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#Study Description
Brief Summary
A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.
Detailed Description
A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. The application force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). The different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.
#Intervention
- OTHER : Microneedle
- A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.
- OTHER : Hypodermic needle
- 30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
- Other Names :
- positive control
- OTHER : Flat patch
- A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
- Other Names :
- negative control | #Eligibility Criteria:
Inclusion Criteria:
* Healthy male
Exclusion Criteria:
* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03855397 | {
"brief_title": "Pain and Safety of Microneedles in Oral Cavity",
"conditions": [
"Oral Cavity Disease"
],
"interventions": [
"Other: Microneedle",
"Other: Flat patch",
"Other: Hypodermic needle"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03855397",
"official_title": "Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-25",
"study_completion_date(actual)": "2018-12-16",
"study_start_date(actual)": "2018-01-16"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-26",
"last_updated_that_met_qc_criteria": "2019-02-25",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-26",
"first_submitted": "2019-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).
Detailed Description
The study will occur in three phases.
In session 1 of Phase 1, participants will engage in ad libitum smoking session of one's preferred cigarette brand (menthol or non-menthol). In session 2, participants will take several puffs each of a commercially available menthol and non-menthol cigarette (i.e., Camel Crush) and complete a complete a series of pre-post smoking questionnaires, and in Session 3 participants will complete a computerized task to measure perceptions of cigarette smoking. For the computerized task, participants will be able to 'win' points toward earning puffs of a cigarette and will be able to smoke puffs earned. Participants will be asked to abstain from smoking for at least 12 hours before each in-person visit.
Phase 2 participants will engage in 14 days of surveys they will complete on their cell to measure different aspects of smoking behavior. These surveys will happen twice a day at random times.
For phase 3, participants will complete an assessment of smoking behavior and related factors 6-months after the baseline assessment either in-person, in the laboratory, or via telephone or online (if in-person follow-up is not viable).
The order in which phases occur differed was a result of COVID-19 restrictions on data collection. For some participants, they started EMA first and then began laboratory data collection when in-person was allowed. For others, they started laboratory data collection when COVID restrictions were lifted. Thus, the participant flow may appear unbalanced.
#Intervention
- OTHER : Cigarette flavor type
- Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.
- Other Names :
- Experimental cigarette smoking | #Eligibility Criteria:
Inclusion Criteria:
* Ages 18 <= age <= 26
* Currently smoke cigarettes 'everyday' or 'somedays'
* A strong preference for menthol or non-menthol cigarettes
* able to read and understand the consent form
* willingness to abstain from nicotine or tobacco products for at least 12 hours prior to smoking sessions
Exclusion Criteria:
* Current use of nicotine replacement therapy
* Pregnant or planning to become pregnant; or breastfeeding
* self-reported diagnosis of lung disease, including asthma, cystic fibrosis, or chronic obstructive pulmonary disease; or
* self-reported history of cardiac event or distress within the past 3-months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 26 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03953508 | {
"brief_title": "Perceptions of Cigarette Smoking in Young Adults",
"conditions": [
"Smoking, Cigarette"
],
"interventions": [
"Other: Cigarette flavor type"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03953508",
"official_title": "Menthol and Non-Menthol Cigarette Smoking in Young Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-01-31",
"study_start_date(actual)": "2020-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-16",
"last_updated_that_met_qc_criteria": "2019-05-14",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-16",
"first_submitted": "2019-05-13",
"first_submitted_that_met_qc_criteria": "2024-10-30"
}
}
} |
#Study Description
Brief Summary
Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.
Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.
| #Eligibility Criteria:
Inclusion Criteria:
* patient hospitalized at the Amiens CHU in a COVID-19 unit
* patient seen as outpatient in the area of infectious pathologies for COVID-19 infection
Exclusion Criteria:
* Patients under 18
* patients under guardianship or curators
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04386551 | {
"brief_title": "Detection of COVID-19 in Saliva Collection",
"conditions": [
"Sars-CoV2",
"RT-PCR",
"Saliva Collection",
"Nasopharyngeal Sample"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04386551",
"official_title": "Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-05",
"study_completion_date(actual)": "2020-08-05",
"study_start_date(actual)": "2020-05-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-11",
"last_updated_that_met_qc_criteria": "2020-05-11",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-13",
"first_submitted": "2020-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this research study is to identify factors and genes (the DNA material that determines the makeup of the human body) that may be associated with how children respond to pain medication. Specifically, the investigators want to study factors that may be associated with pain sensitivity, morphine requirement after surgery and side-effects from morphine and other pain medications. The investigators expect that the information obtained in this research study will help us to develop more effective, safe, and tailored treatment options in the future.
Detailed Description
Opioid drugs as a group have withstood the test of time in their ability to relieve pain. Morphine is the most frequently used 'gold standard' opioid for managing surgical pain. Like other opioids, morphine has a narrow therapeutic index and a large inter-patient variability in response. Certain genetic and non-genetic factors are believed to be responsible for variations in analgesic responses and side effects with morphine. Genetic factors determining an individual's pain sensitivity and regulating morphine's pharmacokinetics (transporters) and pharmacodynamics (receptors and signal transduction elements) are likely contributors to such variability. Frequent variations in analgesic response are unfortunately clinically significant with inadequate pain relief at one end of the spectrum of responses and major side effects including potentially fatal respiratory depression due to relative overdosing at the other end. Much of the inter-individual variability in response to a dose of morphine following surgical procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the genes that encode proteins involved in pain perception, opioid transport and opioid receptor signaling. The genetic variants of mu opioid receptor (OPRM1), Catechol-O-methyltransferase (COMT), the Multi Drug Resistance Transport protein gene ABC B1, have been associated in small adult studies with varying levels of pain sensitivity, analgesic response to opioids and susceptibility to serious side-effects of opioids such as respiratory depression, sedation and vomiting. Effective and safe acute postoperative pain relief in a subset of children is clinically difficult due to frequent clinical variations in perceptions of pain and responses to opioids. To the investigator's knowledge, there is no other study attempting to individualize perioperative analgesia in children. The investigator's long term goal is to identify factors that modify pain sensitivity and responses to morphine in order to develop more effective, safe and tailored therapies. The overall objective of this application is to evaluate the contribution of individual and combined affects of genetic polymorphisms in OPRM1, COMT and ABC B1 genes and their association with postoperative pain relief and adverse effects with morphine. The investigator's central hypothesis is that specific genetic polymorphisms in genes involved in pain perception, opioid transport and opioid receptor signaling pathways contribute significantly to pain sensitivity, morphine consumption, and morphine's side-effects in children.
This study will also explore a set of other important SNPs that might influence pain perception and responses to morphine in children. The data will be analyzed looking at pain scores, morphine doses, incidence of side-effects of morphine including respiratory depression, sedation, vomiting and itching.
| #Eligibility Criteria:
Inclusion Criteria:
* children 6 <= age <= 17 years
* ASA physical status 1 and 2
* scheduled for tonsillectomy (T) and tonsillectomy and adenoidectomy (T and A)
* Children with obstructive sleep apnea will also be included.
Exclusion Criteria:
* children with developmental delay
* liver and renal diseases,
* preoperative pain requiring analgesics (e.g. chronic tonsillitis).
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT01495611 | {
"brief_title": "Multicenter Perioperative Opioid Pharmacogenetic Study",
"conditions": [
"Pain"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01495611",
"official_title": "Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children: A Multicenter Pharmacogenetic Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2017-04-30",
"study_start_date(actual)": "2010-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-31",
"last_updated_that_met_qc_criteria": "2011-12-16",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-20",
"first_submitted": "2011-12-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is imperative to increase self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a well established standard program and a questionnaire-only group. Rehabilitation patients will be treated psychologically and followed up over 18 months. The computerized expert system is expected to help patients better than the standard program. Both interventions are hypothesized to improve self-management competencies over and above the rehabilitation treatment (i.e., questionnaire-only group).
Detailed Description
An experimental study with three groups is planned over a time period of 18 months. Patients in the intervention group receive an interactive, computerized expert system (Intervention Group, IG). Patients in the Active Control Group (ACG) get an interactive computerized standard program. This standard program has already been proven to be effective but which does not tailor treatment components to the individual needs of the patients. Patients in the Passive Control Group (PCG) are asked to answer the questionnaires only. Rehabilitation patients (N = 1000) will be recruited in three rehabilitation clinics and followed up over six measurement points: t1 and t2 with computer interventions during their rehabilitation stay; t3 and t4 with booster-sessions via telephone (6 weeks and 6 months after admission from rehabilitation). Furthermore, patients will be contacted at t5 per mail with motivational material (12 months after admission) and at t6 again per mail (only questionnaire, 18 months after admission).
The hypotheses are: In comparison to the PCG, both the IG and the ACG are expected to have a higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be less likely to relapse into previous unhealthy routines. Also, IG and ACG will be healthier as well as they will report more quality of life and rehabilitation satisfaction. In comparison to ACG, the IG is hypothesized to be more effective than the ACG regarding motivation, behavior and social-cognitive predictors of behavior. Moreover, the interventions (ACG and IG) are supposed to be equally effective for cardiac and orthopedic, as well as out-patient and stationary treated rehabilitation patients. After successful evaluation and some adoptions the intervention will be implemented as a self-help program in all eligible rehabilitation clinics and in the internet.
#Intervention
- BEHAVIORAL : Intervention Group (IG)
- patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
- Other Names :
- FaBA
- BEHAVIORAL : Active Control Group (ACG)
- Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, W. \& Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.)
- Other Names :
- MoVo | #Eligibility Criteria:
Inclusion Criteria:
* to be capable of exercising on their own at the minimum level recommended by the according rehabilitation clinic
* able to fill out a questionnaire (no illiteracy)
* adequate German language ability
Exclusion Criteria:
* the participant not be of age
* severe cognitive deficits
* visual impairments (patients have to read at the PC)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00979719 | {
"brief_title": "Improvement of a Physically Active Lifestyle",
"conditions": [
"Pain",
"Osteoarthritis",
"Rheumatoid Arthritis",
"Heart Diseases",
"Diabetes Mellitus, Type 2",
"Behavior",
"Motivation"
],
"interventions": [
"Behavioral: Intervention Group (IG)",
"Behavioral: Active Control Group (ACG)"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00979719",
"official_title": "Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2012-09",
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-11-15",
"last_updated_that_met_qc_criteria": "2009-09-17",
"last_verified": "2011-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-18",
"first_submitted": "2009-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the appearance of forehead wrinkles.
#Intervention
- DEVICE : iovera | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 65
* Subject has a forehead wrinkle rating by the Investigator/designee of at least '2' in full contraction on the 5-point Wrinkle Scale (5WS) as rated by the study Investigator, which, upon physical manipulation/separation of the skin, demonstrates a reduction in wrinkle severity
* Subject has a glabella wrinkle rating by the Investigator/designee of at least '1' in full contraction on the 5-point Glabella Scale (5GS)
* Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5-point Wrinkle Scale (5WS) as rated by the Investigator/designee
* Subject has Fitzpatrick Skin Type I, II, III, or IV (see Error! Reference source not found.)
* Subject understands and commits to comply with study requirements
* Subject is in good general health and free of any condition that could impair either complete study participation or evaluation of forehead wrinkle rating
* Subject is willing and able to give written informed consent
Exclusion Criteria:
* Subject has a clotting disorder or coagulopathy that requires regular use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidogrel, etc.)
* Subject has used aspirin or any non-steroidal anti-inflammatory drugs (NSAIDs) within seven (7) days prior to screening or use of the device
* Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
* Subject has undergone another surgical cosmetic procedure or botulinum toxin injection at or above the level of the zygoma (cheekbones) within the past six (6) months prior to screening
* Subject has a resting wrinkle score of '3' or higher on the 5WS as rated by the study Investigator
* Subject actively elevates forehead during rest
* Subject has been treated with any fillers listed in Error! Reference source not found. in the temple or forehead area in the time intervals specified prior to screening
* Subject has any of the following conditions:
* Dermatochalasis with <2mm lid margin when looking straight ahead
* Excessive skin laxity/skin aging
* Asymmetry in the upper face
* History of facial nerve palsy
* Eyebrow or eyelid ptosis
* History of neuromuscular disorder
* Chronic dry eye symptoms
* Allergy or intolerance to local anesthetic agents (e.g., Lidocaine)
* Use of narcotic medications for a chronic pain condition
* Other clinically significant local skin condition (e.g., skin infection) at target treatment site
* Any physical or psychiatric condition that in the Investigator's opinion would prevent treatment or adequate study participation
* Chronic medical condition that in the Investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.)
* Known diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria
* Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the Investigator
* Fitzpatrick Skin Type V or VI (see Table 3)
* Subject currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of wrinkle treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01950065 | {
"brief_title": "Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles",
"conditions": [
"Forehead Wrinkles"
],
"interventions": [
"Device: iovera"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01950065",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2013-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-24",
"last_updated_that_met_qc_criteria": "2013-09-20",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-25",
"first_submitted": "2013-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.
#Intervention
- DRUG : MK0557 | #Eligibility Criteria:
Inclusion Criteria:
* Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.
Exclusion Criteria:
* Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00092872 | {
"brief_title": "A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)",
"conditions": [
"Obesity"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00092872",
"official_title": "A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-02",
"study_completion_date(actual)": "2005-02",
"study_start_date(actual)": "2003-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-30",
"last_updated_that_met_qc_criteria": "2004-09-27",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2004-09-28",
"first_submitted": "2004-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland. As humans grow older the levels of DHEA naturally decrease. Low levels of DHEA have been associated with a variety of harmful effects, including increased heart disease, decreased immune system function, decreased bone density (osteoporosis), high cholesterol, and increased fat to muscle ratio.
Blood levels of DHEA and its sulfate form, DHEA-S, begin dropping when humans are in their 20's. By the time humans are in their 40's and 50's, levels of DHEA and DHEA-S levels are at 50% of their peak. Previous studies have shown that levels of these hormones are associated with feelings of 'well-being' and enjoyment of 'leisure' activities.
In this study researchers are interested in the effects on mood and behavior of DHEA in men and women with mid-life related mood disorders. Specifically, researchers would like to find out if increasing levels of DHEA will lessen the symptoms associated with these disorders.
Detailed Description
Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland in concentrations that decrease with age. In humans low DHEA levels have been associated with a variety of adverse biological consequences, including increased cardiovascular disease, decreased immune function, decreased bone density, negative lipid profile and an increased fat to muscle ratio.
In this study, we investigate the effects on mood and behavior of DHEA in men and women with midlife-related mood disorders in a double-blind, placebo-controlled, crossover trial. We specifically ask whether increasing DHEA levels will mitigate any or all of the neurasthenia-like symptoms characteristic of these disorders.
#Intervention
- DRUG : Dehydroepiandrosterone | #Eligibility Criteria:
INCLUSION CRITERIA:
Subjects for this study will meet the following criteria:
A current episode of minor (meeting 3 <= age <= 4 criterion symptoms) or major depression of moderate severity or less on the SCID severity scale for depression and not meeting DSM-IV criteria symptom #9 (suicide) as determined by the administration of the minor depression module of the SADS-L and the Structured Clinical Interview for DSM-IV. Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the Beck Depression Inventory (BDI) or the Center for Epidemiologic Studies - Depression (CES-D) Scale during at least three of the four clinic visits during the two month screening phase. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria #9 (suicide), or anyone requiring immediate treatment after clinical assessment, functional impairment ratings of five or six for more than seven consecutive days on daily ratings;
Age 40 <= age <= 65;
No prior hormonal therapy for the treatment of menopause/andropause-related mood or physical symptoms within the last six months;
In good medical health.
EXCLUSION CRITERIA:
The following conditions will constitute contradictions to treatment with DHEA and will preclude a subject's participation in this protocol:
Positive (threshold) response to SCID major depression section item #9, suicidal ideation;
Anyone requiring immediate treatment after clinical assessment;
Severity ratings greater than moderate on the SCID;
Functional impairment ratings of five or six for more than seven consecutive days on daily ratings
Current treatment with antidepressant medications
Prostate nodules or cancer
Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding
History of ischemic cardiac disease
Renal disease
Hepatic dysfunction
Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer
Women with a history of uterine cancer
Patients with a known hypersensitivity to DHEA or other androgens
Pregnant women
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00001487 | {
"brief_title": "Treatment of Mid-Life-Related Mood Disorders",
"conditions": [
"Depressive Disorder",
"Mood Disorder"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00001487",
"official_title": "Dehydroepiandrosterone Treatment of Mid-Life-Related Mood Disorders in Women and Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-04",
"study_start_date(actual)": "1995-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-03-04",
"last_updated_that_met_qc_criteria": "1999-11-03",
"last_verified": "2004-04"
},
"study_registration_dates": {
"first_posted(estimated)": "1999-11-04",
"first_submitted": "1999-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
#Intervention
- DRUG : TNX-102 SL
- Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
- Other Names :
- Low dose cyclobenzaprine sublingual tablets
- DRUG : Placebo SL Tablet
- Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
- Other Names :
- Placebo sublingual tablets | #Eligibility Criteria:
Inclusion Criteria:
* The patient is male or female 18 <= age <= 65 of age, inclusive.
* The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
* The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.
Exclusion Criteria:
* History of or evidence for a diagnosis of borderline personality disorder (BPD).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04508621 | {
"brief_title": "A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia",
"conditions": [
"Fibromyalgia"
],
"interventions": [
"Drug: Placebo SL Tablet",
"Drug: TNX-102 SL"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04508621",
"official_title": "A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-01",
"study_completion_date(actual)": "2021-11-01",
"study_start_date(actual)": "2020-07-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-18",
"last_updated_that_met_qc_criteria": "2020-08-07",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-11",
"first_submitted": "2020-08-07",
"first_submitted_that_met_qc_criteria": "2022-11-07"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands.
#Intervention
- DRUG : Vascana (0.9% nitroglycerin cream)
- Study drug administered topically
- DRUG : Vehicle Cream (placebo)
- Vehicle administered topically | #Eligibility Criteria:
Inclusion Criteria:
* Provide written consent prior to any study-specific evaluation
* Males and females aged 18 years to 75 years, inclusive
* A clinical diagnosis of secondary Raynaud's Phenomenon (defined as Raynaud's Phenomenon (RP) significant enough to cause a patient to modify daily behavior) as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers, or by such an event observed by the study physician and a diagnosis of a disease state known to be associated with RP. Secondary RP may be due to scleroderma, systemic lupus erythematosus, mixed connective tissue disease, or other connective tissue diseases
* Agree to apply the study drug to their fingers as specified in the protocol
* Agree to the controlled cold exposures as described in the protocol
* Willing to discontinue current vasodilator therapies used specifically for the treatment of Raynaud's
* Agree not to use any other investigational medications or approved or unapproved therapies to treat RP and its symptoms while participating in this study. Such medications include, but are not limited to: other dosages forms of nitroglycerin, eg, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, fluoxetine, pregabalin, and verapamil. Use of phosphodiesterase 5 inhibitors (eg, sildenafil, tadalafil, vardenafil) is excluded unless being used intermittently for male erectile dysfunction and not taken within 48 hours of scheduled study drug dosing
* Negative urine pregnancy test for women of child-bearing potential prior to the first study treatment and who agree to use effective contraception throughout the study
* Able to comply with all study requirements
Exclusion Criteria:
* Past history of RP attacks of sufficient severity as to require inpatient hospitalization
* Presence of an active digital ulcer defined as a painful ulcer with visible depth and loss of epithelialization. Ulcers covered with eschar wherein depth and epithelialization cannot be judged are said to be 'indeterminant' and are not exclusionary.
* Raynaud's Phenomenon secondary to non-connective tissue disorders including thromboangiitis obliterans (Buerger's disease), hemorheologic disorders, major arterial occlusive disease, past exposure to vasopathic agents (including vinblastine, cis platinum, and bleomycin), ongoing therapy with vasoconstrictive agents (eg, beta-blockers), and past frostbite injury amongst others. Subjects with hepatitis C should also be excluded.
* Patients diagnosed with pulmonary arterial hypertension requiring specific therapy.
* Concurrently using any nitrate medication or medications known to interact with nitroglycerin such as sildenafil, and other treatments for erectile dysfunction beyond screening. Subjects may participate in the study once these drugs have been discontinued for at least 5 half-lives
* Concurrently using any medication or device which might interfere with the study medication (including RP therapies, drugs used for hypertension, arrhythmia, depression, and pain), specifically calcium channel blockers and the compounds listed in prohibited concomitant medications beyond screening, unless such medication is required for a condition other than Raynaud's. Subjects may participate in the study once these drugs have been discontinued for at least 5 half-lives.
* Known allergy to nitroglycerin or common topical cream ingredients
* History of migraine, cluster, or vascular headaches, or chronic pain (defined as pain of 3-hour duration or longer on a daily basis) with greater intensity than the pain associated with RP or other chronic pain condition in their fingers
* Any unstable medical problem or any current medical condition that, in the judgment of the investigator, would contraindicate the administration of the study medication, interfere with the study evaluations, or interfere with the subject's ability to comply with the study protocol
* Cognitive or language difficulties that would impair completion of the symptom assessment instruments
* Within the past 3 months, have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension (defined as subjects not being treated medically to control these conditions)
* Participated in a study of any investigational drug within 4 weeks prior to visit 1
* Screening laboratory values are 20% or more from the upper or lower limit of normal and that are considered to be clinically significant to the investigator
* Had major abdominal, thoracic, or vascular surgery within 6 months of visit 1
* Pregnant or nursing women
* Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period
* History of relevant drug and/or food allergies that resulted in a systemic reaction that required medical treatment
* History of alcohol abuse or drug addiction which in the estimation of the principal investigator would affect the subjects ability to participate in the study
* Consumption of alcohol on day before a visit and day of the visit.
* Consumption of two or more alcoholic beverages on a daily basis.
* Use of tobacco products of any type and at any level in the preceding 6 months and for the duration of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02688270 | {
"brief_title": "Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon",
"conditions": [
"Raynaud's Phenomenon Secondary to Connective Tissue Disease"
],
"interventions": [
"Drug: Vehicle Cream (placebo)",
"Drug: Vascana (0.9% nitroglycerin cream)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02688270",
"official_title": "A Double-blinded Crossover Study of Topical Formulation of Nitroglycerine, Vascana®, Versus Matching Vehicle in the Subjective and Physiologic Responses to Controlled Cold Challenge in Subjects With Raynaud's Phenomenon (RP) Secondary to Connective Tissue Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2016-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-02",
"last_updated_that_met_qc_criteria": "2016-02-22",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-02-23",
"first_submitted": "2016-02-18",
"first_submitted_that_met_qc_criteria": "2022-10-11"
}
}
} |
#Study Description
Brief Summary
This pilot work will determine the feasibility of tDCS intervention as an effective adjunct intervention to PT aimed at improving gait, balance, and mobility in older adults at risk of falling.
Detailed Description
Falls are correlated with both physical and cognitive declines in older adults. Recurrent fallers and those at high risk of falls are often referred to physical therapy (PT) for gait and balance training. Although physical therapists are aware of the importance of cortical control of gait and balance, there is no available tool to directly yet non-invasively intervene brain in the clinical setting.
Transcranial direct current stimulation (tDCS) is a noninvasive and safe mean of modulating the excitability of specific brain regions and their connected neural networks. Our group and others have shown that tDCS intervention designed to facilitate the excitability of the left dorsal lateral prefrontal cortex (DLPFC) improves numerous aspects of executive function related to mobility in older adults. However, no studies to date have assessed the feasibility and effectiveness of applying tDCS as an adjunct to PT to improve gait and balance within the geriatric rehabilitation setting.
This study aims to 1) assess the feasibility of implementing tDCS prior to each of their first 10 PT sessions, and 2) gather estimates of variability in outcomes related to gait, balance, cognition, and quality of life over time within older adults referred to PT for recurrent falls.
#Intervention
- OTHER : Real tDCS and Physical Therapy
- The participant will receive 20-minute sessions of real tDCS before each physical therapy visit for up to 10 combined sessions, over approximately 6 weeks.
- Other Names :
- Real tDCS + PT
- OTHER : Sham stimulation and Physical Therapy
- The participant will receive 20-minute sessions of sham stimulation before each physical therapy visit for up to 10 combined sessions, over approximately 6 weeks.
- Other Names :
- Sham stimulation + PT | #Eligibility Criteria:
Inclusion Criteria:
* Ages 65 years and above
* Admitted to Physical Therapy for gait and balance training due to the high risk of falls
Exclusion Criteria:
* Inability to stand or walk unassisted for 60 seconds
* Severe cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score < 18
* Any unstable medical condition
* Any unstable psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
* Active cancer for which chemo/radiation therapy id being received
* Significant vision and hearing problems that cannot be corrected with visual and hearing aids
* Contraindications to tDCS, including seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, implanted medical devices, or the presence of dermatological conditions such as eczema on the scalp.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT04181658 | {
"brief_title": "The Brain Stimulation and Physical Therapy Study",
"conditions": [
"Fall",
"Gait, Unsteady",
"Aging",
"Accidental Fall"
],
"interventions": [
"Other: Sham stimulation and Physical Therapy",
"Other: Real tDCS and Physical Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04181658",
"official_title": "The Feasibility and Effectiveness of Combining Non-invasive Brain Stimulation and Physical Therapy to Improve Gait and Balance in Older Adults at Risk of Falling",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-01",
"study_completion_date(actual)": "2021-05-01",
"study_start_date(actual)": "2019-10-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-05",
"last_updated_that_met_qc_criteria": "2019-11-26",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-29",
"first_submitted": "2019-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.
#Intervention
- DEVICE : Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
- A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan. | #Eligibility Criteria:
Inclusion Criteria:
* Subjects who are 12 <= age <= 18 of age
* Subjects who have signed the Informed Consent Form
* Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures
* For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation
* Subjects with planned pressure monitoring with an arterial line
Exclusion Criteria:
* Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy);
* Subjects with contraindications for Arterial Line Placement;
* Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease).
* Subjects with a physical site area too limited for proper Sensor placement
* Subjects with finger size less than the smallest finger cuff size
* Documented >= moderate pulmonary hypertension (PAPm > 25mmHg, PVRI > 3.0 WUxm2)
* Presence of intracardiac shunting (i.e., ASD, VSD)
* Aorto-pulmonary collaterals
* >= Moderate tricuspid regurgitation, per echocardiogram criteria
* > Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria
* Persistent cardiac arrythmias during the cardiac catheterization period (> 3min)
* Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04465370 | {
"brief_title": "Pediatric Cardiac Output Monitoring Observational Study",
"conditions": [
"Pediatric ALL"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04465370",
"official_title": "A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-05",
"study_completion_date(actual)": "2023-01-05",
"study_start_date(actual)": "2020-09-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-18",
"last_updated_that_met_qc_criteria": "2020-07-07",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-10",
"first_submitted": "2020-07-07",
"first_submitted_that_met_qc_criteria": "2024-09-13"
}
}
} |
#Study Description
Brief Summary
Participants with chronic or recurrent headache, unrelated to any known pathology or disease, will be randomly assigned to one of four interventions: Osteopathic manipulation of the body other than the head, osteopathic manipulation of the head, osteopathic manipulation of the head and rest of the body, or light touch on the head only but no manipulation. Measurements of heart rate and blood pressure variability, peripheral blood flow, and behavioral changes, such as mood, pain duration, intensity and frequency will be assessed.
Detailed Description
Sixty subjects will be recruited to participate in the study via word of mouth and mass email notification of employees and students at Western University of Health Sciences in Pomona, CA.
Patients will be randomly assigned to 1 of 4 groups for a specific Osteopathic Manipulative Treatment (OMT): Compression of Fourth Ventricle (CV4) only, CV4 and subject appropriate OMT, subject appropriate OMT only (no CV4), and sham (touch only). There will be 8 subjects per OMT group, making it 24 subjects altogether assigned to one of the three OMT groups, and 24 sham subjects.
Power analysis for determination of sample sizes: The investigators have no data on preliminary studies of the effect of OMT on chronic headaches, and there is only one study of the immediate effect on tension type headache patients after CV4, so power analysis is a rough estimate at this point for the one week headache symptom evaluation post OMT. From preliminary studies in this lab, the investigators can expect for 'CV4 only' 80% of participants to have significant still point objective response vs sham treatment which the investigators expect will significantly effect about 10% of the participants. There needs to be at least 16 subjects in each of two groups assessing this outcome measure, so 16 receiving CV4 and 16 sham to detect the 70% difference in still point measure. To detect differences between any OMT and sham, since there are three groups receiving OMT of some type, when the investigators consider how many in each of these three groups vs the sham group, the investigators figured 8 per each OMT group, of which 2 are CV4 (thus 16 get CV4), making it 24 subjects in the combined OMT groups. Therefore, the investigators need 24 sham subjects to make it equal numbers for balanced analysis (OMT vs sham), and to detect differences in the OMT interventions and sham interventions. Considering a possibility of 25%, or 12 subjects, not responding to the follow up survey at one week, the investigators figured recruitment of 60 subjects would ensure the investigators would have enough to make our calculations and be able to determine if there are significant differences between groups.
The investigators have no preliminary studies on the effect of OMT or sham on mood in patient with headaches, so this part of the study is an exploratory assessment and sample size calculations will be able to be performed with the data gathered from this study for subsequent studies.
#Intervention
- PROCEDURE : Osteopathic Manipulative Treatment (OMT)
- O OMT applied to areas of somatic dysfunction other than the head region.
- Other Names :
- headache; OMT; somatic dysfunction ICD-9 code 739.0
- PROCEDURE : Light touch
- Light touch applied to head region for 10 minutes with patient supine at rest.
- Other Names :
- placebo; sham | #Eligibility Criteria:
Inclusion Criteria:
* chronic or recurrent headaches at least as often as one time per week
Exclusion Criteria:
* recent head trauma
* brain disease or pathology
* seizure disorder
* using beta or alpha blocker medications
* allergy to sticky tape used to affix leads to skin
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01332864 | {
"brief_title": "Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache",
"conditions": [
"Headache",
"Cephalgia",
"Migraine"
],
"interventions": [
"Procedure: Light touch",
"Procedure: Osteopathic Manipulative Treatment (OMT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01332864",
"official_title": "Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2011-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-13",
"last_updated_that_met_qc_criteria": "2011-04-08",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-11",
"first_submitted": "2011-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
With the aging population, the needs for total joint replacement are increasing. A successful recovery after joint replacement surgery depends on timely and active physical therapy in the early postoperative period. To accomplish it, an integrated care model based on clinical pathway has been implemented to secure the medical quality and patient safety. Recently, the emerging technology of electronic medical record and medical informatics have made challenges to the traditional health care models such as the clinical pathway. As a matter of fact, the integration of informatics technology also provides an opportunity to modernize the clinical pathway and make it smarter. By bridging the HIS system and the medical cloud of a virtual platform of interactive clinical pathway, the quality of care and patient safety can be better secured and the performance can be stored for analysis.
The project ' The effects of intelligent clinical pathway for total joint replacement' is a subproject of the integrated project ' An integrated model of intelligent medical service for total joint replacement'. It will be carried out in a facility built with intelligent environment (Kaohsiung CGMH) and the data will be stored and computed in the medical care cloud and specialist system server. Collaborating with subproject 2 and 4 (smart wearing device) and subproject 3 (total nursing care), this project is intended to set the milestones for the postoperative recovery after total joint replacement. Supplemented with the specialist system and interactive programs, it will be implemented in total joint replacement patients as an vehicle for perioperative assessment, follow-up, monitoring, and instruction. The big data of the objective analytic results and feedback from the patients will be the important reference for medical and health promotion.
Detailed Description
With the aging population, the needs for total joint replacement are increasing. On the basis of 2000-to-2014 data from National Inpatient Sample (NIS), primary total knee arthroplasty (TKA) is projected to grow by 85% to 1.26 million procedures in the United States by 2030. In a 2012 report of Orthopaedic Industry, and the global sales of joint replacement products exceeded $49.3 billion, with knees taking about half of them. The high financial burden of joint replacement surgery on health care system highlights the importance of cost containment without compromising the quality of patient care.
Clinical pathways for total joint arthroplasty can reduce care variability and improve the quality of care. Taiwan's Bureau of National Health Insurance (BNHI) has initiated a prospective payment system for TKA under diagnosis-related group (DRG) since 1997. It was found the length of hospital stay, and the medical expenditure could be reduced because standard clinical pathways were implemented in most hospitals. However, to optimize the results and meet with patients' expectation are more challenging currently than before because the length of hospitalization is markedly reduced and the standard care processes are accelerated. The accelerated programs for total joint arthroplasty are revolutionizing the standard clinical pathways. Patients can even be discharged from the hospital within one day after the surgery. While a successful joint replacement surgery depends on well-practiced clinical pathways delivered in a timely manner, patient's medical literacy should also have a significant impact for his or her recovery. Unfortunately, patients may acquire incorrect information from the internet or have unrealistic expectations before or during the hospitalization that may compromise the decision making and clinical results.
Recently, the emerging technologies of the electronic medical record and medical informatics have made challenges to the traditional healthcare models such as the clinical pathways. The integration of informatics technology also provides an opportunity to modernize the clinical pathways. But the effect of an interactive infotainment system on TKA is unknown. The purpose of this study was to analyze whether the implementation of an interactive infotainment system into a standard clinical pathway of TKA could influence the hospital course and the medical quality in an arthroplasty specialty ward.
#Intervention
- DEVICE : Patient infotainment system
- The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires. | #Eligibility Criteria:
Inclusion Criteria:
* Admission to the hospital, scheduled for total joint replacement surgery
* Sign informed consent form
Exclusion Criteria:
* In-patient, not scheduled for total joint replacement surgery
* Any psychological condition or other condition that may influence the study result
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03788798 | {
"brief_title": "An Integrated Model of Intelligent Medical Service for Total Joint Replacement",
"conditions": [
"Health Knowledge, Attitudes, Practice"
],
"interventions": [
"Device: Patient infotainment system"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03788798",
"official_title": "An Integrated Model of Intelligent Medical Service for Total Joint Replacement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-19",
"study_completion_date(actual)": "2018-03-07",
"study_start_date(actual)": "2016-03-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-28",
"last_updated_that_met_qc_criteria": "2018-12-24",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-28",
"first_submitted": "2018-12-13",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range 20-50 years). Ethical approval, which included informed consent, was from Cardiff University, Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for seven days and then provided a repeat blood sample. Following a 2-month period, participants were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.
#Intervention
- DRUG : Aspirin
- 1 week of aspirin supplementation prior to sampling | #Eligibility Criteria:
Inclusion Criteria:
* two-week washout period from any non-steroidal anti-inflammatory drugs (NSAIDs) use.
* Ability to take aspirin 75 mg once daily for seven days and sampled thereafter, before stopping the aspirin.
* Willingness to repeat this process after two months and four months of the initial sampling date.
Exclusion Criteria:
* Recent NSAID use
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT05604118 | {
"brief_title": "Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin",
"conditions": [
"Platelet Dysfunction Due to Aspirin"
],
"interventions": [
"Drug: Aspirin"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05604118",
"official_title": "Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-01",
"study_completion_date(actual)": "2022-06-01",
"study_start_date(actual)": "2016-08-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-03",
"last_updated_that_met_qc_criteria": "2022-10-27",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-11-03",
"first_submitted": "2022-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
One way to assess impacts of nutrition supplements to health is to measure physical activity. Physical activity can be measured with small devices called 'accelerometers'. Before they can be used, the devices need to be validated in the population in question. Objectives of this study are to test accelerometers in field conditions and validate their use in 16-18 months old Malawian toddlers. This study does not have a pre-set hypothesis.
Detailed Description
Accelerometers have not been validated in children under 2 years of age. In this study 50 toddlers from Lungwena will be recruited. The participants will wear an ActiGraph GT3X+ -accelerometer fitted on their waist with an elastic belt for 7 days. During the measuring, they will have two videotaped one-hour activity observations while wearing and additional accelerometer device fitted on their ankle. The output from the two devices will be compared to observed activity classified with CPAF-method.
| #Eligibility Criteria:
Inclusion Criteria:
* signed informed consent from at least one guardian
* age 16.00 months to 17.99 months
* availability during the period of the study
Exclusion Criteria:
* any guardian reported or observed illness that limits child's physical activity
* a condition reported by the guardian that limits child's activity co-operate in the study
* wasting (weight-for-height < 2 SD)
* concurrent participation in any clinical trial with an intervention
Sex :
ALL
Ages :
- Minimum Age : 16 Months
- Maximum Age : 18 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT01188044 | {
"brief_title": "Validating Accelerometers to Study Physical Activity of Toddlers",
"conditions": [
"Motor Activity"
],
"interventions": null,
"location_countries": [
"Malawi"
],
"nct_id": "NCT01188044",
"official_title": "Validating the Use of Accelerometers for the Study of Physical Activity Among Young Malawian Toddlers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-01-06",
"last_updated_that_met_qc_criteria": "2010-08-24",
"last_verified": "2011-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-25",
"first_submitted": "2010-08-23",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To assess the safety and tolerability of IV administered LZM009 in subjects with advanced solid tumors who have progressed or are non-responsive to available therapies.
#Intervention
- BIOLOGICAL : LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection
- LZM009 doses of 1, 3, and 10 mg/kg will be administrated intravenously on day 1 and 29 and every 3 weeks thereafter until disease progression or intolerable toxicity, withdrawal of consent, or end of study | #Eligibility Criteria:
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
* Histologically or cytologically confirmed solid malignancy.
* Male or non-pregnant, non-lactating female patients age >=18 years.
* Locally advanced or metastatic disease that is refractory to standard therapy [note for patients with NSCLC patients with activating ALK translocation or EGFR mutations must have been treated and failed appropriate therapy], or for which there is no standard available therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2.
* Subject with a life expectancy of >= 12 weeks.
* Adequate hematologic function as indicated by
1. Platelet count >= 100,000/mm3
2. Hemoglobin >= 9.0g/dL
3. Absolute neutrophil count (ANC) >=1000/uL Note: Use of growth-factors to maintain ANC criterion (within 28 days prior to the first dose of study drug and within 28 days after day 1 of Cycle 1) is not permitted.
* Adequate renal and liver function as indicated by:
1. Serum creatinine <= 1.5 x upper limit of normal (ULN); if serum creatinine is >1.5 x ULN, creatinine clearance must be >= 50 mL/min either by calculation or by measured 24-hour urine collection
2. Total bilirubin <=1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
3. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <=3 x ULN of institution's normal range; for patients with known liver metastases, AST and ALT may be <= 5 x ULN.
4. Coagulation: aPTT and PT<= 1.3 x ULN
* Patients with brain metastases are eligible if clinically controlled that is defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
* Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.
* Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
* Willingness and ability to comply with study procedures and follow-up examination.
Exclusion Criteria:
To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
* Receiving concurrent anti-cancer therapy or investigational therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, (with the exception of hormones for hypothyroidism, estrogen replacement therapy, or LHRH agonists required to suppress serum testosterone levels).
* Patients who have experienced a Grade 3 or higher toxicity related to prior PD-1/PD-L1 treatment.
* Prior anticancer therapy less than 21 days of study entry, or 5 half-lives, whichever is shorter.
* Steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of study drug.
* Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to <= Grade 1.
* Known bleeding diathesis/disorder unless controlled.
* Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
* Have active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
* Serious gastrointestinal bleeding within 3 months.
* Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug and within 28 days after the first dose.
* Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the planned first dose of study drug. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Ophthalmologic, nasal and intra-articular injections or steroids are acceptable.
* Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
* Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
* Neurologic instability per clinical evaluation due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for>28 days may be enrolled.
* Positive laboratory test for HBsAg or anti-HCV. Patients with anti-hepatitis B core antibody are eligible if negative for HBsAg; patients positive for anti-HCV may be enrolled if negative by nucleic acid amplification test.
* Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
* Any diagnosis of autoimmune disease. Subjects with hypothyroidism stable on hormone replacement, adrenal insufficiency on steroid replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment are permitted to enroll.
* Grade 3 or higher pneumonitis or neuropathy during previous treatment with immunotherapy.
* Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled diabetes (blood glucose > 250 mg/dL), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* Patient has received a live, attenuated vaccine within 28 days of planned start of study therapy.
* Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia), or to LZM009 recipients (refer to Investigator's Brochure).
* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 21 days or 5 half-lives, whichever is shorter, before the start of study treatment, the exception of participants in the follow-up phase.
* Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03286296 | {
"brief_title": "LZM009 to Treat Patients With Advanced Solid Tumors",
"conditions": [
"Solid Tumor"
],
"interventions": [
"Biological: LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03286296",
"official_title": "A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation Study of LZM009 in Subjects With Advanced Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-06",
"study_completion_date(actual)": "2019-04-23",
"study_start_date(actual)": "2017-08-21"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-02",
"last_updated_that_met_qc_criteria": "2017-09-13",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-18",
"first_submitted": "2017-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. The study involves patients in the Pigmented Lesion Clinic that have received total body photography for skin monitoring.
#Intervention
- BEHAVIORAL : Digital photographs loaded onto a mobile device
- BEHAVIORAL : Skin exam reminders
- BEHAVIORAL : Social support network | #Eligibility Criteria:
Inclusion Criteria:
* Patients presenting to the Penn Dermatology Pigmented Lesion Clinic who have a mobile device for personal use that either:
* (1) already have total body photography images, have a compact disc (CD) of digital versions of these images, and who do NOT already conduct proper monthly skin exams at home, and
* (2) patients that are having new images taken
Exclusion Criteria:
* Patients that are children or adolescents
* Patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
* Patients that are incompetent to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02520622 | {
"brief_title": "Digital vs. Printed Photographs: Impact on Skin Self-Examinations",
"conditions": [
"Melanoma"
],
"interventions": [
"Behavioral: Digital photographs loaded onto a mobile device",
"Behavioral: Social support network",
"Behavioral: Skin exam reminders"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02520622",
"official_title": "Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01-25",
"study_completion_date(actual)": "2017-01-25",
"study_start_date(actual)": "2015-02-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-02",
"last_updated_that_met_qc_criteria": "2015-08-07",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-13",
"first_submitted": "2015-08-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. If proven, this relationship may partly explain the inverse association between fruit and vegetable intake and cardiovascular disease risk. There are currently no published dietary interventions that have examined in detail the relationship between fruit and vegetable intake and insulin resistance. There is, however, some preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables may have a beneficial effect on insulin resistance. Evidence to date indicates that an investigation of the direct association between fruit and vegetable intakes and insulin resistance in a carefully controlled intervention study is warranted. This study will investigate the dose-response effect of fruit and vegetable intake on insulin resistance in people who are overweight and at high-risk of CVD using state-of-the-art techniques.
#Intervention
- OTHER : Fruit and vegetable intervention
- Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks) | #Eligibility Criteria:
Inclusion Criteria:
* BMI between 27 <= age <= 35
* CVD risk >20% > 10 years (using the Joint British Society risk assessment tables)
* Low consumers of fruit and vegetables (<2 portions per day)
Exclusion Criteria:
* Diabetes
* Existing CVD
* Food intolerance/sensitivity preventing adherence to a high fruit and vegetable diet
* Subjects taking antioxidant supplements
* Surgery within the last 3 months
* Pregnancy/lactation
* Aspirin
* Subjects following a weight loss diet
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00874341 | {
"brief_title": "Effect of Fruit and Vegetables on Insulin Resistance",
"conditions": [
"Cardiovascular Disease"
],
"interventions": [
"Other: Fruit and vegetable intervention"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00874341",
"official_title": "Dose-Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07",
"study_completion_date(actual)": "2011-07",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-08",
"last_updated_that_met_qc_criteria": "2009-04-01",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-02",
"first_submitted": "2009-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Soft multifocal contact lenses are used for a variety of reasons in patient care. Multifocal contact lenses are most often used to correct presbyopic vision by providing a range of clear vision at both distance and near. Multifocal contact lenses correct vision at different distances by introducing a power gradient over the eye. They are designed using center near or center distance designs. For center near designs, the near addition is place in the center of the lens, and the power becomes more negative in the periphery. Conversely, for center distance designs, the distance prescription is placed in the center, and the power of the lens becomes more positive in the periphery in order to provide the near addition. Center near and distance designs have varying advantages and disadvantages for presbyopic vision correction, so a fitter may choose a specific design based on a patient's individual visual needs. Generally, it is thought that center near designs provide the most accommodative relief and superior near vision because the near addition is centered in the pupil and able to allow maximum near correction, even with miotic pupil size changes associated with accommodation.
Plus lenses, or add powers, in spectacles are often used in the management of accommodative and binocular vision disorders. An add power, or plus lens, relieves accommodative demand. There is conflicting evidence on whether the add power in soft multifocal contact lenses can be used to manage accommodative and binocular vision disorders. Some case reports demonstrate benefits of multifocal contact lenses in accommodative insufficiency and convergence excess but the evidence is not clear and many previous studies utilize lenses that are not readily used anymore. Studies show that soft multifocal contact lenses alter accommodation in participants who wear lenses, but most studies use enter-distance lens designs, which is the most commonly used lens for myopia management.
Most studies that have evaluated accommodative ability and function while wearing soft multifocal contact lenses have examined center distance lenses. Because center distance lenses are used for myopia management, the interest has been to determine if children maintain normal accommodative function while wearing the lenses. Accommodative function while wearing center near lenses has likely not been studied often because these lens designs are used most in presbyopic populations who have no or waning accommodative ability and are using the lenses, specifically, to account for that accommodative inability.-Knowing how spectacle lenses with add powers effectively treat some binocular vision and accommodative disorders and understanding how center near multifocal contact lenses correct presbyopic vision, it is reasonable to hypothesize that center near multifocal contact lenses may provide a greater therapeutic effect for accommodative and binocular vision disorders than center near designs because the central portion of the lens is the addition power, unlike the center-distance lens designs. This study will aim to determine how accommodative function varies with center distance and center near multifocal contact lenses.
#Intervention
- DEVICE : Contact Lens
- Coopervision Biofinity Multifocal Lens | #Eligibility Criteria:
Inclusion Criteria:
* Ages 18 to <= 30 years
* Acuity of 20/25 or better in both eyes with habitual contact lens prescription
* No history of ocular disease or active ocular inflammation
* No history of ocular or refractive surgery
* No current history of rigid contact lens wear
* Astigmatism <=1.00 D
* Free of binocular vision disorder (strabismus, amblyopia, vergence dysfunction, accommodative dysfunction)
Exclusion Criteria:
* No prior or concurrent participation in myopia control or use of low dose atropine, multifocal contact lenses
* No use of any medications suspected to affect accommodation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT06064617 | {
"brief_title": "Accommodative Behaviors in Multifocal Contact Lenses",
"conditions": [
"Accommodation Disorder"
],
"interventions": [
"Device: Contact Lens"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06064617",
"official_title": "Accommodative Behaviors in Multifocal Contact Lenses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-30",
"study_completion_date(actual)": "2024-04-30",
"study_start_date(actual)": "2023-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-05",
"last_updated_that_met_qc_criteria": "2023-09-26",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-03",
"first_submitted": "2023-09-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under fasting conditions.
Detailed Description
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
#Intervention
- DRUG : Alprazolam Extended-Release 3 mg Tablets
- 1 x 3 mg, single dose fasting
- DRUG : Alprazolam Extended-Release 3 mg Tablets
- 1 x 3 mg, single dose fasting
- Other Names :
- XANAX XR® | #Eligibility Criteria:
Inclusion Criteria:
* Screening Demographics: All subjects selected for this study will be healthy non-smoking men and women 18 years or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
* Screening procedures: Each subject will complete the screening process within 28 days prior to Period I dosing.
* Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
* Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.
* The physical examination will include, but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.
* The screening clinical laboratory procedures will include:
* Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
* Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
* HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens;
* Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
* Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, and phencyclidine.
* Serum Pregnancy Screen (female subjects only)
* FSH (to verify postmenopausal status; female subjects only)
* If female and:
* is postmenopausal for at least 1 year and has a serum FSH level >= 20mIU/mL; or
* is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Exclusion Criteria:
* Subjects with a recent history of dug or alcohol addiction or abuse.
* subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
* Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
* Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
* Subjects demonstrating positive drug abuse screen when screened for this study.
* Female subjects demonstrating a positive pregnancy screen.
* Female subjects who are currently breast-feeding.
* Subjects with a history of allergic response(s) to alprazolam or related drugs.
* Subjects with a history of clinically significant allergies including drug allergies.
* Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
* Subjects who currently use or report using tobacco products within 90 days of Period I dose administration.
* Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
* Subjects who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
* Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
* Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
* Subjects who report an intolerance of direct venipuncture.
* Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00829426 | {
"brief_title": "Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Alprazolam Extended-Release 3 mg Tablets"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00829426",
"official_title": "A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Fasting Conditions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-06",
"study_completion_date(actual)": "2005-06",
"study_start_date(actual)": "2005-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2009-01-26",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-27",
"first_submitted": "2009-01-26",
"first_submitted_that_met_qc_criteria": "2009-06-18"
}
}
} |
#Study Description
Brief Summary
Overall study aim of this study is to analyse descriptive statistics of Patient-Reported Outcome（PROs） which will be used in the Hyperkalemia（HK） registry study in hyperkalemia patients with Chronic Kidney Disease（CKD） or Heart Failure（HF） to describe the practice patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this study will provide the information for the applicability of PRO measurements which will be used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients with hyperkalemia
| #Eligibility Criteria:
Inclusion Criteria:
* Outpatients aged >=20 years
* Hyperkalemia patients defined as meeting either of the following criteria:
1. Having a history of S-K >=5.1 mmol/L >=2 times within 6 months before enrolment
2. Having a history of S-K >=5.5 mmol/L once within 6 months before enrolment
3. Currently treated by potassium binders for the treatment of hyperkalemia at enrolment
* Having been diagnosed as CKD (>=stage 3b) or HFrEF by investigators as defined below:
CKD is diagnosed based on the guidelines of CKD issued by the Japanese Society of Nephrology (JSN, 2018) as being either or both of condition 1 and 2 for >=3 months
* Clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy. Especially, existence of >=0.15 g/gCr of proteinuria (>=30 mg/gCr of albuminuria) is important.
* GFR <45 mL/min/1.73m2 Within the routine clinical practice, GFR is estimated by serum creatinine, gender, and age using following the formulation.
eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for female patients, x 0.739)
>=Stage 3b CKD is diagnosed based on the following eGFR categories:
* Stage 3b: 30 mL/min/1.73m2 <= eGFR <45 mL/min/1.73m2
* Stage 4: 15 mL/min/1.73m2 <= eGFR <30 mL/min/1.73m2
* Stage 5: eGFR <15 mL/min/1.73m2
Patients with HFrEF is enrolled if patients meet following criteria within 6 months:
* EF <=40%
* NYHA class II-IV
* Provision of signed, written, and detailed informed consent
* Signed written informed consent by themselves
Exclusion Criteria:
* Currently on any chronic RRT (including hemodialysis or peritoneal dialysis >30 days, or kidney transplant) within 6 months before enrolment
* Patients with acute kidney injury at enrolment
*Patients who took blood transfusion or potassium supplements within 6 months before enrolment
* Active malignancy or life expectancy of less than 6 months.
* Patients who have GI disturbance/chronic diarrhoea/stoma, and investigators determine those affect significantly serum K level
* Patients who have autoimmune disorders, and investigators determine those affect significantly serum K level
* Patients whose lab data have suspicion for pseudohyperkalemia
* Patients who are pregnant, lactating, or planning to become pregnant
* Current participation in interventional studies and/or clinical trials
* Patients who, in the opinion of the investigators, would be unlikely to comply with self-assessments
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04466969 | {
"brief_title": "Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study",
"conditions": [
"Hyperkalemia"
],
"interventions": null,
"location_countries": [
"Japan"
],
"nct_id": "NCT04466969",
"official_title": "Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-30",
"study_completion_date(actual)": "2020-11-30",
"study_start_date(actual)": "2020-07-31"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-13",
"last_updated_that_met_qc_criteria": "2020-07-07",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-10",
"first_submitted": "2020-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.
#Intervention
- DRUG : Arfolitixorin
- Bevacizumab 5 mg/kg intravenous infusion; Oxaliplatin 85 mg/m2 intravenous infusion; 5-FU 400 mg/m2 intravenous bolus; Arfolitixorin 60 mg/m2 intravenous bolus; 5-FU 2400 mg/m2 intravenous infusion; Arfolitixorin 60 mg/m2 intravenous bolus
- DRUG : Leucovorin
- Bevacizumab 5 mg/kg intravenous infusion; Oxaliplatin 85 mg/m2 intravenous infusion; Leucovorin 400 mg/m2 intravenous infusion; 5-FU 400 mg/m2 intravenous infusion; 5-FU 2400 mg/m2 intravenous infusion | #Eligibility Criteria:
Inclusion Criteria:
* Colorectal adenocarcinoma verified by biopsy.
* Availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression.
* Non-resectable metastatic CRC planned for first line therapy with 5-FU, Leucovorin, oxaliplatin, and bevacizumab.
* Evaluable disease with at least one measurable lesion of metastatic disease (>=10 mm in longest diameter on axial image on CT-scan or alternatively MRI with <5 mm reconstruction interval) or lymph node (>= 15 mm in shortest axis when assessed by CT) obtained within 28 days of randomization.
* Life expectancy of more than 4 months.
* ECOG performance status 0 or 1.
* Hemoglobin (Hb) > 80 g/L, Absolute neutrophil count (ANC) > 1.5x10E9/L. Thrombocytes > 100x10E9/L.
* Creatinine clearance > 50 mL/min, Total bilirubin < 1.5 x ULN, AST and ALT < 3 x ULN (and < 5 x ULN in case of liver metastases).
* Male or female >=18 years.
* Female patients of childbearing potential must have a negative urine pregnancy test and use adequate contraceptive measures . Male patients must use adequate contraceptive measures .
* Voluntarily signed informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Exclusion Criteria:
* Malignant tumors other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
* Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/radiotherapy/immunotherapy, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.)
* Confirmation of progressive disease within 6 months after completion of prior adjuvant anti-cancer treatment.
* Indication for any metastatic Colo-rectal Cancer (mCRC) surgery or anti-cancer treatment other than study treatment.
* Prior treatment with arfolitixorin.
* Indication for treatment with a 5-FU analogue, or 5-FU for a condition other than mCRC.
* Known Dihydropyrimidine Dehydrogenase Deficiency (DPD) deficiency.
* Known or suspected central nervous system (CNS) metastases.
* Unresolved bowel obstruction, uncontrolled Crohn's disease, or ulcerative colitis.
* History of cardiac disease with a New York Heart Association Class II or greater, congestive heart failure, myocardial infarction, or unstable angina at any time during the 6 months prior to randomization, or serious arrhythmias requiring medication for treatment.
* Current CTCAE >= grade 3 diarrhea.
* Current chronic infection or uncontrolled serious illness causing immunodeficiency.
* Known or suspected hypersensitivity or intolerance to arfolitixorin, LV, 5-FU, oxaliplatin, or bevacizumab.
* Breastfeeding patients.
* Patient who received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug, prior to randomization.
* Patient with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Ongoing drug or alcohol abuse, as deemed by the Investigator.
* Any condition that, in the opinion of the Investigator, could compromise the patient's safety or adherence to the study protocol.
* Involvement, or related to people involved in the planning or conduct of the study (applies to both Isofol Medical AB (publ) staff and staff at the study site)
* Surgery (excluding previous diagnostic biopsy) in the 28-day period before randomization
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03750786 | {
"brief_title": "A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer",
"conditions": [
"Colo-rectal Cancer"
],
"interventions": [
"Drug: Leucovorin",
"Drug: Arfolitixorin"
],
"location_countries": [
"France",
"Japan",
"Sweden",
"United States",
"Germany",
"Canada",
"Austria",
"Spain",
"Australia",
"Greece"
],
"nct_id": "NCT03750786",
"official_title": "A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-18",
"study_completion_date(actual)": "2022-11-18",
"study_start_date(actual)": "2018-12-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-26",
"last_updated_that_met_qc_criteria": "2018-11-20",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-23",
"first_submitted": "2018-11-19",
"first_submitted_that_met_qc_criteria": "2023-10-19"
}
}
} |
#Study Description
Brief Summary
Adequate antioxidant supply is essential for maintaining metabolic homeostasis and reducing oxidative stress during detoxification. The emerging evidence suggests that certain classes of phytonutrients can help support the detoxification process by stimulating the liver to produce detoxification enzymes or acting as antioxidants that neutralize the harmful effects of free radicals. This study was designed to examine the effects of a guided 28-day metabolic detoxification program in healthy adults. The participants were randomly assigned to consume a whole food, multi-ingredient supplement (education and intervention) or control (education and healthy meal) daily for the duration of the trial.
Detailed Description
In this study, the focus is on a cohort of healthy adults enrolled in a guided detoxification program that included a healthy diet education session with or without 28-day nutritional supplementation with a whole food, proprietary multicomponent blend. The primary objective was to determine the improvement in quality of life by a validated self-reported wellness questionnaire known as Promis Global 10. The secondary outcomes were to quantify the functional markers of metabolic detoxification in blood and urine compared to the study baseline to understand the efficacy of the study formulation as part of 28-day nutritional supplementation with a whole food, proprietary multicomponent blend.
#Intervention
- DIETARY_SUPPLEMENT : SP Detox Program
- The production use and disposal of toxic chemicals and synthetic materials have increased the risk of exposure to health-threatening toxins. Causal relationships between toxic chemicals and diseases have been well established. However, many patients endure chronic symptoms that are associated with exposure to toxins before advanced stages of specific diseases are realized. Thus, there is a great demand for noninvasive laboratory tests that can provide timely assessment of chemical exposure and the capability of hepatic detoxification | #Eligibility Criteria:
Inclusion Criteria:
* Willingness to comply with study protocol for 30 days
* No allergy to any study products (check formulation section below)
* Participant is > 18 years or older
* Participant is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit, and is not actively planning a pregnancy.
* Participant has at least two weeks wash out period between completion of a previous research study that required ingestion of any study food or drug and their start in the current study.
Exclusion Criteria:
* Prohibited Medications, Supplements or Herbal Products
* Subjects who are experiencing any adverse events due to any nutraceutical, OTC, or pharmaceutical or investigational products
* Celiac and other gastrointestinal health concerns
* Subjects may not receive any other investigational products not part of normal clinical care
* Lipid lowering drugs or the use of anticoagulant medications in the preceding 4 weeks and for duration of study
* Pregnant and nursing women are excluded from participation and women of childbearing age expecting to be pregnant soon will be excluded from the study
* TC levels less than 220
* Subjects with untreated endocrine, neurological, or infectious disease
* Subjects with the diagnosis of HIV disease or AIDS
* Significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment)
* Rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, polymyositis, scleroderma, polymyalgia rheumatic, temporal arteritis or Reiter's Syndrome
* Psoriasis, Deep vein thrombosis or pulmonary embolus (blood clot to lungs)
* History of cancer
* Serious medical illness
* Substance Use - Use of ethanol within 24 hours of the evaluation visits (baseline, 4 weeks)
* Any other sound medical, psychiatric and/or social reason as determined by the PI
* Co-enrollment in other studies is restricted. Study staff should be notified of co-enrollment as it may require the approval of the investigator
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT06061289 | {
"brief_title": "Guided Metabolic Detox Program",
"conditions": [
"Detoxification Response"
],
"interventions": [
"Dietary Supplement: SP Detox Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06061289",
"official_title": "Effects of Standard Process's SP Detox Balance Dietary Supplements on Metabolic Detoxification",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-27",
"study_completion_date(actual)": "2022-09-30",
"study_start_date(actual)": "2022-03-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-29",
"last_updated_that_met_qc_criteria": "2023-09-27",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-29",
"first_submitted": "2023-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for individual prognosis and life expectancy.
Imaging modalities are important in the assessment of follow up of structural lung changes and monitoring of pulmonary complications in CF. Although high resolution computed tomography (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF, chest-X-ray is widely used as standard imaging procedure for assessment and follow up in these young patients due to less radiation exposure.
Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due to recent technical developments MRI of the lung became possible.
Our study group was able to show that MRI is a competitive imaging modality for evaluating changes of the CF-lung in comparison to the gold standard (HRCT).
So far only patients from the age of 6-7 years were examined. According to recent studies CF is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even in infants and young children. In this age group lung function testing is difficult and not broadly available. An early optimized therapy is crucial for the long term course and outcome of the pulmonary disease.
The aim of this study is to evaluate morphological and functional MRI for early diagnosis of lung changes in children (0-6 years) with CF.
Detailed Description
Month 1-2: Protocol adaptation for infants and small children Month 3-14: Patient examinations (20 Patients with sedation) Month 15-18: Data evaluation
| #Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed by the parents or a legal guardian
* Sedation as necessary
* Conventional clinical indicated diagnostic procedures (lung function test, chest-X-ray, CT)
Exclusion Criteria:
* Study exclusion in case of contra indications for MRI:
* Patients with cardiac pace maker, metallic implants (e.g. cerebral vessel clips) as well as other conditions that prohibit the exposition of a patient to a strong magnetic field.
* No informed consent
* Dyspnea, which disables the patient to follow breathing instructions during the study.
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT00760071 | {
"brief_title": "Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)",
"conditions": [
"Cystic Fibrosis",
"Lung Disease"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT00760071",
"official_title": "Evaluation of Morphological and Functional Magnetic Resonance Imaging (MRI) for Early Diagnosis of Lung Changes in Children (0-6 Years) With Cystic Fibrosis (CF)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2009-09",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-04-15",
"last_updated_that_met_qc_criteria": "2008-09-24",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-25",
"first_submitted": "2008-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
#Intervention
- DRUG : Desloratadine
- Desloratadine 5 mg once daily
- Other Names :
- SCH 034117 | #Eligibility Criteria:
Inclusion Criteria:
* Outpatient men or women, age 12 years and above.
* Diagnosis of Allergic Rhinitis or Chronic Idiopathic Urticaria
Exclusion Criteria:
* Known hypersensitivity to Desloratadine.
* Pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00724698 | {
"brief_title": "Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria",
"conditions": [
"Rhinitis",
"Urticaria"
],
"interventions": [
"Drug: Desloratadine"
],
"location_countries": null,
"nct_id": "NCT00724698",
"official_title": "Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-12",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2005-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-09",
"last_updated_that_met_qc_criteria": "2008-07-25",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-29",
"first_submitted": "2008-07-25",
"first_submitted_that_met_qc_criteria": "2009-05-28"
}
}
} |
#Study Description
Brief Summary
Stroke is one of the commonest causes of severe disability in adults. Stroke often results in spasticity and motor impairments in the upper limb. Permanent upper extremity impairments can lead to limitations in activities of daily living, social participation, and quality of life. Spasticity may obscure motor learning ability after stroke. Spasticity control is one of the main aims of most therapists in the rehabilitation process for patients with chronic stroke. Traditional approaches for managing spasticity may not be enough for gaining satisfactory results. Virtual reality-based therapy is one of the most innovative and developments in rehabilitation technology. It could be effective in accelerating motor recovery and modulating spasticity for the involved upper limbs. The purpose of this study was to examine the impact of virtual reality-based therapy on upper limb spasticity and motor functions in patients post-stroke.
Detailed Description
Stroke is an acute, medical event, which mainly results in neurological damage leading to disability and mortality. Stroke is a common, serious, and disabling problem. The most widely recognized impairment caused by stroke is motor impairment of one side of the body called hemiplegia, which restricts function in muscle movement or mobility. Following a stroke, many upper limb impairments may influence the patient's ability to perform functional activities. These include spasticity, muscle weakness, restricted and in-coordinated movement. The impact of upper limb dysfunctions on participation in home, work, community life, and daily living activities is great. Upper limb recovery after stroke is unacceptably poor; with only 50% of stroke survivors likely to regain some functional use. In many neurological disabilities associated with spasticity such as hemiplegia post-stroke, the rehabilitation process is of long duration and clinicians face the challenge of identifying a variety of meaningful and motivating intervention tasks that could be effective in controlling spasticity and preventing its negative hazards. Current rehabilitation techniques have focused on teaching and reinforcing different strategies that encourage the use of the non-involved upper extremity to decrease functional limitations. Treatment options for controlling spasticity and enhancing upper limb functions include physical therapy, occupational therapy, neurodevelopmental therapy, peripheral splinting and casting, constrained induced movement therapy, pharmacotherapy (e.g., botulinum toxin type A), and surgery. Till now, there is a lack of strong evidence of successful treatment with any of these approaches. Virtual reality is a relatively recent approach to stroke rehabilitation. It has been shown to be an interactive and enjoyable medium that, with sufficient use, may improve upper limb motor function in adults with stroke. Enhanced feedback provided by a virtual reality system has been shown to promote motor learning in normal subjects. The main advantage of virtual game-based rehabilitation over conventional approaches is the inclusion of an interactive and motivating exercise environment. Until now, there have been limited researches involving the inclusion of virtual reality-based therapy systems in neuro-rehabilitation and spasticity management of the involved upper limb for hemiplegic patients post-stroke. Therefore, the purpose of this study was to evaluate the efficacy of virtual reality technology on modulating spasticity and improving the function of the involved upper extremity in patients having a chronic stroke.
#Intervention
- DEVICE : Virtual reality-based training equipment.
- It is a functional upper extremity rehabilitation device to provide specific therapy with augmented feedback. The equipment facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3D workspace that allows functional therapy exercises in a virtual reality environment.
- OTHER : Traditional physical therapy program
- The traditional physical therapy program aimed for inhibition of spasticity, facilitation of muscle action, and improving the motor functions of the involved upper limbs. | #Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria were as follow:
* Participants were diagnosed as chronic stroke patients.
* Participants were selected to be in the spastic phase, 6 <= age <= 24 months following a first stroke.
* The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+&2) according to Modified Ashworth Scale.
* Participants were all between 50 and 60 years, of both sexes.
* Participants were cognitively able to understand and follow instructions.
* Participants had the ability to extend their wrist joints at least 20° and fingers 10° from full flexion. This range allowed participants to engage easily in performing a designed functional program.
Exclusion Criteria:
The exclusion criteria were as follow:
* Participants who were with any orthopaedic condition or fixed deformity that interfere with the upper limb functions.
* Participants who were with spasticity more than score 2 according to the Modified Ashworth Scale.
* Participants who had cognitive or perceptual problems.
* Participants with surgical interference for the upper limb and spine within the previous 2 years.
* Participants with seizures, visual impairments, or auditory problems.
* Participants who had shoulder pain on a visual analogue scale of > 6/10.
* Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05069480 | {
"brief_title": "Modulation of Upper Limb Spasticity Post-Stroke",
"conditions": [
"Spasticity as Sequela of Stroke",
"Spastic Hemiplegia",
"Upper Extremity Dysfunction"
],
"interventions": [
"Other: Traditional physical therapy program",
"Device: Virtual reality-based training equipment."
],
"location_countries": [
"Saudi Arabia"
],
"nct_id": "NCT05069480",
"official_title": "Interactive Game-Based Rehabilitation for Controlling Upper Limb Spasticity Post Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-30",
"study_completion_date(actual)": "2021-05-30",
"study_start_date(actual)": "2020-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-06",
"last_updated_that_met_qc_criteria": "2021-09-25",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-06",
"first_submitted": "2021-09-25",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to assess whether a novel, enhanced form of biofeedback can help individuals regulate their chronic musculoskeletal pain more effectively.
Detailed Description
Relaxation is a low-cost treatment for managing pain with little or no side effects. The proposed study will use a novel biofeedback treatment to try and enhance the capacity of relaxation to engage pain inhibitory circuits. Specifically, a biofeedback system (Biofeedback Training for Conditioned Pain Regulation, BT-CPR) will be used to monitor the participant's level of sympathetic arousal and will use this to control the intensity of painful stimulations delivered to the participant during biofeedback training. Thus, when the participant successfully relaxes (and reduces their arousal), the intensity is lowered and produces pain relief. Efficacy of the treatment will be tested in a small, randomized controlled trial in which individuals with a verified diagnosis of chronic musculoskeletal pain will receive 10 treatment sessions, or 10 sessions of a control condition (traditional biofeedback, to control for the effects of relaxation on pain). The aim will be to assess whether the treatment results in improvements in clinical pain outcomes (e.g., pain intensity, quality of life, pain interference) and psychosocial variables (e.g., coping, self-efficacy, mood).
#Intervention
- BEHAVIORAL : Biofeedback Training (BT-CPR)
- Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain
- BEHAVIORAL : Biofeedback Training
- Participants will receive biofeedback training to reduce arousal and pain | #Eligibility Criteria:
Inclusion Criteria:
* Adults (>= 18 years) with a verified diagnosis of chronic musculoskeletal pain and currently experiencing pain
Exclusion Criteria:
* under 18 years (given the nature of the treatment study)
* if female, currently pregnant
* persistent feelings of numbness in hands and feet
* difficulty being able to feel or sense things
* lack of access to a computer or smartphone (to complete electronic pain diaries)
* injuries that prevent sensor application
* use of narcotic pain medications with 48 hours of treatment sessions
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02920853 | {
"brief_title": "Enhanced Biofeedback for Musculoskeletal Pain",
"conditions": [
"Musculoskeletal Pain"
],
"interventions": [
"Behavioral: Biofeedback Training (BT-CPR)",
"Behavioral: Biofeedback Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02920853",
"official_title": "Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08",
"study_completion_date(actual)": "2018-08",
"study_start_date(actual)": "2016-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-21",
"last_updated_that_met_qc_criteria": "2016-09-28",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-30",
"first_submitted": "2016-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Research to develop a new, natural-derived formulation that eliminates inflammatory tissue and regenerates new tissue of the lobules, epithelium of the tubules, and connective tissue surrounding the seminiferous tubules in the testes. It restores Leydig cells and Sertoli cells' function (because the inflamed testicles were unable to perform spermatogenesis).
Detailed Description
FPT-20 has stabilized cortisol levels, maintained stable B-lymphocytes in the body, verified by quantitative tests of blood B-lymphocytes and blood cortisol, cut off the chronic inflammation chain, promoted the regeneration of the epithelium of the coiled ducts, and repairs the connective tissue surrounding the coils.
Select a type of flavonoid that has the ability to protect human body cells by destroying toxic proteins. Targeted flavonoids are selected for multiple simultaneous effects, acting as a chemotactic or physiological modifier. Many studies have shown that flavonoids can also act as cell cycle inhibitors, which can also cause cancer cell death at an early stage (at the stage of a few cells). There have been many documents demonstrating that some flavonoids have the ability to kill cancer cells, stabilize stages of cell differentiation, and improve immunity. Flavonoids present in FPT-20 protect and regenerate cells, clean up inflammatory and fibrotic cells, and facilitate the growth of germ cells.
The selected flavonoids in the preparation are also used to regenerate the epithelium in the lumen of the seminiferous tubules, ensure the perfusion of the lobules, and stabilize the spermatogenesis process.
FPT-20 is easily distributed in high concentrations in immune cells. It has natural antibacterial activity, promotes lymphocyte proliferation, and is rapidly consumed during inflammation. The effects show a prominent role in the regulation of the immune system, and there is a high degree of interaction, which requires more research to understand its mechanism, FPT-20 will not be effective in the absence of one of the components selected to participate in the test.
FPT-20 will reach its therapeutic effect after 6-12 months. After 6-12 months, an amount of progressively motile sperm was found in the semen.
According to research, FPT-20 created a homeostasis, protecting cell membranes, cutting off the cell's inflammatory chain, and preventing transcription and translation errors. The mediators regulated the protective responses in the body. Cytokines that have a beneficial effect through specific receptors, and many other unexplained processes, have altered the spermatogenesis status of the testes. The body will absorb the components in FPT-20 through the small intestine wall, this metabolism has created a significant amount of B lymphocytes to provide for the process of restoring the function of the testicles. An appropriately calculated dose of FPT-20 is provided during the treatment, using precursors, enzymes, and flavonoids available in nature to supplement and interfere with biochemical processes taking place in the body. The extracts in the preparation should be used regularly (\>6 months) until the therapeutic purpose is achieved. The product has offered hope to patients who are unable to produce sperm from spermatogonia (because the process has been disrupted). Stabilize the semen pH within good limits, to produce high-quality sperm as well as to achieve efficiency into egg penetration.
#Intervention
- DRUG : FPT-20
- FPT-20 should be used regularly, the daily maintenance dose is 1 tablet once a day(\>6 to 12 months) until the therapeutic purpose is achieved. | #Eligibility Criteria:
Inclusion Criteria:
* The selected person has evidence of spermatogenesis disorder, no sperm, and weak sperm that do not meet the standards in terms of quantity and quality.
* There are signs of orchitis.
* Accepting patients with other comorbidities such as metabolic diseases, congenital or acquired immunodeficiency, HIV/AIDS, HBV, HCV, and Tuberculosis.
Exclusion Criteria:
* Do not select patients with advanced cancer.
Sex :
MALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT05399212 | {
"brief_title": "Composition for Treating Spermatogenesis and Semen Disorders / FPT-20",
"conditions": [
"Spermatogenesis and Semen Disorders"
],
"interventions": [
"Drug: FPT-20"
],
"location_countries": [
"Vietnam"
],
"nct_id": "NCT05399212",
"official_title": "A New Natural Origin Product, Achieving More Than 80% Efficiency in Spermatogenesis in the Seminiferous Tubules. This Method Opens up Hope for Cases of Infertility Caused by the Inability of Spermatogonia to Develop Into Mature Sperm.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-20",
"study_completion_date(actual)": "2022-05-20",
"study_start_date(actual)": "2020-10-29"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-15",
"last_updated_that_met_qc_criteria": "2022-05-26",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-01",
"first_submitted": "2022-05-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Background: Patients are put under invasive mechanical ventilation (MV) during respiratory failure because they can no longer breathe in a way that delivers enough oxygen to their body. MV involves placing a tube into the wind pipe that is attached to a machine (known as a ventilator) which helps the patient breathe. However, MV is associated with complications such as shrinkage and damage of the diaphragm muscle fibres. It has been shown that the diaphragm (the main breathing muscle which provides approximately 70% of the work in healthy persons) can be affected after only 3-4 days of MV. Disconnection from the ventilator (a process known as extubation) is conducted with the calculated risk that the patient may become exhausted due to the additional workload of breathing off the ventilator resulting in needing to be reconnected to the ventilator (a process known as reintubation). Reintubation requires additional deep sedation of the patient and leads to longer time connected to the ventilator, increased risk of new lung infections, prolonged stay in the intensive care unit (ICU) and further immobilisation. Thus, the intensive care physician must constantly evaluate the need for MV to maintain adequate breathing versus withdrawal as quickly as possible to reduce the risk associated with long-term use of MV. However, to date, there is no technique for continuous assessment of diaphragm function that can be easily used at the patient's bedside. RESPINOR DXT, which offers continuous ultrasound monitoring of the right diaphragm velocity without the need of the continued presence of an operator, could offer an interesting solution.
Aim: The primary objective of this study is to compare diaphragm excursion values obtained around a 30-minute SBT using RESPINOR DXT in patients who are successfully and unsuccessfully extubated. Data analysis will be performed using post-processing. The timepoints to be analysed will be:
* Pre-SBT: 10, 30 and 60 minutes before the start of the SBT
* During the 30-minute SBT: 0, 1, 2, 3, 4, 10, 20 and 30 minutes
* Post-SBT: 5, 10, 20, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after the end of the 30-minute SBT.
Hypothesis: The investigators hypothesise that there will be significantly different median diaphragm excursion between successful and failed extubation groups in at least one of the timepoints of interest. The information from this pilot study will be used to design a fully-powered observational study.
Primary outcome: Median diaphragm excursion
| #Eligibility Criteria:
Inclusion Criteria:
* >= 17 years years,
* At least 24 hours and maximum of 7 days of invasive controlled mechanical ventilation prior to commencing pressure support ventilation,
* A minimum 30-minute SBT is planned to be initiated by the ICU physicians in charge on or before the 14th day of MV, before extubation is considered,
* The reason for admission to the ICU is adequately treated and the general condition is steadily improving, defined as reduction of general supportive ICU therapy, e.g. fluid supplements, cardiovascular stabilising medications, sedative agents, oxygen supply below 50% and mechanical ventilator support,
* Informed consent to participate in the study from patient or the close relative/next to kin.
Exclusion Criteria:
* Central or spinal neurological injury influencing central ventilation or its transmission, including critical illness neuropathy and myopathy,
* Diagnosed chronic neuromuscular disease prior to admission,
* Administration of neuromuscular blocking agents within the previous 24 hours,
* Known paralysis of a hemidiaphragm or suspicion of paralysis of a hemidiaphragm, defined by the radiographic evidence of elevation of a dome >2.5 cm compared to the contralateral dome,
* Patient with therapeutic limitation, i.e. reduced expectancy to survive,
* Women known to be pregnant,
* Protected adult who is not legally responsible and has a legal guardian,
* Skin damage or dressing at the subcostal area at the site of the probe placement.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03896048 | {
"brief_title": "Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure",
"conditions": [
"Respiration, Artificial"
],
"interventions": null,
"location_countries": [
"Norway"
],
"nct_id": "NCT03896048",
"official_title": "Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-03",
"study_completion_date(actual)": "2020-10-13",
"study_start_date(actual)": "2019-03-25"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-14",
"last_updated_that_met_qc_criteria": "2019-03-28",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-29",
"first_submitted": "2019-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.
Detailed Description
Gut microbiota (GM) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered GM such as elderly population as age-related changes. Several studies have shown that ageing alter GM, both in diversity and integrity.
Probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components.
The aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. The hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.
#Intervention
- DIETARY_SUPPLEMENT : Lactobacillus rhamnosus and Bifidobacterium lactis
- Probiotics
- DIETARY_SUPPLEMENT : Placebo
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* be aged 55 years or over,
* voluntarily agree to participate in the study in accordance with the Helsinki declaration,
* not be participating in another study that could interfere with the results.
Exclusion Criteria:
* suffer from any serious mental illness other than depression and anxiety,
* score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
* be using medications that affect cognition,
* taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
* have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).
Sex :
ALL
Ages :
- Minimum Age : 56 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04828421 | {
"brief_title": "The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT04828421",
"official_title": "The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-30",
"study_completion_date(actual)": "2022-04-30",
"study_start_date(actual)": "2020-07-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-01",
"last_updated_that_met_qc_criteria": "2021-03-31",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-02",
"first_submitted": "2021-03-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
In integrative medicine wraps are applied for different indications. In this study the effects of thorax with ginger and mustard flour are investigated under standardized conditions. Heart rate variability, well being, warmth distribution and respiratory activity of healthy subjects will be measured.
Detailed Description
The purpose of this study is to investigate the effects of different thorax wraps in healthy subjects. Subjects undergo three different interventions (wraps with ginger flour, mustard flour or warm water (placebo)) on three different days. Heart rate variability and respiratory activity is measured for ten minutes before, during (up to 20 minutes) and for ten minutes after each thorax wrap. To investigate the effects on heat development and regulation, photos are taken with a thermographic infrared camera at various moments in time. Participants are asked to fill in questionnaires referring to their subjective perceptions of warmth, bodily warmth distribution and wellbeing. The order of the thorax wrap interventions is randomized.
#Intervention
- DRUG : Zingiberis Rhizoma plv.
- DRUG : Sinapis nigrea semen
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent.
Exclusion Criteria:
Inflectional disease with body temperature > 38 °C. Skin damage on the thorax area Known intolerance or hypersensitivity to mustard or ginger products. Heart failure. Asthma bronchiale. Taking medication with influence on heart rate variability ( mainly tricyclic antidepressants and beta blocker).
Consumption of coffee or nicotine less than three hours before the intervention.
Pregnancy. Deficient knowledge of the German language.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02285452 | {
"brief_title": "Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Sinapis nigrea semen",
"Drug: Placebo",
"Drug: Zingiberis Rhizoma plv."
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02285452",
"official_title": "Psychophysiological Efficacy of Thorax Wraps With Ginger or Mustard Flour in Comparison to Wraps With Warm Water in Healthy Subjects - a Randomized, Placebo-controlled, Three-armed Study With Cross-over Design",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2014-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-09",
"last_updated_that_met_qc_criteria": "2014-11-06",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-07",
"first_submitted": "2014-11-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective of this study is to generate expert consensus statements on the definitions of success and failure and its influencing factors in Post-graduate medical education.
Detailed Description
A study will be performed using a e-Delphi process with Portuguese expert panel to generate recommendation statements related to the definitions of success and failure in Post-graduate medical education and its influencing factors and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:
1. Success in Post-graduate medical education: definition, influencing factors
2. Failure in Post-graduate medical education: definition, influencing factors
3. Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (75% agreement).
Part 1: planning and evidence review
* Series of planning sessions with study investigators
* Literature is reviewed/summarized
* Initial statements will be developed based on Round 1 results. Round 1 will be composed of 4 open-ended questions
Part 2: Survey to achieve consensus
* Survey, based on the initial statements developed on Round 1 results
* At least 2 additional rounds of review (remote rounds using an online platform) will be held to achieve consensus on each topic of interest and finalize consensus statements
| #Eligibility Criteria:
Inclusion Criteria:
* residency programs directors,
* members of the medical residents representing committee,
* members of patients representing associations,
* members of health institutions management teams,
* members of Portuguese Medical Association,
* authors of relevant scientific articles on medical education
Exclusion Criteria:
* Panelists who are not able to commit to all rounds of the modified Delphi process will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05081635 | {
"brief_title": "Consenso2_F1 Delphi Consensus Study on Post-graduate Medical Education Success and Failure and Its Influencing Factors",
"conditions": [
"Medical Education"
],
"interventions": null,
"location_countries": [
"Portugal"
],
"nct_id": "NCT05081635",
"official_title": "Definitions of Success and Failure in Post-graduate Medical Education and Its Influencing Factors: A Delphi Consensus Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-28",
"study_completion_date(actual)": "2022-03-31",
"study_start_date(actual)": "2021-09-23"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-09",
"last_updated_that_met_qc_criteria": "2021-10-05",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-18",
"first_submitted": "2021-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.
#Intervention
- PROCEDURE : Sensory nerve coaptation
- A recipient sensory nerve branch of the 11th-12th intercostal nerve was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.
- Other Names :
- Neurotization, Reinnervation, Neurorrhaphy | #Eligibility Criteria:
Inclusion Criteria:
* Female patients >= 18 years
* Unilateral or bilateral DIEP flap breast reconstruction
* Returned for follow-up between August 2016 and August 2019
* Informed consent
Exclusion Criteria:
* Total flap loss complication
* Flaps that required a take-back
* Follow-up less than six months postoperatively
* Only one postoperative measurement at less than 12 months follow-up
* Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04093999 | {
"brief_title": "Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Procedure: Sensory nerve coaptation"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT04093999",
"official_title": "Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-01",
"study_completion_date(actual)": "2019-09-01",
"study_start_date(actual)": "2016-08-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-23",
"last_updated_that_met_qc_criteria": "2019-09-17",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-18",
"first_submitted": "2019-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in general practitioner consultation.
| #Eligibility Criteria:
Inclusion Criteria:
* male or female > or = 18 years
* Known hypertension
* agree to take part in this study
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00695656 | {
"brief_title": "National Survey on Hypertension in General Practitioner (GP) Consultation",
"conditions": [
"Hypertension"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00695656",
"official_title": "Profile of Hypertensive Patients Seen in General Practitioner Consultation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2008-11",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-08-06",
"last_updated_that_met_qc_criteria": "2008-06-11",
"last_verified": "2009-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-12",
"first_submitted": "2008-06-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. Both techniques have their own advantages and disadvantages.
This study aims to compare the success rates of femoral artery catheterization using both imaging techniques.
Detailed Description
The research will include newborns undergoing open heart surgery and patients requiring arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral artery cannulation will be randomized with the closed envelope method and separated into two groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique (Group B). The intervention will be performed by a single experienced individual. The preparation duration, puncture duration, number of punctures, number of unsuccessful arterial punctures, development of hematoma and other complications will be recorded and the groups will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1. Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS
1. Local infection
2. Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES)
1. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament, femoral artery diameter, femoral artery and vein location properties 2. Preparation duration, number of punctures, complications developing during the procedure
#Intervention
- PROCEDURE : Femoral artery catheterization
- The intervention will be performed by a single experienced individual. | #Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling
Exclusion Criteria:
* Local infection
* Coagulopathy
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 28 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT02986542 | {
"brief_title": "Comparison of Success Rates of Femoral Artery Catheterization",
"conditions": [
"Pulmonary Disease",
"Electrolyte Disorder",
"Metabolic Disease",
"Sepsis"
],
"interventions": [
"Procedure: Femoral artery catheterization"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT02986542",
"official_title": "Comparison of Success Rates of Femoral Artery Catheterization for Newborns With In-plane and Out-of-plane Ultrasonography Techniques",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-25",
"study_completion_date(actual)": "2018-04-02",
"study_start_date(actual)": "2016-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-04-03",
"last_updated_that_met_qc_criteria": "2016-12-05",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-08",
"first_submitted": "2016-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories.
Detailed Description
The investigators conducted an experimental, double-blind, placebo-controlled study in 60 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg hydrocortisone or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following seven days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.
#Intervention
- BEHAVIORAL : Stress Film
- Film scene with severe physical and sexual violence.
- DRUG : Hydrocortisone
- 10mg
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* healthy participants
* German on a native level
Exclusion Criteria:
* former or present DSM IV Axis I disorders
* physical illnesses
* any medication intake (except oral contraceptive)
* history of sexual abuse or rape
* pregnancy or lactation period
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 34 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02552654 | {
"brief_title": "Cortisol and the Formation of Intrusive Memories",
"conditions": [
"Intrusive Memories"
],
"interventions": [
"Drug: Placebo",
"Drug: Hydrocortisone",
"Behavioral: Stress Film"
],
"location_countries": null,
"nct_id": "NCT02552654",
"official_title": "Cortisol and the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-03",
"last_updated_that_met_qc_criteria": "2015-09-16",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-17",
"first_submitted": "2015-09-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Prospective randomized double blinded, placebo controlled study that will evaluate the effect of intra-operative ketamine administration on post-operative analgesic requirements and self-reported pain in patients undergoing total hip and total knee arthroplasty who demonstrate high levels of pain catastrophizing.
Detailed Description
Pain management can be one of the most challenging aspects of care for total joint arthroplasty patients. Poor post-operative pain control can lead to poor patient satisfaction and functional outcomes. Moreover, prolonged post-operative opioid utilization for post-operative pain is associated with substantial adverse sequelae. Identifying patients at high risk for poor post-operative pain control, and implementing strategies to improve pain management in this population is of utmost importance. One patient feature that has been shown to reliably predict poor post-operative pain management is pain catastrophizing. Currently available self-reported metrics such as the pain catastrophizing scale allow for pre-operative identification of patients who exhibit high levels of pain catastrophizing. Furthermore, there currently exist strategies which may effectively improve post-operative pain management in this population. One such strategy is 'pre-emptive' analgesia utilizing ketamine administered at the time of surgery. Ketamine is commonly utilized in the treatment of both acute and chronic pain, and is believed to reduce pain intensity through a complex mechanism involving opioid receptors and excitatory neurotransmitters. It has been utilized in a variety of surgical procedures and has consistently been shown to reduce acute post-operative pain and analgesic consumption as long as 6 months after surgery, without a significant incidence of medication related side effects. To date, no study has evaluated the use of ketamine for total joint arthroplasty patients who demonstrate high levels of pain catastrophizing. We aim to study the effect of intra-operative ketamine administration on post-operative analgesic requirements and self-reported pain in patients undergoing total hip and total knee arthroplasty who demonstrate high levels of pain catastrophizing.
#Intervention
- DRUG : Ketamine
- Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers | #Eligibility Criteria:
Inclusion Criteria:
* Adults, 18 years and older, undergoing primary total hip arthroplasty or total knee arthroplasty
Exclusion Criteria:
* History of intolerance or allergy to ketamine, either documented or self-reported.
* History of increased intra-ocular pressure, uncontrolled hypertension, increased intra-cranial pressure, psychosis.
* Unable to provide consent.
* Current incarceration.
* Pregnant or breast feeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04437888 | {
"brief_title": "Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty",
"conditions": [
"Pain, Postoperative",
"Arthroplasty Complications"
],
"interventions": [
"Drug: Ketamine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04437888",
"official_title": "Randomized Blinded, Placebo Controlled Trial of Intrapoperative Ketamine for Patients Undergoing Total Joint",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-05",
"study_completion_date(actual)": "2024-06-01",
"study_start_date(actual)": "2020-09-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-27",
"last_updated_that_met_qc_criteria": "2020-06-16",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-18",
"first_submitted": "2020-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies.
#Intervention
- DRUG : Zanubrutinib
- Oral administration by capsule
- Other Names :
- BGB-3111, Brukinsa | #Eligibility Criteria:
Inclusion Criteria:
* Aged >= 18 years, voluntarily consented to the study.
* WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.
* Requirement for treatment in the opinion of the investigator.
* Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2.
* Adequate hematologic function, as defined by neutrophils >= 1.0 x 10^9/L and platelets >= 50 x 10^9/L; participants with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to >= 1.0 x 10^9/L.
* Adequate renal function, as defined by creatinine clearance of >= 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
* Adequate liver function, as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 x upper limit of normal (ULN), and bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome).
* International normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (APTT) <= 1.5 x ULN.
* Female participants of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
* Male participants must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.
Exclusion Criteria:
* Current central nervous system (CNS) involvement by disease
* Current histologically transformed disease.
* Prior Bruton's tyrosine kinase (BTK) inhibitor treatment.
* Allogeneic stem cell transplantation within 6 months, or has active graft-versus-host disease (GVHD) requiring ongoing immunosuppression.
* Receipt of the following treatment prior to first dose of zanubrutinib: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks.
* Not recovered from toxicity of any prior chemotherapy to grade <= 1.
* History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
* Uncontrolled systemic infection requiring parenteral anti-microbial therapy.
* Major surgery in the past 4 weeks.
* Known HIV, or active hepatitis B or hepatitis C infection (detected positive by PCR).
* Cardiovascular disease resulting in New York Heart Association function status of >= 3.
* Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
* Inability to comply with study procedures.
* On medications which are cytochrome P450 (CYP) 3A inhibitors.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02343120 | {
"brief_title": "Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies",
"conditions": [
"B-cell Malignancies"
],
"interventions": [
"Drug: Zanubrutinib"
],
"location_countries": [
"United States",
"United Kingdom",
"New Zealand",
"Australia",
"Italy",
"Korea, Republic of"
],
"nct_id": "NCT02343120",
"official_title": "A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-31",
"study_completion_date(actual)": "2021-03-31",
"study_start_date(actual)": "2014-09-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-28",
"last_updated_that_met_qc_criteria": "2015-01-15",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-21",
"first_submitted": "2015-01-09",
"first_submitted_that_met_qc_criteria": "2022-03-30"
}
}
} |
#Study Description
Brief Summary
Prostate biopsy is indicated in patients with suspected prostate cancer and has been traditionally performed through the rectum using antibiotic prophylaxis. Increasing antibiotic resistance of intestinal bacteria is causing a growing number of patients to get post-biopsy infections. Sepsis rate after transrectal biopsies is approximately 4-10%.
To reduce the risk of post-biopsy infections, transperineal approach in general anesthesia and antibiotic prophylaxis has been used. The investigators at Oslo University Hospital Aker developed MRI -TURS elastic image fusion guided transperineal prostate biopsy technique in local anesthesia and Bactrim prophylaxis as outpatient procedure. The investigators found 0.4% post-biopsy infection rate. Afterwards a pilot study using the same biopsy technique however without antibiotic prophylaxis was realized in 90 patients. None of these subjects experienced infection.
The investigators wish to perform a prospective randomized trial of antibiotic prophylaxis versus none before transperineal MRI-TRUS fusion guided prostate biopsy in local anesthesia in outpatient clinic.
Detailed Description
Background: Unnecessary use of antibiotics promotes antibiotic resistance. Efforts for antibiotic use reduction without increase the risk of serious infection complications are therefore needed.
Purpose: The aim of this trial is to compare the rates of infectious complication after transperineal prostate biopsy in patients with and without antibiotic prophylaxis.
Materials and methods: A total of 450 patients will be included in this trial. A 1:1 randomization to receive or not receive antibiotics prophylaxis will be performed using randomization system WebCRF-3 system. MRI-TRUS fusion prostate biopsy will be done with transperineal prostate approach in local anesthesia in outpatient clinic. In patients with normal MRI,12-core systematic prostate biopsies with 3D biopsy registration will be done according to the EAU guidelines. In patients with positive MRI, 2-4 targeted biopsies from the suspicious MRI areas will be realized and systematic prostate biopsies will also be done. All prostate biopsies will be performed using Koelis MRI-TRUS image fusion and organ based tracking system. Post-biopsy infection and any adverse events will be systematically prospectively registered in all patients. Pain during the local anesthesia application and during the biopsy procedure will be registered using Visual Analog Score, 10 points scale questionnaire.
#Intervention
- PROCEDURE : Transperineal prostate biopsy with or without antibiotic prophylaxis
- As described above. | #Eligibility Criteria:
Inclusion Criteria: Clinical indication for prostate cancer
*
Exclusion Criteria:
* Patients with symptoms of urinary tract infection or positive findings on urine dipstic before biopsy
* Patients with indwelling urethral catheter
* Patients with immunodeficiency disorders
* Patients with high risk for infective endocarditis [European Society of Cardiology]
1. Patients with a prosthetic aortic or pulmonary valve
2. Patients with previous infective endocarditis
3. Patients with congenital heart disease who are cyanotic and those who have had palliative shunts/conduits/other prostheses
* Patients with a history of thromboembolic disease
* Patients with a history of allergy to the study drug
* Patients who do not wish to participate in the study
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04146142 | {
"brief_title": "Transperineal MRI-TRUS Fusion Guided Prostate Biopsy With vs Without Antibiotic Prophylaxis",
"conditions": [
"Prostate Biopsy",
"Antibiotic"
],
"interventions": [
"Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis"
],
"location_countries": [
"Germany",
"Norway"
],
"nct_id": "NCT04146142",
"official_title": "A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-28",
"study_completion_date(actual)": "2021-04-30",
"study_start_date(actual)": "2019-11-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-12-07",
"last_updated_that_met_qc_criteria": "2019-10-29",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-31",
"first_submitted": "2019-10-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Brief summary: Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) is a regional anesthesia technique shown to be effective at the dorsal and ventral rami of the thoracic spinal nerve along with sympathetic nerve fibers. The purpose is to demonstrate the contribution of ESP block to the postoperative analgesia by ultrasonography and to increase intraabdominal tissue oxygenation compared to the control group.
Detailed Description
50 patients with American Society of Anesthesiologists (ASA) physical score I-II were randomly divided into 25 patients in the ESP group and 25 patients in the control group. Patients were premedicated with oral midazolam 0.5 mg kg-1, 30 minutes before surgery Anesthesia monitorization was made with electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation (SpO2), end-tidal carbon dioxide, temperature, Bispectral index (BIS), and Regional tissue saturation (rSO2). Anesthesia was induced with a face mask distributing 8% sevoflurane and 50% air in oxygen while the patients were breathing spontaneously. After anesthesia induction, peripheral venous access was established and propofol 2 mg kg-1 and fentanyl citrate 1 μg kg-1 were administered. Laryngeal mask airways were used to secure the upper airways. Anesthesia was maintained with sevoflurane and 50% air in oxygen. The concentration of sevoflurane was adjusted by targeting BIS scores at 50-60 in all groups. During the operations, fentanyl was administered at a dose of 0.5 μg kg-1 if the blood pressure and heart rates were 20% higher than the baseline value. In ESP blok groups, after general anesthesia induced, patients were placed in the lateral position and ESP block was performed under ultrasound guidance. For ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine was administered. In all groups, regional tissue saturation (RSO2) was evaluated Continuously with near infrared spectroscopy (NIRS) probe from anesthesia induction to the end of surgery. Commercially available device (INVOS Cerebral Oximeter; somatics Corp, Troy, Mich) was used to monitor rSO2 values in the surgery side flank during surgical intervention. Pain was evaluated and recorded using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at the 1st, 2nd, 8th, 12th and 24th hours. Total analgesic consumption was recorded during the operation and postoperative time to first analgesic drug and number of patients who required analgesic in the first 24 hours, parents satisfaction score, discharge time as well as adverse effects such as nausea and vomiting were recorded in the postoperative periods.
#Intervention
- DRUG : Bupivacaine and Lidocaine
- ESP block was administered under general anesthesia before the surgery. Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine
- Other Names :
- ESP block | #Eligibility Criteria:
Inclusion Criteria:
* Children aged 6 months to 2 years
* According to American Anesthesia Society Anesthesia Risk Scale ASA I-II class patients
* Patients with lower abdominal surgery
Exclusion Criteria:
* Children under 6 months and older than 2 years
* According to American Anesthesia Society Anesthesia Risk Scale Patients with ASA III-IV class
* Patients with contraindication to regional anesthesia
* Patients with a history of local anesthetic allergy
* Patients with abnormal coagulation profile
* Patients with infection at the injection site
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT03808129 | {
"brief_title": "Erector Spinae Plane Block for Peroperative Analgesia and Intraabdominal Tissue Oxygenation",
"conditions": [
"Lower Abdominal Surgery"
],
"interventions": [
"Drug: Bupivacaine and Lidocaine"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT03808129",
"official_title": "The Evaluation of Ultrasonography-guided Erector Spinae Plane Block in Perioperative Analgesia and Intraabdominal Tissue Oxygenation in Pediatric Patients Undergoing Lower Abdominal Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-12",
"study_completion_date(actual)": "2019-04-20",
"study_start_date(actual)": "2019-01-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-20",
"last_updated_that_met_qc_criteria": "2019-01-15",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-17",
"first_submitted": "2018-12-13",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum creatine kinase (CK) and serum myoglobin were observed. This high intensity resistance trainings is a part of Military Training(MT)，which all the middle school students must finish before admission。
| #Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of rhabdomyolysis;
* Caused by military training;
* Informed consent；
* Must be able to cooperate with blood test.
Exclusion Criteria:
* Caused by drugs and other reasons;
* No hospitalization event
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03737513 | {
"brief_title": "Exercise-induced Collective Rhabdomyolysis",
"conditions": [
"Rhabdomyolysis"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT03737513",
"official_title": "Exercise-induced Collective Rhabdomyolysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-31",
"study_completion_date(actual)": "2019-05-31",
"study_start_date(actual)": "2018-09-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-25",
"last_updated_that_met_qc_criteria": "2018-11-08",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-09",
"first_submitted": "2018-11-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).
Detailed Description
The recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of CABG-related bleeding. There is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel.
For example, studies of the VerifyNow P2Y12 platelet function assay have shown that Platelet Reactivity Units (PRU) \> 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 There is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. In other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? This is an especially relevant question, given the emergence of prasugrel as a therapeutic option.
The investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing CABG, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.
#Intervention
- OTHER : Platelet reactivity assessment
- Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay. | #Eligibility Criteria:
Inclusion Criteria:
* Patients >= 18 years from both genders.
* Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
* Referred for CABG (which is scheduled to be performed during the current admission).
Exclusion Criteria:
* Known allergies to aspirin, clopidogrel, or prasugrel.
* Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
* Patient known to be pregnant or lactating.
* Patient with known history of bleeding diathesis or currently active bleeding.
* Platelet count <100,000/mm the day of initial blood draw.
* Hematocrit <25% the day of initial blood draw.
* On warfarin therapy at the time of initial blood draw.
* Known blood transfusion within the preceding 10 days of the blood draw.
* Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
* Plan for patient to be discharged before undergoing CABG.
* Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01406483 | {
"brief_title": "Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting",
"conditions": [
"Complication of Coronary Artery Bypass Graft",
"Peri-operative Hemorrhage or Hematoma",
"Post Operative Bleeding"
],
"interventions": [
"Other: Platelet reactivity assessment"
],
"location_countries": null,
"nct_id": "NCT01406483",
"official_title": "Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2010-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-16",
"last_updated_that_met_qc_criteria": "2011-07-29",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-01",
"first_submitted": "2011-07-22",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected on the precaution in the use, ADRs already known, non-serious ADRs and other safety related information (laboratory values changes, etc).
Detailed Description
This is a long-term prospective, observational post-marketing surveillance study of azilsartan medoxomil in participants with essential hypertension. This study will assess the safety and effectiveness of azilsartan medoxomil prescribed as a monotherapy or taken concomitantly with other anti-hypertension therapies in real-world clinical practice settings.
The study will enroll approximately 3000 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
* Participants With Essential Hypertension
The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits over the surveillance period, scheduled at Visit 1 (Baseline), Visit 2 (6 Weeks), Visit 3 (3 Months or more less than 6 Months) and Visit 4 (6 Months or more \[Month 9\]). The overall duration of the study will be approximately 6 years. All participants will be followed up for 9 months after drug administration.
#Intervention
- DRUG : Azilsartan Medoxomil
- Azilsartan Medoxomil | #Eligibility Criteria:
Inclusion Criteria:
* With Essential Hypertension.
* Newly diagnosed with essential hypertension or who have no long-term history of hypertension medication after diagnosis (The participant has a SBP or DBP >=140 or 90 mmHG, respectively).
* Receiving treatment with other hypertension medications.
* Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.
Exclusion Criteria:
* Treated with azilsartan medoxomil outside of the locally approved label in South Korea.
* With known hypersensitivity or presence of any contraindication to azilsartan medoxomil.
* Use of aliskiren in combination with azilsartan medoxomil in participants with diabetes or with moderate to severe renal impairment (glomerular filtration rate [GFR ] < 60 milliliter per minute [mL/min]/1.73 m^2).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04470817 | {
"brief_title": "A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea",
"conditions": [
"Essential Hypertension"
],
"interventions": [
"Drug: Azilsartan Medoxomil"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04470817",
"official_title": "Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil in the Treatment of Adult Patients With Essential Hypertension in South Korea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-25",
"study_completion_date(actual)": "2023-05-25",
"study_start_date(actual)": "2018-08-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-26",
"last_updated_that_met_qc_criteria": "2020-07-13",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-14",
"first_submitted": "2020-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.
Detailed Description
Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent and has dramatic consequences on the quality of life and health of affected patients. Due to the complex interrelation between these conditions, patients often experience both psychological and physiological difficulties. Furthermore, Veterans with diabetes and depressive symptoms in rural settings have limited access to care. Interventions that reach Veterans in rural / community-based primary care are needed, especially those that blend treatment strategies for physical and emotional health.
Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6 and 12 month follow-up.
Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured by PHQ-9 scores) than will EUC.
Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significant greater improvements in HbA1c and PHQ-9 compared with EUC participants.
Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for all enrolled patients (regardless of intervention group assignment). Potential mediating and moderating variables include patient-level (clinical factors-diabetes distress and self-efficacy and sociodemographics) and facility-level factors (availability of medical and mental health services by clinical site).
Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm. Intervention factors include adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment implementation (e.g., goal setting quality and self-management behaviors) as well as any significant predictors obtained from Aim 1a.
Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention processes within a VA CBOC using the REAIM framework for evaluating effectiveness of behavioral interventions.
Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled study participants with the characteristics of all potentially eligible patients at each CBOC.
Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians' perceptions of behavioral coaches, patients' use of action plans, and responses to coaches' recommendations in preparation for future implementation
Project Methods: The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period. Coaches will use a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Participants' primary care providers will be notified about session discussions and the resultant goals and action plans. Both groups will receive only usual primary care during the subsequent 6 months maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. Changes in measurements from baseline will be compared between groups. Analytic evaluations of intervention mediators/moderators and implementation will also be conducted at 6 and 12 months follow-up.
#Intervention
- BEHAVIORAL : Healthy Outcomes through Patient Empowerment (HOPE)
- HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.
- BEHAVIORAL : Enhanced Usual Care
- All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. | #Eligibility Criteria:
Inclusion Criteria:
* Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
* as well as MEDVAMC patients living >20 miles from the hospital who face similar distance related treatment barriers
Participants must have:
* a diagnosis of diabetes mellitus
* an average HbA1c level >7.5% in the prior 6 months
* clinically significant symptoms of depression
* Verification of diabetes mellitus diagnoses will be based on data collected from the VA data warehouse.
* To verify that participants meet the depression criteria, the investigators will use participant self-report of clinically significant depressive symptoms according to the PHQ-9, where a score of greater than/equal to 10 on the PHQ-9 will signify a clinically meaningful symptom burden.
Exclusion Criteria:
* The investigators will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
* Specific exclusion criteria are:
* lack of regular access to a telephone
* significant cognitive impairment (three or more errors) on an established six-item screening exam
* meeting criteria for bipolar, psychotic, or substance-abuse disorders
* presence of uncorrected hearing or vision impairment
* their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
* they live within 20 miles of the MEDVAMC.
* Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
* Patients receiving mental health services at the time of study recruitment will not be excluded.
* All mental health treatments and health service-use characteristics will be included in study analyses as covariates.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01572389 | {
"brief_title": "Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression",
"conditions": [
"Diabetes Mellitus",
"Depression"
],
"interventions": [
"Behavioral: Enhanced Usual Care",
"Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01572389",
"official_title": "Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-24",
"study_completion_date(actual)": "2016-09-30",
"study_start_date(actual)": "2012-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-01",
"last_updated_that_met_qc_criteria": "2012-04-03",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-06",
"first_submitted": "2012-03-07",
"first_submitted_that_met_qc_criteria": "2017-06-14"
}
}
} |
#Study Description
Brief Summary
The relationship of body function, participation and quality of life in patients with burn: A longitudinal study
Detailed Description
Early rehabilitation to partial-thickness and full-thickness dermal injury are of vital importance for burn patient. Literature reviews have shown that burn patients experiences ADL and quality of life (QOL) difficulties. Due to varied severity, the outcome and expression of each patient also differs. The limitation of body function may consequently affect social participation and QOL thereafter.
| #Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of burn injuries admitted to Burn Center or followed in burn clinic
* Age >14
* No mental diseases
* Understand written Chinese or could complete the questionnaires with staff's assistance
Exclusion Criteria:
* Died during or after hospitalization
* Refused to participate in the investigation
* Concurrent medical illness that affecting the subjectivity of post burn sequelae (ex. progressive muscular or mental diseases, trauma or seizure)
* Age >74
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT02950675 | {
"brief_title": "The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study",
"conditions": [
"Burn"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT02950675",
"official_title": "The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07",
"study_completion_date(actual)": "2019-07",
"study_start_date(actual)": "2016-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-02",
"last_updated_that_met_qc_criteria": "2016-10-31",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-01",
"first_submitted": "2016-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Researchers are trying to incorporate a process known as Functional MRI (fMRI) scanning to reveal a pattern in brain activity during Deep Brain Stimulation (DBS), which will correlate to possible seizure freedom.
#Intervention
- DIAGNOSTIC_TEST : Functional MRI
- A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain. | #Eligibility Criteria:
Inclusion Criteria
* Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy
Exclusion Criteria
* Contraindication to MRI
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03870308 | {
"brief_title": "fMRI of Active DBS Stimulation in Epilepsy",
"conditions": [
"Epilepsy"
],
"interventions": [
"Diagnostic Test: Functional MRI"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03870308",
"official_title": "fMRI of Active DBS Stimulation in Epilepsy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-31",
"study_completion_date(actual)": "2021-01-11",
"study_start_date(actual)": "2019-03-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-17",
"last_updated_that_met_qc_criteria": "2019-03-08",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-12",
"first_submitted": "2019-03-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.
#Intervention
- DRUG : Placebo
- BID
- DRUG : Pregabalin
- Dose 75 mg titrated to 150 mg, bid
- DRUG : Tramadol SR
- Dose 50mg titrated to 200 mg, bid | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.
* Brush allodynia score of >=4 and calculated average pain score of >=3 on an 11-point numerical rating scale by the completion of down-titration of existing medications.
* Right-handed
Exclusion Criteria:
* Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).
* Phantom limb pain, painful diabetic neuropathy.
* Subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from NeP of peripheral origin.
* Subjects with diabetes mellitus and with an HbA1C value of >10% upon measurement at screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00610155 | {
"brief_title": "A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients",
"conditions": [
"Pain"
],
"interventions": [
"Drug: Tramadol SR",
"Drug: Pregabalin",
"Drug: Placebo"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00610155",
"official_title": "A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-22",
"last_updated_that_met_qc_criteria": "2008-01-24",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-07",
"first_submitted": "2008-01-14",
"first_submitted_that_met_qc_criteria": "2013-09-19"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
Detailed Description
The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.
#Intervention
- DRUG : tinzaparin
- tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
- Other Names :
- innohep
- DRUG : acenocoumarol
- tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
- Other Names :
- Vitamin K antagonists | #Eligibility Criteria:
Inclusion Criteria:
* Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
* either sex and > 18 years
* referred to the Vascular Surgery Department of the hospital
* onset of symptoms less than 2 weeks
* documented by compression ultrasonography,
Exclusion Criteria:
* received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
* pulmonary embolism requiring thrombolytic therapy
* Need of surgical thrombectomy or vena cava interruption
* receiving oral anticoagulant treatment or antiplatelet agents for other conditions
* contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
* platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
* severe renal failure necessitating dialysis
* pregnancy
* lumbar puncture within the previous 24 hours
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00689520 | {
"brief_title": "Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis",
"conditions": [
"Venous Thromboembolism"
],
"interventions": [
"Drug: acenocoumarol",
"Drug: tinzaparin"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT00689520",
"official_title": "Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-01",
"study_completion_date(actual)": "2005-01",
"study_start_date(actual)": "2002-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-06-03",
"last_updated_that_met_qc_criteria": "2008-06-02",
"last_verified": "2008-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-03",
"first_submitted": "2008-05-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary aim of the study is to determine the rate sedation-induced adverse events, comparing BIS-guided sedation with clinical observation. Secondary outcomes were to examine patient characteristics who developed adverse events, propofol and remifentanil dosage and patient satisfaction analyzing different time points undergoing elective colonoscopy.
Detailed Description
Randomized double-blind clinical trial in patients undergoing scheduled colonoscopies in endoscopy rooms of the Galdakao-Usánsolo Hospital (Bizkaia, Spain) and Mendaro Hospital (Gipuzkoa, Spain). The investigators will compare the rate of cardiorrespiratory adverse events as well as the anesthetic drugs dosage, need for rescue medication and patient satisfaction among the experimental group in which sedation is guided by BIS and the control group in which the anesthesiologist is blind to the result of the BIS. The investigators hypothesized that BIS monitoring would be associated with better outcomes than clinical observation.
The BIS is the parameter of anesthetic depth monitoring most used today. Its use was approved by the Food and Drug Administration (FDA) in 1996 as an aid to control the effects of certain anesthetic agents. It is validated in the operating room (Recommendation grade A), but not outside it due to lack of conclusive studies.
180 patients are needed to obtain statistically significant differences between both groups. Qualitative variables are expressed in the form of frequencies and percentages and continuous variables in the form of means and standard deviations. Comparisons of percentages will be made by the Chi square test (or Exact Fisher's test, when the expected frequencies are less than 5) and the difference of means in the continuous variables by the t test as well as by the Wilcoxon nonparametric test if the distribution of the variable requires it. The degree of agreement between the BIS and Ramsay scale will be made through the weighted Kappa test. Statistical significance will be assumed when p \<0.05. All statistical analyzes will be carried out using SAS V9.4. (SAS institute, Inc., Carey, NC).
#Intervention
- DEVICE : BIS monitor
- The investigators will place on the forehead of all patients the sensor BIS quatroTM, that connects with this monitor, and they will guide sedation and will record the values obtained.
- Other Names :
- BIS VISTA; Aspect Medical Systems, USA
- DEVICE : Ramsay scale
- In this group, sedation is guided by the Ramsay monitoring scale. The investigators will talk with the patients and will determine the corresponding level of sedation.
- Other Names :
- Conventional monitoring | #Eligibility Criteria:
Inclusion Criteria:
* Indication of complete colonoscopy on a scheduled basis.
* Classification of physical status ASA I, II and III, with the exception of patients with moderate to severe kidney and / or liver disease.
* Intermittent or persistent mild asthma. It implies the absence of daily symptoms and FEV1> 80% (GINA 2004).
* Body Mass Index (BMI) less than 35 kg / m2, and greater than 18 kg/m2.
* Intact neurological capacity.
* Acceptance to participate in the study after the contribution of written informed consent.
Exclusion Criteria:
* ASA IV.
* BMI greater than 35 kg / m2, and less than 18 kg/m2.
* Refusal to participate in the study.
* Allergy to any of the medications used in sedation, or its components.
* Known mental or neurological disease.
* Renal and / or moderate to severe Hepatic insufficiency.
* Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
* Chronic opiate users.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03453359 | {
"brief_title": "Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial",
"conditions": [
"Colonoscopy"
],
"interventions": [
"Device: BIS monitor",
"Device: Ramsay scale"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03453359",
"official_title": "Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-20",
"study_completion_date(actual)": "2020-06-30",
"study_start_date(actual)": "2018-01-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-07",
"last_updated_that_met_qc_criteria": "2018-03-02",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-05",
"first_submitted": "2018-01-27",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to visual ethanol cues, followed by oral ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the association between stress, cortisol release, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.
Detailed Description
Results from the 2014 National Survey on Drug Use and Health show that 26% of adults in the US engaged in binge drinking in the past month (SAMHSA 2014). Why some people 'mature out' of this behavior while others persist may be due to one's physiological response to binge drinking. No previous study has assessed whether disrupted cortisol and neural network responses to alcohol cues may drive the compulsive alcohol consumption seen in binge drinking individuals who do not yet have an AUD.
The investigator will recruit beer drinking, non-smoking men and women ages 21-45 (N=80, equal gender) who are either moderate drinkers or binge/heavy drinkers for two neuroimaging and neuroendocrine assessments to determine if their 'real world' drinking behavior, in a prospective one month follow up, can be predicted based upon the cortisol and neural network responses to alcohol cues (with a placebo control, counter-balanced and randomized). Finally, the influence of genetic variation in the FK506-binding protein 5 (FKBP5) gene, which regulates cortisol activity, on the cortisol and neural network responses to alcohol cues will be explored.
#Intervention
- DRUG : Intravenous blood draw
- In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session
- Other Names :
- Indwelling catheter for blood draws | #Eligibility Criteria:
Inclusion Criteria:
* Binge/Heavy Social Drinkers (HSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of at least 10 drinks per week, including at lease one occasion per week consuming >4 drinks (males) or >3 drinks (females).
* Able to read and write English.
* Light Social Drinkers (LSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of 1 <= age <= 3 drinks per occasion, 1 <= age <= 3 times weekly, with no more than one occasion per month of drinking >4 drinks (male) or >3 drinks (females) (King et al., 2002).
* Do not meet criteria for any Axis I DSM-IV psychiatric diagnoses except for individuals with a past diagnosis of Post-Traumatic Stress Disorder, Major Depressive Disorder, or Obsessive Compulsive Disorder
* Provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
* Body Mass Index between 20 <= age <= 35.
* No current or former nicotine dependence.
Exclusion Criteria:
* Meet current criteria for dependence on any psychoactive substance, excluding caffeine.
* Current or past history of alcohol dependence or abuse.
* Any current use of opiates or past history of opiate abuse/dependence.
* Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
* Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
* Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
* Peri and post-menopausal women, and those with hysterectomies.
* Pregnant and lactating women will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04412824 | {
"brief_title": "Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation",
"conditions": [
"Alcohol Use Disorder"
],
"interventions": [
"Drug: Intravenous blood draw"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04412824",
"official_title": "Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2020-05-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-22",
"last_updated_that_met_qc_criteria": "2020-06-01",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-02",
"first_submitted": "2020-05-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.
Detailed Description
Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.
Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.
#Intervention
- PROCEDURE : Graft augmented posterior repair
- Posterior repair with graft
- PROCEDURE : Control
- Native tissue repair | #Eligibility Criteria:
Inclusion Criteria:
* Women with stage 2 or greater symptomatic rectocele
* Women electing to undergo surgical rectocele repair
* Women over age 21 years
* Women willing to comply with study procedures and follow-up
Exclusion Criteria:
* Pregnant or nursing women
* History of porcine allergy
* History of connective tissue disease, pelvic malignancy, or pelvic radiation
* Women undergoing concurrent sacral colpopexy
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00321867 | {
"brief_title": "Graft-Augmented Rectocele Repair-A Randomized Surgical Trial",
"conditions": [
"Rectocele"
],
"interventions": [
"Procedure: Control",
"Procedure: Graft augmented posterior repair"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00321867",
"official_title": "Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-05-28",
"last_updated_that_met_qc_criteria": "2006-05-03",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-04",
"first_submitted": "2006-05-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Objective:
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg \[Test formulation, Torrent Pharmaceuticals Ltd., India\] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) \[Reference formulation, Forest Laboratories Inc, USA\] . Dosing periods were separated by a washout period during fasted study.
Study Design:
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
#Intervention
- DRUG : Escitalopram Oxalate Tablets | #Eligibility Criteria:
Inclusion Criteria:
The volunteers were included in the study based on the following criteria:
* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18 <= age <= 27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01996462 | {
"brief_title": "Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Escitalopram Oxalate Tablets"
],
"location_countries": [
"India"
],
"nct_id": "NCT01996462",
"official_title": "An Open Label, Randomised, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet Containing Escitalopram (20mg) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® Tablet (20mg) [Reference Formulation, Forest Laboratories, USA] in Healthy Human Volunteers Under Fasting Condition",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05",
"study_completion_date(actual)": null,
"study_start_date(actual)": null
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-11-27",
"last_updated_that_met_qc_criteria": "2013-11-21",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-27",
"first_submitted": "2013-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Many active and passive rehabilitation programs are applied in the rehabilitation processes after flexor tendon repair. There is no clear rehabilitation program accepted by the whole world. An accurate understanding of these injuries at the histological and biomechanical level is necessary to improve rehabilitation outcomes. Mechanical properties of tendons, such as their viscoelasticity, are affected by the increase in stiffness caused by the rupture, repair, and healing process. Previous studies have shown that the mechanical properties of a repaired tendon, such as stiffness, material properties and functionality of tendon tissue Shear-wave elastography can detect pathological changes in tendinopathy before they are visible on conventional Ultrasonography imaging. In addition, shear wave elastography allows the evaluation of quantitative measurements and is considered more objective because it provides reproducible results. Our aim in this study is to evaluate the changes in the mechanical properties of the hand flexor tendons repaired using shear wave elastography (SWE) during the rehabilitation process and natural process and their effect on functionality.
Detailed Description
Patients' affected tendons will be evaluated by shear wave elastography within 3 - 5 days after surgery. The tendons of the healthy hands of the patients will also be evaluated as the control group.
Afterwards, patients will be randomized into two groups by computer-assisted randomization.
Group 1: early passive mobilization Within 3 to 5 days following surgery, patients will begin using a dorsal forearm-based orthosis with 30\* flexion of the wrist, 70\* flexion of the metacarpophalangeal (MCP) joints, full extension of the interphalangeal (IF) joints. Home exercises will be performed as passive flexion and active extension exercises with rubber band 10 times per hour on the postoperative 3rd day for 3 weeks. Passive flexion and extension exercises will be performed ten times a day, four times a day, on the MCP + Proximal Interphalangeal (PIP) + IF joints. The bands will be removed at night and the fingers will be kept in full extension. In 3 weeks, the orthosis will be modified so that the wrist is in a neutral position and the MCP joints are extended a little more. Approximately 3 weeks after the repair, the dorsal orthosis will be removed during the exercises, and non-resistance active movement and tenodesis exercises will be started in the presence of a physiotherapist. From the 6th week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking exercises will be started.
Group 2: early active mobilization Patients will begin to use a dorsal forearm-based orthosis that positions the wrist in a neutral position, metacarpophalangeal (MCP) joints 50\* -70\* flexion, IF joints in full extension within 3 to 5 days after surgery. After the flexion active extension exercises, full passive flexion of the fingers with the other intact hand and then gently keeping the fingers in the flexion position for 3-5 seconds when the contralateral hand is raised will be performed for 3 weeks, no force will be applied on the fingers. Passive flexion and extension exercises will be performed ten times a day, four times a day, on the MCP + PIP + IF joints. These exercises will be organized as a home exercise program. The patients will be evaluated by the physiotherapist and clinician once a week in the first two weeks of the exercises, and 3 days a week in the third week, in terms of monitoring the exercises, and the exercises will be shown again. The bands will be removed at night and the fingers will be kept in full extension. Approximately 3 weeks after the repair, the dorsal orthosis will be removed during the exercises, and the patients will be started with non-resistance active movement and tenodesis exercises in the form of a home exercise program 3 days a week with a physiotherapist on the remaining days. From the 6th week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking exercises will be started.
Patients will be evaluated by an investigator blinded to the treatment groups at week 8 and week 12 using the following methods.
1. Tendon elasticity will be evaluated with shear wave elastography
2. Measurements of hand grip strength and pinch strength (only at 12 weeks) will be evaluated with a dynamometer device.
3. Duruoz Hand Index will be filled.
4. Total active movements of the fingers will be calculated.
#Intervention
- PROCEDURE : early active mobilization
- In the active rehabilitation group, active extension and passive flexion of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints were performed with kleinert splint at angles suitable for active mobilization group.Then, the patients were asked to passively flex the injured side with their healthy hand and hold it in the flexion position for 3-5 seconds.
- PROCEDURE : early passive mobilization
- In the passive rehabilitation group, active extension and passive flexion of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints were performed with kleinert splint at angles suitable for passive mobilization group. | #Eligibility Criteria:
Inclusion Criteria:
* Forty patients aged 18 <= age <= 75 years who had flexor tendon injury and underwent primary surgical repair (within the first 10 days after injury) will be included in the study
Exclusion Criteria:
* Patients with a history of previous hand trauma, neurological or systemic disease affecting the hand, patients with a history of upper extremity surgery, concomitant extensor tendon injury, fracture and amputation will be excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05598918 | {
"brief_title": "Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand",
"conditions": [
"Tendon Injuries"
],
"interventions": [
"Procedure: early passive mobilization",
"Procedure: early active mobilization"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05598918",
"official_title": "Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand, and Investigation of Factors Affecting the Results",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-01",
"study_completion_date(actual)": "2022-12-01",
"study_start_date(actual)": "2022-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-08",
"last_updated_that_met_qc_criteria": "2022-10-27",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-28",
"first_submitted": "2022-08-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.
#Intervention
- PROCEDURE : Sudden wean of nasal CPAP
- PROCEDURE : Gradual wean of nasal CPAP | #Eligibility Criteria:
Inclusion Criteria:
* Gestational age < 32 weeks at birth
* Current gestational > 28 years6 weeks
* Nasal CPAP for > 24 hours
* Nasal CPAP pressure < 8 cmH2O
* Oxygen requirement < 30% and not increasing
* Respiratory rate < 70 per minute
* Less than 3 episodes of oxygen saturation < 70% or a heart rate < 70 beat per minute in the preceding 24 hours
* Tolerates time off CPAP during cares (up to 15 minutes)
Exclusion Criteria:
* Congenital malformations of the heart (except patent ductus arteriosus, atrial septal defect and patent foramen ovale), lung, and gastrointestinal tract
* Surgical procedures performed on the gastrointestinal tract
* Known or suspected to have congenital neuromuscular disease
* Known or suspected syndrome
Sex :
ALL
Ages :
- Maximum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT01721629 | {
"brief_title": "Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants",
"conditions": [
"Prematurity",
"Respiratory Distress Syndrome, Infant"
],
"interventions": [
"Procedure: Gradual wean of nasal CPAP",
"Procedure: Sudden wean of nasal CPAP"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT01721629",
"official_title": "Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-28",
"study_completion_date(actual)": "2017-04-28",
"study_start_date(actual)": "2012-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-01",
"last_updated_that_met_qc_criteria": "2012-11-05",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-06",
"first_submitted": "2012-09-25",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The goal of this observational study is to study the features of psychophysical development and the morbidity patterns of children born after assisted pregnancy, and to identify the connection with the health status of mothers, followed by the development of a prediction model and general principles of management of children born after ART. The main questions it aims to answer are: • the influence of premorbid background of mothers on children's physical development, disease occurrence and morbidity patterns of children born as after ART.
* To identify the indicators of cellular and humoral immunity in children born after different oocyte fertilization methods in IVF programs (classical IVF or ICSI).
* To study the long-term effects of ART on the endocrine status of children.
It will be studied hemogram examination, immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) and laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) in 120 children born after ART. Researchers will compare 132 children conceived spontaneously to see if ART can influent on the health status in future.
Detailed Description
The tasks of the planned scientific and engineering project are based on the study of health status of children born after ART. The presence of a large cohort of children after ART in Kazakhstan will allow us to study morbidity patterns with the connection of mother's anamnesis, as well as to develop a prediction model and algorithms for the management of children conceived by assisted pregnancy. A comprehensive assessment of the health status of children born after ART will make it possible to determine the effect of the method of conception on the risks of immunity-related diseases and endocrine system pathology. It will allow us to predict deviations and ensure timely access to specialists and further examination. The presence of a burdened psychological background in couples with infertility may further influence the psychosocial adaptation of children conceived by ART and/or provoke higher morbidity rates in this group of children. It is important for the healthy and full integration of these children into society, including successful professional development in the future.
2.2. The project objective: to study the features of psychophysical development and the morbidity patterns of children born after assisted pregnancy, and to identify the connection with the health status of mothers, followed by the development of a prediction model and general principles of management of children born after ART.
Project Tasks
1. To study the influence of premorbid background of mothers on children's physical development, disease occurrence and morbidity patterns of children based on a retrospective study of 120 medical records of mothers and their children born as after ART.
2. To determine the indicators of cellular and humoral immunity (hemogram examination, cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) in children born after ART.
3. To study the long-term effects of the hormone therapy in 120 mothers on the endocrine status (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) of children born after ART.
4. To develop a prediction model and algorithms for the management of children born after ART.
#Intervention
- DIAGNOSTIC_TEST : hemogram examination
- It will be studied hemogram examination, immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) and laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) in 120 children born after ART. Researchers will compare 132 children conceived spontaneously to see if ART can influent on the health status in future.
- Other Names :
- immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG), laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) | #Eligibility Criteria:
Inclusion Criteria:
* successful ART program after IVF and ICSI,
* the transfer of fresh and frozen-thawed embryos (FET)
* a single or multiple pregnancy
* the birth of a child in the period from 2017 to 2023.
Exclusion Criteria:
* intrauterine insemination
* ART programs with donor gametes
* surrogacy.
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 60 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT06094998 | {
"brief_title": "Health Status of Children Born After Assisted Reproductive Technologies",
"conditions": [
"Children Born After Assisted Reproductive Technologies",
"Health Status",
"Child Development"
],
"interventions": [
"Diagnostic Test: hemogram examination"
],
"location_countries": [
"Kazakhstan"
],
"nct_id": "NCT06094998",
"official_title": "Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-19",
"study_completion_date(actual)": "2024-01-22",
"study_start_date(actual)": "2023-10-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-07",
"last_updated_that_met_qc_criteria": "2023-10-17",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-23",
"first_submitted": "2023-10-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.
#Intervention
- DEVICE : INSORB
- dermal stapler for skin closure
- PROCEDURE : classic intradermal suture
- intradermal suture for skin closure | #Eligibility Criteria:
Inclusion Criteria:
* Patient who will have thyroid surgery
Exclusion Criteria:
* done thyroid surgery before
* done any radiotherapy on neck
* who needs neck dissection
* laparoscopic ot robotic surgery
* under 18 years or > 70 years
* bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
* who used immunosuppressive drugs in 6 months
* breast feeder or pregnancy
* who disagrees to do this trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03108742 | {
"brief_title": "Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy",
"conditions": [
"Thyroidectomy",
"Pain",
"Esthetic",
"Dermal Stapler"
],
"interventions": [
"Procedure: classic intradermal suture",
"Device: INSORB"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03108742",
"official_title": "Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-28",
"study_completion_date(actual)": "2019-01-28",
"study_start_date(actual)": "2016-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-25",
"last_updated_that_met_qc_criteria": "2017-04-05",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-11",
"first_submitted": "2017-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the peer telephone cessation counseling that has been and continues to be implemented at the Ann Arbor VA as part of the Tobacco Tactics intervention.
Detailed Description
Background: As part of the nurse-administered Tobacco Tactics intervention, we developed a novel program to train veterans from Voluntary Services to provide peer telephone cessation counseling calls.
Objectives: The objective of this study is to conduct an in-depth evaluation of the volunteer peer telephone cessation counseling that has been implemented and continues to be implemented at the Ann Arbor Veterans Affairs (VA) hospital as part of the inpatient Tobacco Tactics intervention.
Methods: Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, this quasi-experimental study will collect both quantitative and qualitative data to evaluate the peer telephone cessation counseling component of the Tobacco Tactics intervention. The Reach of the program will be evaluated by determining differences in the demographics, health characteristics, and smoking characteristics of those who do and do not participate in the peer telephone cessation counseling. The Effectiveness of the program will be evaluated by determining if there were differences in quit rates between those that do and do not participate in the peer telephone cessation counseling. The Adoption and Implementation of the program will be evaluated by determining the satisfaction with the counseling, reasons for nonparticipation, the type and quality of counseling actually provided, and barriers and facilitators to implementing the counseling as perceived by staff. The Maintenance of the program will be evaluated by determining the estimated costs of implementing the peer telephone cessation counseling.
Impact: The Tobacco Use/Smoking Cessation goal of the VA Substance Use Disorders (SUD) Quality Enhancement Research Initiative (QUERI) is to develop, implement and evaluate cost-effective interventions for increasing access to and use of evidence-based smoking cessation treatment. Telephone counseling has been shown to be efficacious and teaching volunteer veterans to provide this service is an option that is likely to be cost effective. Hence, evaluating the peer cessation telephone counseling program at the Ann Arbor VA will provide valuable information as to whether or not the program is a viable option for wider scale dissemination.
#Intervention
- BEHAVIORAL : Peer telephone cessation counseling
- For Veterans who received the inpatient Tobacco Tactics intervention, trained volunteers initiated follow-up telephone cessation counseling at 2, 14, 21 and 60 days after in-patient discharge; three attempts were made per time point.
- Other Names :
- Tobacco Tactics | #Eligibility Criteria:
Inclusion Criteria:
* The inclusion criteria: veterans who received the Tobacco Tactics intervention as an inpatient in the hospital.
Exclusion Criteria:
* The exclusion criteria: veterans who are too ill or impaired to consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01359371 | {
"brief_title": "Evaluation of Peer Telephone Cessation Counseling for Smokers",
"conditions": [
"Smoking"
],
"interventions": [
"Behavioral: Peer telephone cessation counseling"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01359371",
"official_title": "Evaluation of Peer Telephone Cessation Counseling for Smokers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2012-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-16",
"last_updated_that_met_qc_criteria": "2011-05-20",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-24",
"first_submitted": "2011-05-20",
"first_submitted_that_met_qc_criteria": "2014-11-21"
}
}
} |
#Study Description
Brief Summary
Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) as a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2). Long COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that persists after the acute infection has resolved. The most frequent symptoms of Lonf-term COVID are fatigue and dyspnea. But two classes of symptoms have been received scientific attention: the musculoskeletal pain and oral complaints related to Long COVID, mainly xerostomia and burning mouth. Photobiomodulation (PBM) therapy is often used for oral diseases and presents itself as a non-invasive, low-cost, safe therapy that has benefits in relation to the quality of life of patients with xerostomia. This study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia and oral complaints related to Long-Covid. This will be a single-center, randomized, controlled, blinded clinical trial that will involve patients with Long COVID in follow-up at the Medical and Multiprofessional outpatient clinic of University Nove de Julho (UNINOVE) which remained hospitalized with COVID-19 at Lydia Storópoli Universitarian Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022. All those patients presenting xerostomia, burning mouth or oral complaints related to Long Covid will be randomized into 2 groups: PBM Group (standard rehabilitation treatment for Long COVID and xerostomia + PBM therapy) or PBM placebo group (standard rehabilitation treatment for Long COVID and xerostomia + placebo PBM therapy). PBM consists of the application of Red LED on the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, 3 J/cm2, for 36 seconds, twice a week for 06 weeks. Functional and quality of life evaluations will be perform pre and post therapy period.
Detailed Description
Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) and which results in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2) The scientific literature has made progress in the characterization of the new coronavirus and works extensively on therapies and vaccines against the virus. However, it is now known that SARS-CoV-2 is more than just an acute respiratory syndrome. Long-term COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that was first reported online in groups of COVID-19 survivors discussing their symptoms after the acute infection has resolved. It begins to gain recognition in the scientific and medical communities. Although a universally accepted definition does not yet exist, reviews have identified that the most frequent symptoms of Lonf-term COVID are fatigue and dyspnea. But two classes of symptoms have been received scientific attention: the musculoskeletal pain and xerostomia. Xerostomia is defined as a subjective sensation of dry mouth described by patients and which is commonly related to hyposalivation (decreased salivary flow rate). The pathophysiology and clinical evolution of xerostomia in COVID-19 still lacks studies, but there are reports of 2 to 30% of patients presenting the complaint of dry mouth sensation even after the resolution of acute COVID. Regular physical therapy, cognitive behavioral therapy have been used and encouraged in the follow-up of patients with post- COVID, demonstrating that even today these practices seem to be more promising than pharmacological treatment. In parallel, studies demonstrate that Photobiomodulation (PBM) therapy is often used for oral diseases and presents itself as a non-invasive, low-cost, safe therapy that has benefits in relation to the quality of life of these patients. PBM refers to a series of therapies in which non-ionizing light beams, including lasers, LEDs and broadband light in the visible and infrared spectra, are used to interact with biological tissues for different purposes. In this sense, this study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia related to Long-Covid. This will be a single-center, randomized, controlled, blind clinical trial that will involve patients with Long-COVID in follow-up at the Medical and Multiprofessional outpatient clinic of University Nove de Julho (UNINOVE). An analysis will be carried out of all medical records of patients who remained hospitalized with COVID-19 at Lydia Storópoli Universitary Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022, for a survey of telephone contact and epidemiological data collection by medical records. All those patients who answer the questions referring to one or more symptoms related to the oral or nasal cavity, which have arisen after the onset of acute COVID infection, will be invited to participate in the study by making a first face-to-face evaluation at the University to confirm the diagnostic criteria of xerostomia, the diagnosis of Long COVID and evaluation of inclusion criteria in the study (adults with COVID-19 with complaints of xerostomia diagnosed more than 4 weeks after the acute infection and persisting for at least 02 months). Pre- and post-treatment evaluations are composed by the Brazilian Version of the SF 36 Quality of Life Scale, salivary sialometry and salivary pH, Oral Health Impact Profile (OHIP-14), Abbreviated Xerostomia Inventory (SXI), Brazilian version of the Functional Independence Measure (FIM), Post -Covid-19 Functional Status Scale and WHO Disability Assessment Scale (WHODAS 2.0) All patients included will be randomized into 2 groups: PBM Group (standard rehabilitation treatment for Long COVID and xerostomia + PBM therapy) or PBM placebo group (standard rehabilitation treatment for Long COVID and xerostomia + placebo PBM therapy). PBM consists of the application of Red LED on the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, 3 J/cm2, for 36 seconds, twice a week for 06 weeks. The results will be sent for statistical analysis.
#Intervention
- COMBINATION_PRODUCT : Institutional standard treatment for xerostomia and Long Covid
- (Medical follow-up at the general outpatient clinic for prescription and control of medications, underlying diseases, clinical status and routine short, medium and long-term care follow-up, standard guidelines for the use of aerobic physical activity in those who do not have contraindications, stretching exercises, ergonomics, home adaptation to maximize functionality and energy savings, emotional cognitive support psychotherapy, socio-educational measures, sleep hygiene, Nutritional follow-up and monitoring, dentistry follow-up at the University's odontological team, guidance on proper oral hygiene, use of low-sugar diets, daily topical use of fluoride and antimicrobial mouthwash to prevent dental caries, oral hydration, guidance on avoiding cigarette use or intake of caffeine-containing beverages . When necessary, measures such as oral lubricants, artificial saliva, measures to prevent aspirations, as well as the careful use of liquids during meals, can be instituted ) +
- RADIATION : Photobiomodulation Therapy
- Application of Red LED in the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, for 36 seconds, twice a week for 06 weeks.
- Other Names :
- PBM therapy
- RADIATION : Placebo Photobiomodulation Therapy
- All parameters as the number of points, dose and place of application of the PBM will be the same as described in the item PBM therapy Intervention Group, however in the placebo PBM equipment will be turned off. The device activation noise will be recorded and used to mimic the irradiation. | #Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis xerostomia related to Long-COVID;
* more than 4 weeks after the acute infection hat have persisted for at least 02 months (regardless of whether these patients are already using treatment for the complaints or not);
* Age greater than 18 years.
Exclusion Criteria:
* Clinical diagnosis of other previous rheumatological or musculoskeletal diseases that presents xerostomia;
* Previous use in the last 90 days of laser treatment or other photobiomodulation technique for the same or another indication;
* Clinical manifestations or complaints of xerostomia related to diseases other than Long COVID;
* Previous diseases of the oral or nasal cavity that occur with the symptom of xerostomia;
* Systemic inflammatory diseases (rheumatoid arthritis, Reiter's arthritis, ankylosing spondylitis, generalized polyarthritis, neoplasms);
* Uncontrolled metabolic or endocrine diseases;
* Neoplastic diseases;
* Serious cognitive or psychiatric disorders that that do not allow the understanding of the study;
* Steroid injections during the last 48 hours prior to baseline study assessment;
* Use of corticosteroids at an immunosuppressive dose (20mg daily of prednisone or equivalent for at least 14 days);
* Infection or tumor at the site of therapy application;
* Current chronic infections such as tuberculosis or chronic hepatitis treated or not;
* Severe blood dyscrasia;
* Blood clotting disorders (including thrombosis) at the application site;
* Psychoaffective disorder that prevents adherence to treatment;
* Signs, symptoms or laboratory changes suggestive of acute reinfection by COVID 19;
* Elevated resting heart rate (>100 beats/min);
* Low or high blood pressure (<90/60 or >140/90 mmHg);
* Low blood oxygen saturation (<95%) at rest, or dyspnea grade 3, 4, or 5 on the Medical Research Council Dyspnea Scale (KOVELIS et al., 2008), or exacerbation of dyspnea on exertion;
* Any condition where exercise is a contraindication such as decompensated heart disease, decompensated diabetes;
* Contraindications to the rehabilitation treatment of post-COVID syndrome recommended by the WHO: presence of heart disease after acute COVID, decrease in blood oxygen saturation after exercise (below 94% or decrease of at least 3% of the baseline saturation), presence of orthostatic hypotension;
* Any photosensitive disease or light sensitivity condition;
* Loss of follow-up at the follow-up clinical outpatient clinic, despite maintaining use of PBM according to the study protocol;
* Pregnancy;
* Any adverse effect on the previous use of PBM.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT05760092 | {
"brief_title": "The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19.A Randomized Controlled Trial.",
"conditions": [
"Xerostomia",
"COVID-19",
"Long COVID",
"Persistent COVID-19"
],
"interventions": [
"Radiation: Placebo Photobiomodulation Therapy",
"Combination Product: Institutional standard treatment for xerostomia and Long Covid",
"Radiation: Photobiomodulation Therapy"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT05760092",
"official_title": "The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19. A Randomized Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-01",
"study_completion_date(actual)": "2024-03-08",
"study_start_date(actual)": "2023-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-12",
"last_updated_that_met_qc_criteria": "2023-03-07",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-03-08",
"first_submitted": "2022-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a single centre, controlled phase I study, which evaluates safety and efficacy of stimulation of lower caudal two contacts (GPI) vs. upper cranial two contacts (GPE) in Huntington´s disease (HD).
Detailed Description
A total of 6 HD patients will be selected out of an existing larger HD patient cohort upon careful evaluation of the inclusion and exclusion criteria at month 0. Patients will be recruited if no significant cognitive deterioration is observed between month 0 and month 3. The preoperative clinical status will be evaluated twice including the United Huntington Disease Rating Scale (UHDRS), neuropsychological, neurophysiologic and neuroradiological assessments. At 4 weeks postoperatively an extensive evaluation of effects and side effects of every single contact of the bilateral quadripolar electrodes takes place.
All patients will receive a stereotactic placement of bilateral stereotactic insertion of two quadripolar electrodes into the Globus pallidus, two contacts reaching the GPE, two the GPI within both hemispheres. Surgery will be done under general anesthesia, The implantation of the stimulator (Kintera®) will take place in the same procedure. Postoperatively patients will be monitored at three and six months and regularly up to 60 months with a battery of clinical, neuropsychological, psychiatric, neurophysiological and neuroimaging tests.
We expect that this trial will provide a rational basis to conclude about the efficacy, safety, reproducibility and long-term effects of pallidal Deep Brain Stimulation (DBS) on motor symptoms of HD.
#Intervention
- PROCEDURE : Stimulation
- 6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)
- Other Names :
- GPI, GPE
- PROCEDURE : Stimulation
- 6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)
- Other Names :
- GPE, GPI | #Eligibility Criteria:
Inclusion Criteria:
* clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36)
* age: > 18
* moderate stage of the disease (UHDRS motor>= 30)
* predominant movement disorder
* compliance of the patient, stable cognition during a 6 months phase prior to inclusion (MDS>= 120)
* signed informed consent
Exclusion Criteria:
* advanced disease, precluding the ability to give informed consent
* very early stage of disease causing minor disability
* severe comorbidity that could compromise the life prognostic or preclude general anaesthesia or immunosuppression
* Mattis Dementia Rating Scale < 120
* psychiatric or personality disturbances that might compromise the follow-up
* participation at another trial (in particular transplantation)
* severe cortical atrophy seen on CT and MRI
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00902889 | {
"brief_title": "Deep Brain Stimulation of the Globus Pallidus in Huntington's Disease",
"conditions": [
"Huntington's Disease"
],
"interventions": [
"Procedure: Stimulation"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00902889",
"official_title": "Single Centre (Pilot) Study for Deep Brain Stimulation (DBS) of the Globus Pallidus in Huntington's Disease (HD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-04",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2009-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-11",
"last_updated_that_met_qc_criteria": "2009-05-14",
"last_verified": "2012-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-15",
"first_submitted": "2009-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to find out whether the addition of blood stem cells from a close family member, when added to umbilical cord blood will make the transplant safer.
Detailed Description
This is a phase 2 study to obtain an estimate of the speed of neutrophil recovery after myeloablative double-unit cord blood (CB) transplantation (CBT) with abrogation of prolonged cytopenia by the infusion of T-cell depleted peripheral blood stem cells (PBSC) from a haplo-identical family member. The CB graft will consist of two units from unrelated newborn donors and haplo-identical related PBSC. Candidates for this trial will include patients aged 2-70 years with high-risk or advanced forms of hematologic malignancies for whom an allogeneic hematopoietic stem cell transplant is indicated and for whom no suitably human leukocyte antigen (HLA)-matched and readily available unrelated donor exists. Patients will receive myeloablative conditioning and cyclosporine-A/ mycophenolate mofetil. CB grafts will consist of two CB units 4-6/6 HLA-matched to the patient to augment graft cell dose and additional T-cell depleted PBSC from a haplo-identical donor. The aim of the haplo-identical PBSC graft is to facilitate transient engraftment and consequent abrogation of the prolonged cytopenia normally associated with CBT by providing a myeloid bridge until CB engraftment occurs.
#Intervention
- DEVICE : CliniMACS Fractionation system (Arm A)
- 7 days before transplant Admit to hospital. Line insertion 6 days before transplant Fludarabine (chemotherapy) Cyclophosphamide (chemotherapy) 5 days before transplant Fludarabine Thiotepa 4 days before transplant Fludarabine Thiotepa 3 days before transplant Fludarabine Start CSA and MMF 2 days before transplant Fludarabine and TBI (radiation therapy)
1 day before transplant TBI (radiation therapy) Day of transplant Transplant day (infuse cord blood) Day after cord blood transplant Infuse family member stem cells 7 days after transplant Start G-CSF
- DEVICE : CliniMACS Fractionation system (Arm B)
- 8 days before transplant Admit to hospital. Line insertion 7 days before transplant Fludarabine 6 days before transplant Fludarabine Cyclophosphamide 5 days before transplant Fludarabine Cyclophosphamide 4 days before transplant Rest 3 days before transplant TBI x 3 Start CSA and MMF 2 days before transplant TBI x 3
1 day before transplant TBI x 3 Day of transplant TBI x 2 then infuse cord blood
1 day after the cord blood transplant Infuse family member stem cells 7 days after transplant Start G-CSF
- BIOLOGICAL : Haploidentical donor CD34+ cells
- CB grafts will consist of two CB units 4-6/6 HLA-matched to the patient to augment graft cell dose and additional T-cell depleted PBSC from a haplo-identical donor. | #Eligibility Criteria:
Inclusion Criteria:
Note: protocol eligible patients according to the criteria outlined below will then be divided according to age, diagnosis, performance status, organ function, prior transplantation, hematopoietic cell transplant comorbidity index (HCT-CI)23, and CB TNC dose into those who are at standard risk (Arm A) or high risk (Arm B) for early post-transplant death for the purposes of applying stopping rules and outcome analysis.
Age:
o 2 - 70 years. Diagnosis of severe aplastic anemia: eligibility to be discussed with PI and Service Chief. Such patients will be assessed in Arm B.
Diagnosis of high risk hematological malignancy:
Any acute leukemia in first complete remission (CR) considered at high risk for relapse, or second or third CR, or relapse/refractory less than 10% blasts in bone marrow, or aplasia post-therapy. This includes de novo acute leukemia or acute leukemia that is therapy related or arising from an antecedent hematologic disorder including myelodysplasia (MDS), chronic myeloid leukemia (CML) or other myeloproliferative disorder.
* Juvenile myelomonocytic leukemia (JMML) in CR, or relapse with less than 10% bone marrow blasts.
* CML with tyrosine kinase inhibitor failure in chronic or accelerated phase or evolved to acute leukemia.
* MDS or other myeloproliferative disorder with life-threatening cytopenia(s), and/or red blood cell or platelet transfusion dependence, or patients with aplasia, or patients with excess blasts less than 10% blasts in the bone marrow at work-up.
* Aggressive lymphoma: patients in CR1 with disease at high risk of relapse or CR2 <= age <= 3.
* Indolent lymphoma or chronic lymphocytic leukemia (CLL): any disease status provided any transformed component is in CR.
* Hodgkin's lymphoma that is primary refractory or relapsed not suitable for other therapy and in PR or CR or small volume stable disease.
Performance status:
* Karnofsky score >= 70 or Lansky score >= 70.
* Organ function:
* Resting left ventricular ejection fraction (LVEF) >= 50%.
* Spirometry (FEV1 and FVC) & corrected DLCO >= 50% predicted. In small children use history and physical and CT scan to determine pulmonary status.
* Total bilirubin <= to 1.5 mg/dl (unless benign congenital elevated bilirubin); ALT <= 3 x upper limit of normal (ULN).
* Calculated creatinine (calc. creat.) clearance >= to 60 ml/min.
* Albumin >= 3.0.
Graft:
o Cryopreserved dose will be >= 1.5 x 10^7 TNC/kilogram in each unit for double unit CB grafts. This will be the CB graft for the majority of patients.
In select patients with access to CB units that have high TNC (> 5.0 x 10^7/kg), and are from good quality CB banks a single unit could be considered with a back-up CB unit on standby.
* In select patients who have a very poor search and only have one suitable CB unit available, this unit could be given as a single unit. This unit must have a TNC >= 2.0 x 10^7 TNC/kilogram and a CD34+ cell dose >= 1.5 x 10^5 CD34+/kilogram.
* Haploidentical donors who are 5/10 or better but not HLA-identical will be used as outlined in section 6.4.
Assignment of conditioning intensity (high dose vs reduced intensity) will be based on patient disease status, age, extent of prior therapy, organ function and presence of significant comorbidities as outlined in Section 9.2.
For the purposes of analysis (not assignment of preparative regimen), patients will be assigned to Arms A and B as summarized below according to their risk of early post-transplant death.
Eligible patients who fulfill all of the following criteria will be assigned to risk Arm A:
Age 2 <= age <= 49 years Diagnosis Any acute leukemia in CR1 - CR2 (includes therapy-related and arising from MDS or myeloproliferative disease). JMML in CR. CML with TKI failure & < 5% blasts. MDS with < 5% blasts at work-up. Lymphoma (including CLL) CR1 <= age <= 2.
Performance Status Karnofsky >= 80; Lansky >= 80 Organ Function Resting LVEF >= to 60% Spirometry (FEV1 and FVC) & corrected DLCO >= 80% predicted. Total bilirubin normal; ALT normal-1.4 x ULN. Calc. creat. clearance >= 70 ml/min.
Prior HSC Transplant No HCT-CI score^23 0 <= age <= 2 Pre-thaw TNC Dose Each unit >= to 2.0 x 10^7/kg
Eligible patients who meet any of the following criteria will be assigned to risk Arm B:
Age 50 <= age <= 70 years Diagnosis Any acute leukemia in relapse/ refractory disease in BM or circulating blasts or CR3 or aplasia. JMML not in CR. MDS with aplasia or >= 5% blasts. Lymphoma (including CLL) with disease other than CR1 <= age <= 2. Severe myelofibrosis of the bone marrow Performance Status Karnofsky 70; Lansky 70 Organ Function LVEF 50 <= age <= 59%. Spirometry & corrected DLCO 50 <= age <= 79% predicted. Total bilirubin 1.1 <= age <= 1.5 mg/dl; ALT 1.5 <= age <= 3 x ULN. Calc. creat. clearance 60 <= age <= 69 ml/min. Prior HSC Transplant Yes HCT-CI score23 3 or higher Pre-thaw TNC Dose Either or both units 1.5 <= age <= 1.9 x 10^7/kg.
Exclusion Criteria:
* Active CNS leukemia.
* Any acute leukemia (including prior myelodysplasia or CML blast crisis) with morphologic relapse or persistent disease >= 10% blasts in the BM, or doubling of the blasts in the blood in the 2 weeks preceding admission, or need for hydroxyurea in the 2 weeks prior to admission, or uncontrolled extra-medullary disease.
* Two prior stem cell transplants of any kind.
* One prior autologous stem cell transplant within the preceding 12 months.
* One prior allogeneic stem cell transplant within the preceding 24 months.
* Prior radiation therapy with 400 cGy or more of TBI. If 200 cGy of prior TBI then only 400 CGy of TBI on this protocol is permitted.
* Uncontrolled viral, bacteria or fungal infection at time of study enrollment.
* Sero-positive or NAT positive for HIV.
* Females who are pregnant or breast feeding.
* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
Cord Blood Grafts:
Units will be selected based on the HLA-match to the patient and individual cell doses of the units according to current MSKCC unit selection criteria. HLA-testing will be done using molecular techniques. The standard cord blood graft for this protocol will consist of 2 units as a double unit graft although single units are permitted. Each unit will be at least 4 of 6 HLA-A, -B antigen and -DRB1 allele matched with the recipient. Each unit of a double unit graft will have a cryopreserved dose of at least 1.5 x 10^7 TNC/recipient body weight (TNC/kg). In the occasional patient with a large well matched good quality single unit or the rare patient with only one unit of suitable match and dose characteristics the cord blood graft can consist of a single unit as described in section 6.1 .
Haploidentical Donor Inclusion Criteria:
A HLA-haploidentical related donor will be selected as available as per standard MSKCC Adult BMT guidelines. Mismatched family members who are matched at more than 5 of 10 HLA-loci are permitted. Factors to be taken into account when selecting a haplo-identical donor will include donor age, weight, health status and comorbidities, compliance, venous access, recipent donor specific HLA-antibody status, and NK cell alloreactivity.
* The donor must meet criteria outlined in the FACT-approved SOP for 'DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION' in the Blood and Marrow Transplant Program Manual, document E-1 (see attached, or link to URL:(https://one.mskcc.org/sites/pub/corp/bmt/Documents/D2_SOP_Donor%20Selection%20and%20Evaluation_04_2015.pdf)
* The donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.
* The donor must be >25 kg in weight.
Haploidentical Donor Exclusion Criteria:
Evidence of active infection (including active urinary tract infection, or upper respiratory tract infection) or evidence of viral hepatitis exposure on screening unless only HbsAb+ and HBV DNA negative.
* Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.
* Factors which place the donor at increased risk for complications from leukapheresis or G-CSF therapy (e.g., active autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy).
* Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT01682226 | {
"brief_title": "Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies",
"conditions": [
"Leukemia",
"Myelodysplastic Syndrome",
"Lymphoma"
],
"interventions": [
"Device: CliniMACS Fractionation system (Arm B)",
"Biological: Haploidentical donor CD34+ cells",
"Device: CliniMACS Fractionation system (Arm A)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01682226",
"official_title": "Myeloablative Unrelated Donor Cord Blood Transplantation With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cells for Patients With High Risk Hematological Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-08",
"study_completion_date(actual)": "2021-01-08",
"study_start_date(actual)": "2012-09-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-08-05",
"last_updated_that_met_qc_criteria": "2012-09-06",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-10",
"first_submitted": "2012-09-06",
"first_submitted_that_met_qc_criteria": "2022-07-12"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to study the effects of transthoracic electrical cardioversion for restoration of sinus rhythm in patients who present with recent onset atrial fibrillation, with regard to new silent cerebral thrombo-embolic lesions and cognitive function, as well as electrical and functional/structural reverse remodelling, and its effects on inflammatory changes / specific cardiac biomarkers, vasoactive peptides, coagulation activity, and active fibrinolysis.
Detailed Description
Working plan This study will give information about the incidence of silent cerebral thrombo-embolic events in patients with recent onset AF, a population which is expected to consist mostly of paroxysmal AF patients.
Patients with atrial fibrillation (AF) duration less than 48 hours and fulfilling inclusion and not exclusion criteria will be included in the study by a cardiologist on the day of cardioversion, and study nurse will be notified to plan for the investigations. The patient will undergo clinical examination, clinical history will be taken and blood sampling. Once 12 lead ECG, echocardiography, questionnaires, telemetry and MR have been done the patient will be electrically cardioverted After the cardioversion the patient will be subject to echocardiography of the heart again, blood-sampling, 12 lead ECG, and MR brain. The patient is discharged but will be studied by echocardiography of the heart and MR brain again on day 7 - 10. Thereafter the patient will be followed for 30 days - see flowchart.
The day of cardioversion is defined as Day 0.
3.1. ASSESSMENT OF REMODELING/REVERSE REMODELING 3.1.1. Electrical remodeling Standard 12-Lead electrocardiography (ECG) at every health care visit. (Day -1, Day 0 before and immediately after DCC, Day 0 at discharge, Day 7-10 and 30). Recorded with automatic analysis of intervals, Paper speed 50 mm/sec.
O Data to be collected: Rhythm, heart rate, P wave duration and amplitude.
3.1.2. Functional remodeling (Echocardiographic analysis) - App. 1. Left and right atrial dimensions and volumes 53. Global left atrial function, left atrial ejection fraction: (assessed by 2D and speckle tracking )53, 54 Left ventricular ejection fraction and left ventricular diastolic function (transmitral velocities, E/E' index)53-56 O Echocardiographic data will be collected and stored in the routinely used database of the department of Clinical Physiology and as raw images in a separate database dedicated for the study (in the care of the investigators) for offline review and measurements. The Core lab in Uppsala will do all analysis.
O Time of collection: prior to cardioversion, within 24 h after cardioversion and at day 7 - 10 after cardioversion.
3.1.3.Neurohormonal - inflammatory indices, cardiac biomarkers, vasoactive peptides.
High-sensitivity cardiac troponin T (hsTnT) and N-terminal pro-brain natriuretic peptide (Nt-proBNP) will be measured as sensitive and specific markers of cardiac injury ⁄ strain ⁄ filling pressures and B-type natriuretic peptide levels correlate with AF burden in patients with lone AF and is a strong predictor of recurrent arrhythmia after ablation. (A stable fragment of vasoactive peptide, C-terminal -proendothelin-1 will be measured because of its relation recurrence of AF, which may be a risk factor for embolism and because of its possible role in the pathogenesis and recurrence of AF, and the association with atrial dilatation, fibrosis, and hypertrophy, which may contribute to AF persistence and embolism) C-Reactive protein (CRP) Interleukin-662-65 Routine blood tests: (Hb, Platelets, White blood cell count, Na, K, Creatinine, international normalized ratio (INR), thyroid-stimulating hormone (TSH), free-T4): only once before cardioversion.
O Blood sampling test: Day 0 before (sample 1) and 4 + 1 hours after cardioversion at time for MRI no 2 before discharge (sample 2) and day 7-10 (sample 3). The core lab in Uppsala will do all analysis.
3.2. RHYTHM MONITORING O Continuous ECG monitoring O During and after cardioversion to be printed from cardioverter or telemetry or 7 - 10 day Holter.
O 7-day Holter monitoring. To be initiated on Day 0 prior to cardioversion for 7 days. The Core lab in Uppsala will do all analysis.
12 lead ECG recording As above and at symptoms indicating recurrence of AF.
Data to be collected:
Time to first P-wave to assess sinus node recovery after DC and time for immediate recurrence of AF.
AF burden (defined as total time in AF during the first 7 days) Time to first AF recurrence (sustained AF; duration \>30 seconds during first 7 days, then at first symptom of AF confirmed on ECG) Number of sustained and non-sustained AF episodes during the first 7 days Mean, median - range of duration of AF episodes during the first 7 Days
3.3. ASSESSMENT OF THROMBOEMBOLIC BIOMARKERS, MENTAL TESTS AND CEREBRAL ISCHEMIC EVENTS
3.3.1. Biomarkers Coagulation activity by analysing plasma markers for thrombin activity (P-selectin, d-dimer, and prothrombin fragment 1+2, von Willebrand factor antigen (vWF-Ag)) and factor VIII:C.
Active fibrinolysis (plasmin-alpha 2-plasmin inhibitor complex: PIC) P-fibrinogen och P-Fibrin Platelet activity (platelet factor 4: PF4). Brain damage markers: S100 Blood sampling test as above.
3.3.2. Neurological / Cognitive assessment National Institute of Health Stroke Scale (NIHSS): Standardized assessment of neurological deficit66.
To be performed: Day 0 prior to cardioversion, Day 7-10, Day 30 and when clinically evident cerebrovascular event.
Mini-Mental-Test (Mini Mental State Examination, MMSE) and Trail Making Test A och B (TMT A och B) To be performed: Day 0 prior to cardioversion, Day 7-10, Day 30 and if clinically evident cerebrovascular event.
3.3.3. Brain magnetic resonance imaging. MRI is performed for the assessment of silent thromboembolism, which is defined as 2-3 mm or larger lesion with restricted diffusion on MRI with diffusion weighted sequence.51,71-75 Silent or clinically evident cerebrovascular events occurring during cardioversion will be detected and eventually not counted as late coming emboli in relation to reverse remodeling.
To be performed: Prior to and within 24 hours after DCC, on Day 0, and on Day 7 - 10 after DCC.
Data to be collected: presence, size, number, and vascular distribution of any focal abnormality consistent with embolic lesion.
Technique for MRI without contrast injection:
Sag T2 or T1 to position and obtain transversal slices with high reproducibility.
'DWI' transversal, 5 mm slices, b=0 och b=1000, calculation of 'ADC' maps, usually automatic by scanner T2 tse/fse transversal, 5 mm slices T2 FLAIR transversal, 5 mm slices
4. Statistical analysis, sample size, data handling This pilot study will give information about the incidence of silent cerebral thromboembolic events and associated clinical variables that may affect the outcome, in patients with recent onset AF who are expected to mainly suffer from paroxysmal AF.
Based on previous reports of patients undergoing MRI before and after AF ablations, the % of patients with chronic cerebral lesions detected on MRI at baseline varies widely from 4 to 79 %, with 10 % being the most representative figure for patients with paroxysmal AF. Previous observations have reported varying frequencies of new silent cerebral lesions on MRI after AF ablation (4-38 %), coronary angiography (10 %) and retrograde aortic catheterisation of patients with aortic valve stenosis (22 %). New asymptomatic cerebral ischemic lesions in patients undergoing AF ablation have been reported after the use of irrigated radiofrequency (RF) catheters (7-11 %), the most common routine ablation procedure, and even a higher frequency of lesions (37 %) using a specialized circular RF ablation catheter. Based on these observations the investigators argued that a 20 % increase in incidence of new asymptomatic cerebral ischemic lesions in patients undergoing DC cardioversion would be clinically significant and warrant alternative routines for cardioversions.
Determination of sample size Considering a 20% increase (i.e. from 10% at baseline to 30%) in incidence of silent cerebral lesions following electrical cardioversion, the required number of patients to reject the null-hypothesis with 90% power and at the 0.05 significance level (two-sided) is 35. To allow for drop-outs, 40 patients will be included in the study. The sample size calculations were performed in the software 'nQuery Advisor' version 7.0.
It is reasonable to perform a pilot study of 40 patients, in order to get an indication of the number of silent cerebral events. A total of 70 patients will be screened to ensure that 40 patients will remain in sinus rhythm at least 7 days after cardioversion.
Categorical variables will be reported as counts and percentages, whereas continuous variables as means and standard deviations (SD) or medians and interquartile ranges, as applicable.
The relationship between clinical variables (qualifying history duration of AF, AF duration, CHADS2VASC score, biomarkers, conversion to sinus rhythm, left atrial function and left atrial volume), confounding variables and incidence of new silent cerebral ischemic lesions at Day 1 and 7-10 post MR will be tested in a multiple logistic regression model, using a stepwise selection procedure (p\<0.05). The model will be validated using bootstrapping.
The number of new silent cerebral ischemic lesions will be modelled as poisson or negative binomial regression models, as applicable.
Median concentrations of the biomarkers will be compared with baseline levels by nonparametric Wilcoxon rank-sum test or Kruskal- Wallis test when appropriate.
The association between biomarker concentrations and new embolic lesion will be evaluated over a follow up period 7 -10 days. The association between baseline concentration of each biomarker and new embolic lesion will be assessed by univariable Cox proportional hazards models. Biomarkers will be modelled as continuous variables (expressed as 1 SD increment) as linearity of the hazard will be tested by appropriate transformation using restricted cubic splines to account for possible nonlinear relationships. Cox multivariable models will be performed to evaluate the independent prognostic value of each biomarker separately; adjusting for baseline covariates emerged as statistically significant from a stepwise selection procedure (p \< 0.05). The investigators will also investigate whether the addition of different combinations of the biomarkers improve the discrimination of the model. The independent prognostic value of each biomarker on new embolic lesion will be assessed by univariable and multivariable Cox models.
Each biomarker measured at baseline, Day 1 before and immediately after DCC, at discharge, after 7 - 10 days, and 1 months will be analysed graphically over time at the patient level as well as by summary statistics.
All probability values are two-tailed, and 95% confidence intervals (CIs) will be calculated. Because of the exploratory nature of this study, adjustments for the multiplicity of statistical analyses will not be made.
A 2-sided P-value \<0.05 will be considered statistically significant.
5. Clinical Significance It is of paramount importance to assess if electrical cardioversion performed within 48 hours after AF onset, without preceding oral anticoagulation, results in silent strokes, as it is the present clinical routine and no scientific data is available.
A 20 % increase in incidence of new asymptomatic cerebral ischemic lesions in patients undergoing DC cardioversion is in this study defined as clinically significant. If other cardioversion strategies can be identified that result in 10 % lower incidence of events, that figure may then be regarded as clinically significant.
#Intervention
- PROCEDURE : Electrical cardioversion
- Transthoracic direct current electrical cardioversion | #Eligibility Criteria:
Inclusion Criteria:
Atrial fibrillation of recent onset (less than 48 hours) ongoing at time for baseline MRI.
Age: 18 <= age <= 75 years
Exclusion Criteria:
* Recent (less than 3 months) cardioversion of AF or atrial flutter
* Previous clinical cerebrovascular event
* Congestive heart failure New York Heart Association (NYHA) function class III and IV
* Previously documented moderate or severely decreased left ventricular ejection fraction (LVEF less than 35%)
* Previously documented marked mitral regurgitation or stenosis
* Atrial flutter, atypical atrial flutter or intra-atrial re-entry tachycardia
* Contraindications to electrical cardioversion
* Permanent implanted cardiac device (event recorders accepted)
* Contraindication to nuclear magnetic resonance imaging (MRI) - see separate list addendum 1.
* Known coagulation defects or spontaneous INR or activated partial thromboplastin time (APTT) levels at therapeutic levels
* Current Vitamin K antagonists (VKA) or Novel Oral Anticoagulation (NOAC) treatment
* Spontaneous conversion to sinus rhythm prior to first MRI
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02955004 | {
"brief_title": "Electrical Cardioversion of Recent Onset Atrial Fibrillation - Silent Thromboembolic Events, Reverse Atrial Remodeling",
"conditions": [
"Intracranial Embolism"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT02955004",
"official_title": "Electrical Cardioversion of Recent Onset Atrial Fibrillation - a Study of Silent Thromboembolic Events, Reverse Atrial Electrical and Functional Remodeling Including Inflammatory, Neurohormonal and Thromboembolic Biomarkers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2015-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-17",
"last_updated_that_met_qc_criteria": "2016-11-01",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-04",
"first_submitted": "2015-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Although selective removal of carious tissue to soft dentin (SRCT-S) has been proposed as the standard of care for the management of deep dentin caries, it is unclear whether a cavity liner is necessary. This double blinded randomized controlled clinical trial aims to analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. The study will include 142 restorations allocated to either experimental arm. After 12 and 24 months, restoration survival, pulp response and radiographic lesion progression will be assessed.
Detailed Description
Introduction: Minimally invasive dentistry has been proposed as an conceptual framework for the conservative management of caries lesions. This approach allows reducing potential adverse effects derived from the conventional treatment, including the loss of pulp vitality. Complete removal carious tissues compromising deep dentin significantly increases the risk of pulp exposure and post-operative symptoms, leading in many cases, to the need for endodontic treatment, with the subsequent high costs and low coverage for the population. In this context, a new technique for the management of deep caries lesions has been introduced called selective removal of carious tissue to soft dentin (SRCT-S), which partially removes only the outer layer of the affected tissue, leaving carious tissue in the pulpal wall, but not on the lateral walls of the operatory cavity. This procedure has been reported in several studies, with lower clinical time, cheaper cost and lower discomfort for the patient. The SRCT-S aims to preserve pulp vitality, prevent access of nutrients to carious tissue, stopping the caries process and preserving a greater amount of dental structure. Although the SRCT-S technique has proven effective compared to conventional treatments, it is unclear and with insufficient evidence about how to manage the remaining carious tissue and whether a cavity lining agent is needed. This decision may have important clinical implications, but there is no general consensus, strongly suggesting further research. Objective: To analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. Methodology: A double blinded randomized controlled clinical trial was devised. Trained dentists will treat the 142 restorations included in deep dentin carious lesions of permanent molars, at the dental clinics of the University of Talca. After recruiting, patients will be randomly assigned to the experimental groups: Group 1: (n=71) no cavity lining, treating carious tissue with self-conditioning adhesive followed by composite resin restoration and Group 2: (n=71) remaining carious tissue covered with a conventional glass ionomer followed by composite resin restoration. The dependent variables (outcomes) will be; a. clinical: restoration survival and pulp response and b. radiographic: lesion progression. Clinical and radiographic outcomes will be monitored annually at 12 and 24 months. The analysis of the restorations and the pulp response will be performed with Weibull regression. The Friedman test will be applied for the analysis of the data regarding radiographic subtraction, (p≤0.05). Given the lack of studies on the subject with longitudinal evaluations, this project is expected to contribute relevant evidence that impacts the generation of novel guidelines for the management of deep dentin caries. Additionally, the results will contribute evidence to increase the support to a more conservative clinical behavior.
#Intervention
- DEVICE : Self-etching Adhesive
- A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
- Other Names :
- Self-conditioning Adhesive, Self-etching primer, Single Bond Universal (3M)
- DEVICE : Glass Ionomer
- A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
- Other Names :
- Conventional Glass Ionomer, Ketac Molar (3M) | #Eligibility Criteria:
Inclusion Criteria:
* Patients with a permanent molar or premolar with a deep caries lesion that compromises from the inner half of the dentin (determined by radiographic examination).
* Tooth restorable by a direct resin restoration.
* Absence of pulp sensibility verified by cold test
* Absence of a history of spontaneous pain or vertical and horizontal percussion.
* Absence of periapical lesion, verified through periapical radiographs.
* Primary injury.
Exclusion Criteria:
* Systemic conditions with poor control or uncompensated.
* Cervical margin of the cavity in dentin or root cement.
* Tooth already restored or with secondary caries.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT04250142 | {
"brief_title": "Pulp Protection in Selective Carious Tissue Removal",
"conditions": [
"Dental Caries"
],
"interventions": [
"Device: Self-etching Adhesive",
"Device: Glass Ionomer"
],
"location_countries": [
"Chile"
],
"nct_id": "NCT04250142",
"official_title": "Effect of Pulp Protection After Selective Carious Tissue Removal in Permanent Teeth, a Randomized Controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-23",
"study_completion_date(actual)": "2022-03-18",
"study_start_date(actual)": "2019-03-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-28",
"last_updated_that_met_qc_criteria": "2020-01-30",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-31",
"first_submitted": "2020-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of the study is to determine the efficacy of aerobic exercise for improving cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor (VEGF) as mediators of response to exercise.
Detailed Description
The cognitive, emotional and physical effects of TBI are well documented in the literature. Specifically, reduced cognitive functioning and depression, which are much more prevalent than in the general population, represent key challenges in the rehabilitation of persons recovering from TBI. Aerobic exercise has been shown to improve cognition and mood in the general population. Although the positive effects of exercise have been known for some time, only recently have some of the mechanisms underlying these effects been defined. One hypothesized mechanism was that exercise elevates the levels of BDNF and VEGF in the CNS. Although research examining the effects of aerobic exercise in individuals with TBI is limited, exercise has been effective in improving cognition and depression in individuals with other medical conditions, such as cancer, multiple sclerosis, fibromyalgia, dementia, chronic fatigue syndrome, chronic obstructive pulmonary disease and the elderly.
The effects of aerobic exercise on patients with TBI will be examined in this clinical trial, using a crossover design with a wait-list control. The classic crossover design has been modified to examine the effects of an additional 8 weeks of exercise, for a total 16-week intervention, in one group. Participants will be randomized into one of two conditions: Group A - immediate eight weeks of intervention followed by monitoring or Group B - monitoring followed by 8 weeks of intervention. In addition, the participants in Group B will serve as their own controls to determine if another 8 weeks of exercise, for a total of 16 weeks, is necessary for cognitive improvement.
Each person will undergo individual interviews and testing/ questionnaires aimed at measuring cognition, mood, fatigue, and life satisfaction. Blood will be drawn 2 or 3 times to monitor BDNF and VEGF levels. Assessment of cognition, mood, fatigue and life satisfaction will occur at four time points for both groups.
It is hypothesized that aerobic exercise will result in improved cognition and mood from both subjective and objective perspectives. In addition, we will explore the effect of post-TBI exercise on community participation and life satisfaction and explore personal and injury characteristics that mediate effectiveness of aerobic exercise in individuals with TBI.
#Intervention
- BEHAVIORAL : Exercise
- Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.
- BEHAVIORAL : Exercise
- Aerobic exercise program - 55 min aerobic exercise on the treadmill 3 days a week for either 8 or 16 weeks | #Eligibility Criteria:
Inclusion Criteria:
* Be 18 to 99
* Have experienced a TBI as a result of a blow to the head with a loss of consciousness or a period of being dazed and confused. This must be medically documented (e.g. EMS report, hospital record, physician record).
* Be at least six-months post-injury
* Be English-speaking since assessments and treatment sessions will be conducted by English-speaking therapists
* Have residential telephone service since follow up assessments may be completed via phone
* Live within 1.5 hours of NYC to be able to participate in baseline assessment and attend treatment sessions
* Provide written informed consent for participation
* Be willing to complete questionnaires and interviews about mood, thinking skills, fatigue, and life satisfaction
* Being willing to comply with protocol requirements and a schedule of exercise and assessments visits
* Being able to take part in a treadmill-based exercise program
Exclusion Criteria:
* Any medical condition in which exercising may be harmful, e.g., evidence of cardiovascular compromise including: history of acute myocardial infarction, history of coronary artery disease, unstable angina, uncontrolled hypertension, orthostatic hypotension, significant aortic valve disease, uncontrolled arrhythmia, uncompensated congestive heart failure, 3rd degree AV block without a pacemaker, active pericarditis, active myocarditis, or any evidence of pulmonary, endocrine or neurologic compromise; impaired left ventricular dysfunction; or syncopal episode within the past year
* Any medical condition requiring treatment with beta blockers or calcium channel blockers
* Under the age of 18 years
* Any clinically significant evidence of pulmonary, endocrine or neurologic (ataxia, gait disturbance, vertigo) compromise
* Resting pulse oxymetry of less than 95% oxygen (O2) saturation, in normal air
* Recent diagnosis of deep vein thrombosis or pulmonary embolism
* Active systemic illness or chronic infection that is not stable
* Active inflammatory process that is not stable
* Clinically significant anemia
* Clinically significant abnormal thyroid function tests
* Pregnant females
* Any reason that, in the investigator's opinion, makes the person unsuitable to participate
* Unable to physically participate in an exercise program
* Active participation in regular aerobic exercise in the six months prior to potential enrollment.
* Active substance abuse
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00619463 | {
"brief_title": "Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI",
"conditions": [
"Traumatic Brain Injury"
],
"interventions": [
"Behavioral: Exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00619463",
"official_title": "Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2007-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-24",
"last_updated_that_met_qc_criteria": "2008-02-20",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-21",
"first_submitted": "2008-02-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP.
Detailed Description
age group between 18-65 years, intubated and ventilated patients due to respiratory failure from severe lung infection and/or traumatic lung contusion \[respiratory failure was diagnosed by arterial blood gases (ABG) with partial pressure of oxygen (PaO2) ≤60 mmHg, partial pressure of carbon dioxide (PaCO2)≥60 mmHg, PH \> 7.30, respiratory rate \>25 min\]. All patients ventilated for 4 days with CMV with respiratory rate 12/min, PEEP 5 cm/H2O, FIO2 adjusted to maintain arterial oxygen saturation above 90%. And sedated with both fentanyl and midazolam intravenous infusion to adjust sedation level to achieve Richmond Agitation-Sedation Scale (RASS) -2 to -3 as illustrated in table. All patients received broad spectrum antibiotics in form of meropenem 1 gm slowly intravenous every 8 hours in this period (four days) and a qualitative sputum culture collected from all patients after 3 days from ventilation. Feeding started on the second day of ventilation to all patients through feeding pump at rate of 70 ml insure plus (Abbot company) with 1.47 kilo-calorie/ml to supply patients with approximately 2500 kilo-calorie in 24 hours calculated by approximately 35 kilo-calorie/kg. The 5 points of bundle for pneumonia prevention were strictly applied to all patients: Elevation of the head of the bed 30º to 45º, Daily evaluation for possible ex-tubation, The use of endotracheal tube with subglottic secretion drainage, oral care with oral antiseptics, initiation of safe enteral nutrition, within 24-48 hours from ICU admission and ventilation.
200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled \> 2 parameters on SOFA score and \> 6 on pneumonia score and randomly allocated in two groups 100 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time.
All patients selected underwent a percutaneous tracheostomy on the same day. Sepsis documented in our study by \> 2 on Sequential Organ Failure Assessment (SOFA) score. While VAP documented in our study by \>6 on CPIS score. Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl infusion to get same sedation score mentioned before (RASS-2/-3), increase FIO2 to 100% during the procedure, use xylocaine spray 10% by Astra Zeneca company 2 puffs in each nostril before application of the rubber tube of the bronchoscope, keep patient's head elevated 20 degree during procedure, use CMV mode with previous mentioned parameters with 100% FIO2 during the procedure, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture and the other isotonic saline injected in the remaining three syringe used only for wash the small airways and not for bacteriological sampling, monitoring of patients during the procedure done by SPO2, non-invasive blood pressure measurement every 5 minutes, electro cardiac gram for heart rate, clinical assessment of depth of sedation every 5 minutes.
Duration of the study selected to be 2 weeks and evaluation of all patients in both groups done on three periods, at the end of the first 5 days, at the end of the second 5 days and at the end of last 4 days.
#Intervention
- DRUG : Meropenem
- all patients in both groups receive meropenam and put on the ventilators for 2 weeks
- PROCEDURE : bronchoscopy
- Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period
- DEVICE : ventilator
- ventilator | #Eligibility Criteria:
Inclusion Criteria:
* patients with age group between 18 <= age <= 65 years,patients Respiratory failure, patients with pneumonia - ventilated for more than 10 days - showed no satisfactory improvement on intravenous antibiotics
Exclusion Criteria:
* pediatric patients, patients with anoxic brain insult
* permenant neurological deficit- post cardiac arrest
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT06072222 | {
"brief_title": "Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation",
"conditions": [
"ARDS",
"Septic Shock"
],
"interventions": [
"Drug: Meropenem",
"Device: ventilator",
"Procedure: bronchoscopy"
],
"location_countries": [
"Saudi Arabia"
],
"nct_id": "NCT06072222",
"official_title": "Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-01",
"study_completion_date(actual)": "2021-12-01",
"study_start_date(actual)": "2020-07-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-10",
"last_updated_that_met_qc_criteria": "2023-10-06",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-10",
"first_submitted": "2023-10-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
#Intervention
- BIOLOGICAL : HPV vaccine for strains -6, -11, -16, and -18
- All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24). | #Eligibility Criteria:
Inclusion Criteria:
* Young women age 16 years and 0 days to 23 years and 364 days
* HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA > 1,000 copies/ml
* HIV treatment history that falls in one of the following categories:
Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry
* Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
* Anticipated ability and willingness to complete all study vaccines and evaluations
* Ability and willingness to participate in the study by providing written informed consent
Exclusion Criteria:
* History of any prior vaccination with an HPV vaccine
* Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
* Previous allergic reaction to any constituents of the HPV vaccine
* Pregnancy
* Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
* Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
* Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
* Receipt of any routine vaccine within four weeks prior to study entry
* Receipt of any immune globulin or plasma product within six months prior study entry
* Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
* Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
* Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
* Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
* Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for > 2 consecutive weeks)
* Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
* Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
* If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 23 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00710593 | {
"brief_title": "Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women",
"conditions": [
"HIV Infection"
],
"interventions": [
"Biological: HPV vaccine for strains -6, -11, -16, and -18"
],
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT00710593",
"official_title": "Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-02",
"study_completion_date(actual)": "2011-02",
"study_start_date(actual)": "2008-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-02",
"last_updated_that_met_qc_criteria": "2008-07-02",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-04",
"first_submitted": "2008-07-02",
"first_submitted_that_met_qc_criteria": "2017-04-13"
}
}
} |
#Study Description
Brief Summary
This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
#Intervention
- DRUG : Placebo
- Administered orally
- DRUG : Baricitinib
- Administered orally
- Other Names :
- LY3009104, INCB028050 | #Eligibility Criteria:
Inclusion Criteria:
* You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study
* You are a candidate for systemic therapy and/or phototherapy
* You must have active plaque psoriasis covering at least 12% body surface area
* You must have Psoriasis Area and Severity Index (PASI) score of at least 12
* You must have Static Physician's Global Assessment (sPGA) score of at least 3
Exclusion Criteria:
* You must not have received a biologic agent/monoclonal antibody within 8 weeks prior to entry into the study
* You must not have prior treatment with an oral Janus kinase (JAK) inhibitor
* You must not have received a systemic psoriasis (Ps) therapy within 4 weeks prior to entry into the study
* You must not have received a phototherapy within 4 weeks prior to entry into the study
* You must not have received a topical Ps therapy with psoralens within 4 weeks prior to entry into the study
* You must not be pregnant or nursing
* If female of childbearing potential or a male, and do not agree to use 2 forms of highly effective methods of birth control for at least 28 days following the last dose of investigational product
* You must not have had symptomatic herpes zoster or herpes simplex infection within 12 weeks or have a history of disseminated/complicated herpes zoster
* You must not have evidence of active infection, such as fever >=38.0ºC (100.4ºF)
* You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* You must not be immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
* You must not have known history hypogammaglobulinemia
* You must not have had a serious systemic or local infection within 12 weeks prior to entry into the study
* You must not have been exposed to a live vaccine within 12 weeks prior to entry into the study, or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
* You must not have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
* You must not have a serious and/or unstable illness that, in the opinion of the investigator, poses an unacceptable risk for the your participation in the study
* You must not have or have had a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years
* You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse within the last 2 years
* You must not have donated blood of more than 500 mL within 4 weeks
* You must not have received a topical Ps treatment within 2 weeks prior to entry into the study
* Exceptions:
* class 6 (mild, such as desonide) or class 7 (least potent, such as hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or genitalia
* non-medicated shampoos (for example, that do not contain corticosteroids, coal tar, or vitamin D3 analogues)
* emollients that do not contain alpha or beta hydroxyl acids
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01490632 | {
"brief_title": "A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis",
"conditions": [
"Psoriasis",
"Skin Diseases",
"Skin Diseases, Papulosquamous"
],
"interventions": [
"Drug: Placebo",
"Drug: Baricitinib"
],
"location_countries": [
"Japan",
"Canada",
"Puerto Rico",
"United States"
],
"nct_id": "NCT01490632",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of Baricitinib in Patients With Moderate-to-Severe Plaque Psoriasis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-27",
"last_updated_that_met_qc_criteria": "2011-12-09",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-13",
"first_submitted": "2011-12-09",
"first_submitted_that_met_qc_criteria": "2017-06-19"
}
}
} |
#Study Description
Brief Summary
This study is to establish the safety and pharmacokinetic (PK) profile of IMC-11F8, administered either: (1) in a 3-week cycle; or (2) in a 2-week cycle to Japanese participants with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.
Detailed Description
This single center, open-label, single-arm, Phase 1 study will enroll 18 participants at a maximum. The actual size will vary depending on the dose-limiting toxicities (DLTs) observed and the resultant sizes of the cohorts. Participants will receive IMC-11F8 administered intravenously, once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (1 cycle). All infusions can be administered within ± 1 day of the scheduled administration date. After 1 cycle of treatment, participants who have an objective response or stable disease may continue to receive IMC-11F8 at the same dose and schedule until disease progression or other withdrawal criteria are met.
A minimum of 3 participants will be enrolled in each cohort. Dose escalation in successive cohorts will occur once all participants complete 1 cycle of therapy.
Participants will be enrolled sequentially into each cohort. A completed participant will be either a participant who completes the initial 6-week treatment period (Cycle 1) or a participant who discontinues therapy for an IMC-11F8-related toxicity during Cycle 1. Participants who do not complete the first 6 weeks of treatment for reasons other than an IMC-11F8-related toxicity will be replaced. Toxicity data for each cohort will be reviewed prior to dose escalation. Upon completion of all required safety evaluations during the initial 6 weeks, the next cohort of new participants will be treated at the next higher dose level using a dose escalation scheme.
#Intervention
- BIOLOGICAL : IMC-11F8
- 600 milligrams (mg) intravenously, Days 1 and 8 every 3 weeks
- Other Names :
- Necitumumab, LY3012211
- BIOLOGICAL : IMC-11F8
- 800 mg intravenously, every 2 weeks
- Other Names :
- Necitumumab, LY3012211
- BIOLOGICAL : IMC-11F8
- 800 mg intravenously, Days 1 and 8 every 3 weeks
- Other Names :
- Necitumumab, LY3012211 | #Eligibility Criteria:
Inclusion Criteria:
* Solid tumor participant who has been histopathologically or cytologically documented
* Advanced primary or recurrent solid tumors participant who has not responded to standard therapy or for whom no standard therapy is available
* The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 guidelines
* The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 at study entry
* The participant is able to provide written informed consent
* The participant is age >= 20 years
* The participant has a life expectancy of > 3 months
* The participant has adequate hematologic function
* The participant has adequate renal function
* The participant agrees to use adequate contraception for the duration of study participation and for at least 12 weeks after the last dose of study therapy
* The participant has adequate recovery from recent surgery, chemotherapy, and radiation therapy (including palliative radiation therapy). At least 28 days (6 weeks for nitrosoureas or mitomycin C) must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. For treatment with nonapproved monoclonal antibodies, a minimum of 8 weeks must have elapsed
* The participant is willing to comply with study procedures until the End-of-Therapy visit
Exclusion Criteria:
* The participant has received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or the participant has ongoing side effects >=Grade 2 due to agents administered more than 28 days earlier (except alopecia)
* The participant has documented and/or symptomatic brain or leptomeningeal metastases (participants who are clinically stable [no symptoms during the 4 weeks prior to enrollment] with an assessment that no further treatment [radiation, surgical excision, or administration of steroids] is required are permitted to enter the study)
* The participant has an uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection requiring systemic antibiotic treatment
* Congestive heart failure (Class III or IV per the New York Heart Association heart disease classification guidelines)
* The participant has participated in clinical studies of nonapproved experimental agents or procedures within 4 weeks prior to first dose of study therapy, or within 8 weeks prior to first dose of study therapy for nonapproved monoclonal antibodies
* The participant has received any previous treatment with monoclonal antibodies targeting the epidermal growth factor receptor (EGFR). Previous treatment with EGFR tyrosine kinase inhibitors (TKI), approved or nonapproved, is allowed. There must be a time interval of at least 4 weeks between the last EGFR TKI dose and the first dose of IMC-11F8
* The participant has acute or subacute intestinal occlusion/obstruction
* The participant has a history of inflammatory bowel disease (for example, Crohn's disease, ulcerative colitis) requiring medical intervention in the 3 years prior to study entry
* The participant has acute pulmonary disorder, interstitial pneumonia, pulmonary fibrosis, or history thereof
* The participant has a known allergy to any of the treatment components, or to monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins. In the event that there is suspicion that the participant may have allergies, the participant should be excluded
* The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating
* The participant has known alcohol or drug dependency
* The participant is hepatitis B virus (HBV) antigen, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody positive
* The participant is assessed as inadequate for the study by the investigator
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01088464 | {
"brief_title": "Study of IMC-11F8 in Participants With Advanced Solid Tumors",
"conditions": [
"Neoplasms"
],
"interventions": [
"Biological: IMC-11F8"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01088464",
"official_title": "A Phase 1 Study of IMC-11F8 in Patients With Advanced Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-02",
"study_start_date(actual)": "2010-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-03",
"last_updated_that_met_qc_criteria": "2010-03-16",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-17",
"first_submitted": "2010-03-16",
"first_submitted_that_met_qc_criteria": "2016-12-09"
}
}
} |
#Study Description
Brief Summary
This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin hydrochloride (SY-004).
Detailed Description
Glucokinase is a characteristic hexokinase isoenzyme in hepatocytes that catalyzes the first step in glucose metabolism. In addition to its role in glucose metabolism, glucokinase is expressed in pancreatic islet beta cells where it acts as a 'glucose sensor' for insulin release. Activation of glucokinase increases the glucose sensitivity of insulin secretion, effectively lowering the glucose threshold for insulin secretion. Because of its potential to enhance insulin secretion and affect hepatic glucose metabolism, is being investigated for use as a treatment for hyperglycaemia,glubalagliatin( the active ingredient in SY-004 capsule) is being investigated for use as a treatment for T2DM patients. This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of SY-004 administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of SY-004.
#Intervention
- DRUG : globalagliatin hydrochloride
- orally administration, single dose
- Other Names :
- SY-004 capsule
- DRUG : placebo
- orally administration, single dose | #Eligibility Criteria:
Inclusion Criteria:
* males and females between the ages of 18 and 65 years, inclusive, healthy subjects
* A screening body mass index (BMI) of 18 to 26 kg/m2 inclusive, body weight above 50kg
* FPG>=3.9mmol/L and <6.1 mmol/L
* Have medical history, physical examination, laboratory tests and other relative test results within the normal range or with abnormalities deemed clinically insignificant by the investigator.
* Have given written informed consent.
* The subjects took effective contraceptive measures, and had no birth plan within 3 months.Female subjects should be non lactating, negative pregnancy test, or no fertility potential (Women who were 12 months of menopause or without uterus were found to have no potential for pregnancy )
Exclusion Criteria:
* There is a serious history of systemic disease, or a family history (including cardiovascular system, digestive system, urinary system, etc.)
* Have taken a special diet or exercise before 48 hours of drug administration or other factors are capable of significantly altering the absorption, or metabolism or elimination of drugs.
* A significant abnormality in ALT,AST or other lab test results
* Frontal chest X light result is clinical significantly abnormal.
* Have known intolerance of or allergies to glucokinase activators, or related compounds.
* Have known allergies to other compounds or biologic products.
* Have a major surgery in the last 4 weeks before dosing.
* To inoculate any live vaccine within 4 weeks before drug administration.
* Have a history of drug abuse
* Use any prescription drugs within 4 weeks prior to administration or use OTC or traditional Chinese medicine within 1 weeks before enrollment.
* Regular drinkers within 6 months before or during the trial (Subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) [1 unit = 360 mL of beer; or 150 mL of wine; or 45 mL of distilled spirits])
* The amount of daily cigarette smoking was more than 5/day in last 3 months, or subjects unwilling to stop cigarette consumption during the trial.
* Are enrolled in 4 or more clinical trials within last year, or participated any clinical trail within 3 months before enrollment ; plan to donate blood or blood donation of 450 mL or more in the last 3 months; or have blood transfusion 4 weeks before the trial.
* An clinical significant abnormality in the 12-lead ECG at screening or baseline: QT interval> 450 ms
* Subjects deemed unsuitable by the Investigator for low compliance or any other reason.
* investigator and their immediate families.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03171623 | {
"brief_title": "The Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride",
"conditions": [
"Hyperglycaemia (Diabetic)",
"Healthy Volunteers"
],
"interventions": [
"Drug: globalagliatin hydrochloride",
"Drug: placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT03171623",
"official_title": "A Randomised,Double-blind,Placebo-controlled Study to Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride (SY-004) in Chinese Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-25",
"study_completion_date(actual)": "2018-01-09",
"study_start_date(actual)": "2017-04-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-31",
"last_updated_that_met_qc_criteria": "2017-05-26",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-31",
"first_submitted": "2017-05-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).
#Intervention
- DRUG : Rivaroxaban (Xarelto, BAY59-7939)
- Treatment parameters following the summary of product characteristics and the physician's decision | #Eligibility Criteria:
Inclusion Criteria:
* Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.
Exclusion Criteria:
* Patients who are contraindicated based on the product label and have already received Xarelto treatment.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02558465 | {
"brief_title": "Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)",
"conditions": [
"Venous Thromboembolism"
],
"interventions": [
"Drug: Rivaroxaban (Xarelto, BAY59-7939)"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT02558465",
"official_title": "Special Drug Use Investigation of Xarelto for VTE",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-01",
"study_completion_date(actual)": "2021-05-31",
"study_start_date(actual)": "2015-11-13"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-01",
"last_updated_that_met_qc_criteria": "2015-09-23",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-24",
"first_submitted": "2015-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
Detailed Description
Medical abortion (MA) consists of administering medication, typically a combination of mifepristone and misoprostol, to induce an abortion without any invasive procedures. Early first trimester MA is effective1, highly acceptable to women, and safe. The risk of infection following medical abortion is small, at less than 1%. In rare circumstances, pelvic infection with clostridia bacteria following medical abortion has resulted in death. Since 2000, when mifepristone was registered in the United States, 8 such deaths have been recorded in the US.
Following the publication of case reports of four clostridium-associated deaths after medical abortion in 2005, the reproductive health community reacted swiftly. Medical abortion protocols were altered in an effort to curb these drastic and rapidly fatal infections. Antibiotic treatment, typically a seven-day course of doxycycline, has become widespread in the United States.
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
| #Eligibility Criteria:
Inclusion Criteria:
* Women who are having MA at the study clinic and are willing to complete a self-administered, computer-based questionnaire 7 <= age <= 14 days after taking mifepristone
* Women who can read English or Spanish
* In the doxycycline arm: Women who have been prescribed doxycycline
Exclusion Criteria:
* Women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment
* Women who have previously enrolled in this study
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT01799252 | {
"brief_title": "Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion",
"conditions": [
"Abortion"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01799252",
"official_title": "Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2012-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-02-03",
"last_updated_that_met_qc_criteria": "2013-02-23",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-26",
"first_submitted": "2012-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed throughout the day may provide better rehabilitation outcomes for stroke patients. Such a program can be implemented using constraint-induced therapy in which the Veteran is provided with opportunities to use the affected limb while participating in a video game and completing complementary tasks in therapy. Additionally, rehabilitation outcomes may improve if Veterans are provided with regular opportunities to participate in gaming therapy at home after discharge from the hospital rather than having to travel to a clinic or receive limited or no follow-up in rural areas.
This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy 'constraint induced therapy'. In this study, participants focus on using the impaired limb rather than the unaffected limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Up to twenty-four (24) Veterans inpatient with hemiparesis due to stroke in the brain will be recruited from the Minneapolis VA Health Care System. Study participants will only be able to play the game using the impaired limb. Participants may also receive automated reminders to use the impaired arm throughout the day. Gaming will occur in patient room and during occupational therapy. Participants will have the option of being discharged with the gaming system for continued gameplay. Outcome measures will include motor function tests that evaluate upper extremity function.
Detailed Description
Research Question
The two questions to be answered by this study are: 1) To what extent does game-based CI therapy (with the Transfer Package) increase use of the more affected upper extremity from inpatient rehabilitation through subacute follow-up.
2) What is the clinical effectiveness of distributed gaming CI therapy for improving motor function of the more affected upper extremity at 3 months post-discharge.
Background
Constraint-Induced (CI) Movement therapy is arguably the best treatment paradigm to pilot throughout the continuum of care because it is established as the most empirically-supported intervention in subacute and chronic stroke and is more effective than standard care in acute stroke when lower duration/intensity protocols are utilized. CI therapy has strong evidence of increased effectiveness relative to standard care in the only positive definitively-powered upper extremity trial. A limitation of the acute CI therapy literature is that most studies omitted the most essential component of CI therapy: The Transfer Package of behavioral techniques that promotes carry-over of training to daily activities. In absence of the Transfer Package, everyday use of the weaker arm does not substantially improve and structural brain plasticity and quality of life gains are not realized. Early studies also show that any treatment advantage of CI therapy acutely is not maintained in follow-up, suggesting that maintenance therapy post-discharge is likely essential for altering the recovery trajectory.
Clinical Significance
This work will have a positive impact on the field of rehabilitation because it offers a solution to the main barriers of delivering distributed empirically-based treatment within an inpatient rehabilitation setting. By providing a paradigm for delivering distributed upper extremity practice, the product of this work has the potential to improve post-stroke health outcomes, lower-cost, and maintain the continuity of treatment from inpatient rehabilitation to community care.
Methods
The project will involve participatory action research methods to identify potential barriers to implementation of this new intervention within the VA and to refine the treatment approach to meet the needs of an inpatient population. A focus group will involve at least 3 patients who are currently on the inpatient rehabilitation unit (or recently discharged), their families, and occupational therapy/physical therapy (OT/PT)/recreational therapy staff. This meeting will serve to finalize the treatment protocol for this study. Areas that will be addressed will include the 'dosing' schedule for the game-based intervention and needed adaptations to the CI therapy Transfer Package techniques (described below) to promote maximal carry-over from trained activities to everyday use of the weaker upper extremity. Any needed modifications to the technology platform (e.g. data storage) will also be made to comply with the VA's regulatory policies regarding adoption of new technology.
Up to 24 stroke survivors with upper extremity hemiparesis will be enrolled. Participants have the option of taking the gaming system home after discharge.
Gaming CI Therapy (Approximate Schedule)
1. 30 total inpatient hours OT/PT:
* One 30-minute session to teach game play
* 4.5 hours devoted to Transfer Package
* Remainder time spent in usual care activities
2. 14 hours independent game play while inpatient
3. 18 hours independent game play following discharge (30 min, 3 times weekly) over and above standard care (will be documented as covariate)
4. Optional use of smart watch with biofeedback
This study will be conducted at the Minneapolis Veterans Affairs Medical Center (MVAMC). The MVAMC is home to the Stroke Specialty Program (SSP), a Commission on Accreditation of Rehabilitation Facilities (CARF) accredited program. The SSP tailors rehabilitation for survivors of any stroke mechanism (hemorrhagic, occlusive, etc.) affecting any part of the brain. Services can be adapted for survivors with cognitive challenges. The SSP has averaged 41 admissions in the past three years, though 2017 has projected admissions over 50. Retrospective chart review demonstrates the primary diagnosis resulting from stroke to be hemiplegia in approximately half of the admissions. Most patients (85%) are older than 60 years, predominantly Caucasian (85%) or African-American (10%) and male (98%).
Study participants will be patients enrolled in the MVAMC Stroke Specialty Program. Prospective participants will be screened by study staff. A retrospective chart review will be conducted to review outcomes of patients who underwent stroke rehabilitation at the Minneapolis VA but did not receive the study intervention. These subjects will serve as a retrospective control.
#Intervention
- DEVICE : Recovery Rapids
- This project utilizes a new gaming system technology called Recovery Rapids. The game is custom-made by Games That Move You, LLC and runs on an XBOX platform with motion input via a Kinect system. | #Eligibility Criteria:
Inclusion Criteria:
* Veteran between 18 and 88 years
* Inpatient at the Minneapolis VAHCS
* Willing and able to give Informed Consent or meets criteria for surrogate consent
* Upper extremity hemiparesis resulting from stroke in the brain (including brainstem) or tumor resection at the discretion of the therapist
* Lives within vicinity of the Minneapolis VA
Exclusion Criteria:
* Complete loss of arm function
* No contact address or telephone
* Active substance use disorder or major uncontrolled psychiatric disorder
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 88 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03578536 | {
"brief_title": "Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting",
"conditions": [
"Stroke"
],
"interventions": [
"Device: Recovery Rapids"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03578536",
"official_title": "Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-30",
"study_completion_date(actual)": "2021-06-30",
"study_start_date(actual)": "2019-09-30"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-16",
"last_updated_that_met_qc_criteria": "2018-07-03",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-06",
"first_submitted": "2018-06-04",
"first_submitted_that_met_qc_criteria": "2023-04-17"
}
}
} |
#Study Description
Brief Summary
To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
#Intervention
- DRUG : Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)
- DRUG : Dabigatran polymorph I | #Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age >=65 and <=85 years
* BMI >=18.5 and BMI <=32.0 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria:
* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Clinically relevant surgery of gastrointestinal tract
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Any relevant bleeding history
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT02171013 | {
"brief_title": "Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Dabigatran polymorph I",
"Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)"
],
"location_countries": null,
"nct_id": "NCT02171013",
"official_title": "Bioequivalence of Two Different Drug Product Batches of 150 mg of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double Blind, Randomised, Single-dose, Replicate Design in a Two-treatments, Four Periods Crossover Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-23",
"last_updated_that_met_qc_criteria": "2014-06-20",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-23",
"first_submitted": "2014-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to investigate whether there has been a change in low birth weight and perinatal and infant mortality following the July 2007 introduction of a ban on smoking in public places and workplaces in England.
Detailed Description
Primary research question Has there been a change in the numbers of babies being born with low birth weight or dying in the perinatal or infant period following the 1 July 2007 introduction of a ban on smoking in public places in England?
Study design Retrospective cohort study (using prospective routinely collected health care data)
Study population All singleton births in England between 1 January 1995 and 31 December 2011.
Intervention The intervention under study is the ban on smoking in enclosed public places and the workplace implemented in England overnight on 1 July 2007.
Inclusion and exclusion criteria We will include all registered singleton births in England occurring between 1 January 1995 and 31 December 2011. This is the maximum time period surrounding the ban's introduction for which the required birth data are available through the data source. Data were originally extracted for 1 January 1993 to 31 December 2011. However, postcode was not recorded in 1993-1994, leading to missing values for Index of Multiple Deprivation (IMD) quintile, region, and urbanisation level in this period. As these variables were considered key potential confounders in the primary analyses, a decision was made to restrict the modelling to the time period 1 January 1995-31 December 2011.
International Classification of Disease (ICD) coding changed from version 9 to 10 as of January 2001, leading to an important drop in recorded SIDS cases. Therefore, analyses of SIDS are restricted to the time period 2001-2011.
Babies with chromosomal anomalies will be excluded.
Outcome
The primary outcomes are:
* Low birth weight (birth weight \< 2500 grams)
* Stillbirth (intrauterine death from 24+0 weeks gestation)
* Neonatal mortality (death within the first 28 days of life)
* Sudden infant death syndrome (SIDS; death within first year of life with mentioning on the death certificate of ICD-10-U code R95, or R99 with no other specification)
To assess whether smoke-free legislation had a selective impact on certain subgroups of outcomes we furthermore identified a number of secondary outcomes:
* Very low birth weight (birth weight \< 1500 grams)
* Early neonatal mortality (death within first week of life)
* Late neonatal mortality (death between 7 and 28 days of life)
* Post-neonatal mortality (death between 28 days and 1 year of life)
* Infant mortality (death within the first year of life)
Data sources Data are obtained via the Office for National Statistics (ONS). All registered stillbirths and livebirths occurring in England between 1 January 1995 and 31 December 2011 are included. These are linked to death certificates for all deaths occurring before the first birthday.
Data extraction and handling Individual perinatal and mortality data are linked by ONS in a single database including the following individual-level covariates: month of birth, year of birth, month of death, year of death, age at death, sex, birth weight, maternal age, maternal marital status, parity, IMD, region, urbanisation level.
The following covariates are categorised for information governance reasons:
* Age at death: early neonatal, late neonatal, post-neonatal
* Birth weight: \<1000 grams, 1000-1499 grams, 1500-2499 grams, 2500-3999 grams, ≥4000 grams
* Maternal age: \<20 years, 20-24 years, 25-29 years, 30-34 years, 35-39 years, \>40 years
* Parity: 0, 1, 2, ≥3
* IMD: quintiles
* Region: 10 regions
* Urbanisation level: urban, rural
Sample size Sample size calculation for time-oriented analyses is complicated given the complexity of the models. We will use national data for the current study, which will - to the best of our knowledge - be the largest evaluation of the impact of smoke-free legislation on perinatal health, both regarding population size and time span. As we use the maximum time span and population available, sample size calculation can in a way be considered redundant.
We are aware of only one published study on smoke-free legislation and early-life mortality (reference 1). Due to design issues it is not possible to involve data from this study for comparison to the current study.
A number of studies have previously assessed the impact of smoke-free legislation on low birth weight. Our proposed approach is best comparable to that performed earlier in Scotland (reference 2). Using Scottish data on 757,795 deliveries occurring between 1996 and 2009, they showed an immediate -9.9% (95%CI -14.2; -5.2) drop in low-birth-weight-babies. Given the longer study period (1993-2011) and the much larger population size (n\>10 million) our study can be expected to have sufficient power to detect a similar reduction in low-birth-weight-babies in England, if present.
Statistical analysis
Relevant population characteristics will be described. Logistic regression analysis will be performed to investigate the association between introduction of smoke-free legislation and sudden ('step') and/or gradual ('slope') changes (as appropriate) in the odds of developing each outcome. Analyses will be adjusted for birth weight, sex, maternal age, maternal marital status, parity (secondary analyses only, see below), IMD quintile, region, and urbanisation level. Seasonal patterning and non-linearity of the underlying time trend will be accounted for as appropriate. Final model selection will be based on Akaike's and Bayesian information criteria (AIC and BIC). The denominator for the analyses will differ according to the various outcomes:
* stillbirths: all births in the dataset
* low birth weight, very low birth weight, neonatal mortality, early neonatal mortality, infant mortality: all livebirths in the dataset
* late neonatal mortality: all livebirths in the dataset surviving the early neonatal period
* post-neonatal mortality: all livebirths in the dataset surviving the neonatal period
The primary analyses will be performed on cases with complete data on all covariates. Parity is the only variable that has \>10% missing data (approximately 40-50%), as it is only recorded in married women. As parity is not expected to be a key confounder, we will perform the primary analyses without involving parity in the models in order to maximise population size.
Sensitivity analyses To assess possible confounding by parity, sensitivity analyses will be performed that include parity in the model. In a second set of sensitivity analyses, imputation will be performed to investigate the robustness of the findings to missing data. In order to minimise issues regarding multiple testing, sensitivity analyses will be performed for the primary outcomes only.
All analyses will be performed using Stata 12.0.
#Intervention
- OTHER : Smoke-free legislation
- The intervention under study is the smoke-free legislation in England introduced overnight on 1 July 2007. As of this date virtually all enclosed public places and workplaces were by law required to be smoke-free. More detail can be found via the link provided at the end of this protocol. | #Eligibility Criteria:
Inclusion Criteria:
* singleton birth occurring in England between 1 January 1995 and 31 December 2011
Exclusion Criteria:
* chromosomal anomalies
* stillbirth (applies to all outcomes other than stillbirth)
Sex :
ALL
Ages :
- Maximum Age : 1 Year
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT02039583 | {
"brief_title": "Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England",
"conditions": [
"Stillbirth",
"Infant Mortality",
"Sudden Infant Death",
"Infant, Low Birth Weight",
"Infant, Very Low Birth Weight"
],
"interventions": [
"Other: Smoke-free legislation"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02039583",
"official_title": "Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England: a Quasi-experimental Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "1995-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-17",
"last_updated_that_met_qc_criteria": "2014-01-16",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-17",
"first_submitted": "2014-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the 'concentration-time profile'.
#Intervention
- OTHER : Avenanthramides
- AVAs are a group of diphenolic acids that are found only in oats (Avena sativa). In this study, each dietary group of subjects will receive three cookies made with oat flour containing high-AVA (H-AVA, 229.56 mg/kg) and low-AVA (L-AVA, 32.69 mg/kg). | #Eligibility Criteria:
Inclusion Criteria:
* Male and female non-obese subjects (18kg/M2<BMI<28kg/M2)
* Age 20 <= age <= 45 years)
* Sign an informed consent form approved by UMN-IRB
* Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study
Exclusion Criteria:
* Presence of GI conditions that interfere with absorption;
* Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders;
* Major trauma or surgery within 3 months of visit;
* Cancer in the prior 2 years;
* Allergic to oat products;
* Women who are pregnant or lactating;
* Smoking;
* Drinking alcohol >5 drinks/week;
* Using nutraceuticals;
* Blood pressure medication;
* NSAID (>800 mg ibuprofen/week);
* Vitamin supplementation;
* Anticoagulants or hypoglycemic drugs;
* Oat products consumption the day before the test;
* Rigorous physical activity the day before the test;
* Consumption of a high-flavonoid diet in the week prior to the test.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02415374 | {
"brief_title": "Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical",
"conditions": [
"Bioavailability",
"Metabolism",
"Avenanthramides"
],
"interventions": [
"Other: Avenanthramides"
],
"location_countries": null,
"nct_id": "NCT02415374",
"official_title": "Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07-15",
"study_completion_date(actual)": "2015-07-15",
"study_start_date(actual)": "2015-01-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-10",
"last_updated_that_met_qc_criteria": "2015-04-08",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-14",
"first_submitted": "2015-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.
Detailed Description
This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points. The primary outcome of interest was systolic blood pressure. Additional secondary outcomes of interest were diastolic blood pressure, HbA1c, BMI, total cholesterol, depressive symptoms, and life functioning. These outcomes were analyzed as continuous variables using linear regression with backward model selection. Longitudinal analyses were also conducted using a likelihood-based approach to general linear mixed models.The intervention and control groups were patients with an SPMI diagnosis over 18 years of age who were not receiving primary care services prior to enrollment and were eligible to receive behavioral health services from TTBH. The participants resided in Cameron or Hidalgo County and had one or more chronic conditions: hypertension (blood pressure of 140/90 mmHg or higher), poorly controlled diabetes (HbA1c over 8.5%), obesity (body mass index of 30.0 or higher), or hypercholesterolemia (total cholesterol level above 200).
#Intervention
- BEHAVIORAL : Reverse Colocated Integrated Care
- A reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting.
- BEHAVIORAL : Usual Care
- Behavioral health services without primary care or integrated care services | #Eligibility Criteria:
Inclusion Criteria:
* Reside in Cameron, Hidalgo, or Willacy County
* Have a severe, persistent mental illness as diagnosed by a licensed behavioral health care provider
* Be eligible to receive behavioral health services from TTBH
* Must not be receiving any primary care outside of TTBH (as ascertained via patient self-report)
* Have a diagnosis of one or more chronic conditions:
* Hypertension (blood pressure of 140/90 mmHg or higher)
* Obesity (body mass index of 30.0 or higher)
* Poorly controlled diabetes (HbA1c over 8.5%)
* Hypercholesterolemia (Total cholesterol level above 200)
Exclusion Criteria:
* Not actively suicidal at time of enrollment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03881657 | {
"brief_title": "Reverse Colocated Integrated Care Intervention Among Persons With Severe Persistent Mental Illness at US-Mexico Border",
"conditions": [
"Mental Illness Persistent",
"Chronic Disease",
"Hypertension",
"Diabetes",
"Hypercholesterolemia",
"Depression",
"Obesity"
],
"interventions": [
"Behavioral: Usual Care",
"Behavioral: Reverse Colocated Integrated Care"
],
"location_countries": null,
"nct_id": "NCT03881657",
"official_title": "Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08-22",
"study_completion_date(actual)": "2017-08-22",
"study_start_date(actual)": "2015-11-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-19",
"last_updated_that_met_qc_criteria": "2019-03-18",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-19",
"first_submitted": "2019-03-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results.
To help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.
The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.
Detailed Description
Cystic fibrosis (CF) is a genetic disease caused by malfunctioning of a protein called CFTR.
CF affects various organs including the sweat glands and the lungs. An FDA approved drug called ivacaftor helps some people with CF, and laboratory tests show that it produces further improvement when combined with an investigational drug called lumacaftor. However, results from clinical tests of the two drugs used together gave mixed results: lung function improved but sweat gland function did not improve. This study will measure CFTR-dependent sweat rate to test the hypothesis that CFTR in the normal sweat glands might be functioning at peak efficiency, and so can't be improved further with ivacaftor, thus accounting for the apparent discrepancy between lung function and sweat gland results. CFTR-dependent sweat rate is important to understanding CF because it is a very accurate measure of CFTR function.
#Intervention
- DRUG : Ivacaftor
- 150mg administered orally twice daily.
- Other Names :
- Kalydeco
- DRUG : β-Adrenergic cocktail
- Administered subcutaneously to induce sweating. Cocktail composed of atropine (280µM), isoproterenol (160µM), and aminophylline (20 mM).
- DRUG : Pilocarpine Nitrate 5%
- Administered subcutaneously using Macroduct sweat stimulator device.
- DEVICE : Macroduct sweat stimulator | #Eligibility Criteria:
Inclusion Criteria:
* Healthy adults without a Cystic Fibrosis (CF) mutation
* Carriers with a known CF mutation
Exclusion Criteria:
* Documented liver disease
* Participants should not be taking:
* medicines that are strong CYP3A (Cytochrome P450, family 3, subfamily A) inducers, such as:
* the antibiotics rifampin and rifabutin;
* seizure medications (phenobarbital, carbamazepine, or phenytoin); and
* the herbal supplement St. John's Wort, substantially decreases exposure of ivacaftor and may diminish effectiveness.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02310789 | {
"brief_title": "(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?",
"conditions": [
"Cystic Fibrosis"
],
"interventions": [
"Drug: Pilocarpine Nitrate 5%",
"Drug: Ivacaftor",
"Drug: β-Adrenergic cocktail",
"Device: Macroduct sweat stimulator"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02310789",
"official_title": "(Study: Vertex IIS) A Study To Access the Effects of Ivacaftor on Wild Type CFTR-Open Probability (PO) In The Sweat Gland Secretory Coil",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08-02",
"study_completion_date(actual)": "2017-08-23",
"study_start_date(actual)": "2015-07-31"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-09",
"last_updated_that_met_qc_criteria": "2014-12-05",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-08",
"first_submitted": "2014-09-03",
"first_submitted_that_met_qc_criteria": "2018-03-19"
}
}
} |
#Study Description
Brief Summary
This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.
#Intervention
- DRUG : GSK1755165; placebo; zopiclone
- Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone | #Eligibility Criteria:
INCLUSION CRITERIA:
* Healthy male and female subjects providing written informed consent.
EXCLUSION CRITERIA:
* Significant medical disorders;
* Sleeping difficulties; alcohol and/or substance abuse;
* Recent use of psychotropic medications, or need to use them during study;
* Very high BMI or very low BMI or bodyweight;
* Known hypersensitivity to the study medications or their excipients;
* Unwilling or unable to meet certain lifestyle or dietary restrictions during the study.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00699608 | {
"brief_title": "An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.",
"conditions": [
"Healthy Subjects",
"Sleep Initiation and Maintenance Disorders"
],
"interventions": [
"Drug: GSK1755165; placebo; zopiclone"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00699608",
"official_title": "A Randomised, Double-blind, Double-dummy, Placebo-controlled, 3-way Crossover Study to Evaluate Potential Next-day Residual Effects of a Single Evening Dose of 3mg Eszopiclone and 7.5mg Zopiclone in Healthy Adult Subjects.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2008-10",
"study_start_date(actual)": "2008-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-06-05",
"last_updated_that_met_qc_criteria": "2008-06-17",
"last_verified": "2011-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-18",
"first_submitted": "2008-06-17",
"first_submitted_that_met_qc_criteria": "2010-04-22"
}
}
} |
#Study Description
Brief Summary
This study was conducted in a primary school in turkey.It was aimed to examine the effects of health education given to children in primary school period.As a result, it has been seen that education can be effective.
Detailed Description
Investigation of the Effects of Health Education Provided to Saraçoğlu Toki Mustafa Çetin Primary School Students on Health Screening Results The aim of this study is to find the effect of health education given to primary school students on health screening results.
The research is a pre-test and post-test quasi-experimental model with a single subject group. Saracoglu Toki Mustafa Cetin Primary School is that located in Turkey; It was held between September 2019 and March 2020. It was aimed to reach the entire universe, not choosing the sample. The pre-test screening was completed with 460 students and the post-test screening with 400 students. An Introductory Information Form and Screening Test Application Form were used to collect data. After the health education was given by the researchers using visual, auditory materials and drama technique, the results were evaluated.
#Intervention
- BEHAVIORAL : Health Education
- All students who attended the school were provided training by the researchers to improve oral and dental health and general hygiene. These trainings were made using slide shows and various entertaining materials. In addition, education was transformed into a drama with a theater show, and the importance of hand washing, hair and toilet hygiene was explained.
In addition to hygiene, students were given training on correct eating patterns for a day so that they could develop healthy. | #Eligibility Criteria:
Inclusion Criteria:
* All students who regularly attend school at Saraçoğlu TOKI Primary School and who had no communication problems and whose parents gave their research approval were included in the study.
Exclusion Criteria:
* Students who could not attend school were excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT04690712 | {
"brief_title": "Health Education Provided to Primary School Students",
"conditions": [
"Nurse's Role",
"Health Behavior"
],
"interventions": [
"Behavioral: Health Education"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04690712",
"official_title": "The Effect of Health Education Provided to Primary School Students on Screening Results",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-25",
"study_completion_date(actual)": "2020-02-21",
"study_start_date(actual)": "2019-05-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-31",
"last_updated_that_met_qc_criteria": "2020-12-28",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-31",
"first_submitted": "2020-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.
Detailed Description
This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.
#Intervention
- DRUG : Bevacizumab
- Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
- Other Names :
- Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- DRUG : Capecitabine
- 650mg/m\^2 taken by mouth twice a day 15-52 during the radiotherapy.
- Other Names :
- Xeloda
- RADIATION : Radiotherapy
- Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
- Other Names :
- XRT | #Eligibility Criteria:
Inclusion Criteria:
* Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
* Patients with nonmetastatic, unresectable, disease are eligible.
* Patients with regional nodal disease are eligible.
* Karnofsky performance status >=70.
* No upper age restriction.
* Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3.
* Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression.
* Adequate bilateral renal function.
* Serum creatinine <1.5 mg/dl.
* Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)<=5 times upper limit of normal.
* Sexually active men must practice contraception during study.
* Patients must sign study-specific consent form.
Exclusion Criteria:
* History or evidence upon physical examination of CNS disease.
* Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
* Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent.
* Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications.
* Pregnancy or lactation.
* Proteinuria at baseline or impairment of renal function.
* Serious, nonhealing wound, ulcer, or bone fracture.
* Evidence of bleeding diathesis or coagulopathy
* Clinically significant cardiovascular disease, congestive heart failure, serous cardiac arrhythmia requiring medication, or significant peripheral vascular disease within 1 year prior to Day 0.
* History of aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations.
* Serous concomitant medical or psychiatric disorders.
* Cohort receiving Capecitabine
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT00047710 | {
"brief_title": "Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer",
"conditions": [
"Pancreatic Cancer"
],
"interventions": [
"Drug: Capecitabine",
"Radiation: Radiotherapy",
"Drug: Bevacizumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00047710",
"official_title": "A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": "2006-07",
"study_start_date(actual)": "2002-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-08-01",
"last_updated_that_met_qc_criteria": "2002-10-15",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-10-16",
"first_submitted": "2002-10-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The researchers propose a two-arm pilot study of telephone and video delivered Mindfulness-based Cognitive Therapy (MBCT-T and MBCT-V) in people with migraine and depressive symptoms.
Detailed Description
This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This first phase is aimed at fidelity optimization of MBCT-T and MBCT-V in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).
#Intervention
- BEHAVIORAL : MBCT-Telephone
- Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via telephone by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.
- BEHAVIORAL : MBCT-Video
- Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via WebEx video-conferencing by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment. | #Eligibility Criteria:
Inclusion Criteria:
* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4 <= age <= 14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5 <= age <= 14 on the PHQ-9
* Age >= 18
* Ability to read and speak English
* Capacity to consent
Exclusion Criteria:
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
* Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin A, anti-calcitonin gene related peptide treatment) within 3 months of intake
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current meditation practice >3x/week
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04992494 | {
"brief_title": "Treatment for Migraine and Mood (Team-M)",
"conditions": [
"Migraine",
"Depression"
],
"interventions": [
"Behavioral: MBCT-Telephone",
"Behavioral: MBCT-Video"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04992494",
"official_title": "Treatment for Migraine and Mood (Team-M): A Pilot Trial of a Mindfulness-based Training Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-13",
"study_completion_date(actual)": "2022-06-13",
"study_start_date(actual)": "2021-11-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-18",
"last_updated_that_met_qc_criteria": "2021-08-01",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-05",
"first_submitted": "2021-08-01",
"first_submitted_that_met_qc_criteria": "2023-06-26"
}
}
} |
#Study Description
Brief Summary
This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.
Detailed Description
Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of diabetes. Although the relative importance of these two alterations is controversial, growing evidence is swinging to the concept that there is no hyperglycemia without β-cell dysfunction. Also there is agreement that deterioration of glucose tolerance over time is associated with a progressive decrease of beta cell function.
Beside the role of genetic factor, the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid. A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell. Recently, many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes.
Some studies have shown that early intensive insulin therapy(IIT) to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin. It is suggested that long term glycemic control is associated with improvement of β-cell function.
In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control. To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function, the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.
#Intervention
- DRUG : intensive insulin group
- Once daily long acting insulin and preprandial rapid acting insulin injection
- DRUG : Oral AntiDiabetic Drug (glimepiride and metformin)
- glimepiride and metformin combined therapy
- Other Names :
- glimepiride(amaryl), metformin(diabex) | #Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
* Initial HbA1c : 8.0 % <= HbA1c < 12.0%
Exclusion Criteria:
* Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
* Patients with proliferative diabetic retinopathy
* Severe liver disease or AST, ALT >= 2.5 x ULN
* History of lactic acidosis
* Unstable or severe angina
* Congestive heart failure
* Chronic disease treated with continuous corticosteroid therapy
* Diagnosis of cancer
* Positive urine pregnancy test or plan to become pregnant during the clinical trial
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00474838 | {
"brief_title": "Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy",
"conditions": [
"Type 2 Diabetes Mellitus",
"Pancreatic Beta Cell Function",
"Glucotoxicity"
],
"interventions": [
"Drug: Oral AntiDiabetic Drug (glimepiride and metformin)",
"Drug: intensive insulin group"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT00474838",
"official_title": "The Effect of Intensive and Short-term Insulin Treatment on Long-term Pancreatic β-cell Function in Newly Diagnosed People With Type 2 Diabetes in Korea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2007-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-26",
"last_updated_that_met_qc_criteria": "2007-05-16",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-17",
"first_submitted": "2007-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.
#Intervention
- DRUG : Imipenem
- A wide-spectre antibiotic from the carbapenem group
- Other Names :
- Imipenem-cilastatin
- DRUG : Placebo
- An imipenem-matching placebo | #Eligibility Criteria:
Inclusion Criteria:
* diagnosis of acute pancreatitis defined by the Revised 2012 Atlanta Criteria
* first manifestation of acute pancreatitis regardless of etiology
* APACHE II >= 8 calculated within the first 24 hours of admission
* onset of symptoms < 72 hours before admission
Exclusion Criteria:
* age < 18 years
* pregnant and breastfeeding women
* active and documented infection at admission
* concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment
* acute pancreatitis diagnosed at surgery
* active malignancy
* known immune deficiency
* patients with chronic pancreatitis
* patients unwilling to participate in the trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02897206 | {
"brief_title": "Imipenem Prophylaxis in Patients With Acute Pancreatitis",
"conditions": [
"Acute Pancreatitis"
],
"interventions": [
"Drug: Placebo",
"Drug: Imipenem"
],
"location_countries": [
"Croatia"
],
"nct_id": "NCT02897206",
"official_title": "Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2014-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-20",
"last_updated_that_met_qc_criteria": "2016-09-10",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-13",
"first_submitted": "2015-12-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Lung cancer is a common cancer, associated with a high mortality rate. Pleural effusions are common in lung cancer, developing in up to 40% of patients. Ascites is common in patients with abdominal malignancies and can be the presenting feature in up to 50% of patients. There is a need for new techniques to improve our diagnostic ability of cancer. FTIR technology could enable a point-of-care test that would provide an initial diagnosis that may determine a change in treatment at the time of the investigation.
Detailed Description
Lung cancer accounts for 13% of all new cancer cases in the UK and is the third most common cancer. However, lung cancer has the highest mortality rate, thought partly related to late diagnosis. Pleural effusions develop in up to 40% of patients with lung cancer, and can be the first presenting sign. Current methods of analysing pleural fluid are based on using Light's criteria to distinguish between exudates and transudates depending on the protein and LDH component of the fluid. However, this system does not discriminate between causes of exudative effusions for example malignant effusions vs infective causes. Pleural fluid cytology can identify malignant effusions but gives an average yield of 60% through a labour intensive and time consuming process. If pleural fluid cytology is non-diagnostic, patients require further invasive investigations such as local anaesthetic thoracoscopy, lymph node biopsies or image-guided biopsies to gain a tissue diagnosis. Therefore, determining an alternative, accurate method of diagnosing cancer at the earliest opportunity would reduce the need for further invasive investigations and would provide patients with increased treatment options, thereby increasing survival rates. There are differences in the biochemical composition of malignant and non-malignant effusions thereby offering an opportunity to develop alternative techniques of investigating the cause of these effusions.
Ascites is a common symptom of patients with various underlying cancers; most commonly breast cancer, colon cancer, gastrointestinal cancer and ovarian cancer, and is often associated with significant morbidity. However, up to 50% of patients with malignant ascites present with ascites as the first feature. This symptom is not specific to any type of cancer; current investigations including using serum tumour markers have a low diagnostic specificity and there is a need for new techniques to improve our diagnostic ability.
Fourier transform mid-infrared spectroscopy (FTIR) is a reproducible and relatively simple investigation used to analyse the structural components of tissue or cells. As infrared light is passed through a sample, some light is absorbed and some transmitted through. The resulting signal at the detector presents as a spectrum, representing a 'molecular fingerprint' of the sample. Each chemical structure produces a unique spectral fingerprint making FTIR a useful tool for identifying components of tissue or cells.
Attenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy is a variant of IR spectroscopy in which samples can be examined directly with no preparation needed. ATR-LVF spectroscopy can be performed on benchtop spectrometers with minimal operator training and an immediate result can be obtained.
Both FTIR and ATR-LVF are non-invasive, reproducible, do not damage the sample and have the benefit of only requiring a small sample size to generate results all of which are desirable qualities in developing a new investigation.
FTIR has been used to successfully discriminate between malignant and non-malignant lung tissue6, and also to identify spectral differences in samples of pleural fluid from malignant and non-malignant participants. There is currently ongoing work investigating FTIR in diagnosing malignant pleural mesothelioma and initial results have shown significant spectral differences in this population too. There is very little information regarding the use of FTIR in assessing ascitic fluid. However, despite the technology, it is not available as a bedside point-of-care test for clinicians. The differences and discrimination of the model has not been tested prospectively to determine sensitivity and specificity of the FTIR test. A mobile point-of-care devices that may be able to provide rapid diagnostic results. This study aims to confirm that the spectral changes between malignant and non-malignant samples are present in a UK population in both pleural effusions and ascites.
| #Eligibility Criteria:
Inclusion Criteria:
* Aged >=18 years.
* A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria):
* Malignant pleural effusion: confirmed cancer
* lung cancer
* mesothelioma
* or metastatic cancer
* Non-malignant pleural effusion: effusion confirmed to be caused by alternative diagnosis
* Malignant ascites: confirmed cancer
* Non-malignant ascites: ascites confirmed to be caused by alternative diagnosis
* Willing and able to give informed consent for participation in the study.
Exclusion Criteria:
* Unable to comprehend the study
* Unable to provide informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04533854 | {
"brief_title": "Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis",
"conditions": [
"Pleural Effusion",
"Ascites"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04533854",
"official_title": "SPECTRA: Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-26",
"study_completion_date(actual)": "2023-09-26",
"study_start_date(actual)": "2021-03-26"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2020-08-26",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-01",
"first_submitted": "2020-08-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.
Detailed Description
Introduction:
The chronic strictures of the ureter are usually treated by double J stents. They allow the emptying of the kidney and avoid the deterioration of renal function. Unfortunately, double J stents have to be replaced every 6 month and are at the origin of irritative lower urinary tract symptoms and lumbar pain which corrupt the quality of life of the patients.
Ureteral stricture could also be treated with MEMOKATH 051. These new ureteral stents seem not to require iterative changes and also not to cause irritative symptoms and lumbar pain. MEMOKATH 051 could therefore allow to reduce the number of changes and to ameliorate the quality of life of the patients.
Main objective:
Main objective is to assess effectiveness and tolerance of the MEMOKATH ® 051 in the treatment of chronic strictures of the ureter.
Resume:
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy.
After this procedure, the patients will have medical examination, blood exams, radiography and renal sonography at 1 month, 3 month and every 6 month during a 3 years follow up period.
If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent and an adverse event will be declared.
#Intervention
- PROCEDURE : Insertion of Memokath 051
- Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or superior
* Chronic stenosis of the ureter treated by placement of a ureteral endoprosthesis for more than six months;
* No possibility for surgical or endoscopic treatment of the ureteral stricture
* Free Consent, dated and signed by the patient
* Affiliated Subject of a regime of French national health and pensions organization.
Exclusion Criteria:
* Age under 18 year old
* Pregnant or nursing Women
* Patient having a life expectancy of less than 1 year
* Patient having unique kidney
* Patient having severe renal insufficiency (creatinin clearance under 30 ml/min)
* Possible surgical or endoscopic treatment of ureteral stricture
* Repeated urinary tract stones
* Urothelial tumor of the bladder
* Retro peritoneal fibrosis in the course of evolution
* Complications of double J stents requiring more thanks a lot every 6 months
* Against anaesthetic indication
* Lithiasic inlay probe Double J with obstruction within 6 months
* Persons put under maintenance of justice
* Persons in inability to understand the sequence of try
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00790686 | {
"brief_title": "Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter",
"conditions": [
"Ureteral Obstruction"
],
"interventions": [
"Procedure: Insertion of Memokath 051"
],
"location_countries": [
"France"
],
"nct_id": "NCT00790686",
"official_title": "Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-21",
"last_updated_that_met_qc_criteria": "2008-11-12",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-11-13",
"first_submitted": "2008-11-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. The investigators will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. The investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.
#Intervention
- DEVICE : Hands-free oral-positive pressure device (oPEP)
- This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. We will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, we will have patients use the device after their clinical echocardiogram for their clinic appointment. We will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements. | #Eligibility Criteria:
Inclusion Criteria:
* Patients with single ventricle with Fontan palliation
* Over the age of 8 years who would be cooperative with breathing through the oPEP device
Exclusion Criteria:
* Patients with Fontan palliation under the age of 8 years
* Patients who have interrupted inferior vena cava
* Patients with abnormal pulmonary artery anatomy
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT05634226 | {
"brief_title": "Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan",
"conditions": [
"Single-ventricle"
],
"interventions": [
"Device: Hands-free oral-positive pressure device (oPEP)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05634226",
"official_title": "Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-31",
"study_completion_date(actual)": "2024-01-31",
"study_start_date(actual)": "2023-08-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-10",
"last_updated_that_met_qc_criteria": "2022-11-21",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-12-02",
"first_submitted": "2022-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Objectives: To analyze the relationship of physical activity, fitness, energy intake and dietary pattern with the circadian pattern of blood pressure, central and peripheral blood pressure pulse wave velocity and biological markers of endothelial dysfunction in active and sedentary people without atherosclerotic disease.
Detailed Description
Objectives: To analyze the relationship of physical activity, fitness, energy intake and dietary pattern with the circadian pattern od blood pressure, central and peripheral blood pressure pulse wave velocity and biological markers of endothelial dysfunction in active and sedentary people without atherosclerotic disease.
Methods:
Design: Cross- sectional study 1ª step of clinical trial later. Project multicentric with seis research groups.
Subjects: From subjects of PEPAF project cohort, that remain in last control 3105 (1.163 active and sedentary 1942) and 2346 were excluded for actives. By Random sampling included 352 subjects who remained sedentary, 588 who have become active and 560 of which were excluded for being active in baseline assessment, a total of 1,200. Each of the six groups included 250 subjects.
Measurements: We evaluated height, weight, abdominal perimeter, blood pressure clinic, ambulatory blood pressure with Radial pulse wave acquisition device (BPro), central blood pressure, (aortic) and Augmentation index with Pulse Wave Application Software (A-Pulse) and Sphigmo cor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with Sphigmo cor System Px (Pulse Wave velocity), nutritional pattern with a food consumption survey, physical activity 7 Par-day questionnaire and the accelerometer (MTI/CSA 7164) and physical fitness with cicloergometro (PWC170) and endothelial dysfunction biomarkers (endoglin and osteoprotegerin).
| #Eligibility Criteria:
Inclusion Criteria:
* Healthy people
* Ages 20 <= age <= 80 years
Exclusion Criteria:
* Cardiovascular disease
* Respiratory failure
* Patient ends
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01083082 | {
"brief_title": "Lifestyles and Endothelial Dysfunction",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT01083082",
"official_title": "Physical Exercise, Fitness and Dietary Pattern and Theirs Relationship With Blood Pressure Circadian Pattern, Augmentation Index and Endothelial Dysfunction Biological Markers. (EVIDENT Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-24",
"last_updated_that_met_qc_criteria": "2010-03-08",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-09",
"first_submitted": "2010-03-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.
#Intervention
- BIOLOGICAL : HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) | #Eligibility Criteria:
Inclusion Criteria:
* Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region
Exclusion Criteria for vaccination study:
* acute illness
* immunocompromised conditions
* renal insufficiency
* pregnancy
* allergic history to HB vaccine or yeast
* positive for any of HBsAg, anti-HBs or anti-HBc
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT01861613 | {
"brief_title": "Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students",
"conditions": [
"Hepatitis B",
"Immune Response",
"Seroprevalence"
],
"interventions": [
"Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)"
],
"location_countries": [
"China"
],
"nct_id": "NCT01861613",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-05-24",
"last_updated_that_met_qc_criteria": "2013-05-22",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-23",
"first_submitted": "2013-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Mixed Reality Gaming for Chronic Low Back Pain
Detailed Description
The company, From the Future and University of Alabama at Birmingham (UAB) team aimed to develop a virtual reality (VR) game that integrated with the features of a specialized self-driven treadmill to provide accessible and progressive walking challenges for individuals with chronic low back pain (LBP). The game was designed to go beyond typical VR research efforts and provide a truly immersive and engaging experience that would motivate individuals with high pain-related fear to keep moving.
#Intervention
- DEVICE : Exergaming
- Mixed Reality Gaming for Chronic Low Back Pain
- Other Names :
- Mixed Reality | #Eligibility Criteria:
Inclusion Criteria:
History of chronic low back pain
Exclusion Criteria:
No major neurological, cardiac, pulmonary, or other orthopedic injuries
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03603028 | {
"brief_title": "Mixed Reality Gaming for Chronic Low Back Pain",
"conditions": [
"Recurrent Low Back Pain"
],
"interventions": [
"Device: Exergaming"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03603028",
"official_title": "Mixed Reality Gaming for Chronic Low Back Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-30",
"study_completion_date(actual)": "2018-09-30",
"study_start_date(actual)": "2018-08-17"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-22",
"last_updated_that_met_qc_criteria": "2018-07-25",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-27",
"first_submitted": "2018-04-30",
"first_submitted_that_met_qc_criteria": "2020-01-13"
}
}
} |
#Study Description
Brief Summary
Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.
#Intervention
- OTHER : Using a 3 dimentional post processing filter
- Using a 3 dimentional post processing filter | #Eligibility Criteria:
Inclusion Criteria:
* Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast.
Exclusion Criteria:
* Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01059032 | {
"brief_title": "Enhancement and Restoring of Low Dose Abdominal CT Images",
"conditions": [
"Radiation Protection"
],
"interventions": [
"Other: Using a 3 dimentional post processing filter"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01059032",
"official_title": "Enhancement and Restoring of Low Dose Abdominal CT Images by a Novel Adaptive Nonlinear 3D Post Processing Filter - a Prospective Blinded Interventional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2009-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-02",
"last_updated_that_met_qc_criteria": "2010-01-28",
"last_verified": "2009-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-29",
"first_submitted": "2010-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).
Materials and Methods: Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), Grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.
Detailed Description
Hand function is the most important for ADL and learning ability. Many cerebral palsy(CP) suffered problems with the gross motor dysfunction and hand function disability. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg, school). Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility for cerebral palsy(CP).
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).
Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.
#Intervention
- BEHAVIORAL : Robot-assisted hand rehabilitation
- Robot-assisted hand rehabilitation: 20 minute of warm-up exercise and 40 minute of robot-assisted hand exercise intervention. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task, robot-assisted task, and game task. | #Eligibility Criteria:
Inclusion Criteria:
* Children with cerebral palsy(CP) or stroke
* Age younger than 18 and older than 6 years
* Could follow 2 step order instruction
* No Botulinum injection during the recent 6 month and the experiment period
* Chronicity > 1 years and stable medicine condition
* Could sit steady after the position
Exclusion Criteria:
* Individuals with other medical symptoms that can affect movement
* Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03490591 | {
"brief_title": "Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study",
"conditions": [
"Cerebral Palsy"
],
"interventions": [
"Behavioral: Robot-assisted hand rehabilitation"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03490591",
"official_title": "The Effects on Hand Function With Robot-assisted Rehabilitation for Children With Cerebral Palsy: a Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-31",
"study_completion_date(actual)": "2018-12-31",
"study_start_date(actual)": "2018-04-15"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-12",
"last_updated_that_met_qc_criteria": "2018-03-30",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-06",
"first_submitted": "2018-02-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
#Intervention
- OTHER : In this observational study no study specific intervention is planned
- Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided. | #Eligibility Criteria:
Inclusion Criteria:
* Age: >= 18
* Post renal transplantation time: >= 6 months
* Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days)
* Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS)
* Written and oral informed consent
Exclusion Criteria:
* Well-known poor compliance with immunosuppressives
* Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01353417 | {
"brief_title": "Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection",
"conditions": [
"Chronic Kidney Insufficiency"
],
"interventions": [
"Other: In this observational study no study specific intervention is planned"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT01353417",
"official_title": "A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08-31",
"study_completion_date(actual)": "2015-08-31",
"study_start_date(actual)": "2011-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-07",
"last_updated_that_met_qc_criteria": "2011-05-12",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-13",
"first_submitted": "2011-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an iPad app with art, music and games to relax and distract children, reduce anaesthetic induction time and make drug cost savings prior to surgery.
Detailed Description
The most distressing part of a parent's experience in hospital is watching a child undergo intravenous cannulation.1 This is commonly performed in the anaesthetic room prior to induction of anaesthesia. At Chelsea and Westminster Foundation Trust (CWFT) over 5000 children undergo operations every year. Traditional methods of distracting the child during have included blowing bubbles, storybooks, and a variety of toys and games. These methods are not always effective and may present an infection risk due to inability to clean between uses.
The use of an android/iPad provides a platform for effectively distracting the child with a choice of games, video and music, with the advantage of being cleaned between uses. Users of this platform are required to select the application that is most appropriate for the age, sex, method of anaesthesia, and compliance level of the child. To assist with this, the investigators have developed an application system that will select a range of entertainment applications appropriate for each child based on these four variables and hopefully help to keep children calm before their operations.
#Intervention
- OTHER : iPad app containing art, music and games
- An iPad app that takes demographic information on a child and suggests suitable art, music and games for use by the anaesthetist and nurse to distract them during anaesthetics
- OTHER : Toys, books and games
- Games, books and toys used to distract | #Eligibility Criteria:
Inclusion Criteria:
* children ages 2 -12 years
* requiring general anaesthesia
* ASA assessment of fitness for surgery score 1 - 3
Exclusion Criteria:
* intravenous cannula already in situ
* play therapist already in use
* anaesthetist refusal to participate
* parental / patient refusal to participate
* sedative or opiate pre-med already administered
* not requiring general anaesthesia
* ASA assessment of fitness for surgery score 4 or 5
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT02321657 | {
"brief_title": "RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia",
"conditions": [
"Surgery"
],
"interventions": [
"Other: Toys, books and games",
"Other: iPad app containing art, music and games"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02321657",
"official_title": "RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-10-27",
"last_updated_that_met_qc_criteria": "2014-12-19",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-22",
"first_submitted": "2014-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Phase IIIb confirmatory study of efficacy and safety, longitudinal, multicenter, randomized, double-blind study of the combination Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin.
Detailed Description
Study to evaluate the efficacy and safety of the fixed-dose combination of Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin. Patients who meet the inclusion criteria of the protocol and start treatment with the combination Pregabalin / Tramadol (75 mg / 50 mg) or Pregabalin 75 mg will be included. To evaluate the proportion of subjects who reported a success rate in the reduction of pain by 50%, the percentage of change in the pain intensity reported through the Visual Analog Pain Scale (VAS) will be calculated. This percentage will be categorized and the proportion of patients per treatment group will quantify. Changes in pain intensity during the intervention will be evaluated with the fixed-dose combination of Pregabalin/Tramadol (75 mg / 50 mg) or Pregabalin 75 mg, comparing the average difference in pain reported through VAS at days 1, 3, 5, 7, 10, 13 and 15 with respect to their baseline measurement. The mean change in reported neuropathic pain intensity across the DN4 questionnaire will also be evaluated, comparing its measurement on day 3, 10 and 15 with respect to the baseline, in each treatment group.
At visit 1 (day 3) the need for dose escalation will be evaluated (Pregabalin/Tramadol (150 mg / 50 mg) or pregabalin (150 mg)) in both treatment groups, continuing with its follow-up in the evaluation of the intensity of pain reported by EVA and DN4. The proportion of subjects who started on the dose of Pregabalin / Tramadol (75 mg / 50 mg) or Pregabalin 75 mg, those that required adjustment of dose to treatment (Pregabalin / Tramadol (150 mg / 50 mg) or Pregabalin (75 mg)), as well as the proportion of patients who suspended the treatment.
The percentage of adherence to the intervention by treatment group will be reported.
The proportion of adverse events presented during the conduct of the study will be evaluated, regardless of the dose administered, to all the subjects who have received at least one dose of the investigational drug Which will be reported be reported through frequencies and percentages and classified according to frequency, gravity, severity (intensity) and the causality of the clinical manifestation.
#Intervention
- DRUG : Pregabalin 75mg/ Tramadol 50 mg
- Pharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral
- Other Names :
- LOBUXAL
- DRUG : Pregabalin 75mg
- Pharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral
- Other Names :
- Pregabalin | #Eligibility Criteria:
Inclusion Criteria:
* Any gender.
* That the subject agrees to participate in the study and give its informed consent in writing.
* Age >18 years and <=65 years at the start of the study.
* Neuropathic Pain Questionnaire (DN4) >= 4.
* Patients with proven tolerability (absence of moderate-serious adverse events) to pregabalin, defined by consumption of pregabalin 50 mg/day for 3 days.
* Women of childbearing age who have an acceptable method of contraception (eg barrier, oral hormonal, injectable, subdermal).
Exclusion Criteria:
* Contraindication and known hypersensitivity to the use of pregabalin and/or tramadol.
* The patient is participating in another clinical study involving an investigational treatment or participated in any in the previous 4 weeks.
* In the medical opinion, a disease that affects the prognosis and prevents outpatient management, for example, but not limited or restricted to: terminal cancer, heart failure, obstruction gastrointestinal including paralytic ileus, suspected surgical abdomen, respiratory failure with scheduled surgical or hospital procedures.
* Positive pregnancy test, women who are pregnant, nursing or planning a pregnancy during the conduct of the study.
* Patients with a diagnosis of respiratory diseases: status asthmaticus, asthma, chronic obstructive pulmonary disease (COPD), cor pulmonale, acute respiratory depression, hypercapnia.
* Patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received within the last 2 weeks.
* Patients with a history of seizure disorders, epileptic status, and grand mal seizures.
* Patients with a history of severe depression of the central nervous system due to consumption of opiates.
* History of acute intoxications with hypnotics, opioid analgesics and psychotropics.
* History of alcohol or drug abuse (including opiates) in the last year according to DSM-V.
* Patients with a history of severe head trauma and/or brain edema.
* History/presence of any disease or condition which, in the opinion of the Investigator, could pose a risk to the patient or confound the efficacy and safety results of the study.
* Patients with symptoms suggestive of active COVID-19 infection (i.e., fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19.
* Patients whose participation in the study may be influenced (employment relationship with the center investigator or sponsor, inmates, etc.).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05324059 | {
"brief_title": "Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin",
"conditions": [
"Neuropathic Pain"
],
"interventions": [
"Drug: Pregabalin 75mg/ Tramadol 50 mg",
"Drug: Pregabalin 75mg"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT05324059",
"official_title": "Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-18",
"study_completion_date(actual)": "2023-04-25",
"study_start_date(actual)": "2022-07-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-15",
"last_updated_that_met_qc_criteria": "2022-04-04",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-12",
"first_submitted": "2022-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
Detailed Description
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
#Intervention
- BEHAVIORAL : intensive one-on-one behavioral treatment
- Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
- BEHAVIORAL : Individualized in home parent training
- Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention | #Eligibility Criteria:
INCLUSION CRITERIA:
*-Disease Characteristics--
Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
*-Patient Characteristics--
Other:
Must reside within 60 km (37.5 miles) of a treatment site
EXCLUSION CRITERIA:
Severe medically induced limitations defined as:
* Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
* Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
* Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
* Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT00004449 | {
"brief_title": "Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism",
"conditions": [
"Autistic Disorder"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00004449",
"official_title": "Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-09",
"study_completion_date(actual)": "2006-04",
"study_start_date(actual)": "1998-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-27",
"last_updated_that_met_qc_criteria": "1999-10-18",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "1999-10-19",
"first_submitted": "1999-10-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Insertional Achilles tendinopathy is a disabling injury that is common in running athletes. Exercise therapy is considered the best treatment option, but there is still no agreement on the modalities. For example, it is thought that compression overload may be a major cause of tendinopathy and should therefore be restricted during rehabilitation. However, this recommendation is based on expert opinion and not on hard scientific evidence. Therefore, this randomised controlled trial (RCT) will investigate whether a therapy that limits the amount of compression of the tendon during a progressive tendon-loading rehabilitation protocol actually has better outcomes in athletes with insertional Achilles tendinopathy.
Athletes with insertional Achilles tendinopathy will be randomised into two treatment groups; (1) an experimental rehabilitation protocol in which the amount of tendon compression is limited and (2) a control rehabilitation protocol in which the amount of tendon compression is not limited and is rather high. Both treatments consist of supervised progressive tendon-loading exercise therapy and patient education. In addition, the experimental group will also receive heel inserts to limit the amount of dorsiflexion during sports or daily activities. At baseline, at 12 weeks (end of intervention) and at 24 weeks (follow-up), pain, functionality, structure and intratendinous pressure will be determined.
Detailed Description
Achilles tendinopathy is a debilitating injury that is common among athletes, especially those involved in running sports. Around 30% of all runners exhibit Achilles tendinopathy with an annual incidence of 7-9%. Of these patients, roughly one-third will have insertional Achilles tendinopathy (IAT). Several mechanisms are considered to play a role in the aetiology of Achilles tendinopathy, yet a prominent role seems present for excessive overload. Traditionally, the nature of this overload is thought to be purely tensile. However, the Achilles tendon can also be exposed to compressive loads at the insertion when the tendon wraps around the posterior prominence of the calcaneus during dorsiflexion of the ankle. The formation of fibrocartilage-like tissue, which is typically found in histological examination of tendinopathy, can be considered as an adaptation to this compressive load, driven by the tenocyte's mechanotransduction process. Therefore, it is recommended to reduce the amount of compressive load on the tendon during rehabilitation while exerting sufficient tensile load. However, these recommendations are mainly based on a pilot study and expert opinion. Therefore, this RCT investigates whether a therapy in which the amount of tendon compression is restricted during a progressive tendon-loading rehabilitation protocol actually has better outcomes in terms of pain scores, functionality and structure of the Achilles tendon in athletes with insertional Achilles tendinopathy. Limiting the amount of tendon compression on the Achilles tendon insertion will be achieved by (1) patient education, (2) heel inserts and (3) an adapted exercise regimen.
#Intervention
- OTHER : Exercise therapy
- The intervention treatment consists of a progressive 4-stage, criteria-based exercise protocol, in which the amount of tendon compression is limited. This includes:
1. Education: Specific information on the importance of limiting tendon compression during rehabilitation, as well as general information on load management, the importance of active exercise therapy and setting expectations.
2. Orthotic treatment: heel inserts to reduce ankle dorsiflexion during daily activities and sports
3. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) restricting the amount of tendon compression by limiting dorsiflexion of the ankle and prohibiting stretching
- OTHER : Exercise therapy (usual care)
- The control treatment consists of a progressive 4-phase, criteria-based exercise protocol, in which the amount of tendon compression is not limited. This includes:
1. Education: general information on load management, the importance of active exercise therapy and setting expectations.
2. No orthotic treatment.
3. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) without any restriction around tendon compression and encouraging stretching | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 60 years
* Diagnosed with insertional Achilles Tendinopathy by a sports medicine physician
* Have experienced symptoms for more than 3 months but less than 3 years
* A severity level of less than 80 points on the VISA-A score
* Playing running-based sports at least twice a week
* Able to comply with both exercise programs
Exclusion Criteria:
* Have a history of Achilles tendon rupture or surgery
* Have other disorders of the Achilles tendon or ankle (mid-portional Achilles tendinopathy, paratenonitis, osteoarthritis,...)
* Have rheumatological disorder (e.g. Spondylitis Ankylosis)
* Have metabolic or endocrine disorders, such as type I or type II diabetes
* Have had an Achilles injection in the past 3 months
* Have other conditions that prevent following an active exercise programme
* Have already been treated with physiotherapy, shockwave therapy or orthotics in the past 3 months
* Medication use with (fluoro)quinolones antibiotic in the past 2 years
* Currently pregnant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05456620 | {
"brief_title": "Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy",
"conditions": [
"Insertional Achilles Tendinopathy"
],
"interventions": [
"Other: Exercise therapy (usual care)",
"Other: Exercise therapy"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT05456620",
"official_title": "Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy: a Randomised Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-01",
"study_completion_date(actual)": "2024-08-01",
"study_start_date(actual)": "2022-12-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-07",
"last_updated_that_met_qc_criteria": "2022-07-12",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-13",
"first_submitted": "2022-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.
#Intervention
- DRUG : intramuscular hepatitis B virus immune globulin
- Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months
- Other Names :
- Igantibe | #Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Age > 18 years and < 70 years.
* OLT recipient for HBV infection-related disease for > 18 months before inclusion in the clinical trial.
* Serum HBsAg-positive within 3 months before transplantation.
* Serum HBsAg-negative just before inclusion in the clinical trial.
* Serum HbeAg-negative just before inclusion in the clinical trial.
* Serum HBV DNA-negative by DNA PCR-amplification assay (lower detection limit 102 genomes/ml) just before inclusion in the clinical trial.
* Continuous and interrupted prophylaxis with HBIG after an-hepatic phase as part of the subject clinical care.
* Trough serum HBsAg Ab (HBsAg IgG) titer (immediately pre-dose) > 150 I.U./l in at least 2 consecutive determinations within last 3 months before inclusion in the clinical trail.
* Signed informed consent.
Exclusion Criteria:
* Serum HBsAg-positive just before inclusion in the clinical trial.
* Serum HBeAg-positive within 3 months before transplantation.
* Serum HBV DNA-positive by standard DNA hybridisation assay (lower detection limit 105 genomes/ml), or by any less sensitivity technique, within 3 months before transplantation.
* Unknown serum HBV replication status (no data about HbeAg and HBV DNA) within 3 months before transplantation.
* Previous recurrence of HBV in the transplanted liver defined by serum HBV DNA- positive by sensitive hybridisation (lower detection limit 105 genomes/ml) assay or any less sensitive technique, and/or serum HBeAg-positive, and/or serum HBsAg-positive.
* Re-transplanted liver even for reasons not related to HBV infection.
* Evidence of hepatocellular carcinoma in the transplanted liver, or metastatic disease, at time of inclusion in the clinical trial.
* Evidence of graft rejection at time of inclusion in the clinical trial.
* Life-expectancy less than 1 year.
* VHC infection.
* HIV type 1 or type 2 infection.
* Acute HAV infection.
* Previous treatment with i.m. HBIG Grifols within 3 months before inclusion in the clinical trial.
* Intolerance or allergy to any i.m. HBIG Grifols containing substance (glycine, sodium chloride, sterile water for injection, homologous human immune globulin).
* History of SAEs related to the administration of human blood-derived products.
* History of frequent AEs, even non-serious, related to the administration of human blood-derived products.
* Selective IgA deficiency with Abs against IgA.
* Platelet count < 50 x 109/L.
* Prothrombin time (PT) < 60%.
* Activated partial thromboplastin time (APTT) ratio > 1.5.
* Any haemostatic abnormality contraindicating i.m. injection according to investigator's judgement.
* Haemoglobin < 11 g/dl.
* Alcohol or drug abuse at the moment or within 1 year before inclusion in the clinical trial.
* Pregnant woman or woman who is expecting to be pregnant within 1 year after inclusion in the clinical trial.
* Breast-feeding woman.
* Any severe acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, makes the subject inappropriate for entry in this clinical trial.
* Impossibility to donate a serum sample before the first investigational product administration.
* Planned treatment with Ig other than i.m. HBIG Grifols within the clinical trial period.
* Planned modification, during the clinical trial period, of the prophylactic regimen with nucleoside analogues followed by the subjects, if any, within last 3 months before inclusion in the clinical trial.
* The subject has been previously admitted to this clinical trial.
* Participation in other clinical trial within 3 months before study inclusion.
* Subject's incapacity of giving consent personally.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00895713 | {
"brief_title": "Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation",
"conditions": [
"Hepatitis B, Chronic"
],
"interventions": [
"Drug: intramuscular hepatitis B virus immune globulin"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT00895713",
"official_title": "Efficacy and Safety of Intramuscular Hepatitis B Virus Immune Globulin Grifols for the Prevention of Hepatitis B Virus Recurrence After Orthotopic Liver Transplantation.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-06",
"study_completion_date(actual)": "2005-07",
"study_start_date(actual)": "2004-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-05-08",
"last_updated_that_met_qc_criteria": "2009-05-07",
"last_verified": "2009-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-08",
"first_submitted": "2009-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.
| #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of OAG
* CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation
Exclusion Criteria:
* Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
* Prior incisional glaucoma surgery
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02228577 | {
"brief_title": "Safety and Performance Study of the CyPass System Applier Model 241",
"conditions": [
"Open Angle Glaucoma (OAG)"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT02228577",
"official_title": "A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2014-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-15",
"last_updated_that_met_qc_criteria": "2014-08-27",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-29",
"first_submitted": "2014-08-27",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study includes designing, implementing and evaluating the effectiveness of process-based measures for improving interprofessional collaboration in Norwegian primary schools (5-7th grades). Focusing on leadership and organizational development, the overarching aim is to improve the use of existing interprofessional competence within schools. The interventions include meetings at municipal-level (strategic), school-level (operative) and class-level (operative), with feedback procedures to ensure communication between and within all levels. Also school internal and school external collaborators are involved at all levels of intervention.
In order to avoid contradictory roles, an implementation team is responsible for developing and implementing the intervention, while the research team conduct an independent evaluation. The model will be evaluated by a cluster-randomized design to evaluate the effectiveness of the intervention. The hypothesis is that schools that utilize the process-based intervention (intervention group) will improve their interprofessional team work in a way that enhances the pupil's learning- environment and teachers professional competence, self-efficacy and efficient use of working hours compared to their counterparts in the control group. We anticipate main effects to be found at pupil level, mainly through improved early assessment, intervention and efficient follow-up. The project is a collaboration between four Norwegian municipalities and includes a total of 37 Schools, half of which will be randomized to experimental condition and half to control condition.
The project is financed by The Norwegian Directorate for Education and Training with a duration of three years and three months. The project is led by Professor Ira Malmberg-Heimonen. The project is a collaboration between Faculty of Social Sciences and the Work Research Institute (AFI), at Oslo and Akerhus University College of Applied Sciences. Participants in the project are Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Therese Saltkjel, Knut Fossestøl, Elin Borg and Selma Therese Lyng. Participants in the implementation team are Øyvind Pålshaugen, Hanne Christoffersen and Christian Wittrock, also from Oslo and Akerhus University College of Applied Sciences, in addition to Torbjørn Lund from the Arctic University of Norway
Detailed Description
Comprehensive process-based intervention for improving interprofessional team collaboration in schools. A cluster-randomized study.
Start at 01.04.2017 Finnish at 30.06.2020. Funding: The Norwegian Directorate for Education and Training Collaboration: All public schools at primary level in four Norwegian municipalities
Primary schools participating in the study:
From the municipality of Ålesund: Åse, Aspøy, Blindheim, Ellingsøy, Emblem, Flisnes, Hatlane, Hessa, Larsgården, Lerstad, Spjelkavik, Vik and Stokke, and Voldsdalen.
From the municipality of Harstad: Bergseng, Bjarkøy, Harstad, Kanebogen, Kila, Lundenes, Medkila skole, Seljestad and Sørvik From the municipality of Nedre Eiker: Mjøndalen, Krokstad, Solberg, Steinberg, Stenseth and Åsen.
From the municipality of Lillehammer: Vingar, Vingrom, Søre Ål, Røyslimoen, Kringsjå, Ekrom and Buvollen (will be merged), Hammartun and Jørstadmoen
Advisory Board for the project:
Senior researcher Mary Visher, Manpower Demonstration Research Corporation (MDRC), USA Professor Nancy Cartwright, Durham University, UK, and University of California, San Diego, USA Analyst and content director Jarl Inge Wærnes, LearnLab, Oslo Norway
There are interprofessional resources in Norwegian schools and municipalities that are not fully utilized/exploited. Oslo and Akershus University College of Applied Sciences has been commissioned to design, implement and evaluate the effectiveness of a process-based model for interprofessional team collaboration in Norwegian primary schools. In order for municipal school owners and leaders to better utilize the potential related to existing interprofessional resources in schools, municipalities will implement a process-based model with a focus on leadership and better coordination of existing interprofessional resources. While the work process will be the same for all schools enrolled to experimental group, the content of the intervention will vary based on local conditions, resources and needs. A manual describes how the work process should be carried out. The model is hereafter referred to as the LOG-model, a Norwegian acronym, referring to the terms leadership, organization and coordination
The evaluation will be conducted as a cluster-randomized trial, where 37 primary schools will be randomly assigned to experimental and control groups. Schools randomized to experimental group will implement the LOG-model, while schools assign to the control group will work as previously with interprofessional collaboration. While schools in the experimental group will receive economic resources to compensate for implementing the model and participating in the research, schools randomized to control group will get, however, somewhat less financial compensation for taking part in the research. The implementation team offer supervision and support to schools randomized to the experimental group throughout the project period.
The main working method in the LOG-model is the interchange and feedback process between discursive practices, i.e. the discussion of interprofessional team collaborating measures and the execution/testing of these measures.
Staff from Oslo and Akershus College of Applied Sciences will have different roles in the project. Beside the implementation team with the role of facilitating implementation processes in schools randomized to experimental group, the process evaluation team will study implementation processes mainly based on qualitative data. The researchers in the effect-evaluation team will mainly work with quantitative data.
Prior to randomization a baseline questionnaire will be collected from the teachers and their interprofessional collaborators e.g. educational and psychological counseling services, public health nurses and child welfare social workers. Baseline information on pupils will be based on a survey data collected autumn 2017 and survey data and administrative data for follow-up + 12 and + 24 months. Long-term effects for pupils will be measured after the project has formally ended, up to 4 years after baseline, given that the Norwegian Directorate for Education and Training authorize access and deliver administrative data for follow-up.
The project will assess whether schools randomized to experimental group that are implementing the LOG-model improve their interprofessional collaboration in a way that has positive effects on learning environment, learning outcomes and early intervention for pupils. At teacher level we expect the model to increase competence for interprofessional collaboration, teacher self-efficacy and more efficient use of teachers working time.
This knowledge will inform the debate on what the effects of interprofessional team collaboration can be in schools.
The project is funded by The Norwegian Directorate for Education and Training and led by professor Ira Malmberg-Heimonen, Oslo and Akershus University College.
Participants in the project are Ira Malmberg-Heimonen (project leader), Knut Fossestøl, Øyvind Pålshagen, Elin Borg, Selma Therese Lyng, Anne Grete Tøge, Hanne Christensen, Thorbjørn Lund and Therese Saltkjel.
#Intervention
- OTHER : LOG-model
- Besides the LOG-manual, school owners and leaders receive economic compensation and the intervention team will supervise the implementation. School-owners, school leaders and teachers will participate in dialogue-seminars at the municipal level and the school level respectively. The aim is to discuss and agree on the goal and content of the work and discuss the experiences from the implementation. The main arena for discussing and practical implementation will be in local collaborating teams or 'resource teams' in each school. The resource teams at schools will consist of various interprofessional competences in addition to the school leader. The main method in the LOG-model is the interchange and feedback process between the discussion of measures and the execution of these measures.
- OTHER : TAU
- Ordinary practices related to interprofessional team collaboration | #Eligibility Criteria:
Inclusion Criteria:
* Pupils in grades 5 - 7 in 4 municipalities and 37 primary schools
* Teachers in grades 5 <= age <= 7 in 4 municipalities and 37 primary schools
* Interprofessional collaborators at municipal level
Exclusion Criteria:
* NA
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT03248245 | {
"brief_title": "Improving Interprofessional Collaboration in Norwegian Primary Schools",
"conditions": [
"Interprofessional Team Collaboration"
],
"interventions": [
"Other: TAU",
"Other: LOG-model"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT03248245",
"official_title": "Improving Interprofessional Collaboration in Norwegian Primary Schools - A Cluster-randomised Study Evaluating the Effects of the LOG-model.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-30",
"study_completion_date(actual)": "2020-06-30",
"study_start_date(actual)": "2017-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-07",
"last_updated_that_met_qc_criteria": "2017-08-11",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-14",
"first_submitted": "2017-08-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.
Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.
The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.
The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.
Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.
Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.
#Intervention
- DEVICE : Acoustic reflection method
- An acoustic reflection device gives the longitudinal cross-sectional area profile along airways. It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway. | #Eligibility Criteria:
Inclusion Criteria:
* Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy will be invited to participate in the study.
* Women are eligible for the study if they are:
* healthy (no previous disease, hypertension, nor obesity),
* 18 years or more
* with a singleton live fetus at the routine ultrasound scan
* with a normal pregnancy.
Exclusion Criteria:
* Pregnancy complications
* Multiple pregnancy
* High risk for preterm labor
* Underlying diseases that could interfere with the results (such as pre-existing upper airway problems) and participation.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01087047 | {
"brief_title": "Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method",
"conditions": [
"Pregnancy"
],
"interventions": [
"Device: Acoustic reflection method"
],
"location_countries": [
"France"
],
"nct_id": "NCT01087047",
"official_title": "Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-06-12",
"last_updated_that_met_qc_criteria": "2010-03-12",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-15",
"first_submitted": "2010-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
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