | null | 679 | null | null | ALL | false | Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery.
To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis. | Methods
Objective: To investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality among patients who underwent a liver transplantation.
Study design and participants:
All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM) will be included in the study. Because phlebotomies are mostly performed in patients with a near normal renal function, patients who were under renal replacement therapy prior to surgery as well as those who had a glomerular filtration rate below 30 mL/h (based on MDRD formula) will be excluded.
Exposure:
The exposure of interest will be the performance of an intraoperative phlebotomies. Intraoperative phlebotomies are performed at the beginning of liver transplant surgery to reduce portal and hepatic venous pressure and thus reduce bleeding and the need for transfusions. After graft reperfusion, retrieved blood is reinjected to patients to optimize volemia and cardiac output. Intraoperative phlebotomy is thus a manipulable well-defined exposure amenable to causal analysis by consistency.
Covariables:
Many variables are associated with bleeding in liver transplantation. Most of them are also associated with our exposure of interest and are cofounding factors. Phlebotomies will be more often performed in non-anemic cirrhotic patients with high portal and central venous pressure, but less often in patients with severe acute disease with end-organ damage such as renal failure. Thus, patients who received a phlebotomy have different baseline prognostic characteristics than those who do not receive as phlebotomy. To control for such confounding, a sufficient set of variables based on a directed acyclic graph (DAG) constructed using published data and knowledge of the clinical practice (see figure 1) will be included. Since MELD score is a very robust marker of liver disease severity, it will increase in most situations of worsening liver disease (such as acute-n-chronic liver failure) and adjust for all such situations. Since an observational study from the CHUM suggested that intraoperative bleeding and transfusions have increased since recipients are prioritized by the MELD score, the calendar year as a covariable will be added, although it is not expected that phlebotomy practices have significantly changed over time.
Data management:
Data for patients who received their transplantation between 2008 and 2017 is already available in a dataset used for previous analyses (CHUM Research Ethic Board (REB) approval #17.036). Data from patients who received a transplantation between January 2018 and January 2021 will be extracted from patients' chart after REB approval or from the dataset used for another already approved study (CHUM REB #17.251). Data from all these patients will be merged in a common dataset, cleaned and analyzed.
Data analyses:
Main analyses:
The patient cohort based on the exposure category will be described. Frequencies and proportions for categorical variables and mean with standard deviation for continuous variables (or median with quartiles for skewed distributions) will be summarized. Crude outcome incidence without any relative risk (table 2) will also be presented. For analytical purposes, intraoperative bleeding will be used as a continuous variable and because many patients do not receive any perioperative RBC transfusions, perioperative RBC transfusions between "no transfusion" and "any transfusion" will be dichotomized.
A causal analysis will be conducted based on a balancing score, the propensity score. No previous sample size calculation was computed as a convenience sample of all transplanted patients that meet the inclusion criteria will be used. By excluding patients with at least moderate renal failure prior to surgery (almost only untreated patients), a cohort with more treated than untreated patients will be obtained. Treated patients are also the ones for whom clinicians believed a phlebotomy was helpful based on measured covariables (and potential unmeasured ones ("confounding by indication bias")). Also, many untreated patients may not be at risk of receiving the intervention (positivity) and not overlap treated patients. Thus, an average treatment effect in the treated (ATT) by the inverse probability of treatment weighting (IPTW) will be estimated.
To do so, a propensity score (π_i) for the exposure (intraoperative phlebotomies) based on all identified and measured previously mentioned confounders will be computed. Quadratic terms for continuous variables (for more flexibility) and an interaction term between the MELD score and the central venous pressure (since more severe disease usually have higher cardiac filling pressure), important drivers of the exposure, will be included. The overlap of the propensity score between the treated patients and their untreated counterparts will be evaluated. In case many treated patients do not overlap with any untreated ones, the specifications of the propensity score model further (remove quadratic terms for example) will be modified to further restrict the population of interest. The calculated propensity score to compute weights will be used and create an untreated pseudo-population comparable to the treated ones (conditional exchangeability); Weights for treated patients and weights will be used for untreated patients. In case extreme weighs are estimated, truncation (between 1% and 5% percentiles of the propensity score distribution depending on overlap effect) will be used to minimize variance and effect of near violations of practical positivity. The population of interest may be further restriced, if deemed necessary. The pseudo-population will be described using weighted descriptive statistics and the balancing effect of the weights will be verified. The causal marginal effect on bleeding will be estimated using a weighted mean difference and the causal marginal effect of transfusions using a weighted risk difference. Survival up to 1 year will be reported using a marginal structural model using a weighted proportional hazard Cox model and express a causal marginal hazard ratio. Results will be expressed with non-parametric bootstrap percentile 95% confidence intervals.
Senstivity analyses:
IPTW analyses may be more sensitive to misspecification of the propensity score model as well as have a higher estimated variance. Thus, a sensitivity analysis to estimate ATT for all outcomes will be conducted using a propensity score based matching analysis. This analysis will use a 1:2 (1 treated and 2 untreated) greedy matching using a caliper (0.2 linear propensity score standard deviation). For matching, balancing between groups by comparing covariables' central tendency measurement and variance will be explored, including quadratic terms for continuous variables, as well as q-q plots. Distribution homogeneity between groups will also be assessed using Kolmogorov-Smirnov tests. The matching specifications (caliper, matching ratio) may bemodified if group balancing is not satisfactory. However, the propensity score specifications will not be modified, to maintain consistency across analyses. Once balancing is considered appropriate to estimate an ATT, the causal effects will be estimated by using the Abadie-Imbens estimator. The Abadie-Imbens variance will be used to compute 95% confidence intervals. R software (R Core Team, 2020, version 4.0.3) will be used, as well as the Matching, survival, survey and tableone packages. IPTW analyses and bootstrap will be computed manually.
Subgroup analysis:
The effect of phlebotomies is considered to be mechanistically mediated by reducing portal pressure and splanchnic congestion. The effect of the intervention should thus be stronger in patients with cirrhosis. Thus, a subgroup analysis will be conducted by conduction the primary analysis (IPTW and bleeding) only in patients transplanted for cirrhosis by excluding retransplantations and transplantation for acute liver failure. | Inclusion Criteria:
- All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).
Exclusion Criteria:
- All patients who were under renal replacement therapy prior to surgery as well as those who had a glomerular filtration rate below 30 mL/h (based on MDRD formula). | Centre hospitalier de l'Université de Montréal (CHUM) | OTHER | {
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"Liver Cirrhosis",
"Surgery",
"Surgery--Complications",
"Postoperative Complications",
"Transplant; Failure, Liver"
] | null | null | [
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NCT01834066 | null | Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy. | Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial | mdp | INTERVENTIONAL | UNKNOWN | 2013-02-26T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 25 | 6 | 25 | ALL | true | This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy. | Muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition. slowly progress diseases.it causes Muscle weaknesses, Difficulty with motor skills ,Progressive difficulty walking.Breathing difficulties and heart disease,Frequent falls,weak limbs,lose motor Function.Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.Trouble getting up from a lying position or climbing stairs. | Inclusion Criteria:
* Patient with Diagnose of Duchenne Muscular Dystrophy.
* Aged in between 6 to 25 Years.
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up
Exclusion Criteria:
* Patient who is not Diagnose of Duchenne Muscular Dystrophy.
* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+,Tumor Markers+
* History of Life threatening allergic or immune -Mediated Reaction.
* the site of bone marrow aspiration potentially limiting Procedure.
* Alcohol and drug abuse / dependence.
* Patients with History of Hypertension and Hypersensitive. | Chaitanya Hospital, Pune | OTHER | {
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NCT06641466 | null | A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE | None | INTERVENTIONAL | RECRUITING | 2024-10-11T00:00:00 | null | 2026-11-29T00:00:00 | 2027-03-30T00:00:00 | [
"PHASE3"
] | 723 | 18 | 45 | FEMALE | false | The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks. | null | Inclusion Criteria:
1. Participant has regular menstrual cycles ≥24 days and ≤34 days
2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
3. A history of menstrual migraine attacks of at least 3 months
4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study
Exclusion Criteria:
1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening
3. History of retinal migraine, basilar migraine or hemiplegic migraine
4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea | Pfizer | INDUSTRY | {
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} | {
"date": "2024-10-15",
"type": "ACTUAL"
} | [
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"timePerspective": null
} | [
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],
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NCT02081066 | null | Identification of CETP as a Marker of Atherosclerosis | Relationship Between Endogenous CETP Activity and Atherosclerosis Distribution in Patients With High Cardiovascular Risk | CETP-ATHERO | INTERVENTIONAL | COMPLETED | 2014-02-10T00:00:00 | null | null | null | [
"NA"
] | 99 | 18 | null | ALL | false | The reverse cholesterol transport (RCT) pathway, which involves the centripetal movement of free cholesterol from peripheral tissues, including the vessel wall, to the liver represent the primary mechanism by which HDL protects against atherosclerosis and by which it may induce plaque regression. Recent data reveal that the capacity of HDL to efflux cholesterol from macrophages, a metric of HDL function reflecting the initial step of the RCT, is clinically relevant, displaying a strong inverse association with both carotid intima-media thickness and the severity of angiographic CAD; such observations were independent of HDL-C levels.
In human, the Cholesteryl Ester Transfer Protein (CETP), represents a key protein of the RCT pathway and mediates redistribution of neutral lipids between lipoproteins, has been identified as a potential therapeutic target against atherosclerosis. It is known that CETP activity correlates with HDL-C levels and represents a key modulator of the ability of whole plasma to mediate free cholesterol efflux from human macrophages.
Recent studies showed that 23% of endogenous plasma CETP activity variability is explained by plasma LDL-C (12.0%), HDL-C (6.4%) and TG (4.4%) whereas sex and BMI accounted together for only 0.7% of its variability. Scoring patients for cardiovascular risk on the basis of their plasma lipid levels (TC, TG, LDL-C and HDL-C), revealed that patients with high cardiovascular risk (score ≥3) displayed a mean endogenous plasma CETP activity above 34%. Therefore plasma CETP activity represents a potent indicator of cardiovascular risk in patients with metabolic disorders since it integrates major independent risk factors.
The objective of this study is to decipher the relationship between CETP, HDL efflux capacity and the development of atherosclerosis in humans in order to identify CETP as a potent biomarker of atherosclerosis distribution. | null | Inclusion Criteria:
* Signed informed consent prior to initiation of the study
* Men and women aged 18 or more years
* Patients displaying at least one abnormal plasma lipid parameter and/or receiving a lipid-lowering therapy unchanged for at least 3 months.
Exclusion Criteria:
* Current significant renal disease, including: nephrotic syndrome; chronic renal failure and/or serum creatinine \>1.7 x upper limit of the reference range (ULRR)
* Uncontrolled hypothyroidism defined as TSH \>2 x ULRR
* Active hepatobiliary disease, including chronic hepatitis B or hepatitis C infection (confirmed by serology); or an aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \>3.0 x ULRR
* Any prior history of malignancy or current cancer
* Current chronic or acute inflammatory syndrome defined as CRP\>10 mg/l | Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV | {
"id": "C13-20",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2014-03-06T00:00:00 | {
"date": "2021-08-26",
"type": "ACTUAL"
} | {
"date": "2014-03-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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},
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"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Cardiovascular Disease"
] | null | null | [
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"facility": "Inserm Umrs1166",
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"lon": 2.3488
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"measure": "Endogenous CETP activity",
"timeFrame": "Day 1"
},
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"description": null,
"measure": "carotid intima-media thickness",
"timeFrame": "day 1"
},
{
"description": null,
"measure": "Coronary calcium score",
"timeFrame": "Day 1"
}
],
"secondary": [
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"description": null,
"measure": "plasma efflux capacity from human macrophage",
"timeFrame": "Day 1"
},
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"description": null,
"measure": "HDL genetic variant",
"timeFrame": "Day1"
}
]
} | [
{
"affiliation": "Institut National de la Santé Et de la Recherche Médicale, France",
"name": "Maryse Guerin, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D001161",
"term": "Arteriosclerosis"
},
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"term": "Vascular Diseases"
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},
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NCT05095766 | null | Comparaison Between MRI Alone or Combined With Positron Emission Tomography for Brain Metastasis Diagnosis | Differentiation Between Radionecrosis and Tumor Recurrence for Post-stereotactic Radiosurgery Follow-up by Pharmacokinetic Analyses in Perfusion MRI and Positron Emission Tomography | ITIRR | OBSERVATIONAL | COMPLETED | 2021-10-15T00:00:00 | null | 2022-04-30T00:00:00 | 2024-02-13T00:00:00 | null | 40 | 18 | null | ALL | false | During gamma scalpel treatment of brain tumors and metastases, a follow-up magnetic resonance imaging (MRI) scan is performed. The radiologist who reviews the MRI assesses whether there is an increase in signal at the tumor site. This increase potentially indicates that the treatment was not effective. However, in 25% of cases (one in four people), this signal enhancement is not due to ineffective treatment, but to inflammation (swelling/damage) and tissue death around the tumor. This is why when an increase in signal is detected, additional follow-up is essential. The standard additional follow-up has an accuracy of about 83%.
This is an observational study on patients with brain metastatis comparing MRI alone or combined to PET-FET to improve accuracy of diagnosis of metastasis recurrence. | null | Inclusion Criteria:
* Male or female over 18 years of age;
* Having undergone gamma knife radiosurgery for brain metastasis;
* Presenting for a first MRI follow-up (Cohort C1);
* Presence of one or more brain metastases with increased enhancement on follow-up MRI (Cohort C2.1 and C2.2); A participant recruited for Cohort C1 could be recruited for follow-up in Cohort C2.1 or C2.2 if the MRI result is ambiguous.
Exclusion Criteria:
* Pregnancy or breastfeeding;
* Other condition that may influence the imaging result;
* Renal impairment (\<30 mL/min/1.73 m2). This threshold is consistent with recent RAC recommendations; Note: For participants with intermediate renal clearance (30-60 mL/min/1.73 m2), the total gadobutrol dose injected is set at the manufacturer's recommended clinical dose. For patients with renal clearance greater than 60 mL/min/1.73 m2, a dose of 1.5x the normal dose is used. These dose values have been approved by Dr. Chénard and are consistent with the RAC recommendations.
* Inability to maintain supine position for the required duration (variable, depending on the sequence);
* Patients who have previously received full brain irradiation;
* Patients who are claustrophobic and cannot tolerate insertion into the MRI scanner; | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER | {
"id": "2017-1488",
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"type": null
} | Unknown | {
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"nctId": null,
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} | 2021-10-15T00:00:00 | {
"date": "2024-08-23",
"type": "ACTUAL"
} | {
"date": "2021-10-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Adults with brain metastases undergoing MRI | NON_PROBABILITY_SAMPLE | false | {
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} | [
"Brain Metastases, Adult"
] | ["Magnetic resonance imaging", "Radiofrequency", "Radionecrosis", "Tumor recurrence", "Post-stereotactic surgery", "Positron emission tomography", "CT scan", "18F-fluoroethyl-tyrosine", "Perfusion MRI"] | null | [
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"city": "Sherbrooke",
"country": "Canada",
"facility": "CIUSSS de l'Estrie-CHUS",
"geoPoint": {
"lat": 45.40008,
"lon": -71.89908
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"state": "Quebec"
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{
"class": "OTHER",
"name": "Université de Sherbrooke"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Comparison of novel MRI method with current MRI exam method",
"timeFrame": "Following MRI exam"
},
{
"description": null,
"measure": "Comparison of DCE-MRI method with FET PET",
"timeFrame": "Following MRI exam"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "D016543",
"term": "Central Nervous System Neoplasms"
},
{
"id": "D009423",
"term": "Nervous System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
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},
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"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
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}
],
"browseLeaves": [
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},
{
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"id": "M14850",
"name": "Recurrence",
"relevance": "LOW"
},
{
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"id": "M5209",
"name": "Brain Neoplasms",
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},
{
"asFound": null,
"id": "M12330",
"name": "Neoplastic Processes",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18937",
"name": "Central Nervous System Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12367",
"name": "Nervous System Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5204",
"name": "Brain Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009362",
"term": "Neoplasm Metastasis"
},
{
"id": "D001932",
"term": "Brain Neoplasms"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "AA",
"name": "Amino Acids"
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{
"asFound": null,
"id": "T22",
"name": "Tyrosine",
"relevance": "LOW"
}
],
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} | {
"conditions": [
{
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"term": "Neoplasm Metastasis"
},
{
"id": "D001932",
"term": "Brain Neoplasms"
}
],
"interventions": []
} |
NCT01515566 | null | Breakthrough Dyspnea Fentanyl Study in Cancer Patients | Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2012-01-13T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 26 | 18 | null | ALL | false | The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo.
Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. | Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to either receive fentanyl or placebo. You will have an equal chance of being assigned to either group.
Study Drug/Placebo Administration:
Before you receive the study drug/placebo, you will walk back and forth in an indoor corridor for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.
After that, you will sit down and rest (for up to 1 hour). During this time, the study drug/placebo will be prepared.
You will then be given a study drug/placebo shot under the skin in your arms or legs. You will then wait for another 15 minutes and repeat the walking test.
Study Visit:
During your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
You will also complete 2 walking tests. Before the walk tests, you will complete 2 questionnaires. One (1) of them asks about any breathing symptoms you may be having, and the other asks about any other symptoms you may be having. It should take about 10 minutes to complete these questionnaires.
Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of air breathed out using a measuring device that will be clipped onto your finger. The study staff will also ask you questions about how hard it is to catch your breath and your level of tiredness.
During each walk test, you will be asked about how hard it is to catch your breath. The distance you walked and how often and for how long you stopped will be recorded. Before and after the second walk test, the study staff will ask you about any side effects from the study drug/placebo that you may be having.
During the rest period between the 2 walk tests, you may be asked how hard it is to catch your breath several times.
At the end of the study visit, you will fill out 1 questionnaire that asks if you think the study drug/placebo is helping you, and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.
Length of Study:
You will be on this study for up to 100 minutes.You will be taken off study if intolerable side effects occur during the study.
This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. It's use to help with shortness of breath is investigational.
Up to 20 patients will be enrolled in this study. All will be enrolled at MD Anderson. | Inclusion Criteria:
1. Diagnosis of cancer
2. Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level \>=3/10 on the numeric rating scale
3. Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
4. Able to communicate in English or Spanish
5. Ambulatory and able to walk with or without walking aid
6. On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
7. Karnofsky performance status \>=50%
8. Age 18 or older
Exclusion Criteria:
1. Dyspnea at rest \>=7/10 at the time of enrollment
2. Supplemental oxygen requirement \>6 L per minute
3. Delirium (i.e. Memorial delirium rating scale \>13)
4. History of unstable angina or myocardial infarction 1 month prior to study enrollment
5. Resting heart rate \>120 at the time of study enrollment
6. Systolic pressure \>180 mmHg or diastolic pressure \>100 mmHg at the time of study enrollment
7. History of active substance abuse within the past 12 months
8. History of allergy to fentanyl
9. Unwilling to provide informed consent | M.D. Anderson Cancer Center | OTHER | {
"id": "2011-1007",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-01-18T00:00:00 | {
"date": "2014-08-22",
"type": "ESTIMATED"
} | {
"date": "2012-01-24",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Advanced Cancers",
"Dyspnea"
] | ["Advanced Cancer", "Dyspnea", "Exercise-induced breakthrough dyspnea", "Shortness of breath", "Fentanyl", "Sublimaze", "Placebo", "Normal saline", "NS", "Questionnaires", "Surveys", "Walk test"] | null | [
{
"city": "Houston",
"country": "United States",
"facility": "UT MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Retention Rate",
"timeFrame": "Baseline to study completion, up to 100 minutes."
}
],
"secondary": [
{
"description": null,
"measure": "Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea",
"timeFrame": "Baseline to 100 minutes for study participation."
},
{
"description": null,
"measure": "Effect of Fentanyl on Walk Distance",
"timeFrame": "Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation."
}
]
} | [
{
"affiliation": "UT MD Anderson Cancer Center",
"name": "David Hui, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "23830530", "type": "DERIVED", "citation": "Hui D, Xu A, Frisbee-Hume S, Chisholm G, Morgado M, Reddy S, Bruera E. Effects of prophylactic subcutaneous fentanyl on exercise-induced breakthrough dyspnea in cancer patients: a preliminary double-blind, randomized, controlled trial. J Pain Symptom Manage. 2014 Feb;47(2):209-17. doi: 10.1016/j.jpainsymman.2013.03.017. Epub 2013 Jul 3."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012120",
"term": "Respiration Disorders"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D012818",
"term": "Signs and Symptoms, Respiratory"
}
],
"browseBranches": [
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"id": "M7591",
"name": "Dyspnea",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M14957",
"name": "Respiration Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15623",
"name": "Signs and Symptoms, Respiratory",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D004417",
"term": "Dyspnea"
}
]
} | {
"ancestors": [
{
"id": "D000701",
"term": "Analgesics, Opioid"
},
{
"id": "D009294",
"term": "Narcotics"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D000759",
"term": "Adjuvants, Anesthesia"
},
{
"id": "D018686",
"term": "Anesthetics, Intravenous"
},
{
"id": "D018681",
"term": "Anesthetics, General"
},
{
"id": "D000777",
"term": "Anesthetics"
}
],
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"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
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"name": "All Drugs and Chemicals"
},
{
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"name": "Adjuvants, Anesthesia"
}
],
"browseLeaves": [
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"name": "Morphine",
"relevance": "LOW"
},
{
"asFound": "Collection",
"id": "M8418",
"name": "Fentanyl",
"relevance": "HIGH"
},
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"id": "M4032",
"name": "Analgesics",
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"relevance": "LOW"
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"asFound": null,
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005283",
"term": "Fentanyl"
}
]
} | {
"conditions": [
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"term": "Dyspnea"
}
],
"interventions": [
{
"id": "D005283",
"term": "Fentanyl"
}
]
} |
NCT03327766 | null | Assesment of Vit D3 Level in Cases of Unexplaind Pregnancy Loss in Assiut | Assesment of Vit D3 Level in Cases of Unexplaind Pregnancy Loss in Assiut | vitDinRPL | OBSERVATIONAL | UNKNOWN | 2017-10-27T00:00:00 | null | 2018-04-30T00:00:00 | 2018-10-31T00:00:00 | null | 100 | 20 | 35 | FEMALE | true | Assesment of Vit D3 leve in cases of unexplained recurrent pregnancy loss in assiut | Recurrent pregnancy loss is defined as two or more consecutive pregnancy loss before 20 weekse of gestation (1). It affects about 1-5% of women of reproductive age. This not only causes significant physical and mental problems in families, but also a heavy economic burden on families and health systems (2, 3) Recurrent pregnancy loss (RPL) is a syndrome caused by multiple etiologies such as anatomical, endocrine, genetic, infectious, immunological, thrombotic and unexplained etiologies hence an investigation of underlying etiologies is often complicated When the conventional investigation scheme is applied, up to 60% of women with RPL remain unexplained (4). Recent studies have indicated that immune inflammatory and thrombotic conditions are two major under-lying pathologies for RPL (5). Approximately 20% of women with RPL have autoimmune conditions, such as antiphospholipid antibody (APA)(6),antinuclear antibody (ANA), anti-thyroperoxidase antibody and anti-thyroglobulin antibody(7,8).
Immune function in pregnancy From initial implantation of the conceptus, the maternal uterine endometrium undergoes decidualisation to support placental development and function. The resulting decidua is a tissue formed from the maternal endometrium, originating from epithelial and stromal cells, and is characterised by invasion from the extraembryonic fetal-derived trophoblasts and close 'cell-cell juxtaposition' of these different tissues The principal function of the decidua is to facilitate early fetal-maternal exchange of nutrients, gases and waste, while also acting as a secretory source of steroid hormones, cytokines and growth factors (9).However, the decidua also plays a key role in protecting pregnancy against maternal immune surveillance(10) .
Cellular infiltration is a key feature of immune function within decidua, and leukocytes comprise at least 40% of the total decidual stromal cell population(11) . The leukocyte subtypes present include decidual (uterine) natural killer (uNK) cells, macrophage subtypes, CD4C and CD8C T-lymphocytes (including T-regulatory cells (Tregs) and antigen-presenting cells (APCs) such as dendritic cells (DCs)(12) . There has been renewed interest in the role vitamin D, as key regulators of decidual immune cell function and its roles in fetal-maternal immune tolerance (13) .
- 3 - Vitamin D and autoimmunity Vitamin D, a steroid hormone, is well known to be involved in calcium and phosphate homeostasis and bone metabolism (14).The target organs for the non-classical actions of the vitamin D include immune systems, pancreatic b-cells, the heart and cardiovascular system, the brain and reproductive tissues. Tissue responses to vitamin D include regulation of hormone secretion modulation of immune responses, and a control of cellular proliferation and differentiation (15). Vitamin D was also reported to inhibit proliferation of T helper 1 (Th1) cells and limit their production of cytokines, such as interferon gamma (IFN-g), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-a).Conversely, vitamin D induces T helper 2 (Th2) cytokines, such as IL-4, IL-5, IL-6, IL-9, IL-10 and IL-13 (16). Furthermore, in many studies vitamin D has been presented as a modifiable environmental factor for Th1-mediated autoimmune disease and appears to be important for susceptibility to and severity of the disease (17). Vitamin D also regulates B cell immunity. It down-regulates the proliferation and differentiation of B lymphocytes and inhibits IgG production (16).
Vitamin D deficiency in pregnant women is associated with increased risk of obstetrical complications such as pre-eclampsia (18), bacterial vaginosis associated preterm delivery (19), gestational diabetes mellitus (20) and small-for-gestational age births (21). | Inclusion Criteria:
1. Age of women 20:35years old
2. history of unexplained recurrent pregnancy loss (defined as two or more consecutive missed miscarriage before 14 weeks of gestation).
Exclusion Criteria:
1. Un corrected uterine anomalies.
2. Uncontrolled DM .
3. Systemic disease(SLE,Rheumatoid arthritis).
4. Thyroid dysfunction.
5. Antiphospholipid antibody syndrome
6. Cervical incompetence | Woman's Health University Hospital, Egypt | OTHER | {
"id": "Vit D and RPL",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-10-27T00:00:00 | {
"date": "2017-10-31",
"type": "ACTUAL"
} | {
"date": "2017-10-31",
"type": "ACTUAL"
} | [
"ADULT"
] | 50 womens with history of RPL in last 2 pregnanses and last abortion of 6 months at El-mabra H. \& AUH.
50 womens coming for contraception after normal pregnancy outcome. As acotrol group. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"vitD3 Level in Cases of Recuurent Pregnancy Loss"
] | ["vitamin D and recurrent pregnancy loss"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "vitamin D level",
"timeFrame": "1 year"
}
],
"secondary": null
} | [
{
"affiliation": "Professor of obstetrics and gynecology Faculty of medicine-Assiut university",
"name": "Ezat Hamed",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "27222154", "type": "BACKGROUND", "citation": "Hou W, Yan XT, Bai CM, Zhang XW, Hui LY, Yu XW. Decreased serum vitamin D levels in early spontaneous pregnancy loss. Eur J Clin Nutr. 2016 Sep;70(9):1004-8. doi: 10.1038/ejcn.2016.83. Epub 2016 May 25."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D011248",
"term": "Pregnancy Complications"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D003643",
"term": "Death"
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{
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"term": "Pathologic Processes"
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
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"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
}
],
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"term": "Abortion, Spontaneous"
},
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"id": "D005313",
"term": "Fetal Death"
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]
} | {
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"term": "Physiological Effects of Drugs"
},
{
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"term": "Bone Density Conservation Agents"
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"browseBranches": [
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"abbrev": "BDCA",
"name": "Bone Density Conservation Agents"
},
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"abbrev": "Micro",
"name": "Micronutrients"
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"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Vi",
"name": "Vitamins"
}
],
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},
{
"asFound": null,
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},
{
"asFound": "Noninvasive Positive Pressure Ventilation",
"id": "M5375",
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"asFound": null,
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},
{
"asFound": null,
"id": "M16885",
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},
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"asFound": null,
"id": "T479",
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},
{
"asFound": null,
"id": "T442",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "T440",
"name": "Calciferol",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002112",
"term": "Calcifediol"
}
]
} | {
"conditions": [
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],
"interventions": [
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"id": "D002112",
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} |
NCT00500266 | null | Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects | A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment | None | INTERVENTIONAL | COMPLETED | 2007-07-09T00:00:00 | null | null | null | [
"PHASE3"
] | 1,053 | 68 | null | ALL | true | To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment. | null | MAIN INCLUSION CRITERIA:
* Male or female aged 68 years or older
* Determined by medical history, physical examination, and clinical judgment to be eligible for the study
* Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment
MAIN EXCLUSION CRITERIA:
* Known history of severe reaction to a vaccine
* Documented S pneumoniae infection within the past 5 years.
* Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
* Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study. | Pfizer | INDUSTRY | {
"id": "6115A1-3000",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-07-10T00:00:00 | {
"date": "2011-09-16",
"type": "ESTIMATED"
} | {
"date": "2007-07-11",
"type": "ESTIMATED"
} | [
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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NCT01666366 | null | Comparison Between 2 Bilateral Internal Thoracic Artery Coronary Artery Bypass Grafting Configurations | Comparison of Bilateral Internal Thoracic Artery Revascularization Using in Situ or Y Graft Configurations: a Prospective Randomized Clinical, Functional and Angiographic Evaluation | None | INTERVENTIONAL | COMPLETED | 2012-08-01T00:00:00 | null | null | null | [
"PHASE4"
] | 304 | 18 | 75 | ALL | false | Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the left coronary system in terms of patency and survival benefit. Several BITA configurations are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is still unidentified.
From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our institution. 481 patients met the inclusion criteria for randomization and 304 (64%) were randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months, 3 and 7 years . Patient telephone interviews were conducted every 3 months and a stress test performed twice yearly under the referring cardiologist's supervision. Angiographic follow-up was performed 6 months after surgery. The primary and secondary end points were, respectively, major adverse cerebro-cardiovascular events (MACCE) and the proportion of ITA grafts that were completely occluded at follow-up angiography. | Study design All patients referred for isolated surgical coronary revascularization from April 2003 to July 2006 were screened according to the inclusion criteria (Table 1). Patients were randomly assigned to undergo one of two alternative surgical strategies: BITA in situ (LITA to the LAD and RITA to the marginal branches into the transverse sinus) or BITA Y (LITA to the LAD and RITA to the marginal branches but anastomozed proximally to the LITA in a Y configuration as described by Barra JA et al 3). Randomization was performed the day before the operation after the patient's record was reviewed without knowledge of the preoperative angiogram. Complementary grafting was performed with either a saphenous vein graft or a pedicled right gastroepiloic artery depending on the location and quality of the targeted coronary vessel, but also depending on the surgeon's choice. All patients were scheduled for a systematic angiography at 6 and 36 months following surgery. All patients gave written informed consent at the time of bypass surgery and before the angiographic investigation. The study protocol was approved by the Ethics Committee at our institution.
Patients From 2003 to 2006, 1297 consecutive patients underwent isolated bypass surgery at our institution. Of these, 481 patients (37%) met the inclusion criteria for enrolment in the study (Figure 1). Three hundred four of 481 patients (63%) were actually randomized. The remaining 177 patients were not randomized because of a) refusal of systematic angiographic control (85%) and b) logistic incapacity to randomize patients (15%). BITA grafting was performed with a in situ configuration in 147 patients and with a Y configuration in 152. Five patients initially allocated to the BITA in situ group were excluded for protocol violations. In these cases, the surgeon decided to deviate from the assigned revascularisation strategy in favor of a BITA Y configuration. Patient's demographics and clinical characteristics are shown in Table 2. The BITA were harvested and grafted as previously described 4-5. Operative characteristics are detailed in Table 3.
Postoperative management and follow-up Patients received prophylactic low dose fractionated heparin postoperatively, and 160 mg of aspirin daily starting on postoperative day 2. Patients were interviewed by telephone at 3 and 6 months and then twice yearly thereafter. If the patient had been hospitalized between interviews, in-patient records were obtained. Patients had a systematic stress test on a cycloergometer twice a year performed under the supervision of their referring cardiologist.
Follow-up angiography was scheduled at both 6 months and 3 years after surgery. Nitroglycerin (2 mg) was injected into each graft before filming. At least two orthogonal views of each ITA graft were obtained, with continued exposure as required to visualize distal runoff and the size of the target coronary bed.
Data analysis The clinical end point was occurrence of MACCE defined as a combined end-point including: death from any cause; perioperative myocardial infarction (occurring between 0 and 30 days); late myocardial infarction (occurring between 31 days and 6 years); additional cardiac surgery; coronary angioplasty; and stroke. Myocardial infarction was defined as the apparition of a new Q wave, a rise of more than 10 ng / ml of troponin in the early post operative period or any episode of chest pain with typical rise and fall of cardiac enzymes thereafter.
The angiographic end point was the proportion of ITA grafts that were completely occluded at follow-up angiography. Complete occlusion was defined as the absence of visible opacification of the target coronary vessel (TIMI flow grade 0).
All postoperative angiograms were independently reviewed by 2 investigators; discrepancies in patency definition were reviewed by a third investigator and resolved by consensus.
Statistical analysis We calculated that the enrolment of at least 152 patients per group would provide the study with 80% power to detect a relative reduction of 8 % in the rate of graft occlusion, from an estimated 10% with BITA Y grafting 6 to 2% with BITA in situ 7 grafting, assuming a 20% within-patient correlation for graft occlusion, a two-tailed test, and an alpha value of 0.05. Data are expressed as the mean ± 1 SD. In bivariate analyses, the association of independent variables with each outcome variable was tested with Chi square test for independent samples (binary variables).
All p-values are two-tailed. The Statistical Analysis Software (SAS, 9.1 releases, SAS Institute Inc., SAS Campus Drive, Cary, NC USA) was used in the statistical analysis. | Inclusion Criteria:
* Angiographic evidence of severe (\>70% by visual estimate) 3 vessels coronary obstruction
* Elective procedure
* Isolated CABG
* Age \<75 years and life expectancy \>5 years
Exclusion Criteria:
* Diabetes with a HbA1c \>7.5
* FEV1 \< 60 % predicted value
* Body mass index \>35
* Reoperation
* Other configuration then LIMA -\> LAD territory. RIMA -\> LCX territory. | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER | {
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"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003327",
"term": "Coronary Disease"
}
]
} | null | {
"conditions": [
{
"id": "D003327",
"term": "Coronary Disease"
}
],
"interventions": null
} |
NCT00630266 | null | Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair | Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial | MVR + CorCap | INTERVENTIONAL | UNKNOWN | 2008-02-27T00:00:00 | null | null | null | [
"PHASE2"
] | 50 | 18 | 80 | ALL | false | The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.
The CorCapTM CSD is intended to support the heart, potentially preventing further dilation that is associated with progressive heart failure, thereby potentially preserving or improving heart function. | The Acorn CorCap Cardiac Support Device (CSD) is a new therapy for the treatment of heart failure that is designed to reduce left ventricular dilation, which is one of the most important pathophysiological mechanisms underlying the clinical syndrome of heart failure. The Acorn CorCap CSD is intended to reduce wall stress and support the heart, in order to prevent further dilation that is associated with progressive heart failure. It is designed to result in reduced left ventricular size and improve left ventricluar function, which should result in improved patient functional status.
The purpose of the study is to provide confirmatory data to demonstrate an improved benefit-risk profile in support of a Pre-Market Approval (PMA) application for the Acorn CorCap CSD when placed concomitant to Mitral Valve Repair/Replacement (MVR).
The primary efficacy objective is to evaluate patient functional status after 6 months of follow-up. The safety endpoint is perioperative (30 day) mortality. | Inclusion Criteria:
* Dilated cardiomyopathy of either ischemic or non-ischemic origin
* Patients must be on stable, optimally uptitrated medical therapy recommended according to current guidelines as standard of care of heart failure therapy in the United States. This minimally includes:
1. Angiotensin-converting enzyme inhibitors (ACE) or alternate if ACE not tolerated for greater than or equal to 1 month prior to enrollment (not required for patients with a mitral valve anomaly that is not likely to respond to medication and requires surgical intervention).
2. Treatment with a beta-blocker, unless intolerant, for greater than or equal to 3 months prior to enrollment (not required for patients with a mitral valve anomaly that is not likely to respond to medication and requires surgical intervention).
3. Diuretic at least "prn" (as occasion requires).
4. Cardiac medications unchanged for greater than or equal to 1 month except for diuretic adjustments (not required for patients with a mitral valve anomaly that is not likely to respond to medications and requires surgical intervention).
* Adult (18 to 80 years).
* Indexed left ventricular end diastolic dimension (LVEDDi)between 30 mm/m2 and 40 mm/m2 as determined by transthoracic echocardiography.
* Mitral regurgitation (MR) greater than or equal to 2+ and scheduled for mitral valve repair or replacement. Concomitant tricuspid valve repair or replacement (TVR) and/or atrial fibrillation ablation procedures will be permitted.
* Left ventricular ejection fraction (LVEF) less than or equal to 45 percent via transthoracic echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging
* New York Heart Association Functional Class (NYHA) II, III or IV
* Geographically available for follow-up
* Signed Informed Consent
Exclusion Criteria:
* Inability to reach maximal effort CPX test as defined by the CPX Core Lab
* Planned cardiac surgical procedure other than MVR
* Hypertrophic obstructive cardiomyopathy.
* Significant cardiomegaly, which is estimated to exceed the largest available size of CorCap CSD.
* Expectation of existing cardiothoracic adhesions that would cause an inability to gain complete circumferential access to the heart.
* Existing patent CABG.
* Candidates for surgical revascularization as determined by an angiogram. Patients with ischemic heart disease who have not had an angiogram within the past 3 years and in whom lesions amenable to revascularization cannot be excluded should have a repeat angiogram.
* Any condition considered a contraindication for extracorporeal circulation.
* Use of Intra aortic Balloon Pump (IABP), intravenous inotropic or vasoactive agents within 30 days prior to enrollment. Pre-operative hemodynamic optimization with IABP, IV inotropes or vasoactive agents may be permitted if it is scheduled to occur within 48 hours of planned index surgery.
* Current or anticipated need for left ventricular assist device (LVAD) or cardiac replacement device.
* Anticipated need for heart transplant within the next two years.
* Acute myocardial infarction (AMI), unstable angina, or cerebral vascular accident (CVA) or Transient Ischemic Attack (TIA) within past 3 months.
* Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization (TMR or PMR) within the past 3 months.
* Presence of arrhythmias causing hemodynamic instability, history of resuscitated sudden death without subsequent treatment with implantable defibrillator or amiodarone, or atrial fibrillation with a ventricular rate greater than 100 bpm on medication.
* Co-morbid condition that reduces life expectancy to less than 1 year.
* Active infection.
* Pregnancy at the time of enrollment. (Women of child bearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices.)
* Enrolled in another investigational study that would confound interpretation of trial results.
* Patients who participated as control patients in the previous CorCap PMA randomized trial.
* Unable to comply with protocol-required follow-up (as judged by primary investigator or referring cardiologist).
* Late stage heart failure with increased surgical risk as defined by the presence of four or more of the following:
1. LVEDD greater than 80 mm/m2
2. Resting systolic blood pressure (BP) less than or equal to 80 mm Hg (on clinical exam)
3. Atrial fibrillation at time of enrollment or paced rhythm with underlying atrial fibrillation
4. Heart failure greater than or equal to 8 years
5. 6 minute walk less than or equal to 350 meters (1148 feet)
6. POV2 less than or equal to 13 ml/kg/min (CPX test)
7. Exercise induced increase in systolic BP less than 10 percent (CPX test)
8. Previous cardiac surgery
9. BUN greater than 100 mg/dl
10. Cachexia (clinical impression) | Acorn Cardiovascular, Inc. | INDUSTRY | {
"id": "47-1389",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2008-03-05T00:00:00 | {
"date": "2009-06-18",
"type": "ESTIMATED"
} | {
"date": "2008-03-06",
"type": "ESTIMATED"
} | [
"ADULT",
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"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Heart Failure"
] | ["Heart failure", "left ventricular dilation", "mitral valve repair", "mitral valve replacement"] | null | [
{
"city": "Santa Clara",
"country": "United States",
"facility": "Kaiser Permanente Northern California Heart Transplant Program",
"geoPoint": {
"lat": 37.35411,
"lon": -121.95524
},
"state": "California"
},
{
"city": "Oak Lawn",
"country": "United States",
"facility": "Advocate Christ Medical Center",
"geoPoint": {
"lat": 41.71087,
"lon": -87.75811
},
"state": "Illinois"
},
{
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"country": "United States",
"facility": "University of Michigan",
"geoPoint": {
"lat": 42.27756,
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"state": "Michigan"
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"city": "Detroit",
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"facility": "Henry Ford Hospital",
"geoPoint": {
"lat": 42.33143,
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"state": "Michigan"
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"lon": -96.66696
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"facility": "Nebraska Heart Institute",
"geoPoint": {
"lat": 40.8,
"lon": -96.66696
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"state": "Nebraska"
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"city": "Newark",
"country": "United States",
"facility": "Newark Beth Israel",
"geoPoint": {
"lat": 40.73566,
"lon": -74.17237
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"state": "New Jersey"
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"city": "Cleveland",
"country": "United States",
"facility": "Cleveland Clinic Foundation",
"geoPoint": {
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"lon": -81.69541
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"state": "Ohio"
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"facility": "Lancaster General Hospital",
"geoPoint": {
"lat": 40.03788,
"lon": -76.30551
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"state": "Pennsylvania"
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"country": "United States",
"facility": "Hospital of the University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
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"state": "Pennsylvania"
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"city": "Philadelphia",
"country": "United States",
"facility": "PENN-Presbyterian Medical Center",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
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"state": "Pennsylvania"
},
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"city": "Montreal",
"country": "Canada",
"facility": "Royal Victoria Hospital, McGill University",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec"
}
] | null | null | {
"other": null,
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{
"description": null,
"measure": "Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire",
"timeFrame": "6 month follow-up"
},
{
"description": null,
"measure": "Change in maximal exercise tolerance evaluated using cardiopulmonary exercise (CPX) testing (peak VO2 exercise test)",
"timeFrame": "6 Month follow-up"
},
{
"description": null,
"measure": "Change in sub-maximal exercise tolerance as evaluated using the Six Minute Walk test.",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Number of patients who have died (all-cause) or had a re-hospitalization due to heart failure.",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Peri-operative mortality, death occuring within 30 days of baseline surgery.",
"timeFrame": "30 days"
}
],
"secondary": [
{
"description": null,
"measure": "Rate of death and SAEs overall and for each specific type of event",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Change in patient functional status as evaluated using the Minnesota Living with Heart Failure Questionnaire",
"timeFrame": "12 months"
}
]
} | [
{
"affiliation": "University of Michigan",
"name": "Steven F Bolling, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Hospital of the University of Pennsylvania, Cardiovascular Medicine; Penn-Presbyterian Medical Center",
"name": "Michael A Acker, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Kaiser Permanente Northern California Heart Transplant Program",
"name": "Mario Pompili, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Nebraska Heart Institute",
"name": "James Wudel, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "The Cleveland Clinic",
"name": "Randall Starling, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Newark Beth Israel",
"name": "Mark J Zucker, MD, JD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Royal Victoria Hospital, McGill University",
"name": "Renzo Cecere, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "advocate christ medical center",
"name": "Pat Pappas, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Henry Ford Hospital",
"name": "Robert Brewer, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Lancaster General Hospital",
"name": "Jeff Cope, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "BryanLGH Medical Center",
"name": "Edward Raines, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
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],
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
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"name": "All Conditions"
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{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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],
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"asFound": "Heart Failure",
"id": "M9421",
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"relevance": "LOW"
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} | null | {
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NCT03756766 | null | Understanding RSV: Severe Disease and the Long Term Consequences | REspiratory Syncytial Virus Consortium in EUrope (RESCEU):Presumed Risk Factors and Biomarkers for RSV-related Severe Disease and Related Sequelae | None | OBSERVATIONAL | ACTIVE_NOT_RECRUITING | 2018-10-04T00:00:00 | null | null | null | null | 315 | null | 12 | ALL | true | The study design is a case-control, sample based study. 275 cases (Group 1), infants \<12 months old with RSV infection and 40 controls (Group 2), otherwise healthy infants \<12 months old without RSV infection will be recruited. Samples will be taken on enrolment and for infants in Group 1; repeated at 7 weeks convalescence. There will be annual follow up by questionnaire for up to 6 years and a minimum of 1 year, depending at what stage in the study the infant is enrolled. | Human respiratory syncytial virus (RSV) causes severe disease in the very young, elderly and in high risk groups. Worldwide in 2005 there were an estimated 34 million cases of acute lower respiratory tract infection (ALRI), 3.4 million ALRI hospitalisations and 55,000 to 199,000 deaths associated with RSV in children \<5 years old. RSV infection in childhood is associated with subsequent wheezing and asthma. These long-term sequelae pose a substantial additional burden on healthcare systems. There is a parallel need to assemble clinical resources to identify the correlates of severe RSV disease for clinical management, classification of disease severity in clinical trials and identification of biomarkers for severe disease, which are currently lacking.
Group 1: Infants under 12 months with an RSV infection will have nasopharyngeal swabs, blood, urine and stool samples taken at the onset of infection and again 6 - 8 weeks later, in convalescence. An online diary will be completed for 2 weeks during illness to record the participant and parent health. The participant and their family will be followed up annually by questionnaire, for a maximum of 6 years. When the study data are analysed, the infants will be subdivided into 4 further groups; healthy infants requiring hospitalisation, healthy infants not requiring hospitalisation, infants with co-morbidity, requiring hospitalisation and infants with a co-morbidity not requiring hospitalisation. Group 2: Well, healthy infants, under 12 months with no acute respiratory infection will have nasopharyngeal swab,blood, urine and stool samples taken on enrolment. They will receive a follow up contact 7 days after enrolment to assess if they have developed any illness. The participant and their family will be followed up annually by questionnaire, for a maximum of 6 years. | Inclusion Criteria: All of the following must apply
* parent/carer of the infant is willing and able to give informed consent for participation in the study
* Male or female, less than 12 months of age at enrolment
* Parent has a telephone
For group 1 only:
* Hospitalised for \<48 hours at enrolment or within 96 hours of onset of illness
* Live near enough to a participating study centre for the 6-8 week home visit
Exclusion Criteria:
* Infants who have received treatment for RSV infection (eg: ribavirin)
* Infants who have had prior exposure to an RSV vaccine or medication
* Infants who have received preventative therapy for RSV (eg; palivizumab)
* Infants who have received oral steroids or montelukast within 7days of enrolment on the study | University of Oxford | OTHER | {
"id": "OVG 2017/02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-11-26T00:00:00 | {
"date": "2022-11-22",
"type": "ACTUAL"
} | {
"date": "2018-11-28",
"type": "ACTUAL"
} | [
"CHILD"
] | Infants less than 12 months old who present to their GP of to hospital with RSV positive respiratory disease. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Respiratory Syncytial Virus (RSV)"
] | null | null | [
{
"city": "Oxford",
"country": "United Kingdom",
"facility": "Oxford University Hospitals NHS Trust",
"geoPoint": {
"lat": 51.75222,
"lon": -1.25596
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},
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"country": "United Kingdom",
"facility": "Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine",
"geoPoint": {
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"lon": -1.25596
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] | [
{
"class": "OTHER",
"name": "Innovative Medicines Initiative"
},
{
"class": "UNKNOWN",
"name": "Respiratory syncytial virus consortium in Europe"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Ribonucleic acid (RNA) transcripts (Transcriptomics) that are up and down regulated in severe RSV infection",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Cellular protein concentration changes (proteomics) in response to severe RSV infection",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Cellular metabolite concentration changes associated with severe RSV disease",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The relationship between infant RSV infection of different severity and school age asthma",
"timeFrame": "Year 6"
}
],
"secondary": [
{
"description": null,
"measure": "Ribonucleic acid (RNA) transcripts that are up or down regulated and contribute to respiratory sequelae following RSV infection in infants",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Cellular protein concentration changes (Proteomics) affecting respiratory sequelae following RSV infection in infants",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Cellular metabolite concentration changes that contribute to respiratory sequelae following RSV infection",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Respiratory sequelae following RSV infection in infants",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Viral load associated with mild and severe RSV disease",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Genetic sequence of RSV associated with mild and severe disease",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Cellular immune response during RSV infection",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Cytokine release associated with severe RSV disease",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Altered gene expression associated with severe RSV disease",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "RSV disease severity",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Health care costs and resource use",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Interruption to normal activities associated with RSV disease",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections",
"timeFrame": "Year 4"
},
{
"description": null,
"measure": "Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections",
"timeFrame": "Year 5"
},
{
"description": null,
"measure": "Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections",
"timeFrame": "Year 6"
},
{
"description": null,
"measure": "Risk factors for persistent wheeze at 3 and 6 years of age",
"timeFrame": "Year 4"
},
{
"description": null,
"measure": "Risk factors for persistent wheeze at 3 and 6 years of age",
"timeFrame": "Year 5"
},
{
"description": null,
"measure": "Risk factors for persistent wheeze at 3 and 6 years of age",
"timeFrame": "Year 6"
}
]
} | [
{
"affiliation": "Oxford Vaccine Group",
"name": "Andrew Pollard",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "35902389", "type": "DERIVED", "citation": "McGinley JP, Lin GL, Oner D, Golubchik T, O'Connor D, Snape MD, Gruselle O, Langedijk AC, Wildenbeest J, Openshaw P, Nair H, Aerssens J, Bont L, Martinon-Torres F, Drysdale SB, Pollard AJ; RESCEU Investigators. Clinical and Viral Factors Associated With Disease Severity and Subsequent Wheezing in Infants With Respiratory Syncytial Virus Infection. J Infect Dis. 2022 Aug 12;226(Suppl 1):S45-S54. doi: 10.1093/infdis/jiac163."}, {"pmid": "32794560", "type": "DERIVED", "citation": "Jefferies K, Drysdale SB, Robinson H, Clutterbuck EA, Blackwell L, McGinley J, Lin GL, Galal U, Nair H, Aerssens J, Oner D, Langedijk A, Bont L, Wildenbeest JG, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Nadel S, Openshaw P, Thwaites R, Widjojoatmodjo M, Zhang L, Nguyen TL, Giaquinto C, Giordano G, Baraldi E, Pollard AJ; RESCEU Investigators. Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU). J Infect Dis. 2020 Oct 7;222(Suppl 7):S658-S665. doi: 10.1093/infdis/jiaa239."}, {"pmid": "32702120", "type": "DERIVED", "citation": "Lin GL, Golubchik T, Drysdale S, O'Connor D, Jefferies K, Brown A, de Cesare M, Bonsall D, Ansari MA, Aerssens J, Bont L, Openshaw P, Martinon-Torres F, Bowden R, Pollard AJ; RESCEU Investigators. Simultaneous Viral Whole-Genome Sequencing and Differential Expression Profiling in Respiratory Syncytial Virus Infection of Infants. J Infect Dis. 2020 Oct 7;222(Suppl 7):S666-S671. doi: 10.1093/infdis/jiaa448."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "BC01",
"name": "Infections"
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"id": "M17522",
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"relevance": "LOW"
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NCT05943366 | null | Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults | Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study | None | INTERVENTIONAL | RECRUITING | 2023-05-31T00:00:00 | null | 2024-10-01T00:00:00 | 2024-12-01T00:00:00 | [
"NA"
] | 30 | 65 | null | ALL | true | Trial Design: This is a feasibility randomised controlled trial.
Aim: The study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (Keep-On-Keep-Up Nutrition, KOKU-Nut) to improve dietary intake in community-dwelling older adults.
Objectives:
1. Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial.
2. Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut
Study population:
Community-dwelling adults aged 65 and older
Intervention:
Participants in the intervention group will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period. A crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues.
Control:
Participants will continue with usual care and receive a leaflet developed by Age UK about the importance of a healthy lifestyle.
Timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period | Background:
Dietary patterns can play an important role in health in older age. Apps that encourage dietary change are available and commonly used in younger populations, however; few are designed for the nutritional and technical requirements of older adults. Keep-On-Keep-Up Nutrition (KOKU-Nut) is the latest development of the digital tool and includes nutritional games based on the Eatwell guide to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid. The innovation process has brought together researchers, clinicians, software designers and older users to co-develop the digital tool.
In this study, researchers will test the practicality of KOKU-Nut as an intervention before further larger studies are conducted to assess it's effectiveness.
The aim of this study is to assess the feasibility of conducting a randomised controlled trial using this digital health tool (KOKU-Nut) to improve dietary intake in community-dwelling older adults. Participants will be randomised to receive usual care and an information booklet about living a healthy lifestyle or to the intervention group and asked to engage with KOKU-Nut 3 times a week for 12 weeks. | Inclusion Criteria:
* Aged 65 years or older
* Living independently in the community
* Have access to the internet (to complete online dietary assessment)
* Willing to use an iPad or tablet (their own or one provided) for the duration of the study
Exclusion Criteria:
* Unable to communicate in English
* Have a known cognitive impairment | University of Manchester | OTHER | {
"id": "17372",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-07-04T00:00:00 | {
"date": "2024-05-09",
"type": "ACTUAL"
} | {
"date": "2023-07-13",
"type": "ACTUAL"
} | [
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"Malnutrition",
"Healthy Aging",
"Dehydration"
] | ["feasibility", "malnutrition", "dehydration", "digital health"] | null | [
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"facility": "Manchester",
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"timeFrame": "Baseline, 12 weeks"
},
{
"description": null,
"measure": "Change in physical function",
"timeFrame": "Baseline, 12 weeks"
},
{
"description": null,
"measure": "Change in physical function",
"timeFrame": "Baseline, 12 weeks"
},
{
"description": null,
"measure": "Change in health related quality of life",
"timeFrame": "Baseline, 12 weeks"
},
{
"description": null,
"measure": "Change in health related quality of life",
"timeFrame": "Baseline, 12 weeks"
},
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"measure": "Change in mood",
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},
{
"description": null,
"measure": "Adverse events",
"timeFrame": "From recruitment until study end (approximately 14 weeks)"
}
]
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"affiliation": "University of Manchester",
"name": "Emma Stanmore",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT01067066 | null | A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma | A Phase I/II Open-Label Study TPI 287 in Combination With Temozolomide in Patients With Metastatic Melanoma | None | INTERVENTIONAL | TERMINATED | 2010-02-09T00:00:00 | null | 2016-07-06T00:00:00 | 2016-07-06T00:00:00 | [
"PHASE1"
] | 21 | 15 | null | ALL | false | The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma.
The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion. | Study Drugs:
TPI 287 is designed to block tumors from growing by preventing cancer cells from dividing.
Temozolomide is designed to kill cancer cells by causing breaks in the DNA (genetic material) of the cell.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 8 groups of 6 participants will be enrolled in the Phase I portion of the study, and up to 64 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of TPI 287 and temozolomide you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of TPI 287 and temozolomide. Each new group will receive a higher dose of TPI 287 and temozolomide than the group before it, if no intolerable side effects were seen. If any of these participants have a dose limiting toxicity, 6 additional participants will be added at the same dose. If a dose limiting toxicity occurs again, the dose level below this will be considered the maximum tolerated dose.
If any participant experiences a life threatening side effect, no additional participants will be enrolled into that dose level and no higher doses will be given. An additional 3 participants will be treated at the dose level below the one with life threatening toxicity. Once the maximum tolerated dose of the combination is found, Phase II of the study will open.
If you are enrolled in the Phase II portion, you will receive the drug combination at the highest dose that was tolerated in the Phase I portion
Central Venous Catheter (CVC):
You will have a CVC placed. A CVC is a sterile, flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
Study Drug Administration:
You will receive TPI 287 by vein over 1 hour (+/- 10 minutes) on Days 1, 8, and 15 (+/- 1 day) of each 28 day study cycle. Before you receive each dose of TPI 287, you will receive dexamethasone, Benadryl (diphenhydramine), and Pepcid (famotidine) by vein to help prevent allergic reaction. You will also receive drugs to prevent nausea and vomiting. Your vital signs will be measured before and 30 minutes following the end of the infusion of TPI 287. Your vitals will be measured more often, if needed.
You will take temozolomide tablets by mouth on Days 1-5 at bedtime. You should not eat for at least 1 hour before and 1 hour after taking temozolomide.
Study Visits:
Before each cycle, your performance status will be recorded and you will have a physical exam. You will also be asked about any symptoms you may be experiencing and any drugs you are taking.
On Days 1, 8, and 14 of each cycle:
-Blood (about 1 teaspoon) will be drawn for routine tests before you receive TPI 287.
On Day 22 of each cycle:
-Blood (about 1 teaspoon) will be drawn for routine tests.
Every 8 weeks, you will have a CT scan or MRI scan to check the status of the disease. If you have brain metastasis, you will have an MRI of the brain every 4 weeks. If you do not have brain metastasis, you will have MRI of the brain every 8 weeks.
Length of Study:
You will continue taking the study drugs for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.
End-of-Treatment Visit:
About 4 weeks after you stop taking TPI 287 in combination with Temozolomide, you have an end-of-study visit. At this visit, the following tests and procedures will be performed:
* You will have a physical exam.
* You will be asked about any complications or side effects you may be experiencing.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If your doctor thinks it is needed, you will have a CT scan or MRI scan to check the status of the disease.
This is an investigational study. TPI 287 is not FDA approved or commercially available. At this time, TPI 287 is being used in research only. Temozolomide is FDA approved and commercially available for primary brain cancer. The use of temozolomide in combination with TPI 287 is investigational.
Up to 106 patients will take part in this study. All patients will be enrolled at MD Anderson. | Inclusion Criteria:
1. Patients with histologically proven melanoma with metastasis that is unresectable Stage III or Stage IV. This will include bulky stage III and M1-3. Patients with melanoma with documented metastases to the brain are eligible.
2. Patients must have shown unequivocal evidence for tumor recurrence or progression and should have at least one indicator lesion, that can be measured in one dimension as \>/=20mm with conventional techniques (CT, MRI, X-ray) or \>/=10mm with spiral CT scan.
3. Patients may have had up to two prior cytotoxic chemotherapy regimens for their disease (immunological or targeted therapy e.g. vaccine, IL-2, B-RAF inhibitors, will not be considered prior cytotoxic chemotherapy). Patient should not have been treated with Docetaxel, Paclitaxel or other taxanes.
4. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
5. Patients must have a Eastern Cooperative Oncology Group status of \</=2.
6. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
7. Patients must have adequate bone marrow function (ANC \>/= 1,500/mm3 and platelet count of \>/= 100,000/mm3), adequate liver function (SGPT and serum glutamate oxaloacetate transaminase (SGOT) \</= 2.5 times normal, bilirubin \</= 2 mg/dl), and adequate renal function (BUN and creatinine \</=1.5 times institutional normal) prior to starting therapy.
8. TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and international normalized ratio (INR).
9. Females of childbearing potential (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
10. Patient should be 15 years of age or older
Exclusion Criteria:
1. Patients with brain metastases must not be taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants (Enzyme-Inducing Anti-Epileptic Drugs). Patients changing from these anticonvulsants to others that are allowed must be off the drugs listed above for at least 1 week.
2. Patients with any neuropathy.
3. Patients with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, history of myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
4. Because of the concerns of potentially harmful interactions of TPI 287and other medications taken by patients who are HIV positive or have AIDS related diseases, patients who are HIV positive are not be eligible for entry into this study. Only patients with suspected HIV will be tested and if positive, will be ineligible.
5. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible for Phase II part of the study unless in complete remission and off of all therapy for that disease for a minimum of 3 years. However, during Phase I part of the study, a patient with second malignancy is eligible if that malignancy has not recurred after appropriate therapy.
6. Patients with: a) active infection, b) disease that will obscure toxicity or dangerously alter drug metabolism, c) serious intercurrent medical illness, d) prior documented recurrence with temozolomide
7. Females who are pregnant or breastfeeding.
8. Patients younger than 15 years of age
9. Patients with prior therapy with paclitaxel or other taxanes. | M.D. Anderson Cancer Center | OTHER | {
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"date": "2010-02-11",
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} | [
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"ADULT",
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] | ["TPI 287", "microtubule inhibitor", "Temozolomide", "Temodar", "cytotoxic agent", "unresectable Stage III", "Stage IV", "Metastatic Melanoma"] | null | [
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] | [
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"class": "INDUSTRY",
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"description": null,
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"description": null,
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NCT03136666 | null | Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design. | Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design. | None | INTERVENTIONAL | COMPLETED | 2017-04-28T00:00:00 | null | 2010-06-07T00:00:00 | 2010-06-07T00:00:00 | [
"PHASE1"
] | 12 | 30 | 55 | MALE | true | The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects. | * Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as loose combination (Treatment A)
* Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as loose combination (Treatment B)
* Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as loose combination (Treatment C) Before any study drug administration in each treatment period, subjects were fasted from food for at least 10 hours. Subjects continued fasting until at least 4 hours after study drug administration. The wash-out phase between treatments was 5 days.
The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration. | Inclusion Criteria:
* Healthy male volunteers
* Age 30-55 years
* BMI 18.0-29.9 kg/m²
* Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg | Bayer | INDUSTRY | {
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"timeFrame": "48 hours"
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"measure": "Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)",
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"measure": "Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)",
"timeFrame": "48 hours"
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},
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"measure": "Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)",
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},
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"measure": "Pharmacokinetic parameters: Mean residence time (MRT)",
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]
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"name": "All Drugs and Chemicals"
},
{
"abbrev": "AnAg",
"name": "Antihypertensive Agents"
},
{
"abbrev": "VaCoAg",
"name": "Vasoconstrictor Agents"
},
{
"abbrev": "BDCA",
"name": "Bone Density Conservation Agents"
}
],
"browseLeaves": [
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"name": "Nifedipine",
"relevance": "HIGH"
},
{
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"id": "M58172",
"name": "Candesartan",
"relevance": "HIGH"
},
{
"asFound": "Transdermal patch",
"id": "M58182",
"name": "Candesartan cilexetil",
"relevance": "HIGH"
},
{
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"id": "M4277",
"name": "Antihypertensive Agents",
"relevance": "LOW"
},
{
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"id": "M4132",
"name": "Angiotensin II",
"relevance": "LOW"
},
{
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"id": "M289354",
"name": "Giapreza",
"relevance": "LOW"
},
{
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"name": "Angiotensinogen",
"relevance": "LOW"
},
{
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"id": "M25789",
"name": "Angiotensin II Type 1 Receptor Blockers",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M28916",
"name": "Angiotensin Receptor Antagonists",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5381",
"name": "Calcium",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5384",
"name": "Calcium Channel Blockers",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5398",
"name": "Calcium, Dietary",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17412",
"name": "Vasodilator Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17869",
"name": "Tocolytic Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C081643",
"term": "Candesartan"
},
{
"id": "C077793",
"term": "Candesartan cilexetil"
},
{
"id": "D009543",
"term": "Nifedipine"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "C081643",
"term": "Candesartan"
},
{
"id": "C077793",
"term": "Candesartan cilexetil"
},
{
"id": "D009543",
"term": "Nifedipine"
}
]
} |
NCT02348866 | null | Bacterial Contamination on Obstetric Resident Surgical Scrubs | Bacterial Contamination on Obstetric Resident Surgical Scrubs: a Randomized Trial | None | INTERVENTIONAL | COMPLETED | 2015-01-23T00:00:00 | null | null | null | [
"NA"
] | 18 | null | null | ALL | true | This study will determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital. | An area of potential provider-to-patient contamination, and therefore intervention, is in health care worker attire and laundering practices. For providers who work in the operating room or labor \& delivery suites, this uniform usually comprises hospital-issued surgical scrubs. To the best of our knowledge, no study has measured the difference in bacterial contamination on surgical scrubs vis-a-vis the two variables most directly affected by hospital policies for surgical attire: site of scrub laundering and site where scrubs were first put on. In addition, no study has measured the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. Our primary objective is to measure the difference in bacterial contamination (CFU/cm2) between home-laundered/home-donned scrubs ("home/home," group 1), hospital-laundered/home-donned scrubs ("hospital/home," group 2), home-laundered/hospital-donned scrubs ("home/hospital," group 3), and hospital-laundered/hospital-donned scrubs ("hospital/hospital," group 4) in the obstetric setting. Our secondary objective is to determine the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. | Inclusion Criteria:
* ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks
Exclusion Criteria:
- | Prisma Health-Upstate | OTHER | {
"id": "Pro#00041187",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-01-27T00:00:00 | {
"date": "2016-01-14",
"type": "ESTIMATED"
} | {
"date": "2015-01-28",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"Bacterial Contamination"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "difference in bacterial contamination between scrubs donned at home and those put on in the hospital, when location of laundering is considered (as determined by (CFU/cm2)",
"timeFrame": "4 days"
}
],
"secondary": [
{
"description": null,
"measure": "Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting",
"timeFrame": "4 days"
}
]
} | [
{
"affiliation": "Prisma Health-Upstate",
"name": "Kacey Y Eichelberger, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT04470466 | null | Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores | Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser in Treatment of Enlarged Facial Pores: A Split-face Comparative Study | None | INTERVENTIONAL | COMPLETED | 2020-07-04T00:00:00 | null | 2020-10-12T00:00:00 | 2020-10-12T00:00:00 | [
"NA"
] | 30 | 18 | 40 | ALL | false | Facial pores are visible topographic features of the skin that reflect openings of pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many patients desire treatment for this condition, which can be an early sign of skin aging. Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and Q-switched Nd-YAG, can potentially be used in treatment of wide pores.
This study aims at the assessment and comparison of therapy with short pulsed and Q-switched Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial pores. | topical carbon cream will be applied to one side of the face in patients with wide facial pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched ND-YAG laser.
fractional CO2 laser will be performed to the other half of the face. the patients will receive 2 treatment sessions | Inclusion Criteria:
* Participants who are more than 18 years old with the large facial pores and are aware of their problem and seeking treatment
Exclusion Criteria:
* • Previous laser therapy, chemical peeling, microdermabrasion or cosmetic procedure for the face.
* Patients with any contraindication to laser therapy such as photosensitive diseases, skin malignancies, patients on oral retinoids.
* Keloid-forming tendency.
* Local or systemic treatment for skin pores in the previous 3 months
* Connective tissue disease or the use of immunosuppressive medications.
* Pregnancy.
* Present or past history of herpes labialis. | Cairo University | OTHER | {
"id": "las49",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-07-09T00:00:00 | {
"date": "2020-10-19",
"type": "ACTUAL"
} | {
"date": "2020-07-14",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Skin Lesion"
] | null | null | [
{
"city": "Cairo",
"country": "Egypt",
"facility": "Kasr Alainy",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy",
"timeFrame": "2 months"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M21089",
"name": "Facies",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT00699166 | null | Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) | A Randomized, Double-Blind, Placebo-Controlled, Multicenter 2-Week Pilot Study to Evaluate the Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) Given Orally in Female Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) | CDNK333B2201 | INTERVENTIONAL | COMPLETED | 2008-06-12T00:00:00 | null | null | null | [
"PHASE2"
] | 135 | 18 | null | FEMALE | false | This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women. | null | Inclusion Criteria:
Women of 18 - 65 years of age with IBS-D as defined by the Rome II criteria. The Rome II criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms.
Note: Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings.
Clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis.
Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period:
1. ≥ 3 bowel movements/day
2. Bowel urgency
3. Loose or watery stool
-
Exclusion Criteria:
* Patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms?
* Patients with hard or lumpy stools for more than one day during the baseline period
* Lactose intolerant patients relieved on a lactose free diet
* Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial.
* Women of child-bearing potential who do not use an acceptable methods of contraception
* Pregnant or nursing (lactating) women | Novartis | INDUSTRY | {
"id": "CDNK333B2201",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-06-12T00:00:00 | {
"date": "2008-06-17",
"type": "ESTIMATED"
} | {
"date": "2008-06-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Irritable Bowel Syndrome"
] | ["IBS", "Diarrhea", "gastrointestinal functional disorder", "IBS-D"] | null | [
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},
"state": "Alabama"
},
{
"city": "Huntsville",
"country": "United States",
"facility": null,
"geoPoint": {
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"state": "Alabama"
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{
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},
"state": "California"
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{
"city": "Riverside",
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"state": "California"
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{
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"geoPoint": {
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"state": "California"
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{
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{
"city": "Hollywood",
"country": "United States",
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"geoPoint": {
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},
"state": "Florida"
},
{
"city": "Indianapolis",
"country": "United States",
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"geoPoint": {
"lat": 39.76838,
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},
{
"city": "Arkansas City",
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"geoPoint": {
"lat": 37.06197,
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},
"state": "Kansas"
},
{
"city": "Lexington",
"country": "United States",
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"geoPoint": {
"lat": 37.98869,
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},
"state": "Kentucky"
},
{
"city": "Boston",
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"facility": null,
"geoPoint": {
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},
"state": "Massachusetts"
},
{
"city": "Mexico",
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"geoPoint": {
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"state": "Missouri"
},
{
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"state": "Missouri"
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{
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"geoPoint": {
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"state": "Nebraska"
},
{
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},
{
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"state": "Oklahoma"
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{
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},
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},
{
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"state": "Pennsylvania"
},
{
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"geoPoint": {
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"state": "Tennessee"
},
{
"city": "Memphis",
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"geoPoint": {
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},
"state": "Tennessee"
},
{
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"country": "United States",
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},
"state": "Tennessee"
},
{
"city": "Austin",
"country": "United States",
"facility": null,
"geoPoint": {
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},
"state": "Texas"
},
{
"city": "Lake Jackson",
"country": "United States",
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"geoPoint": {
"lat": 29.03386,
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},
"state": "Texas"
},
{
"city": "Salt Lake City",
"country": "United States",
"facility": null,
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline in average stool form score at 2 weeks",
"timeFrame": "2 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Change from baseline in average score at week 1, week 2: Abdominal pain/discomfort, bloating; satisfaction with bowel habits; weekly stool frequency; percent of days with satisfactory control of bowel urgency; satisfactory relief of overall IBS symptoms",
"timeFrame": "2 weeks"
}
]
} | [
{
"affiliation": null,
"name": "Novartis",
"role": null
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D004194",
"term": "Disease"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D003109",
"term": "Colonic Diseases, Functional"
},
{
"id": "D003108",
"term": "Colonic Diseases"
},
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D012817",
"term": "Signs and Symptoms, Digestive"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Syndrome",
"id": "M16355",
"name": "Syndrome",
"relevance": "HIGH"
},
{
"asFound": "Diarrhea",
"id": "M7159",
"name": "Diarrhea",
"relevance": "HIGH"
},
{
"asFound": "Irritable Bowel Syndrome",
"id": "M25118",
"name": "Irritable Bowel Syndrome",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6336",
"name": "Colonic Diseases",
"relevance": "LOW"
},
{
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"id": "M6337",
"name": "Colonic Diseases, Functional",
"relevance": "LOW"
},
{
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"id": "M10444",
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
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"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
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"id": "M15622",
"name": "Signs and Symptoms, Digestive",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D043183",
"term": "Irritable Bowel Syndrome"
},
{
"id": "D013577",
"term": "Syndrome"
},
{
"id": "D003967",
"term": "Diarrhea"
}
]
} | null | {
"conditions": [
{
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"term": "Irritable Bowel Syndrome"
},
{
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"term": "Syndrome"
},
{
"id": "D003967",
"term": "Diarrhea"
}
],
"interventions": null
} |
NCT05067166 | null | Open-Label Expanded Access for Ebola-Infected Patients to Receive Human MAb Ansuvimab As Therapeutic or for HR PEP | Open-Label, Expanded Access Protocol of a Human Monoclonal Antibody, Ansuvimab (mAb114), Administered As a Therapeutic to Ebola-Infected Patients or As a High-Risk Ebola Post-Exposure Prophylaxis | None | EXPANDED_ACCESS | AVAILABLE | 2021-09-23T00:00:00 | null | null | null | null | null | null | null | ALL | null | The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under an expanded access protocol. Ansuvimab is administered at 50 mg/kg as a single intravenous (IV) infusion | This is an open-label, intermediate-size patient population, expanded access protocol (EAP) of ansuvimab administered once by IV infusion at a dose of about 50 mg/kg (weight-based dosing). Participants will be monitored and assessed daily for safety, including clinical observation, laboratory monitoring, the incidence of adverse events (AEs) and serious adverse events (SAEs) as defined by protocol, including AEs that by clinical judgement are atypical for orthoebolavirus zairense (EBOV) in infected patients, and any AEs that occur during product infusions. PEP participants will be followed to determine outcome following ansuvimab administrations through the study period for EBOV status (positive/negative). Blood will be collected for protocol-specific assessments and RT-PCR evaluation of viral load by available assay. A blood sample for Ebolavirus viral load measurement will be collected before mAb114 administration and at subsequent study time points per the Schedule of Evaluations. Participants will be followed for a period as defined by protocol after the product administration. Survival status for infected patients and follow up for PEP participants for signs/symptoms of EBOV will be recorded as applicable.
Ansuvimab will be provided for expanded access in any EBOV outbreak location as authorized by the applicable Regulatory Authorities and/or Ethics Committee(s). | Inclusion Criteria:
* Male or female with laboratory confirmed (based on local standard of care) EBOV infection or with recent high-risk EBOV exposure as determined by a treating Physician or designee.
* Able to provide proof of identity to the satisfaction of the clinical team
* Able and willing to complete the informed consent process personally, or if the patient is unable to do so, then informed consent completed by a legally-authorized representative according to local laws and regulations.
Exclusion Criteria:
- Any medical condition that, in the opinion of the Treating Physician, would place the patient at an unreasonably increased risk through participation in this treatment protocol. | Ridgeback Biotherapeutics, LP | INDUSTRY | {
"id": "Ansuvimab EAP",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-09-23T00:00:00 | {
"date": "2024-12-17",
"type": "ACTUAL"
} | {
"date": "2021-10-05",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | null | null | [
"Ebola Virus Disease"
] | ["EBANGA", "orthoebolavirus zairense, EBOV", "ansuvimab", "Zaire ebolavirus, EVD", "Compassionate Use", "Ebola"] | null | null | null | null | null | null | [{"pmid": "26000499", "type": "BACKGROUND", "citation": "Bebell LM, Riley LE. Ebola virus disease and Marburg disease in pregnancy: a review and management considerations for filovirus infection. Obstet Gynecol. 2015 Jun;125(6):1293-1298. doi: 10.1097/AOG.0000000000000853."}, {"pmid": "27413095", "type": "BACKGROUND", "citation": "Broadhurst MJ, Brooks TJ, Pollock NR. Diagnosis of Ebola Virus Disease: Past, Present, and Future. Clin Microbiol Rev. 2016 Oct;29(4):773-93. doi: 10.1128/CMR.00003-16."}, {"pmid": "28444452", "type": "BACKGROUND", "citation": "Cherif MS, Koonrungsesomboon N, Kasse D, Cisse SD, Diallo SB, Cherif F, Camara F, Kone A, Avenido EF, Diakite M, Diallo MP, Le Gall E, Cisse M, Karbwang J, Hirayama K. Ebola virus disease in children during the 2014-2015 epidemic in Guinea: a nationwide cohort study. Eur J Pediatr. 2017 Jun;176(6):791-796. doi: 10.1007/s00431-017-2914-z. Epub 2017 Apr 25."}, {"pmid": "26917593", "type": "BACKGROUND", "citation": "Corti D, Misasi J, Mulangu S, Stanley DA, Kanekiyo M, Wollen S, Ploquin A, Doria-Rose NA, Staupe RP, Bailey M, Shi W, Choe M, Marcus H, Thompson EA, Cagigi A, Silacci C, Fernandez-Rodriguez B, Perez L, Sallusto F, Vanzetta F, Agatic G, Cameroni E, Kisalu N, Gordon I, Ledgerwood JE, Mascola JR, Graham BS, Muyembe-Tamfun JJ, Trefry JC, Lanzavecchia A, Sullivan NJ. Protective monotherapy against lethal Ebola virus infection by a potently neutralizing antibody. Science. 2016 Mar 18;351(6279):1339-42. doi: 10.1126/science.aad5224. Epub 2016 Feb 25."}, {"pmid": "29153266", "type": "BACKGROUND", "citation": "Fischer WA 2nd, Vetter P, Bausch DG, Burgess T, Davey RT Jr, Fowler R, Hayden FG, Jahrling PB, Kalil AC, Mayers DL, Mehta AK, Uyeki TM, Jacobs M. Ebola virus disease: an update on post-exposure prophylaxis. Lancet Infect Dis. 2018 Jun;18(6):e183-e192. doi: 10.1016/S1473-3099(17)30677-1. Epub 2017 Nov 15."}, {"pmid": "30686586", "type": "BACKGROUND", "citation": "Gaudinski MR, Coates EE, Novik L, Widge A, Houser KV, Burch E, Holman LA, Gordon IJ, Chen GL, Carter C, Nason M, Sitar S, Yamshchikov G, Berkowitz N, Andrews C, Vazquez S, Laurencot C, Misasi J, Arnold F, Carlton K, Lawlor H, Gall J, Bailer RT, McDermott A, Capparelli E, Koup RA, Mascola JR, Graham BS, Sullivan NJ, Ledgerwood JE; VRC 608 Study team. Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study. Lancet. 2019 Mar 2;393(10174):889-898. doi: 10.1016/S0140-6736(19)30036-4. Epub 2019 Jan 24."}, {"pmid": "26321189", "type": "BACKGROUND", "citation": "Jacobs M, Aarons E, Bhagani S, Buchanan R, Cropley I, Hopkins S, Lester R, Martin D, Marshall N, Mepham S, Warren S, Rodger A. Post-exposure prophylaxis against Ebola virus disease with experimental antiviral agents: a case-series of health-care workers. Lancet Infect Dis. 2015 Nov;15(11):1300-4. doi: 10.1016/S1473-3099(15)00228-5. Epub 2015 Aug 25."}, {"pmid": "31000464", "type": "BACKGROUND", "citation": "Mbala-Kingebeni P, Aziza A, Di Paola N, Wiley MR, Makiala-Mandanda S, Caviness K, Pratt CB, Ladner JT, Kugelman JR, Prieto K, Chitty JA, Larson PA, Beitzel B, Ayouba A, Vidal N, Karhemere S, Diop M, Diagne MM, Faye M, Faye O, Aruna A, Nsio J, Mulangu F, Mukadi D, Mukadi P, Kombe J, Mulumba A, Villabona-Arenas CJ, Pukuta E, Gonzalez J, Bartlett ML, Sozhamannan S, Gross SM, Schroth GP, Tim R, Zhao JJ, Kuhn JH, Diallo B, Yao M, Fall IS, Ndjoloko B, Mossoko M, Lacroix A, Delaporte E, Sanchez-Lockhart M, Sall AA, Muyembe-Tamfum JJ, Peeters M, Palacios G, Ahuka-Mundeke S. Medical countermeasures during the 2018 Ebola virus disease outbreak in the North Kivu and Ituri Provinces of the Democratic Republic of the Congo: a rapid genomic assessment. Lancet Infect Dis. 2019 Jun;19(6):648-657. doi: 10.1016/S1473-3099(19)30118-5. Epub 2019 Apr 15."}, {"pmid": "26917592", "type": "BACKGROUND", "citation": "Misasi J, Gilman MS, Kanekiyo M, Gui M, Cagigi A, Mulangu S, Corti D, Ledgerwood JE, Lanzavecchia A, Cunningham J, Muyembe-Tamfun JJ, Baxa U, Graham BS, Xiang Y, Sullivan NJ, McLellan JS. Structural and molecular basis for Ebola virus neutralization by protective human antibodies. Science. 2016 Mar 18;351(6279):1343-6. doi: 10.1126/science.aad6117. Epub 2016 Feb 25."}, {"pmid": "27676206", "type": "BACKGROUND", "citation": "Moekotte AL, Huson MA, van der Ende AJ, Agnandji ST, Huizenga E, Goorhuis A, Grobusch MP. Monoclonal antibodies for the treatment of Ebola virus disease. Expert Opin Investig Drugs. 2016 Nov;25(11):1325-1335. doi: 10.1080/13543784.2016.1240785. Epub 2016 Oct 8."}, {"pmid": "12941881", "type": "BACKGROUND", "citation": "Sullivan N, Yang ZY, Nabel GJ. Ebola virus pathogenesis: implications for vaccines and therapies. J Virol. 2003 Sep;77(18):9733-7. doi: 10.1128/jvi.77.18.9733-9737.2003. No abstract available."}] | {"versionHolder": "2025-06-18"} | {
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NCT00378066 | null | Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer | A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer | None | INTERVENTIONAL | COMPLETED | 2006-09-18T00:00:00 | null | null | null | [
"PHASE2"
] | 49 | 18 | 70 | ALL | false | The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer. | null | Inclusion Criteria:
* Histologically or cytologically documented colorectal adenocarcinoma
* ECOG performance status of 2 or lower
* Adequate bone marrow function
* Adequate kidney function
* Adequate liver function
* Informed consent
Exclusion Criteria:
* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
* Known allergy to study drugs | Asan Medical Center | OTHER | {
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"type": null
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"affiliation": "Asan Medical Center",
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NCT01115166 | null | Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation | Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation | None | OBSERVATIONAL | COMPLETED | 2010-05-03T00:00:00 | null | null | null | null | 10 | 18 | 90 | ALL | false | In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume. | In many clinical situations, such as extensive surgery, it is of value to determine blood volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are combined with increased morbidity and mortality. In this study we which to use the large variations in hemoglobin during extracorporal to calculate both these variables.
Hemoglobin is measured every 5 minutes during one hour beginning shortly before start of the heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to the quick mix and dilution of the priming fluid from the heart-lung machine with the patients blood.
From the amount of priming fluid and the fall of the hemoglobin, the blood volume can be calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin concentration will in most cases increase as a result of the fluid loss from the vascular space. This increase in combination with the diureses can be used to calculate the intravascular fluid loss to the interstitium during surgery.
Sodium concentration will also be measured in parallel with the hemoglobin concentration.
The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced. | Inclusion Criteria:
* open heart surgery, with extracorporal circulation
* consent to participation | University Hospital, Linkoeping | OTHER | {
"id": "BVECC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-05-03T00:00:00 | {
"date": "2012-10-08",
"type": "ESTIMATED"
} | {
"date": "2010-05-04",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients subjected to open cardiac surgery, with the help of extracorporal circulation. | NON_PROBABILITY_SAMPLE | false | {
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"observationalModel": "COHORT",
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"timePerspective": "PROSPECTIVE"
} | [
"Blood Volume, Extravasation"
] | ["blood volume"] | null | [
{
"city": "Linkoeping",
"country": "Sweden",
"facility": "University Hospital, Thoracic operation ward",
"geoPoint": null,
"state": null
}
] | null | null | {
"other": [
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"description": null,
"measure": "Fluid Extravasation",
"timeFrame": "Two distribution half-times. Approximately 16 minutes."
}
],
"primary": [
{
"description": null,
"measure": "Blood Volume",
"timeFrame": "30 minutes after start of CPB"
}
],
"secondary": [
{
"description": null,
"measure": "Intracellular Edema",
"timeFrame": "30 minutes after CPB"
}
]
} | [
{
"affiliation": "University Hospital, Linköping, Sweden",
"name": "Joachim Zdolsek, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "25141112", "type": "DERIVED", "citation": "Tornudd M, Hahn RG, Zdolsek JH. Fluid distribution kinetics during cardiopulmonary bypass. Clinics (Sao Paulo). 2014 Aug;69(8):535-41. doi: 10.6061/clinics/2014(08)06."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06540066 | null | A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors | A Multicenter, Open-label, Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B3227 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors | None | INTERVENTIONAL | RECRUITING | 2024-08-02T00:00:00 | null | 2027-01-31T00:00:00 | 2027-01-31T00:00:00 | [
"PHASE1"
] | 75 | 18 | null | ALL | false | This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE\[s\]) of BGB-B3227 administered alone and in combination with tislelizumab. | null | Inclusion Criteria:
* Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin-1 (MUC1) expression
* At least 1 measurable lesion per RECIST v1.1
* Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
* Adequate organ function
* Willing to use a highly effective method of birth control
Exclusion Criteria:
* History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)
* History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
* Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune disease or history of autoimmune disease(s) that may relapse
Note: Other protocol defined Inclusion/Exclusion criteria may apply. | BeiGene | INDUSTRY | {
"id": "BGB-B3227-101",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-08-02T00:00:00 | {
"date": "2025-04-13",
"type": "ACTUAL"
} | {
"date": "2024-08-06",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Advanced Cancer",
"Advanced Solid Tumor",
"Metastatic Cancer",
"Metastatic Solid Tumor"
] | ["BGB-B3227", "tislelizumab", "BGB-A317", "advanced solid tumor", "metastatic solid tumor"] | null | [
{
"city": "Los Angeles",
"country": "United States",
"facility": "Usc Norris Comprehensive Cancer Center (Nccc)",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California"
},
{
"city": "Saint Louis",
"country": "United States",
"facility": "Washington University in St Louis",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri"
},
{
"city": "Hackensack",
"country": "United States",
"facility": "Hackensack University Medical Center",
"geoPoint": {
"lat": 40.88593,
"lon": -74.04347
},
"state": "New Jersey"
},
{
"city": "Houston",
"country": "United States",
"facility": "Md Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
},
{
"city": "San Antonio",
"country": "United States",
"facility": "Next Oncology",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas"
},
{
"city": "Beijing",
"country": "China",
"facility": "Cancer Hospital Chinese Academy of Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
},
{
"city": "Beijing",
"country": "China",
"facility": "Beijing Cancer Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
},
{
"city": "Shanghai",
"country": "China",
"facility": "Affiliated Zhongshan Hospital of Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai"
},
{
"city": "Milano",
"country": "Italy",
"facility": "Fondazione Irccs Istituto Nazionale Dei Tumori",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null
},
{
"city": "Milano",
"country": "Italy",
"facility": "Istituto Europeo Di Oncologia",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null
},
{
"city": "Roma",
"country": "Italy",
"facility": "Fondazione Policlinico Universitario Agostino Gemelli",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null
},
{
"city": "Rozzano",
"country": "Italy",
"facility": "Istituto Clinico Humanitas",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)",
"timeFrame": "From first dose of the study drug(s) to 30 days after the last dose or 90 days after last dose of tislelizumab, approximately 9 months"
},
{
"description": null,
"measure": "Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)",
"timeFrame": "Approximately 9 months"
},
{
"description": null,
"measure": "Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-B3227",
"timeFrame": "Approximately 9 months"
},
{
"description": null,
"measure": "Phase 1b: Objective Response Rate (ORR)",
"timeFrame": "From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 12 months"
},
{
"description": null,
"measure": "Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-B3227",
"timeFrame": "Approximately 12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Phase 1a: ORR",
"timeFrame": "From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 6 months"
},
{
"description": null,
"measure": "Phase 1b: Progression-Free Survival (PFS)",
"timeFrame": "From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 12 months"
},
{
"description": null,
"measure": "Phase 1b: Number of Participants with AEs and SAEs",
"timeFrame": "From first dose of the study drug(s) to 30 days after the last dose, or 90 days after last dose of tislelizumab; approximately 12 months"
},
{
"description": null,
"measure": "Phase 1a and 1b: Disease Control Rate (DCR)",
"timeFrame": "From first dose of study treatment drug(s) until confirmed response or stable disease; approximately 6 months for Phase 1a and 12 months for Phase 1b"
},
{
"description": null,
"measure": "Phase 1a and 1b: Duration of Response (DoR)",
"timeFrame": "From confirmed response to disease progression or death; approximately 6 months for Phase 1a and 12 months for Phase 1b"
},
{
"description": null,
"measure": "Phase 1a and 1b: Serum Concentrations of BGB-B3227",
"timeFrame": "From first dose of BGB-B3227 up to 30 days after last dose of BGB-B3227; approximately 6 months for Ph1a and 12 months for Ph1b"
},
{
"description": null,
"measure": "Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BGB-B3227",
"timeFrame": "From first dose of BGB-B3227 up to 30 days after last dose of BGB-B3227; approximately 6 months for Phase 1a and 12 months for Phase 1b"
},
{
"description": null,
"measure": "Phase 1a: Area under the Curve (AUC) of BGB-B3227",
"timeFrame": "Approximately 4 months"
},
{
"description": null,
"measure": "Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-B3227",
"timeFrame": "Approximately 4 months"
},
{
"description": null,
"measure": "Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-B3227",
"timeFrame": "Approximately 4 months"
},
{
"description": null,
"measure": "Phase 1a: Trough concentration (Ctrough) of BGB-B3227",
"timeFrame": "Approximately 4 months"
},
{
"description": null,
"measure": "Phase 1a: Accumulation ratio of BGB-B3227",
"timeFrame": "Approximately 4 months"
},
{
"description": null,
"measure": "Phase 1a: Terminal half-life (t1/2) of BGB-B3227",
"timeFrame": "Approximately 4 months"
}
]
} | [
{
"affiliation": "BeiGene",
"name": "Study Director",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M12307",
"name": "Neoplasm Metastasis",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Closure",
"id": "M137899",
"name": "Tislelizumab",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M1346",
"name": "Antineoplastic Agents, Immunological",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C000707970",
"term": "Tislelizumab"
}
]
} | {
"conditions": [
{
"id": "D009369",
"term": "Neoplasms"
}
],
"interventions": [
{
"id": "C000707970",
"term": "Tislelizumab"
}
]
} |
NCT05037266 | null | Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen | Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen | CoviCompare_J | INTERVENTIONAL | TERMINATED | 2021-09-06T00:00:00 | null | 2022-02-14T00:00:00 | 2024-01-29T00:00:00 | [
"PHASE4"
] | 27 | 18 | null | ALL | true | In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs.
The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. It received a European marketing authorization for all adults, without age limit, on March 11, 2021. Janssen's vaccine is a viral non replicating vector (adenovirus) vaccine targeting the Spike protein of the SARS-CoV-2 virus. It differs from currently available vaccines in that it is a single-dose regimen with significant protection at 28 days post-injection. Monitoring of the durability of the immune response is essential to assess the need for a booster vaccination. Insufficient data are available in the adult population regarding the evolution of the immune response. This point seems to be even more important in the elderly. Indeed, their immune system declines with age, leading to a greater susceptibility to infectious diseases and a weaker response to vaccination. This is called immunosenescence. Vaccination in this population is essential to avoid severe COVID-19 cases, since older people are particularly at risk.
Two CoviCompare studies with two licensed vaccines messenger RNA vaccines (Pfizer, Moderna) are underway to evaluate the immune response to each vaccine according to age.
We propose to conduct a study to evaluate the immunogenicity of the Janssen vaccine in different age groups with long-term follow-up. This will allow determining the need of a booster.
A common battery of in vitro and ex vivo immuno-monitoring tests has been set up to systematically assess the acquisition of humoral and cellular immunity over time over a period of 24 months following vaccination in the CoviCompare project. This trial, part of the CoviCompare project will use the same immunomonitoring set. This will also allow comparison of the immune response to different vaccines in subjects of different age in order to determine in this at risk population the better vaccination schedules.
The only difference between this trial and the other 2 trials of the CoviCompare project is that adults aged 18-45 will not be concerned here, because the adenovirus vaccine is not recommended for this age group in France | In this trial of the Covicompare project, we will therefore evaluate the immune response after Janssen vaccine in subjects aged more than 65 years and 55 to 65 years without a prior COVID-19, following the same immunomonitoring analyses as for the other CoviCompare project trials. | Inclusion Criteria:
* Healthy adults, or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
* Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent.
* Able to comply with study procedures based on Investigator judgement.
* Affiliated to a social security system, (except state medical aid)
Exclusion Criteria:
* Subject is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit (ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms)
* History of documented COVID-19 (PCR+, antigenic test+ or chest CT Scan + or serology SARS-CoV- 2+) prior to the vaccine administration
* Subjects with positive serology to SARS-CoV-2 at the enrolment visit.
* Subjects who already received another anti-SARS-CoV-2-vaccine
* Subjects who received BCG (Bacille Calmette and Guérin vaccine) given within the last year.
* An immediate family member or household member of study staff.
* Use of immunosuppressive drugs like e.g. corticosteroids at a dosage \> 10mg/day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
* Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
* Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection (exception for flu vaccine within 2 weeks).
* History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2- vaccine.
* History of severe allergic event
* Participation in another investigational clinical study within 4 weeks before the enrolment visits or planned before the study completion.
* Known HIV (human immunodeficiency virus), active HCV (Hepatitis C virus) or HBV (Hepatitis B virus) infection
* Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
* History of heparin-induced thrombocytopenia (HIT)
* Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
* The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
* Any condition which in the opinion of the investigator may interfere with the aim of the study
* Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit.
* Woman in childbearing without efficacious contraception (in the opinion of the investigator) for 31 days after treatment
* People under legal protection measure (tutorship, curatorship or safeguard measures) | Centre Hospitalier Universitaire de Saint Etienne | OTHER | {
"id": "21CH135",
"link": null,
"type": null
} | The study was stopped due to lack of inclusions | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-09-06T00:00:00 | {
"date": "2025-02-10",
"type": "ACTUAL"
} | {
"date": "2021-09-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Healthy Volunteers"
] | ["vaccine", "immunity", "immunogenicity", "Janssen vaccine", "COVID-19"] | null | [
{
"city": "Dijon",
"country": "France",
"facility": "Chu de Dijon",
"geoPoint": {
"lat": 47.31667,
"lon": 5.01667
},
"state": null
},
{
"city": "Lille",
"country": "France",
"facility": "Centre Hospitalier Regional Lille",
"geoPoint": {
"lat": 50.63297,
"lon": 3.05858
},
"state": null
},
{
"city": "Marseille",
"country": "France",
"facility": "APHM",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": null
},
{
"city": "Nantes",
"country": "France",
"facility": "Centre Hospitalier Universitaire Nantes",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": null
},
{
"city": "Paris",
"country": "France",
"facility": "Hopital Bichat",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null
},
{
"city": "Paris",
"country": "France",
"facility": "Hopital Cochin",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null
},
{
"city": "Rennes",
"country": "France",
"facility": "Centre Hospitalier Universitaire Rennes",
"geoPoint": {
"lat": 48.11198,
"lon": -1.67429
},
"state": null
},
{
"city": "Rouen",
"country": "France",
"facility": "Chu de Rouen",
"geoPoint": {
"lat": 49.44313,
"lon": 1.09932
},
"state": null
},
{
"city": "Saint-Étienne",
"country": "France",
"facility": "Centre Hospitalier de Saint-Etienne",
"geoPoint": {
"lat": 45.43389,
"lon": 4.39
},
"state": null
},
{
"city": "Tours",
"country": "France",
"facility": "Centre Hospitalier Tours",
"geoPoint": {
"lat": 47.38333,
"lon": 0.68333
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "IgG humoral response to vaccine",
"timeFrame": "Day 29"
}
],
"secondary": [
{
"description": null,
"measure": "IgG humoral response to vaccine",
"timeFrame": "Day 1, Day 29, Day 57, Month 6, Month 12, Month 24"
},
{
"description": null,
"measure": "IgA humoral response to vaccine",
"timeFrame": "Day 1, day 29, Day 57, Month 6, Month 12, Month 24"
},
{
"description": null,
"measure": "IgM humoral response to vaccine",
"timeFrame": "Day 1, day 29, Day 57, Month 6, Month 12, Month 24"
},
{
"description": null,
"measure": "neutralizing antibody humoral response to vaccine",
"timeFrame": "Day 1, day 29, Day 57, Month 6, Month 12, Month 24"
},
{
"description": null,
"measure": "T cells response to vaccine",
"timeFrame": "Day 1, Day 57, Month 6"
},
{
"description": null,
"measure": "Mucosal response to vaccine",
"timeFrame": "Day 1, day 29, Day 57, Month 6, Month 12, Month 24"
},
{
"description": null,
"measure": "B cell response to vaccine",
"timeFrame": "Day 1, Day 57, Month 6"
}
]
} | [
{
"affiliation": "CENTRE HOSPITALIER DE SAINT-ETIENNE",
"name": "ELISABETH BOTELHO-NEVERS, MDPHD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D011024",
"term": "Pneumonia, Viral"
},
{
"id": "D011014",
"term": "Pneumonia"
},
{
"id": "D012141",
"term": "Respiratory Tract Infections"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D014777",
"term": "Virus Diseases"
},
{
"id": "D018352",
"term": "Coronavirus Infections"
},
{
"id": "D003333",
"term": "Coronaviridae Infections"
},
{
"id": "D030341",
"term": "Nidovirales Infections"
},
{
"id": "D012327",
"term": "RNA Virus Infections"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "COVID-19",
"id": "M2561",
"name": "COVID-19",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13904",
"name": "Pneumonia",
"relevance": "LOW"
},
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"asFound": null,
"id": "M13914",
"name": "Pneumonia, Viral",
"relevance": "LOW"
},
{
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"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14978",
"name": "Respiratory Tract Infections",
"relevance": "LOW"
},
{
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"id": "M17522",
"name": "Virus Diseases",
"relevance": "LOW"
},
{
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"id": "M20490",
"name": "Coronavirus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6555",
"name": "Coronaviridae Infections",
"relevance": "LOW"
},
{
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"id": "M23685",
"name": "Nidovirales Infections",
"relevance": "LOW"
},
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"id": "M15149",
"name": "RNA Virus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000086382",
"term": "COVID-19"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M17360",
"name": "Vaccines",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D000086382",
"term": "COVID-19"
}
],
"interventions": []
} |
NCT02598466 | null | Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa | Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa | None | OBSERVATIONAL | COMPLETED | 2015-11-04T00:00:00 | null | null | null | null | 69 | 18 | null | ALL | false | Research question: what are the patterns of patient-reported changes in physical function among adult patients using SC abatacept with moderate to severe RA since commencement of the compassionate use program (CUP). | null | Inclusion Criteria:
* The global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. Only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the CUP | Bristol-Myers Squibb | INDUSTRY | {
"id": "IM101-572",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-11-04T00:00:00 | {
"date": "2016-02-08",
"type": "ESTIMATED"
} | {
"date": "2015-11-06",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Primary care clinic | PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
} | [
"Rheumatoid Arthritis"
] | null | null | null | [
{
"class": "OTHER",
"name": "Hexor, South Africa"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Patterns of change in patient assessments of physical function with scores of the Health Assessment Questionnaire (HAQ) among users of SC Abatacept for RA since the commencement of a CUP in South Africa's private sector",
"timeFrame": "Approximately 2 years"
}
],
"secondary": [
{
"description": null,
"measure": "Demographic characteristics (age, gender, education and population group) of patients",
"timeFrame": "Approximately 2 years"
},
{
"description": null,
"measure": "Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients",
"timeFrame": "Approximately 2 years"
},
{
"description": null,
"measure": "Reasons for discontinuation based on the reasons mentioned in Questionnaire",
"timeFrame": "Approximately 2 years"
},
{
"description": null,
"measure": "Reasons for skipping treatment based on the reasons mentioned in Questionnaire",
"timeFrame": "Approximately 2 years"
},
{
"description": null,
"measure": "Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores",
"timeFrame": "Approximately 2 years"
},
{
"description": null,
"measure": "Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events",
"timeFrame": "Approximately 2 years"
}
]
} | [
{
"affiliation": "Bristol-Myers Squibb",
"name": "Bristol-Myers Squibb",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007592",
"term": "Joint Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D012216",
"term": "Rheumatic Diseases"
},
{
"id": "D003240",
"term": "Connective Tissue Diseases"
},
{
"id": "D001327",
"term": "Autoimmune Diseases"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Arthritis",
"id": "M4476",
"name": "Arthritis",
"relevance": "HIGH"
},
{
"asFound": "Rheumatoid Arthritis",
"id": "M4480",
"name": "Arthritis, Rheumatoid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10621",
"name": "Joint Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
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"id": "M15045",
"name": "Rheumatic Diseases",
"relevance": "LOW"
},
{
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"id": "M6323",
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"relevance": "LOW"
},
{
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"id": "M6464",
"name": "Connective Tissue Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4629",
"name": "Autoimmune Diseases",
"relevance": "LOW"
},
{
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"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001168",
"term": "Arthritis"
},
{
"id": "D001172",
"term": "Arthritis, Rheumatoid"
}
]
} | {
"ancestors": [
{
"id": "D000082082",
"term": "Immune Checkpoint Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D007166",
"term": "Immunosuppressive Agents"
},
{
"id": "D007155",
"term": "Immunologic Factors"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018501",
"term": "Antirheumatic Agents"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "ARhu",
"name": "Antirheumatic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Muscle strength",
"id": "M483",
"name": "Abatacept",
"relevance": "HIGH"
},
{
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"id": "M2342",
"name": "Immune Checkpoint Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M1346",
"name": "Antineoplastic Agents, Immunological",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10212",
"name": "Immunosuppressive Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10201",
"name": "Immunologic Factors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20604",
"name": "Antirheumatic Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000069594",
"term": "Abatacept"
}
]
} | {
"conditions": [
{
"id": "D001168",
"term": "Arthritis"
},
{
"id": "D001172",
"term": "Arthritis, Rheumatoid"
}
],
"interventions": [
{
"id": "D000069594",
"term": "Abatacept"
}
]
} |
NCT03721666 | null | Medical Dispatchers' Perception of Visual Information in Real Out-of-hospital Cardiac Arrest | Medical Dispatchers' Perception of Visual Information in Real Out-of-hospital Cardiac Arrest: A Qualitative Interview Study | None | OBSERVATIONAL | COMPLETED | 2018-10-23T00:00:00 | null | null | null | null | 10 | null | null | ALL | false | Dispatcher-assisted cardiopulmonary resuscitation is a complex, nonvisual procedure that is challenging for the dispatcher. The aim was to explore the medical dispatchers' perception of bystanders' responses and dispatchers' reflections about the added value of visual information in out-of-hospital cardiac arrests (OHCA) situations. | Ten individual interviews with medical dispatchers who had previously handled an emergency call concerning OHCA captured on closed-circuit television (CCTV) were conducted. First, the medical dispatcher listened to the emergency call and described their perception of the scenario. Afterward, the CCTV recording was shown to the dispatcher, who was then interviewed. The interviews were videotaped, and the audio files were transcribed verbatim. Thematic content analysis was conducted. | Inclusion Criteria:
* Emergency Medical dispatchers who had previously handled an emergency call concerning OHCA captured on closed-circuit television (CCTV)
Exclusion Criteria:
* None | Emergency Medical Services, Capital Region, Denmark | OTHER_GOV | {
"id": "F-15035-02-GL",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-10-25T00:00:00 | {
"date": "2018-10-26",
"type": "ACTUAL"
} | {
"date": "2018-10-26",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Emergency Medical dispatchers | NON_PROBABILITY_SAMPLE | true | {
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"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
} | [
"Out-Of-Hospital Cardiac Arrest"
] | ["Dispatcher-assisted cardiopulmonary resuscitation", "Out-Of-Hospital Cardiac Arrest", "Emergency Medical dispatcher"] | null | null | [
{
"class": "INDUSTRY",
"name": "TrygFonden, Denmark"
},
{
"class": "OTHER",
"name": "Danish Heart Foundation"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The added value of visual information to the medical dispatcher in out-of-hospital cardiac arrests (OHCA) situations.",
"timeFrame": "One hour interview with earch of the emergency medical dispathers"
}
],
"secondary": null
} | [
{
"affiliation": "Copenhagen Academy for Medical Education and Simulation",
"name": "Doris Oestergaard",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "Emergency Medical Services, Capital Region, Denmark",
"name": "Freddy K. Lippert",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Cardiac Arrest",
"id": "M9411",
"name": "Heart Arrest",
"relevance": "HIGH"
},
{
"asFound": "Out-of-hospital Cardiac Arrest",
"id": "M29208",
"name": "Out-of-Hospital Cardiac Arrest",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M7796",
"name": "Emergencies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006323",
"term": "Heart Arrest"
},
{
"id": "D058687",
"term": "Out-of-Hospital Cardiac Arrest"
}
]
} | null | {
"conditions": [
{
"id": "D006323",
"term": "Heart Arrest"
},
{
"id": "D058687",
"term": "Out-of-Hospital Cardiac Arrest"
}
],
"interventions": null
} |
NCT05509166 | null | Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health | A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking | EQuIP | INTERVENTIONAL | RECRUITING | 2022-08-17T00:00:00 | null | 2027-06-01T00:00:00 | 2027-06-01T00:00:00 | [
"NA"
] | 450 | 18 | null | ALL | true | The purpose of this 2-arm randomized controlled trial is to assess the efficacy of a 10-session lesbian, gay, bisexual, transgender, and queer (LGBTQ)-affirmative cognitive-behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York, New Jersey and Pennsylvania. The investigators will assess whether the EQuIP (Empowering Queer Identities in Psychotherapy) treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative treatment-as-usual. | The purpose of this study is to assess the efficacy of a 10-session LGBTQ-affirmative cognitive behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York, New Jersey and Pennsylvania. The treatment, EQuIP (Empowering Queer Identities in Psychotherapy), uses a CBT-based transdiagnostic approach to target the common cognitive, affective, and behavioral responses to minority stress that lead to mental and behavioral health disparities for sexual minority women. We will assess in a 2-arm randomized controlled trial (RCT) whether the EQuIP treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative Treatment-As-Usual. The investigators will assess whether psychosocial mechanisms (e.g., emotion dysregulation) mediate reductions in heavy drinking and separately and identify whether EQuIP is differentially efficacious across key demographic factors. | Inclusion Criteria:
1. be 18 years of age or older
2. be fluent in English
3. self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
3) report at ≥ 8 standard drinks/week, on average, in the past 30 days, OR report at least 2 heavy drinking days ( ≥ 4 drinks in one day) in the past 30 days 4) currently experience a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 depression or anxiety disorder (screened initially using a cutoff of ≥ 2 on the Brief Symptom Inventory-4 and further confirmed by diagnostic interview via the DIAMOND) 5) report at least minimum motivation to reduce drinking (measured by the Readiness Ruler) 6) live in New York, New Jersey, and Pennsylvania and planning to stay for at least the next 4 months
Exclusion Criteria:
1. report current mental health treatment ≥1 day/mo
2. report having received any CBT in the past 3 months
3. report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous)
4. need alcohol detoxification indicated by ≥9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
5. exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen
6. exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen
7. be currently legally mandated to attend treatment
8. demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status | Yale University | OTHER | {
"id": "2000033355",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-08-17T00:00:00 | {
"date": "2025-01-03",
"type": "ACTUAL"
} | {
"date": "2022-08-22",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants will be immediately assigned to either condition. Outcome assessors will be masked to study condition.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Heavy Drinking",
"Mental Health Issue"
] | ["LGBTQ", "Cognitive Behavioral Therapy"] | null | [
{
"city": "New York",
"country": "United States",
"facility": "Yale LGBTQ Mental Health Initiative with the Yale School of Public Office",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Institute on Alcohol Abuse and Alcoholism (NIAAA)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in heavy drinking",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
}
],
"secondary": [
{
"description": null,
"measure": "Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Depression Symptom Severity",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Anxiety Symptom Severity",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Overall Depression Severity and Impairment Scale (ODSIS)",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Overall Anxiety Severity and Impairment Scale (OASIS)",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "PTSD symptoms",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Suicidal Ideation",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Mental Health Symptom Presence and Severity",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Alcohol Use",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Effects of Alcohol Use",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Frequency of Alcohol Use",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Alcohol Self-Efficacy",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Drug Use and Drug-Related Problems",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
},
{
"description": null,
"measure": "Cannabis Use and Cannabis-Related Problems",
"timeFrame": "Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up"
}
]
} | [
{
"affiliation": "Yale University",
"name": "John E Pachankis, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Columbia University",
"name": "Tonda Hughes, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "27239096", "type": "BACKGROUND", "citation": "Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14."}, {"pmid": "8889403", "type": "BACKGROUND", "citation": "Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x."}, {"pmid": null, "type": "BACKGROUND", "citation": "Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385-401."}, {"pmid": "30239466", "type": "BACKGROUND", "citation": "Fong TG, Inouye SK. The Telephone Interview for Cognitive Status. Cogn Behav Neurol. 2018 Sep;31(3):156-157. doi: 10.1097/WNN.0000000000000165. No abstract available."}, {"pmid": "19016462", "type": "BACKGROUND", "citation": "Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471."}, {"pmid": "9881538", "type": "BACKGROUND", "citation": "Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57."}, {"pmid": "29034525", "type": "BACKGROUND", "citation": "Shankman SA, Funkhouser CJ, Klein DN, Davila J, Lerner D, Hee D. Reliability and validity of severity dimensions of psychopathology assessed using the Structured Clinical Interview for DSM-5 (SCID). Int J Methods Psychiatr Res. 2018 Mar;27(1):e1590. doi: 10.1002/mpr.1590. Epub 2017 Oct 16."}, {"pmid": "2597811", "type": "BACKGROUND", "citation": "Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x."}, {"pmid": "21767028", "type": "BACKGROUND", "citation": "Maisto SA, Krenek M, Chung T, Martin CS, Clark D, Cornelius J. A comparison of the concurrent and predictive validity of three measures of readiness to change alcohol use in a clinical sample of adolescents. Psychol Assess. 2011 Dec;23(4):983-94. doi: 10.1037/a0024136. Epub 2011 Jul 18."}, {"pmid": "28019652", "type": "BACKGROUND", "citation": "Witkiewitz K, Hallgren KA, Kranzler HR, Mann KF, Hasin DS, Falk DE, Litten RZ, O'Malley SS, Anton RF. Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels. Alcohol Clin Exp Res. 2017 Jan;41(1):179-186. doi: 10.1111/acer.13272. Epub 2016 Dec 26."}] | {"versionHolder": "2025-06-18"} | null | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M3777",
"name": "Ethanol",
"relevance": "LOW"
}
],
"meshes": null
} | {
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"interventions": []
} |
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