nct_id
string | updated_at
timestamp[us] | brief_title
string | official_title
string | acronym
string | study_type
string | overall_status
string | study_first_submit_date
timestamp[ms] | start_date
timestamp[ms] | primary_completion_date
timestamp[ms] | completion_date
timestamp[ms] | phases
sequence | enrollment_count
float64 | minimum_age
float64 | maximum_age
float64 | sex
string | healthy_volunteers
bool | brief_summary
string | detailed_description
string | eligibility_criteria
string | lead_sponsor_name
string | lead_sponsor_class
string | org_study_id_info
dict | why_stopped
string | expanded_access_info
dict | last_update_submit_qc_date
timestamp[ms] | last_update_post_date_struct
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dict | std_ages
sequence | study_population
string | sampling_method
string | oversight_has_dmc
bool | design_info
dict | conditions
sequence | keywords
string | interventions
null | locations
list | collaborators
list | arm_groups
null | outcomes
dict | overall_officials
list | study_references
string | misc_info_module
string | condition_browse_module
dict | intervention_browse_module
dict | mesh_terms
dict |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT06219226 | null | Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath | Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial) | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-01-12T00:00:00 | null | 2025-12-18T00:00:00 | 2025-12-18T00:00:00 | [
"NA"
] | 60 | 18 | null | ALL | false | The ODOR trial will be a single-centric, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. The short-term effect of the mouthwashes will be investigated in a 3-hour-long period. The primary endpoint will be the changes in the organoleptic testing scores. | Eligible patients will be randomly allocated to two groups in a 1:1 ratio. Necessary data will be collected with prespecified electronic case report forms (REDCap). The statistician will calculate the sample size at the end of the pilot investigation of the first 30-30 patients. If feasible, investigators will continue the study by enrolling more patients. | Inclusion Criteria:
* Organoleptic test score (OLS)\>=2 for IOH
* Patients with at least 20 teeth
* 8 hours of scented oral hygiene product usage, 4 hours of eating, and 2 hours of drinking restriction
* on the day of investigation, restriction of alcohol, caffeine, perfume usage, and food intake with characteristic smell
Exclusion Criteria:
* Medical history of systematic and infectious diseases (e.g., hepatitis, HIV, tuberculosis).
* Antibiotic use within the month before the study's start or during the trial or any regular medication
* Extraoral halitosis (will be distinguished by observing the nasal breath)
* Eat foods (like garlic) linked to oral malodor on the day before and the sampling day, as well as wear heavily fragrant cosmetics on that day.
* Patients with removable dentures
* Smokers (Cigars, Cigarettes, Pipes, Chewing tobacco, e-cigarette, or vaping products used in the last month) | Semmelweis University | OTHER | {
"id": "838",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-01-12T00:00:00 | {
"date": "2024-01-26",
"type": "ACTUAL"
} | {
"date": "2024-01-23",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Halitosis"
] | ["ClO2", "mouth rinse", "malodor"] | null | null | null | null | {
"other": [
{
"description": null,
"measure": "Side effects",
"timeFrame": "immediately after the rinse and 3 hours later"
}
],
"primary": [
{
"description": null,
"measure": "Changes of the organoleptic testing scores",
"timeFrame": "immediately after the rinse and 3 hours later"
}
],
"secondary": [
{
"description": null,
"measure": "Changes of the volatile sulfur compounds",
"timeFrame": "immediately after the rinse and 3 hours later"
},
{
"description": null,
"measure": "Self-perceived halitosis",
"timeFrame": "immediately after the rinse and 3 hours later"
}
]
} | null | [{"pmid": "36634129", "type": "BACKGROUND", "citation": "Szalai E, Tajti P, Szabo B, Hegyi P, Czumbel LM, Shojazadeh S, Varga G, Nemeth O, Keremi B. Daily use of chlorine dioxide effectively treats halitosis: A meta-analysis of randomised controlled trials. PLoS One. 2023 Jan 12;18(1):e0280377. doi: 10.1371/journal.pone.0280377. eCollection 2023."}, {"pmid": "24223899", "type": "BACKGROUND", "citation": "Noszticzius Z, Wittmann M, Kaly-Kullai K, Beregvari Z, Kiss I, Rosivall L, Szegedi J. Chlorine dioxide is a size-selective antimicrobial agent. PLoS One. 2013 Nov 5;8(11):e79157. doi: 10.1371/journal.pone.0079157. eCollection 2013."}, {"pmid": "31825092", "type": "BACKGROUND", "citation": "Kumbargere Nagraj S, Eachempati P, Uma E, Singh VP, Ismail NM, Varghese E. Interventions for managing halitosis. Cochrane Database Syst Rev. 2019 Dec 11;12(12):CD012213. doi: 10.1002/14651858.CD012213.pub2."}] | {"versionHolder": "2025-06-18"} | {
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{
"id": "D012817",
"term": "Signs and Symptoms, Digestive"
}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M9301",
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"id": "M15622",
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],
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"id": "D006209",
"term": "Halitosis"
}
]
} | {
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"id": "D000891",
"term": "Anti-Infective Agents, Local"
},
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"term": "Anti-Infective Agents"
},
{
"id": "D004202",
"term": "Disinfectants"
},
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"id": "D003879",
"term": "Dermatologic Agents"
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"id": "D019551",
"term": "Dental Disinfectants"
}
],
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"abbrev": "Infe",
"name": "Anti-Infective Agents"
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"name": "All Drugs and Chemicals"
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"abbrev": "Derm",
"name": "Dermatologic Agents"
}
],
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{
"asFound": "Virus",
"id": "M5953",
"name": "Chlorhexidine",
"relevance": "HIGH"
},
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"asFound": "Placenta growth factor",
"id": "M344731",
"name": "Chlorhexidine gluconate",
"relevance": "HIGH"
},
{
"asFound": "C1 Esterase Inhibitor",
"id": "M244369",
"name": "Chlorine dioxide",
"relevance": "HIGH"
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"name": "Anti-Infective Agents",
"relevance": "LOW"
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"name": "Anti-Infective Agents, Local",
"relevance": "LOW"
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"name": "Disinfectants",
"relevance": "LOW"
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"term": "Chlorhexidine"
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{
"id": "C010882",
"term": "Chlorhexidine gluconate"
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{
"id": "C025109",
"term": "Chlorine dioxide"
}
]
} | {
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"term": "Halitosis"
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],
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"term": "Chlorhexidine"
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"id": "C010882",
"term": "Chlorhexidine gluconate"
},
{
"id": "C025109",
"term": "Chlorine dioxide"
}
]
} |
NCT06845826 | null | Point-of-Care Troponin Testing in the Emergency Department | Point-of-Care High-Sensitivity Troponin Testing in the Emergency Department to Assess Myocardial Infarction for Timely Discharge | CERMIT | INTERVENTIONAL | NOT_YET_RECRUITING | 2025-02-12T00:00:00 | null | 2026-06-30T00:00:00 | 2026-12-30T00:00:00 | [
"NA"
] | 1,552 | 18 | 75 | ALL | false | The goal of this study is to evaluate whether a POC-guided testing strategy to exclude non-ST elevation myocardial infarction (NSTEMI) in acute chest pain patients presenting at the emergency department (ED) can result in a shorter length of stay compared to the routine central laboratory testing strategy. Currently, most often two high-sensitivity troponin (hs-cTn) tests are required for exclusion of NSTEMI, and central laboratories are struggling to achieve the recommended turnaround time of 60 minutes. Novel POC hs-cTn testing technology can provide results in minutes, potentially reducing the ED length of stay. This may lead to a reduction in ED crowding, which is a growing worldwide healthcare problem, resulting in poorer patient outcomes. This study may therefore improve patient burden, ED staff workload, and lead to more efficient expenditure of healthcare resources.
We will perform a prospective, cross-sectional, interventional, single-center, open label, randomized trial.
All consecutive patients older than 18 years and younger than 75 years presenting at the UZ Leuven emergency department with chest pain or chest pain-equivalent symptoms suspected of an acute coronary syndrome (ACS) will be invited to participate in the study. After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. Patients in the POCT group will undergo the novel POC test-guided strategy. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the usual testing strategy with one or two hs-cTnT tests performed in the hospital's central laboratory. | Testing strategy Triage nurses, ED registration staff, or the treating physicians will identify eligible patients after which recruitment will be performed by the study collaborator(s). After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. All patients first undergo usual work-up, including clinical history and examination, and an ECG, thereby identifying clinically unstable patients and patients with signs of a STEMI (exclusion criteria), and identifying patients who need further exclusion of a NSTEMI by hs-cTn testing. Patients in the POCT group will undergo the POC test-guided strategy with the Atellica VTLi. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. This represents a novel testing strategy. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the traditional central laboratory hs-cTnT testing strategy. As a safety back-up in all patients in the POCT group, usual central laboratory high-sensitivity troponin testing will be performed as well. Only one additional blood sample tube is required to perform the POC test. The test requires a whole blood or plasma sample of 30-100 μL, which will be collected in a lithium-heparin tube. The sample can be safely transferred from the blood tube to the test cartridge with an accompanying transfer device designed by Siemens Healthineers at the point of care. The left-over material of the blood sample after POC testing will be transferred to the hospital's central laboratory to assess for the presence of haemolysis and its impact on the POC test results.
Management and treatment decisions The troponin test results will be available to the treating ED physicians, immediately influencing medical management decisions. The physicians will be trained correctly to use the POC device within the POC test-guided strategy. The Atellica VTLi will be connected to the laboratory information management system so the test result will be available in the patient's electronic medical health record (KWS). Patients in the POCT group presenting with chest pain after more than 3 hours of onset of the current episode of symptoms, no signs of ischaemia on ECG and with an hs-cTnI value below 7 ng/L on the Atellica VTLi will be considered at very-low risk for NSTEMI and can be considered for early ED discharge.(22) Patients with an hs-cTnI value higher than 60 ng/L are considered at high risk for NSTEMI and should be considered for immediate hospital admission and further treatment. Patients with an hs-cTnI value between 7 ng/L and 60 ng/L are considered at intermediate risk of NSTEMI and should be considered for a second hs-cTnT test within the standard UZ Leuven protocol. As a back-up in all patients in the POCT group an additional central laboratory hs-cTnT test will be performed, as POC test failures are currently seen in 7% of performed test, and since the test at admission is required to calculate the one-hour delta. The treating physician will be blinded to this test result to avoid waiting for a second confirmation of the POCT result and thereby compromising the ED length of stay. The result however will be communicated by the clinical laboratory to the treating physician in case of marked discrepant test results: if the result on the POC test is below 7 ng/L, allowing for rule-out of NSTEMI, while the result on the central laboratory test is \> 14 ng/L, indicating a higher probability of NSTEMI. If the patient has already been discharged by the time the back-up test is communicated to the treating physician, the patient will be contacted to return to the ED for further examinations and further treatment if necessary. Re-admitted patients will be managed according to routine clinical care, and no additional study-related interventions will be applied. In the case of a negative POC test result, and a central lab hs-cTnT value between 5 and 14 ng/L, we deem the probability of an NSTEMI very low, allowing for ED discharge without further treatment. In case of a second test after 1 hour, the 0h hs-cTnT and the 1h hs-cTnT test will be reported together as usual through the electronic medical record, to allow for the assessment of a change in troponin values.
All final medical management decisions are at the discretion of the treating physician, so he or she is allowed to deviate from the proposed algorithm according to their clinical judgement. Other life-threatening causes of chest pain such as pulmonary embolisms, heart failure or pneumonia may be considered next to ACS. If the treating physician deems that NSTEMI is not sufficiently ruled out after a negative POC hs-cTnI test or other conditions should be further excluded, he or she is free to perform additional investigations or to admit the patient to a hospital ward. Patients in the usual care group will undergo usual central laboratory hs-cTnT testing. | Inclusion Criteria:
* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures - At least 18 years of age at the time of signing the Informed Consent Form (ICF)
* Age \< 75 years of age
* Presenting with chest pain or chest pain-equivalent symptom suspect of acute coronary syndrome at the University Hospitals Leuven emergency department; Symptoms must have (had) a minimum duration of 15 minutes, and the current, ongoing episode of symptoms must have started within the past 12 hours.
Exclusion Criteria:
* Unable to provide written informed consent
* Age \<18 years or \>75 years
* Chest pain or equivalent symptom with a duration shorter than 15 minutes, or an onset of the current, ongoing episode of symptoms more than 12 hours ago
* Clinically unstable patients or confirmed STEMI patients, requiring immediate treatment
* Patients with recent chest trauma
* Patients transferred from another hospital
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CISP. | KU Leuven | OTHER | {
"id": "S68277",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-02-20T00:00:00 | {
"date": "2025-04-02",
"type": "ACTUAL"
} | {
"date": "2025-02-25",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "prospective, cross-sectional, interventional, single-center, open label, randomized trial",
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Acute Coronary Syndromes"
] | ["POCT", "troponine testing", "acute coronary syndrome"] | null | [
{
"city": "Leuven",
"country": "Belgium",
"facility": "KU/ UZ Leuven ED",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": "Vlaams-Brabant"
}
] | [
{
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
] | null | {
"other": [
{
"description": null,
"measure": "Degree of user friendliness: questionnaires and qualitative think aloud sessions",
"timeFrame": "Hours: 24"
},
{
"description": null,
"measure": "Phyisican adherence",
"timeFrame": "Hours: 24"
},
{
"description": null,
"measure": "Patient satisfaction",
"timeFrame": "Day: 7"
},
{
"description": null,
"measure": "Comparison of POC and central laboratory hs-cTnI testing, and central laboratory hs-cTnT testing",
"timeFrame": "Hours: 24"
},
{
"description": null,
"measure": "External validation of clinical prediction models Heart score + T-MACS score",
"timeFrame": "after obtaining the sample size"
}
],
"primary": [
{
"description": null,
"measure": "Length of stay at emergency department",
"timeFrame": "Hours: 24"
}
],
"secondary": [
{
"description": null,
"measure": "30-day MACE",
"timeFrame": "Day: 30"
}
]
} | [
{
"affiliation": "Leuven Unit for Health Technology Assessment Research, University of Leuven",
"name": "Jan YJ Verbakel, MD, PhD, Professor",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D017202",
"term": "Myocardial Ischemia"
},
{
"id": "D006331",
"term": "Heart Diseases"
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{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
}
],
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"abbrev": "BC20",
"name": "Immune System Diseases"
},
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"abbrev": "All",
"name": "All Conditions"
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
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"abbrev": "Rare",
"name": "Rare Diseases"
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"relevance": "LOW"
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{
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"term": "Acute Coronary Syndrome"
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]
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} |
NCT02722226 | null | High Fidelity Simulation and Sedation Training of Non-anesthesiologists Residents | The Impact of a High Fidelity Simulation Based Sedation Training on the Performance of Non-anesthesiologists Residents for the Management of Complications Associated to Sedation. | DedSim | INTERVENTIONAL | COMPLETED | 2016-03-17T00:00:00 | null | null | null | [
"NA"
] | 32 | null | null | ALL | false | Objective Sedation is a depression of consciousness varies between anxiolysis and general anesthesia. It is used to facilitate diagnostic tests and minor surgeries. Respiratory complication is the main side effect of the sedation. His Early diagnosis and adequate management prevent serious complications such as hypoxic brain damage or death. A development of a learning program of sedation is required. Simulation as a teaching tool has improved the clinical expertise of learners. The objective of the study is to evaluate the impact of a simulation based medical education program on the performance of non-resident anesthesiologists for the management of complications related to sedation.
Methods This trial is randomized, controlled and single blinded. Non-resident anesthesiologists, without prior training on sedation, are included and randomized to receive or not a simulation based sedation learning. This program includes a pharmacology sedatives learning, teaching technical skills for airway management on low fidelity mannequin and high-fidelity simulation scenarios of these complications. Two evaluators, single-blinded, visualise the recorded performance of residents in simulation session. The evaluation is based on a performance checklist developed by Delphi technique. It compares the performance of the residents within the same group before and after the simulation based medical education program and to compare groups of residents.
Data analysis The sample size is based on similar simulation studies. The results are compared with the variance analysis for repeated measures. The difference in performance before and after simulation is compared using a t test.
The investigators hypotheses that improved performance scores following the simulation based medical education would put the dot on the importance of simulation as a learning tool. | Sedation is a drug depression of consciousness and alertness. It involves intravenous hypnotics and narcotics administration. Depending on doses and blood levels of administered agents, there is a continuum between anxiolysis, light sedation (monitored anesthesia care), deep sedation and general anesthesia.
Sedation is used to facilitate diagnostic examinations, minor surgery, endoscopic surgery and endovascular or transcutaneous therapeutic radiological procedures. It provides comfort to the patient during the procedure and better conditions for examination or treatment for the operator.
The main risk during procedural sedation is compromising the patient's respiratory function and airway. The obstruction of the upper airway by the tongue, soft palate or epiglottis on one hand and respiratory depression due to the sedative on the other hand are the major problems of sedation. In addition to respiratory depression, decreased airway protective reflexes during sedation exposes to the gastric contents aspiration and consequent respiratory complications.
Major complications are rare: one case of death of 160,000, 1 case of tracheal intubation of 58 000 and no cases of permanent neurologic damage of 646,000 gastrointestinal endoscopies performed under sedation. More common, the incidence of partial obstructions requiring airway maneuvers release (mandibular subluxation, oropharyngeal airway device, nasopharyngeal airway device) is 14.4%, 12.8% of hypoxemia, 0.1% of ventilation with face mask and in 0.6% the ongoing procedure needed to be stopped.
Although these incidents are without clinical severity, they can cause serious complications if diagnosed late or in inadequate care. Various analyzes of the American Society of Anesthesiology claims related to sedation, prove the seriousness of these complications and the importance of their early management, 40% of claims involving death or hypoxic permanent brain injury could be prevented and 50% of claims are related to anesthetic procedures performed outside the operating room. Respiratory depression associated with an absolute or relative overdose of sedative is the primary mechanism of complications.
Sedation can be practiced by non-anesthesiologists. There are several publications, other than in the anesthesiology field, on sedation regimes used and their safety and efficacy. The heterogeneity of definitions of respiratory complications and lack of power of these studies failed to show a reduction in respiratory complications and safety of sedation according to the standards of the anesthesiologist. The complications are associated to limited knowledge of anesthetic drugs pharmacology, the monitoring of sedation and the airway management. The anesthesiologist should play a central role in establishing safe sedation standards when administered by non-anesthesiologists.
In addition to the sedation learning need, the majority of residents and non-anesthesiologists sedation practitioners, strongly express their interest in a learning sedation. This interest is related to the residents' discomfort when using sedation associated to a lack of mastering of sedatives pharmacology and airway managements principles.
The simulation as a teaching tool is increasingly used. The literature has shown that simulation can improve the performance of trainees in various technical and non technical skills (expertise, crisis resource management principles).
Simulation is used as an assessment tool of education techniques. It assesses the performance of trainees through reproducible situation.
Simulation based medical education success depends on several factors. The relevance of the subject taught in the professional context, the target population, the identification of educational goals, the educational activities implemented to achieve these objectives, the choice of parameters to be measured and the measurement method are all factors that can strongly affect the impact of the simulation based medical education.
The recent meta-analysis of McGraphie and colleagues reviewed all the studies, from 1990 to 2011, evaluating the effectiveness of simulation based medical education. It shows the simulation based medical education superiority over the traditional clinical education in acquiring limited designed skills. The explanation of simulation use is based on the fact that the simulation seems to fill some gaps of traditional clinical learning, such as delayed and random clinical exposure and scarcity of complications.
The use of simulation for learning sedation to non-anesthesiologists seems to meet the requirements dictated by the subject to teach. It should, indeed, allow sedative drugs pharmacology learning and technical skills mastering. It should also allow, through reproducible scenarios, in high-fidelity simulation, improvement of the overall complications' sedation management and the assessment of the impact of simulation based medical education. However, even if the simulation offers all the theoretical and practical components of safe sedation educational program, the overall result of education based on simulation on the ability of non-resident anesthesiologists to manage sedation's complications remains to be assessed.
The aim of this randomized controlled trial is to evaluate the impact of a high fidelity simulation based sedation learning on non-anesthesiologists residents' performance in the management of sedation's complications, during simulated scenarios.
Methods
1. Description of the simulation based sedation learning program
The program's goal is to offer a comprehensive approach to theory and practice of sedation. It must provide the resident a vision adapted to their daily practice. Being based on the simulation, education should draw profile of all components provided to education from simulation tool.
The simulation based sedation learning program consists of different modules in response to residents' needs in the practice of sedation. The teaching is based on specific educational objectives, experimental learning conditions, repeated practice and an assessment based on the achievement rate of tasks. These modules are developed by anesthesiologists practicing in academic fields and practicing sedation.
The program includes online learning. It is followed by development of interactive presentations, based on simulated cases or simulated patients (actors), low fidelity simulation for specific technical skills as well as high fidelity scenarios of complications related to sedation. The purpose of the high-fidelity simulation is to enable the resident to integrate theoretical and practical learning received, in a similar context to his clinical practice, to develop a comprehensive and contextual (material, human resources and authorized techniques) management of sedation, to prevent, to anticipate, to make an early diagnosis and adequate management of simulated complications.
2. Study Design
This is a prospective, randomized, controlled, single-blind, trial. The study is conducted in the University of Montreal simulation centre. The robotic model used is the SimMan 3G (Laerdal, Inc. http: / /www.laerdal.com/doc/85/SimMan-3G).
The primary objective is the performance scores before and after a simulation based sedation learning program during a high fidelity simulated scenario of sedation's complications managed by non anesthesiologists residents.
3. Population Included in this study, all residents from surgery programs, radiology, gastroenterology, pneumology, family medicine , emergency medicine of the University of Montreal. Residents must have academic supervision with 1: 1 by a senior during their practice. Residents who have received prior instruction on sedation or advanced learning technical skills for airway management during residency will be excluded.
The recruited participants were randomized according to a randomization table, computerized, established prior to inclusion in intervention group that receives simulation based sedation learning and control group.
4. Assessment method and developing the performance checklist The evaluation is based on a list of tasks and behaviours (technical and non technical skills) of the resident during the management of simulated complications related to sedation. It includes items related to the specific management of complications (expertise) and non-specific items of communication and collaboration (Crisis Resource Management principles). It is divided in a) an initial assessment of the situation b) diagnostic steps c) management d) secondary evaluation. The performance list is developed and validated using the modified Delphi method.
5. Procedure A description of the high-fidelity simulation is performed, and a participation in an uncomplicated sedation scenario is made initially for the two groups. This first experience allows them to become familiar with the environment of the simulation and the use of mannequin interface / physician. This simulation is not followed by a debriefing.
Participants are then randomized in:
Intervention group:
Residents included in this group will go through the following steps:
A simulation of respiratory complications related to sedation: Base line performance.
The simulation based sedation program, described above. A second simulation of respiratory complications related to sedation: Post test.
Assessments are conducted by independent instructors blindly. The evaluators attribute scores by viewing the recorded performances, without knowing the group to which the candidate is included, or whether simulation based sedation program is realized or not.
Control group:
Residents included in this group carry out:
A complication related to sedation simulation: Base line performance, not followed by a debriefing.
A self visualization of a video describing sedation in adults. A second simulation, about 2 months later: Post test For equity training, the control group will be offered the simulation based sedation program after the end of the study, if desired.
6. Analysis of results The tasks are classified in 2 categories: properly performed or not / not properly performed.
The performance score represents adequately performed tasks on the total number of tasks (primary outcome).
Secondary outcomes include the comparison of (a) performance scores between pre-test and post-test for each group (b) performance scores related to technical skills (c) performance scores related to non technical skills.
The results are compared with the analysis of variance for repeated measures. The difference in performance before and after the simulation based sedation program is compared using a t test.
The number of participants was the number of eligible residents and who agreed to participate (convenience sample). As the selected population in this study consists of a larger sample, as several residency programs are concerned, the investigators opt for two groups of 25 participants (total n 50). | Inclusion Criteria:
* Residents from surgery programs, radiology, gastroenterology, pneumology, family medicine, emergency medicine of the University of Montreal
* Residents with academic supervision with 1: 1 by a senior during their clinical practice
Exclusion Criteria:
* Resident with prior instruction on sedation or advanced learning technical skills for airway management.
* Refusal to participate | Université de Montréal | OTHER | {
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NCT05608226 | null | Impact of Health Lifestyle on Body Weight | Impact of Health Lifestyle on Body Weight Post Cessation of Pharmacotherapy in Obese Subjects | None | OBSERVATIONAL | UNKNOWN | 2022-11-02T00:00:00 | null | 2023-06-30T00:00:00 | 2023-09-30T00:00:00 | null | 190 | 18 | 65 | ALL | false | Pharmacotherapy becomes an important and effective approach to improve body weight. However, it still remains unclear how to manage potential fluctuation after its cessation. Lifestyle change is the foundation and included as a part of clinical routine in real-world, therefore, we plan to conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from treatment. In addition, body weight related results will be described. | Novel pharmacotherapy is emerging, leading to substantial and sustained improvement in body weight compared with placebo in clinical trials. However, there is no evidence on management of body weight in real world setting after cessation of treatment. Body weight fluctuation is a pivotal difficulty for obese subjects who left off pharmacotherapy. It would be interesting to investigate the impact of real-world health lifestyle and its compliance in this clinical situation and probe into factors affecting compliance. Therefore, we will conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from pharmacotherapy cessation. In addition, body weight related results will be described. | Inclusion Criteria:
* All patients who completed a pharmacotherapy trial
* Those who consent to this FU study
Exclusion Criteria:
* Those who do not consent to this study | Shanghai Zhongshan Hospital | OTHER | {
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NCT06557226 | null | Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients | Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients | Ohyp | OBSERVATIONAL | COMPLETED | 2024-07-01T00:00:00 | null | 2023-09-10T00:00:00 | 2023-09-10T00:00:00 | null | 61 | 70 | null | ALL | true | The goal of this observational study is to learn about the effects of a reduced oral function on the nutritional status of non-acute hospitalized elders and on their oral health quality of life. | Malnutrition is highly prevalent among the elderly, many authors reported on the relationship between oral health and nutrition. However the the relationship between the dental state and the nutritional status was always limited to anatomical criteria such as number of teeth and the presence of prosthetic reconstructions.
The oral function is classified into 4 stages healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function.
This study aims to correlate the oral function with the nutritional status of non-acute hospitalized elders. And to further investigate the correlation between the different parameters defining the oral function and the oral health related quality of life (OHRQoL) as measured by theGeneral Oral Health Assessment Index.
A total 60 participants will be recruited in the University Hospital of Geneva, Loëx rehabilitation center. The investigators will see the patient for 2 visits after informed consent. The first visit will be 45 minutes long and will include a dental examination and an examination of the oral hygiene, the oral dryness, the tongue lip motor function, the tongue pressure, the occlusal force and the swallowing function. Diagnosis for nutrition according to the Glim criteria will be done. Furthermore, the participants will be asked to fill an oral health quality of life questionnaire comprising 12 questions.
Oral hypo function will be defined as a state when 3 or more signs were present from the 7 parameters examined.
Linear multiple regression analysis is used to examine the relationship between the nutritional status and oral function. Spearman's rank correlation coefficient will be used to correlate the oral function score and oral health related quality of life. | Inclusion Criteria:
* • Aged 70 years or over
* Hospitalized in Geneva University Hospitals, in rehabilitation or in long term care (Loëx)
* Able to follow simple instructions and perform the tests
* Understand French and complete or answer the questionnaire
* Give written informed consent
* Consent can be obtained from their next of kin or legal representative if necessary
* Have been admitted into the hospital no longer 15 days before inclusion
Exclusion Criteria:
* Patients with tube/intravenous feeding
* Poorly-controlled diabetes (Liu et al., 2015)
* Patients with gastro-intestinal diseases or symptoms (nausea, vomiting, diarrhea, constipation) affecting oral intake
* If the patient is taking an antimicrobial treatment at this time. | University of Geneva, Switzerland | OTHER | {
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"date": "2024-08-16",
"type": "ACTUAL"
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] | This study will enroll 60 patients aged 70 years or more and admitted to the Geneva University Hospitals (HUG) at Loëx Hospital. Patients will be approached consecutively. | NON_PROBABILITY_SAMPLE | false | {
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NCT04122326 | null | Monitoring and Evaluation of Posture in Office Workstations With Artificial Intelligence | Posture Sensing Method Validation at the Office Workstation | None | INTERVENTIONAL | COMPLETED | 2019-10-08T00:00:00 | null | 2019-10-25T00:00:00 | 2020-01-15T00:00:00 | [
"NA"
] | 20 | 18 | null | ALL | true | Office workers spend 11.6 hours per day in sedentary activities during the day, leading to increased health risks. Although there is literature on prevalence of musculoskeletal disorders and work station modification for office workers, successful implementation and follow-through of evidence-based recommendations in office environments is extremely challenging. This study aims to validate various techniques for evaluating posture, particularly in the neck, shoulder, and trunk, in order to develop evidence-based feedback for the office desk user. This study will include up to 40 volunteers over the age of 18 who regularly work on computer-based tasks at a desk. Participants will be observed working in a provided work station in a variety of different working postures. Data are collected using electromyography sensors, Kinect camera, and at least two video recording cameras to obtain postural information. Measurement of joint positioning and posture will be completed using an ergonomic screening tool from images collected throughout the testing. Participants will provide information on their level of comfort throughout various body regions in response to working in various positions. This will be an iterative study with multiple positions used to test the positioning of sensors, and the development of suitable algorithms to evaluate posture. The collected data will be used to inform sensing methods for office work posture. | There are more than 81 million office workers in the U.S. These office workers spend 11.6 hours per day in sedentary activities during the day. Several studies looked at workplace adjustments to decrease the health risks of sedentary office work, but there is little conclusive evidence showing that the modifications led to decreased risk of musculoskeletal pain. Ergonomic chair interventions have been found to reduce musculoskeletal symptoms and but evidence is inconclusive in supporting different chairs. Similarly, current literature on different computer adjustments (i.e. keyboard and mouse) has been inconclusive. When evaluating work stations that allow for both sitting and standing posture, prolonged static posture in either position can increase musculoskeletal discomfort. Many ergonomic interventions have become commercially available, but there is a lack of conclusive evidence showing that these interventions reduce risk for musculoskeletal pain.
The most successful interventions, meant to promote worker health, include an individualized, behavioral component. Workers who receive individualized attention, have higher overall awareness of ergonomic guidelines, demonstrate significantly better postures, and report higher productivity than their counterparts who receive group education or no intervention. Furthermore, adding real time prompts to an individualized approach can further increase the success of an intervention, with one study indicating that prompts may have up to four-fold effect on outcomes. Finally, it has been shown that the giving users the choice in how they implement ergonomic recommendations, input into methods and timing of cuing, and flexibility in adjusting their work environment demonstrate significant and sustained improvements in postures, productivity and overall well-being. This study will provide valuable input into the sensing mechanism for an intelligent workstation that will adapt the workspace in a way that will promote productivity, health and well-being through consistent behaviors to increase activity and improve posture.
This study will contribute to existing knowledge by:
1. Develop sensing methods that accurately measure postural parameters.
2. Develop guidelines for postural sensing (i.e. type of sensor, suitable algorithms for analysis, placement of sensor) of the trunk, neck, and upper extremities of office workers.
3. Understand individual position changes and the related/associated level of comfort.
If successful, the results of this study can be used to determine posture in order to provide real-time evidence-based ergonomic feedback for the workplace to decrease risk of musculoskeletal pain for office workers.
Method and Procedures The primary objective of this study is to validate various techniques for evaluating posture at an office workstation and relate these postures to physical discomfort. The data will be collected by taking baseline descriptive information on age, gender, and upper body discomfort using the Visual Analog Scale. Participants will be asked to independently arrange the given workstation in any way to work comfortably, and perform office work-like tasks. Then, the participants will be asked to work in a series of alterations to the workstation to test various different postures of the neck, shoulder, arms, and trunk. These will include neck rotation (0-45 degrees), neck lateral flexion (0-45 degrees), neck flex/ext (0-60 degrees), shoulder elevation and scapular protraction, shoulder flex (0-120 degrees), shoulder abduction (0-90 degrees), shoulder horizontal rotation (0-90 degrees), elbow flex/ext (0-145 degrees), wrist flex/ext (0-80 degrees), wrist ulnar/radial deviation (0-20 degrees), trunk rotation, trunk kyphosis/lordosis, and trunk lateral flexion. Participants will rotate between the postures when they become uncomfortable with their current posture and will be observed for a minimum of 2 hours and a maximum of 4 hours per session. Participants may be asked to return for up to two observation sessions. Participants will report any pain, discomfort, and overall comfort in each region of the body every 10-15 minutes. Participants will be informed to notify the study personnel of any increase in discomfort and testing in that posture will be terminated. There will be a termination protocol for clinically significant pain increase (more than 2 points on the Visual Analog Scale).
The study may include up to 40 participants. The sample size was selected to allow for multiple rounds of data collection, as this will be an iterative study to test various methods to sense posture. The Kinect/electromyography will be coded to track joint angles and posture in real-time. The video recording will be analyzed separately after the observation session using the Rapid Upper Limb Assessment and automated computer algorithms. This study will be an iterative process and camera positions and postures may be adjusted to validate various techniques for posture evaluation. The data from the Kinect/electromyography, video recording, original intended posture, and participant self report will be compared during data analysis. | Inclusion Criteria:
* 18 years old or older
* Ability to read, speak, and converse in English
Exclusion Criteria:
* Severe limitations in range of motion through the upper extremity, trunk or neck
* Significant musculoskeletal disorders (e.g., low back pain, carpal tunnel syndrome, cervical radiculopathy)
* Neurological conditions that affect sensation | University of Southern California | OTHER | {
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"date": "2019-10-10",
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"facility": "University of Southern California",
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]
} | [
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"affiliation": "University of Southern California",
"name": "Shawn C Roll, PhD",
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NCT02928926 | null | Cerebral Haemodynamics in Stroke Thrombolysis Study (CHIST) | Cerebral Haemodynamics in Stroke Thrombolysis (CHIST) Study | CHIST | OBSERVATIONAL | COMPLETED | 2016-10-06T00:00:00 | null | 2017-10-31T00:00:00 | 2017-10-31T00:00:00 | null | 22 | 18 | null | ALL | false | Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally maintained at a constant level, over a relatively wide blood pressure range. It can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following moderate to severe stroke, acting as a key role in the development of secondary brain damage related to brain swelling and further damage related to low blood flow. The administration of clotbusting therapy (thrombolysis), one of the main approved treatments of acute ischaemic stroke (AIS), results in recanalization of the blocked artery in over approximately 50% patients. However, due to its clot dissolving property, it may increase the risk of bleeding in the body, especially in the brain, leading to greater disability or even death. To date, there has been very little information regarding the natural history and prognostic significance of impaired Cerebral Autoregulation during and following reperfusion, especially those who receive thrombolysis. This research will use the noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in AIS patient at the initiation and completion of thrombolysis, and during acute, subacute and chronic phase post stroke onset, compared with those AIS patient who did not receive thrombolysis. This study will provide important data regarding perithrombolysis blood pressure management, an important and common clinical dilemma | In the UK alone, approximate 100,000 people suffer a stroke each year. Improved management of stroke patients not only reduces morbidity and mortality, but also reduces the cost of long term social care. The brain has control systems (i.e. cerebral autoregulation) to maintain blood flow to the brain, over a relatively wide blood pressure range. Cerebral Autoregulation can be described as static, reflecting the integrity of such mechanisms over time, or dynamic, occurring in response to sudden fluctuations in perfusion pressure. When blood pressure drops, small arteries increase in size to restore flow levels, and when blood pressure rises, they narrow to protect the most delicate blood vessels. it is known that sudden decompensated blood pressure changes can occur after stroke, this could result in brain bleeding and swelling where there is a reduced blood flow to the brain.
It is known that the clotbusting agent (Alteplase), the main effective treatment used in the acute stroke can improve blood flow in already blocked arteries in 50% of patients. However, as it is a powerful drug that dissolves clots, there is a risk that it may cause bleeding (haemorrhage) in the body. This is most serious when it occurs in the brain, either in the region of the stroke or another part of the brain, which if serious, could lead to greater disability or even death. To date, there has been little information regarding the natural history and prognostic significance of impaired cerebral autoregulation during and following restoration of brain blood flow (reperfusion), especially those who received clotbusting agent (Alteplase). There are also conflicting findings between animal and human models. There is evidence from an animal study that restoration of blood flow in postischaemic brain arteries may result in generation of free oxygen radicals, leading to further cerebral autoregulation impairment. Furthermore, there is evidence from animal models that clotbusting agent (Alteplase) may exhibit additional blood vessel toxic effect and therefore, further impair cerebral autoregulation. However, such findings could not be reproduced in the human settings. To date, there is only one small study looking at cerebral autoregulation in 14 acute ischaemic stroke patients 8 days after clotbusting treatment, there have not been studies to assess blood flow regulation at the initiation and completion of the clotbusting treatment.
Cerebral autoregulation can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes dynamic cerebral autoregulation. However, the use of TCD may be limited by the absence of brain window and/or occlusion of the middle cerebral artery in the acute ischaemic stroke patients. Therefore, it is important to consider alternative sites to the middle cerebral artery to assess brain blood flow regulation, and our group has previously researched the use of the main neck artery (the internal carotid artery) site. In a healthy control population, brain blood flow regulation index (autoregulation index) estimated from the internal carotid artery is not statistically different from the middle cerebral artery. However, such comparisons have not been made in the acute ischaemic stroke population. This research will use noninvasive technique of Trans Cranial Doppler to look at blood flow regulation in the brain (cerebral autoregulation) in clotbusting therapy (thrombolysis) treated acute ischaemic stroke (AIS) patients at the initiation and completion of thrombolysis, and during acute, subacute and chronic phase post stroke onset, compared to those AIS patients who have similar age, sex and blood pressure but not treated with thrombolysis. This study will provide important data regarding peri-thrombolysis blood pressure management, an important and common clinical dilemma. | Inclusion Criteria:
* Informed patient consent or personal consultee declaration form
* Male or female, aged 18 years or above
* Able (in the Investigator's opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner (GP) to be notified of participation in the study
rtPA Stroke Patient-specific Inclusion Criteria:
* Who meet the criteria for thrombolytic therapy with intravenous rtPA
Non- rtPA Stroke Patient-specific Inclusion Criteria:
* Clinical diagnosis of stroke within 6 hours of onset but not eligible for rtPA therapy, and the reason recorded
Exclusion Criteria:
* Male or Female, aged under 18 years
* Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
* Significant pre-stroke dependency (premorbid Modified Rankin Score \>3)
* Co-morbidity with anticipated life expectancy less than 3 months
* Current participation in another investigational drug trial
rtPA Stroke Patient-specific Exclusion Criteria:
* Participants who do not meet the criteria for thrombolytic therapy with intravenous rtPA
Non-rtPA Stroke Patient-specific Exclusion Criteria:
* Clinical diagnosis of stroke greater than 6 hours from onset
* Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved or rapidly improving within 1 hour of onset) | University of Leicester | OTHER | {
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NCT01329926 | null | Molecular Analysis of Human Neural Stem Cells | Molecular Analysis of Adult Human-derived Neural Stem Cells | None | OBSERVATIONAL | WITHDRAWN | 2011-03-31T00:00:00 | null | 2022-12-31T00:00:00 | 2023-12-31T00:00:00 | null | 0 | 35 | 85 | ALL | false | The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease. | In this project the investigators propose to analyze tissue samples from different nervous system regions obtained during neurosurgical procedures in order investigate the presence of neural stem cells in different cerebral areas. The investigators will also evaluate techniques for neural stem cell cryopreservation, for possible future therapeutic uses. Patients with degenerative neurological disorders like Parkinson's disease undergoing neurosurgical procedures meeting our selection criteria will be candidate for this study. | Inclusion Criteria:
1. Able to give informed consent prior to study
2. Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure
3. Age 35 to 85 years old
4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
5. Hoehn and Yahr Stage III or IV
6. Parkinson's disease observed in the absence of:
* Oculomotor palsy
* Cerebellar sign
* Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
* Pyramidal sign
* Amyotrophy
7. Good general health or stable medical condition well controlled, without contraindications to anesthesia
Exclusion Criteria:
1. Patients with severe dementia and brain atrophy on MRI
2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
3. Patients older than 85 or younger than 35
4. Patients who withhold informed consent
5. Patients with a history of alcohol or drug abuse
6. Sexually active women of childbearing potential without adequate form of birth control
7. Evidence of abnormal coagulation or anticoagulant therapy
8. Pregnancy or lactation
9. History of seizure disorders or current use of antiepileptic medication
10. Severe cognitive impairment
11. Clinically significant laboratory abnormality | NeuroGeneration | INDUSTRY | {
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"link": null,
"type": null
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"ADULT",
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NCT05397626 | null | Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome | Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome | None | INTERVENTIONAL | UNKNOWN | 2022-05-25T00:00:00 | null | 2023-05-23T00:00:00 | 2023-05-23T00:00:00 | [
"PHASE1"
] | 39 | 18 | 65 | ALL | false | The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better. | The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.
Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail. | Inclusion Criteria:
Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI\>30.
Exclusion Criteria:
* Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone. | Stony Brook University | OTHER | {
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NCT04781426 | null | PrEP Among MSM and TG in Myanmar | Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar | PrEP | OBSERVATIONAL | COMPLETED | 2021-02-25T00:00:00 | null | 2021-08-31T00:00:00 | 2021-08-31T00:00:00 | null | 200 | null | null | ALL | false | HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP. | null | Inclusion Criteria:
* HIV-negative
* No suspicion of acute HIV infection
* Substantial risk of HIV infection
* Creatinine clearance is more than 30 ml/min
* Willingness to use PrEP as prescribed, including periodic HIV testing
* Willingness to sign informed consent
Exclusion Criteria:
• Anyone who is not eligible with the inclusion criteria | Myanmar Oxford Clinical Research Unit | OTHER | {
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"link": null,
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"date": "2022-03-11",
"type": "ACTUAL"
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"date": "2021-03-04",
"type": "ACTUAL"
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},
{
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"other": null,
"primary": [
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"description": null,
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},
{
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NCT01216826 | null | Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma | Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma | None | INTERVENTIONAL | UNKNOWN | 2010-10-04T00:00:00 | null | null | null | [
"PHASE2"
] | 20 | null | 21 | ALL | false | The purpose of this study is to determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma.
The aim response is defined as complete or partial response (according to RECIST criteria) for at least 4 weeks, or stable disease for at least 12 weeks. | null | Inclusion Criteria:
* Osteosarcoma histological confirmation.
* No option of known curative treatment, neither approved treatment that increases survival with adequate quality of life.
* Karnofsky scale ≥ 50 for patients over 16 years and Lansky scale ≥ 50 for patients under 16 years.
* Subjects should not have received antineoplastic therapy \< 4 weeks before study treatment initiation.
* Adequate hematological function: neutrophil count \> 1.500/mm³, platelets \> 100.000/mm³ and hemoglobin \> 8.0 mg/dL.
* Adequate renal function, as defined below:
Age Maximum serum creatinine (mg/dL) 0 - 29 days 0,4 - 0,7 1 month - 3 years 0,7 4 - 7 years 0,8 8 - 10 years 0,9 11 - 12 years 1,0 13 - 17 years 1,2
≥18 years 1,3
* Adequate hepatic function: total bilirubin ≤ 1.5 x ULN and transaminases ≤ 2.5 x ULN.
* Patient and/or legal responsible must sign ICF.
* Life expectation \> 8 weeks.
* Measurable disease, according to RECIST criteria.
* For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day 0.
* The patient agrees to use effective contraception if procreative potential exists. Use of reliable means of contraception (e.g. hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier, abstinence) for subjects of reproductive potential (males and females) is required during study treatment and for 3 months following last dose of study drug
Exclusion Criteria:
* History of myocardial infarction, angina or cerebrovascular accident related to atherosclerosis.
* Pulmonary disorder (e.g. FEV1 or DLCO ≤ 70% upper expected).
* Significant hematologic or hepatic abnormality (transaminases levels \> 2.5 x ULN or serum bilirubin \>1.5 x ULN, hemoglobin \< 8 g/dL, platelets \< 100.000/ mm3, ANC \< 1.500/mm3).
* Has other existing serious medical conditions that could adversely affect the ability of the patient to be treated in accordance with the protocol.
* Any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives.
* If female, is pregnant or lactating.
* Active infection at the moment of recruitment.
* Previous history of organ transplantation.
* Recent surgery \< 2 months before entering study.
* Concomitant antineoplastic therapy.
* Patient received more than one rescue treatment, previously.
* Previous treatment with mTor inhibitors (ex: sirolimus, temsirolimus, everolimus).
* Use of investigational drug \< 30 days before entering study.
* Non-controlled hyperlipidaemia: serum cholesterol (fasting) \> 300 mg/dL or 7,75 mmol/L and triglycerides (fasting) \> 2,5 x ULN.
* Non-controlled diabetes mellitus defined as: glycemia (fasting) \> 1.5 x ULN.
* Patient with hemorrhagic disorder or using oral anti-vitamin K (except warfarin in low doses).
* Patient with HIV infection.
* Incapable to perform protocol visits.
* Another neoplasia for the last 2 years (except squamous or basocellular skin cancer).
* Hypersensitivity history to rapamycin analogs.
* Chronic treatment with corticoids (except per oral, topical or local treatment) or another immunosuppressor agent. | Hospital Santa Marcelina | OTHER | {
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"date": "2013-08-07",
"type": "ESTIMATED"
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"date": "2010-10-07",
"type": "ESTIMATED"
} | [
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} | [
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"facility": "Hospital Santa Marcelina",
"geoPoint": {
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"lon": -46.63611
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"state": "SP"
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] | null | null | {
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"measure": "Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma",
"timeFrame": "Up to 2 years."
}
],
"secondary": [
{
"description": null,
"measure": "Define Everolimus toxicity in this population",
"timeFrame": "Up to 2 years"
}
]
} | [
{
"affiliation": "Hospital Santa Marcelina",
"name": "Sidnei Epelman, MD",
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"id": "D018213",
"term": "Neoplasms, Bone Tissue"
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"id": "D009372",
"term": "Neoplasms, Connective Tissue"
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"id": "D018204",
"term": "Neoplasms, Connective and Soft Tissue"
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"term": "Neoplasms by Histologic Type"
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"term": "Neoplasms"
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{
"id": "D012509",
"term": "Sarcoma"
}
],
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"abbrev": "BC04",
"name": "Neoplasms"
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"name": "All Conditions"
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"name": "Rare Diseases"
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"id": "T5284",
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"relevance": "LOW"
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],
"meshes": [
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"term": "Osteosarcoma"
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]
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"term": "Physiological Effects of Drugs"
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"asFound": null,
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"relevance": "LOW"
}
],
"meshes": [
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NCT03187626 | null | Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis | Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study | RHIBOT | INTERVENTIONAL | COMPLETED | 2017-06-13T00:00:00 | null | 2021-02-16T00:00:00 | 2021-04-23T00:00:00 | [
"PHASE2",
"PHASE3"
] | 60 | 18 | null | ALL | false | The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis. | Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis | Inclusion Criteria:
* Age ≥ 18 years old
* Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
* Pain involving the base-of-thumb
* X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
* 1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
* Medical examination
* Written consent
* Health insurance
* For women of childbearing age, a negative urinary pregnancy test
Exclusion Criteria:
* History of thumb surgery
* History of inflammatory or crystal-associated rheumatic disease
* Neurological disorders involving the hands other than carpien canal syndrom
* Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
* Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
* Hand or wrist trauma ≤ 2 months
* Hand or wrist intra-articular injections ≤ 2 months
* Contra-indication to botulinum toxin A injection or to splinting
* Cognitive or behavioral disorders making the assessment impossible
* Participant unable to speak, read and write french
* Bilateral BTOA without predominant symptomatic side
* Pregnancy and breast feeding
* Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected minors or adults, guardianship or trusteeship, etc.)
* Patient with epilepsy | Assistance Publique - Hôpitaux de Paris | OTHER | {
"id": "P160404",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-06-13T00:00:00 | {
"date": "2021-06-30",
"type": "ACTUAL"
} | {
"date": "2017-06-15",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
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"maskingDescription": null,
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},
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} | [
"Base-of-thumb Osteoarthritis"
] | ["Base-of-thumb osteoarthritis", "Botulinum toxin A", "Intra-articular therapy", "Randomized trial"] | null | [
{
"city": "Paris",
"country": "France",
"facility": "Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Recherche Clinique Paris Descartes Necker Cochin Sainte Anne"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in base-of-thumb pain 3 months post-injection",
"timeFrame": "3 months post injection"
}
],
"secondary": [
{
"description": null,
"measure": "Change in base-of-thumb pain 1 month post-injection",
"timeFrame": "1 month post injection"
},
{
"description": null,
"measure": "Change in base-of-thumb pain 6 months post-injection",
"timeFrame": "6 months post injection"
},
{
"description": null,
"measure": "Change in hand function 3 months post-injection",
"timeFrame": "3 months post injection"
},
{
"description": null,
"measure": "Change in hand function 6 months post-injection",
"timeFrame": "6 months post injection"
},
{
"description": null,
"measure": "Change in patient's global assessment 3 months post-injection",
"timeFrame": "3 months post-injection"
},
{
"description": null,
"measure": "Change in patient's global assessment 6 months post-injection",
"timeFrame": "6 months post-injection"
},
{
"description": null,
"measure": "Percentage of OARSI responders 3 months post-injection",
"timeFrame": "3 months post-injection"
},
{
"description": null,
"measure": "Percentage of OARSI responders 6 months post-injection",
"timeFrame": "6 months post-injection"
},
{
"description": null,
"measure": "Analgesics consumption at 3 months",
"timeFrame": "from injection to 3 months post-injection"
},
{
"description": null,
"measure": "Analgesics consumption at 6 months",
"timeFrame": "from 3 to 6 months post-injection"
},
{
"description": null,
"measure": "Non-steroidal anti-inflammatory drugs consumption at 3 months",
"timeFrame": "from injection to 3 months post-injection"
},
{
"description": null,
"measure": "Non-steroidal anti-inflammatory drugs consumption at 6 months",
"timeFrame": "from 3 to 6 months post-injection"
}
]
} | [
{
"affiliation": "AP-HP , université Paris Descartes",
"name": "François RANNOU, MD, PhD",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "AP-HP, université Paris Descartes",
"name": "Christelle NGUYEN, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29961037", "type": "DERIVED", "citation": "Gil C, Abdoul H, Campagna R, Guerini H, Ieong E, Chagny F, Bedin C, Roren A, Lefevre-Colau MM, Poiraudeau S, Feydy A, Rannou F, Nguyen C. Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). BMJ Open. 2018 Jun 30;8(6):e022337. doi: 10.1136/bmjopen-2018-022337."}] | {"versionHolder": "2025-06-18"} | {
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NCT00044226 | null | A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH). | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of ML-04A in Subjects With Symptomatic Benign Prostatic Hyperplasia | None | INTERVENTIONAL | UNKNOWN | 2002-08-22T00:00:00 | null | null | null | [
"PHASE2"
] | 350 | 45 | 80 | MALE | true | Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study. | Patients must be willing to discontinue their current medications being taken for BPH for specified time periods before they become eligible. These include: Proscar, Saw Palmetto, and any "alpha-blocker" drugs.
Patients with high blood pressure must be on an acceptable medication that controls this condition.
Medications for other conditions may disqualify a patient from eligibility.Patients who are diabetic are not eligible for this study.
All patients will, at some time during the study, receive placebo (inactive substance). The study medication is given twice a day in liquid form under the tongue. There is a 33% chance that you would receive placebo for the duration of the study. Neither you nor your doctor will know which treatment you are receiving. | * Have an enlarged prostate by DRE (digital rectal examination);
* Have a diagnosis of BPH;
* Have documented symptoms (frequency; urgency; nighttime urination; reduced flow);
* Have a documented urinary flow rate as required | Milkhaus Laboratory | INDUSTRY | {
"id": "ML-BPH-01",
"link": null,
"type": null
} | Unknown | null | 2002-08-22T00:00:00 | {
"date": "2005-06-24",
"type": "ESTIMATED"
} | {
"date": "2002-08-23",
"type": "ESTIMATED"
} | [
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] | null | null | null | null | null | {"versionHolder": "2025-06-18"} | {
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"term": "Pathologic Processes"
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NCT00527826 | null | Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV | A 12 Month Open-label Randomized Parallel Group Study to Investigate the Influence of Salmeterol Xinafoate/Fluticasone Propionate Either in Fixed Combination or Separately Via Diskus Inhalers on the Course of the Disease and Frequency of Exacerbations in Subjects With Severe and Very Severe COPD. | None | INTERVENTIONAL | COMPLETED | 2007-09-10T00:00:00 | null | null | null | [
"PHASE4"
] | 214 | 40 | null | ALL | false | This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups.
Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety. | A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate either in fixed combination (SFC50/500 µg bid) or separately (SAL 50 µg and FP 500 µg bid) via Diskus inhalers on the course of the disease and frequency of exacerbations in subjects with severe and very severe COPD ( GOLD stage III+IV) | Inclusion criteria:
* Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria.
* Male or female subjects, aged \>=40 years. Females must be of Non Child Bearing Potential. The definition of Non Child Bearing Potential is as following: Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal.
* Have diagnosed COPD stage III or IV according to GOLD criteria: a baseline post-bronchodilator Forced Expiratory Volume, measured at 1 second (FEV1) \<50% of predicted normal and a baseline post- bronchodilator FEV1/Inspiratory Vital Capacity (IVC) ratio \<70%.
* Have experienced at least 2 moderate or severe COPD exacerbations leading to medical consultation (requiring oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization) within the 12 months preceding Visit 1.
* Have stable COPD medication within 4 weeks prior to Visit 1 (no new medication added and no dosage changes in medication).
* Current or ex-smokers with a smoking history of at least 10 pack years (number of pack years = \[number of cigarettes per day / 20\] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
* Are currently managed at home (outpatients), are ambulatory and able to travel to the clinic. Subjects can be treated with all relevant COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants, beta-1-agonists (for cardiovascular indication), non-invasive ventilation, long term oxygen therapy and can have Cor Pulmonale.
* A signed and dated written informed consent is obtained prior to participation.
* Able to comply with the requirements of the protocol and be available for study visits over 52 weeks.
Exclusion criteria:
* Known other respiratory disorders or signs for other respiratory disorders (e.g. asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis, bronchoectasis).
* Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and systemic lupus erythematosus).
* Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
* Having undergone lung surgery (e.g. lung resection including lung volume reduction surgery, lung transplant) or subjects scheduled for surgery.
* Concurrent medication from Visit 1 and for the duration of the study with any of the prohibited medications: monoamine oxidase inhibitors and tricyclic antidepressants, and ritonavir (a highly potent cytochrome P450 3A4 inhibitor).
* Subjects receiving chronic or prophylactic antibiotic therapy.
* Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety.
* Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
* History of depression.
* History or presence of clinically significant drug sensitivity or clinically significant allergic reaction to corticosteroids or salmeterol.
* Moderate or severe COPD exacerbation (requiring corticosteroids or increased dosage of corticosteroids and/or antibiotics or hospitalization) within the 4 weeks prior to Visit 1
* Lower respiratory tract infection within the 4 weeks prior to Visit 1 .
* Pregnant or lactating female and female of childbearing potential.
* Subject is a participating investigator, sub-investigator, study coordinator, or other employee of a participating investigator, or is an immediate family member of the before mentioned. Subject is an employee of GlaxoSmithKline (GSK).
* Subject participated in an investigational drug study within 30 days prior to Visit 1 | GlaxoSmithKline | INDUSTRY | {
"id": "SCO107227",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-09-10T00:00:00 | {
"date": "2012-10-30",
"type": "ESTIMATED"
} | {
"date": "2007-09-11",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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} | [
"Pulmonary Disease, Chronic Obstructive"
] | ["Severe and very severe COPD (GOLD stage III / IV) exacerbations", "health care utilisation", "Chronic Obstructive Pulmonary Disease (COPD)", "quality of life", "compliance", "salmeterol/fluticasone combination"] | null | [
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] | null | null | {
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"timeFrame": "Baseline through Week 52"
},
{
"description": null,
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"timeFrame": "Baseline through Week 52"
}
],
"secondary": [
{
"description": null,
"measure": "Compliance and Adherence to Study Medication",
"timeFrame": "Baseline through Week 52"
},
{
"description": null,
"measure": "Mean Number of COPD-related Visits at/by Physician",
"timeFrame": "Baseline through Week 52"
},
{
"description": null,
"measure": "Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)",
"timeFrame": "Baseline through Week 52"
},
{
"description": null,
"measure": "Number of Participants With the Indicated Number of Hospital Stays",
"timeFrame": "Baseline through Week 52"
},
{
"description": null,
"measure": "Mean Number of Days Rescue Medication Was Used",
"timeFrame": "The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])"
},
{
"description": null,
"measure": "Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52",
"timeFrame": "Baseline and Week 52"
},
{
"description": null,
"measure": "Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52",
"timeFrame": "Baseline and Week 52"
},
{
"description": null,
"measure": "Mean Change From Baseline in the Tiffeaneau Index at Week 52",
"timeFrame": "Baseline and Week 52"
},
{
"description": null,
"measure": "Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52",
"timeFrame": "Baseline and Week 52"
},
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"description": null,
"measure": "Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52",
"timeFrame": "Baseline and Week 52"
},
{
"description": null,
"measure": "Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52",
"timeFrame": "Baseline and Week 52"
},
{
"description": null,
"measure": "Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52",
"timeFrame": "Baseline and Week 52"
},
{
"description": null,
"measure": "Mean Total Costs (Related to COPD) Per Participant",
"timeFrame": "Baseline through Week 52"
}
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"name": "GSK Clinical Trials",
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NCT01626326 | null | San Francisco Stop Smoking App - Pilot Study | Evaluation of a Stop Smoking iPhone App | TCapp-1 | OBSERVATIONAL | COMPLETED | 2012-06-20T00:00:00 | null | null | null | null | 9,935 | 18 | null | ALL | true | This is an initial pilot study to determine whether people will use a research version of an iPhone Stop Smoking app. The investigators primary measures will consist of rates of recruitment (that is, number of people installing the app), use of the app, and completion of follow-up surveys regarding self-reported smoking status. The investigators secondary measure will be obtained quit rates and number of cigarettes smoked before and after using the app.
To enter the study, participants must download the app from iTunes at:
https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8 | The investigators research team has developed smoking cessation self-help tools administered as printed brochures and Internet stop smoking sites. These self-help tools have demonstrated quit rates similar to those obtained with the nicotine patch. The investigators now want to see if mobile device apps might also help people quit.
This is the investigators first pilot study with a research version of the investigators stop smoking app for the iPhone. The investigators want to get estimates of how many people will download the app per month, how many will actually use the app, and how many will provide follow-up information on whether they quit, and if not, how many cigarettes they are smoking now. The investigators will use this information to plan a randomized controlled trial to determine efficacy of the app for stopping smoking. | Inclusion Criteria:
* 18 years of age or older
* Must download the iPhone app from iTunes at: https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8
Exclusion Criteria:
* less than 18 years of age | University of California, San Francisco | OTHER | {
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NCT00088426 | null | Clinical and Genetic Studies on Holoprosencephaly | Clinical and Genetic Studies on Holoprosencephaly | None | OBSERVATIONAL | COMPLETED | 2004-07-23T00:00:00 | null | 2020-03-16T00:00:00 | 2020-04-16T00:00:00 | null | 256 | 1 | null | ALL | false | This study will examine how holoprosencephaly (HPE) affects people, how they change over time, and what genes may be involved in the cause of the disorder. HPE is a defect of brain development in utero in which the forebrain fails to sufficiently divide into two hemispheres, resulting in a single-lobed brain and skull and facial malformations. In most cases, the defects are so severe that babies die before birth. There are three classifications of HPE. In alobar HPE the brain does not divide at all; this form is usually associated with severe facial deformities. In semilobar HPE the hemispheres divide somewhat, causing an intermediate form of the disorder. In lobar HPE, the mildest form, separation of hemispheres is nearly normal.
Patients with HPE and their direct blood relatives may participate in this study. Patients are seen by a team of medical specialists at the NIH Clinical Center for the following procedures:
* Physical and neurological examination
* Eye examination
* Imaging studies, such as echocardiogram, abdominal ultrasound, brain MRI
* Electroencephalogram (EEG)
* Hearing evaluation
* Blood and urine samples for genetic and endocrine studies, routine blood chemistries, urinalysis, and urine electrolytes
* Other consultations as needed
* Possibly photographs, including front and side views of the face and other body parts that may be involved in HPE, such as the eyes, teeth, hands, and feet
Parents will be asked questions about the child's prenatal, birth, newborn, and past medical history, growth, behavior and development, and therapy and medication.
Because HPE is a genetic disorder and gene changes can be passed on in a family, parents will also be asked to undergo the following procedures:
* Completion of a medical and family history form
* Physical and neurological examination
* Blood and urine samples (for mothers only)
* Specialty consultations as indicated
* Possibly photographs, including front and side views of the face and other body parts that may be involved in HPE, such as the eyes, teeth, hands, and feet
* Psychosocial study. Some parents will be asked to participate in a telephone interview or complete a questionnaire, or both, about their attitudes, beliefs, and concerns about how they and their family cope with their child's condition. Some questionnaires may include questions about aspects of their marriage and personal feelings and experiences.
Parents will meet with a doctor and a genetics nurse to discuss the results of the tests and answer questions. Parents may be asked to bring their child back to the NIH after 2 years for follow-up examination and possible additional or repeat testing.
... | Holoprosencephaly (HPE) is a defect of midline forebrain development that occurs soon after conception. It has a prevalence of 1 in 250 during early embryonic development, and 1 in 10,000 to 1 in 20,000 at term. In live born infants, the abnormalities associated with HPE are divided into three main categories: alobar, semilobar, and lobar HPE. A fourth variant, middle interhemispheric variant, has also been recognized. The purpose of this study is to increase our understanding of the genetic and clinical manifestations of HPE through detailed physical, psychological, developmental, neurologic, endocrinologic, and radiologic studies. We will examine the spectrum of clinical characteristics of HPE to facilitate early diagnosis and clinical management, including genetic counseling. Finally, we plan to assess the psychosocial impact of HPE on the family as a unit. Most patients and their families will be seen at the NIH Clinical Center. A subset may be examined outside the NIH, and a further subset, for the psychosocial studies, may be interviewed by phone. | * INCLUSION CRITERIA:
1. Depending on their willingness to participate, subjects may enroll in DNA laboratory-only (98-HG-0249), psychosocial-only, or clinical-only. However, to conserve resources and meet study objectives, subjects with known mutations will be given priority in selection for extensive clinical studies. All races and genders are known to be at risk for HPE, anywhere in the world. Nationality or place of origin is not specific barrier to participation.
2. Direct blood relatives (typically parents, and occasionally siblings of affected individuals) of patients with HPE are also eligible to participate.
EXCLUSION CRITERIA:
1. Anyone unwilling to provide informed consent (for themselves as adults, or on behalf of their children as minors) or assent.
2. Medical condition(s) or mental retardation are not in themselves reason for exclusion if in the judgment of the referring physician this would involve no more than minimal risk. We anticipate that children with mental handicaps would be included in the research population. We will make every effort to explain the study for the purpose of assent in a manner that the family feels is both age and developmentally appropriate for that child.
3. We generally review a brief clinical description from the referring physician about a potential research subject to determine that the subject is appropriate to enter into the study. We reserve the right to exclude cases that are clearly not HPE or related to our direct research interests (e.g. HPE cases that are syndromic like Smith Lemli Opitz syndrome, Trisomy 13, Trisomy 18, drug-related, or teratogen-related). This almost never happens, and we would attempt to make referrals to a more appropriate investigator.
It is our intention to try to remove as many economic, cultural, geographic, racial, and gender barriers as we reasonably can to promote participation of HPE cases for research purposes.
Description and justification of clinical inclusion/exclusion criteria for environmental study arm control group (individuals with Williams syndrome) :
Participants must have a confirmed diagnosis of Williams syndrome caused by deletions in chromosome 7q11 involving the Williams-Beuren Syndrome Critical Region (WBSCR). Children should be less than 6 years of age to allow for improved maternal recall of prenatal
environmental exposures. The Williams syndrome cohort (PI: Dr. Beth Kozel; National Heart Lung Blood Institute) was chosen to allow for inherent biases in mothers who have children with multiple anomaly syndromes. | National Institutes of Health Clinical Center (CC) | NIH | {
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"Developmental Delay Disorders",
"Brain Disorders"
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"city": "Bethesda",
"country": "United States",
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"measure": "To characterize the physical, developmental, neurologic, endocrinologic and radiologic phenotype of HPE through this comprehensive natural history study.",
"timeFrame": "Once with possible followup at Year 2"
},
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"measure": "To examine the spectrum of clinical characteristics of HPE and facilitate early clinical recognition, diagnostic confirmation, anticipatory management, prognostication, and proper genetic counseling.",
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"measure": "To determine the spectrum of non-neurologic anomalies resulting from mutations in HPE-associated genes /pathways both in individuals with HPE and individuals without HPE.",
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"affiliation": "National Human Genome Research Institute (NHGRI)",
"name": "Paul S Kruszka, M.D.",
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] | [{"pmid": "9825935", "type": "BACKGROUND", "citation": "Golden JA. Holoprosencephaly: a defect in brain patterning. J Neuropathol Exp Neurol. 1998 Nov;57(11):991-9. doi: 10.1097/00005072-199811000-00001. No abstract available."}, {"pmid": "594909", "type": "BACKGROUND", "citation": "Matsunaga E, Shiota K. Holoprosencephaly in human embryos: epidemiologic studies of 150 cases. Teratology. 1977 Dec;16(3):261-72. doi: 10.1002/tera.1420160304."}, {"pmid": "1227533", "type": "BACKGROUND", "citation": "Roach E, Demyer W, Conneally PM, Palmer C, Merritt AD. Holoprosencephaly: birth data, benetic and demographic analyses of 30 families. Birth Defects Orig Artic Ser. 1975;11(2):294-313."}] | {"versionHolder": "2025-06-18"} | {
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NCT04954326 | null | A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL) | A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL) | ALL | INTERVENTIONAL | COMPLETED | 2021-06-18T00:00:00 | null | 2022-05-20T00:00:00 | 2022-05-20T00:00:00 | [
"PHASE2"
] | 89 | 1 | 17 | ALL | false | The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL | null | Inclusion Criteria:
* Patients aged 1 to \< 18 years
* Patients with cytologically confirmed and documented newly diagnosed ALL according to National Comprehensive Cancer Network guidelines 2020 (see Appendix 2), excluding B-cell Burkitt ALL
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 (see Appendix 3)
* Highly effective contraception method
* Signed informed consent and assent, when appropriate
Non-inclusion Criteria:
* Unlikely to cooperate in the study
* Pregnant and lactating women
* Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed
* Participant already enrolled in the study (informed consent signed)
* Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period
* Inadequate hepatic function (bilirubin \> 1.5 times upper limit of normal (ULN), transaminases \> 5x ULN)
* Inadequate renal function defined as serum creatinine \> 1.5 x ULN
* Prior treatment with chemotherapy or radiotherapy (except steroids and intrathecal therapy)
* Prior surgery or bone marrow transplant related to the studied disease
* Down Syndrome
* Psychiatric illness/social situation that would limit compliance with study requirements
* Known history of pancreatitis
* Known history of significant liver disease
* Known carriers of HIV antibodies
* Significant laboratory abnormality likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
* Pre-existing known coagulopathy (e.g. haemophilia and known protein S deficiency)
* History of previous or concurrent malignancy
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
* Severe or uncontrolled active acute or chronic infection
* Uncontrolled intercurrent illness including life-threatening acute tumor lysis syndrome (e.g. with renal failure), symptomatic congestive heart failure, cardiac arrhythmia | Servier | INDUSTRY | {
"id": "CL2-95014-002",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-06-29T00:00:00 | {
"date": "2023-07-12",
"type": "ACTUAL"
} | {
"date": "2021-07-08",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
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},
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} | [
"Acute Lymphoblastic Leukemia"
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{
"city": "Chelyabinsk",
"country": "Russian Federation",
"facility": "Regional Children Clinical Hospital",
"geoPoint": {
"lat": 55.15402,
"lon": 61.42915
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"state": null
},
{
"city": "Ekaterinburg",
"country": "Russian Federation",
"facility": "Regional Children Clinical Hospital",
"geoPoint": {
"lat": 56.8519,
"lon": 60.6122
},
"state": null
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{
"city": "Krasnodar",
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"facility": "Children Regional Clinical Hospital",
"geoPoint": {
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"state": null
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{
"city": "Moscow",
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"facility": "Russian Children Clinical Hospital",
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"state": null
},
{
"city": "Nizhny Novgorod",
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"state": null
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{
"city": "Saint Petersburg",
"country": "Russian Federation",
"facility": "V.A. Almazov National Medical Research Center",
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"lat": 59.93863,
"lon": 30.31413
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"state": null
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] | [
{
"class": "INDUSTRY",
"name": "ADIR, a Servier Group company"
},
{
"class": "INDUSTRY",
"name": "Les Laboratoires Servier (L.L.S), Russia"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pharmacokinetics Measurement",
"timeFrame": "Predose up to 600 hours"
},
{
"description": null,
"measure": "Pharmacokinetics Measurement",
"timeFrame": "Predose up to 600 hours"
}
],
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"description": null,
"measure": "Pharmacokinetics Measurements",
"timeFrame": "14 days post-dose"
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{
"description": null,
"measure": "Activity Measurement",
"timeFrame": "Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014"
},
{
"description": null,
"measure": "Immunogenicity Measurements",
"timeFrame": "Pre-dose, post-dose (sum of 14 and 25 days post-dose)"
}
]
} | [
{
"affiliation": "Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology.",
"name": "Alexander Isaakovich Karachunskiy, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D008232",
"term": "Lymphoproliferative Disorders"
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{
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],
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"abbrev": "BC04",
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"name": "All Conditions"
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],
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{
"asFound": "Lymphoblastic Leukemia",
"id": "M10951",
"name": "Leukemia, Lymphoid",
"relevance": "HIGH"
},
{
"asFound": "Acute Lymphoblastic Leukemia",
"id": "M27585",
"name": "Precursor Cell Lymphoblastic Leukemia-Lymphoma",
"relevance": "HIGH"
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{
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"id": "M11220",
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{
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"id": "M9490",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M11225",
"name": "Lymphoproliferative Disorders",
"relevance": "LOW"
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{
"asFound": null,
"id": "M11203",
"name": "Lymphatic Diseases",
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},
{
"asFound": null,
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"name": "Immunoproliferative Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T170",
"name": "Acute Graft Versus Host Disease",
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},
{
"asFound": "Acute Lymphoblastic Leukemia",
"id": "T175",
"name": "Acute Lymphoblastic Leukemia",
"relevance": "HIGH"
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{
"asFound": "Acute Lymphoblastic Leukemia",
"id": "T3533",
"name": "Lymphoblastic Lymphoma",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T3543",
"name": "Lymphosarcoma",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D054198",
"term": "Precursor Cell Lymphoblastic Leukemia-Lymphoma"
},
{
"id": "D007945",
"term": "Leukemia, Lymphoid"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
}
],
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"name": "Pegaspargase",
"relevance": "LOW"
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],
"meshes": null
} | {
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{
"id": "D054198",
"term": "Precursor Cell Lymphoblastic Leukemia-Lymphoma"
},
{
"id": "D007945",
"term": "Leukemia, Lymphoid"
}
],
"interventions": []
} |
NCT05528926 | null | RESist Against Irritability Superiority Trial | Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial | RESIST | INTERVENTIONAL | RECRUITING | 2022-08-31T00:00:00 | null | 2026-09-01T00:00:00 | 2026-09-01T00:00:00 | [
"NA"
] | 270 | 6 | 15 | ALL | false | Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders.Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.
Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research. | Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders. Both tonic (e.g. negative quality of mood) and phasic (e.g. temper outbursts) irritability are criteria of the DSM-5 Disruptive Mood Dysregulation Disorder and the World Health Organization has considered the addition of a specifier to indicate whether ODD presents with chronic irritability and anger in the revision of the International Classification of Disease.
Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.
Irritability is included in the negative valence system of RDoC as "frustrative non-reward". According to this neuroscience-based classification, irritability is an excessive response of an individual faced with the impossibility to achieve an expected goal and has been linked to dysregulations of the autonomic nervous system and the reward network. Another pathophysiological line of research conceptualizes irritability as an aberrant response to threat (e.g. irritable individuals may attack more rapidly and in broader contexts).
Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research. One of the first steps in achieving this goal includes testing new therapies against extant interventions. Parent training programs decrease aggressive behaviours in children and are therefore good candidates for the improvement of irritability. Low parental warmth, lack of positive parental emotion socialization and high parental Expressed Emotions have been linked with irritability in children and could therefore be targeted in parental programs.
Research on the biological and psychological mechanisms mediating irritability is also needed to further improve specificity of therapeutic actions.
The project includes two ancyllary studies : RESIST-EXP and RESIST-QUAL.
* RESIST-EXP: Investigate improvement of irritability in both programs throughout emotional testing while collecting ANS functioning measurements.
* RESIST-QUAL: A qualitative interview planned after treatment completion with parents from both parent programme groups. | Inclusion Criteria:
* Male and female subject between 6 and 15 years-old.
* Express informed consent f by at least one of the parents or legal representative, and oral consent of the child.
* A confirmed K-SADS DSM-5 diagnosis of ADHD, ODD, CD, mood/anxiety disorder or DMDD, or a clinical diagnosis of IED. The request of a concomitant mental disorder allows to restrict this intervention to a clinical population.
* A Parental-rated ARI total score of 4 or above at baseline.
* A Clinical Global Impression-Severity score (CGI-S) of 4 or above (=at least moderately ill).
* Persistence of irritability symptoms 6 month or above at baseline (this avoids including children with transitory irritability).
* stable treatment regimen (pharmacological and non-pharmacological) for 2 weeks prior to inclusion and during the trial
* RESIST-QUAL : Same inclusion criteria as above with specific informed consent form signed by the participating parent.
Exclusion Criteria:
* Unavailability of parents or legal representative during the study period.
* Subjects with a DSM-5 diagnosis (clinical presentation or history) that is consistent with Schizophrenia or psychotic disorders or acute manic episodes.
* Diagnosis of Autism Spectrum Disorder (ASD) in patients who are non-verbal and with IQ lower than 70.
* Known or estimated IQ\<70 or clinical diagnosis of intellectual disability.
* Subjects with severe irritability that are better accounted for by another factor, e.g.: general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use), as determined by the clinical judgment of the investigator, or related to child abuse and/or neglect.
* absence of informed consent give by at least one of the parents or legal representatives, and oral consent of the child
* inability to speak and comprehend French
* deemed unable to comply with the trial protocol
* participation in a structured parent program during the last 6 months | University Hospital, Montpellier | OTHER | {
"id": "RECHMPL20_0038",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-09-02T00:00:00 | {
"date": "2023-08-14",
"type": "ACTUAL"
} | {
"date": "2022-09-06",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "3 parallel groups to compare:\n\n* Non-Violent Resistance parent training (NVR)\n* Parent Management Training (PMT)\n* Treatment As Usual (TAU)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "In the RESIST trial, independent evaluators will be blinded to the type of program received by the parents; this aspect will be monitored throughout the study and parents will be instructed before every assessment to avoid disclosing the type of therapy received.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Irritable Mood"
] | ["Irritability", "Parent Management Training (PMT)", "Non-Violent Resistance (NVR)"] | null | [
{
"city": "Montpellier",
"country": "France",
"facility": "UH of Montpellier",
"geoPoint": {
"lat": 43.61092,
"lon": 3.87723
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline level that measure pleasure and arousal",
"timeFrame": "After 3 months follow-up"
}
],
"secondary": [
{
"description": null,
"measure": "Secondary efficacy endpoint at 1-month follow-up",
"timeFrame": "After 1 month follow-up"
},
{
"description": null,
"measure": "Secondary efficacy endpoints at 1 and 3-month follow-up",
"timeFrame": "Between 1 and 3-month follow-up"
},
{
"description": null,
"measure": "Secondary efficacy endpoints at 1 and 3-month follow-up",
"timeFrame": "Between 1 and 3-month follow-up"
},
{
"description": null,
"measure": "Secondary efficacy endpoints at 1 and 3-month follow-up",
"timeFrame": "Between 1 and 3-month follow-up"
},
{
"description": null,
"measure": "Exploratory efficacy endpoints and putative moderators and mediators.",
"timeFrame": "After 3-month follow-up"
},
{
"description": null,
"measure": "Exploratory efficacy endpoints and putative moderators and mediators.",
"timeFrame": "At 1 month and 3 months follow-up"
},
{
"description": null,
"measure": "Exploratory efficacy endpoints and putative moderators and mediators.",
"timeFrame": "After 3 months follow-up"
},
{
"description": null,
"measure": "Exploratory efficacy endpoints and putative moderating and mediating variables.",
"timeFrame": "At 3 months follow-up"
},
{
"description": null,
"measure": "Endpoints of the ancillary study: RESIST-EXP",
"timeFrame": "At baseline ans at 3 months follow-up"
},
{
"description": null,
"measure": "Endpoints of the ancillary study: RESIST-EXP",
"timeFrame": "At baseline ans at 3 months follow-up"
},
{
"description": null,
"measure": "Endpoints of the ancillary study: RESIST-EXP",
"timeFrame": "At baseline ans at 3 months follow-up"
},
{
"description": null,
"measure": "Endpoints of the ancillary study: RESIST-EXP",
"timeFrame": "At baseline ans at 3 months follow-up"
},
{
"description": null,
"measure": "Endpoints of the ancillary study: RESIST-QUAL",
"timeFrame": "After 3 months follow-up"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00297726 | null | A Study to Examine the Efficacy of the Arthritis Self Management Program | A Prospective Study to Examine the Efficacy of the Arthritis Self Management Program (ASMP) in Patients With Osteoarthritis (OA) in Alberta | None | INTERVENTIONAL | COMPLETED | 2006-02-27T00:00:00 | null | null | null | [
"NA"
] | 64 | 18 | null | ALL | false | This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and determine changes in health resource utilization after completeing the ASMP program. | This study will provide an analysis of the efficacy of the Arthritis Self Management Program (ASMP) using both patient administered questionnaires as well as the health utilization data maintained within the administrative databases at Alberta Health and Wellness. This study will also provide other information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information as it is recorded in administrative databases, will include a control group and will adjust for potential confounding variables such as sex, age, body mass index (BMI) and stage of disease. | Inclusion Criteria:
* OA of the hip and/or knee
* Patient is 18 years of age and over
Exclusion Criteria:
* a concurrent systemic inflammatory disease
* Patient has previously participated in an arthritis self management educational program
* Patient is awaiting total hip or total knee replacement surgery patient has a medical co-morbidity that would render the patient to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with anticipated life expectancy of equal to or less than 2 years
* Patient has been diagnosed with senile dementia or Alzheimer's disease | Alberta Bone and Joint Health Institute | OTHER | {
"id": "PRO-OA-00001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-02-27T00:00:00 | {
"date": "2006-03-01",
"type": "ESTIMATED"
} | {
"date": "2006-03-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "ECT",
"timePerspective": null
} | [
"Osteoarthritis"
] | ["Osteoarthritis, Knee", "Osteoarthritis, Hip", "Osteoarthritis, Ankle", "Arthritis", "Self-Management"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "A difference in the WOMAC score of 20 percentage points",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "A change in health care provider and medication utilization.",
"timeFrame": null
}
]
} | [
{
"affiliation": "University of Calgary",
"name": "Cyril B Frank, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D007592",
"term": "Joint Diseases"
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{
"id": "D009140",
"term": "Musculoskeletal Diseases"
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"id": "D012216",
"term": "Rheumatic Diseases"
}
],
"browseBranches": [
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"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
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"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
}
],
"browseLeaves": [
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"asFound": "Osteoarthritis",
"id": "M12926",
"name": "Osteoarthritis",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M17912",
"name": "Osteoarthritis, Hip",
"relevance": "LOW"
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"id": "M4476",
"name": "Arthritis",
"relevance": "HIGH"
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"id": "M6323",
"name": "Collagen Diseases",
"relevance": "LOW"
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],
"meshes": [
{
"id": "D001168",
"term": "Arthritis"
},
{
"id": "D010003",
"term": "Osteoarthritis"
}
]
} | null | {
"conditions": [
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"term": "Arthritis"
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{
"id": "D010003",
"term": "Osteoarthritis"
}
],
"interventions": null
} |
NCT05766826 | null | Coupons for Safe Water Project | Scaling up Coupons for Safe Water Treatment in Kenya | Coupons | INTERVENTIONAL | RECRUITING | 2023-02-02T00:00:00 | null | 2026-02-28T00:00:00 | 2026-10-01T00:00:00 | [
"NA"
] | 3,468 | null | null | FEMALE | true | Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are a cost-effective and effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. | Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are (i) a cost-effective solution to targeting water treatment for households that need it and will use it and (ii) an effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further study the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. Investigators monitor the program's impact at Health and Demographic Surveillance Systems (HDSS) sites in collaboration with the Kenya Medical Research Institute (KEMRI). Data collection includes child mortality, as well as verbal autopsies for deceased children. Data on mortality will be useful for future meta-analyses that pool data from multiple studies in order to estimate the mortality impact of free chlorine distribution schemes. | Inclusion Criteria:
* Currently pregnant women
* Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.
Exclusion Criteria:
- Women who do not consent. | University of Chicago | OTHER | {
"id": "DILChlorine Coupons Project",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-03-10T00:00:00 | {
"date": "2023-03-13",
"type": "ACTUAL"
} | {
"date": "2023-03-13",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study will conduct individual randomization, assigning half of the women to receive coupons and the other half to the control group as we enroll.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Death",
"Death, Infant",
"Diarrhea",
"Diarrhea, Infantile",
"Water-Borne Infectious Disease",
"Water-Related Diseases"
] | ["Child health", "Child mortality", "Chlorine", "Safe water", "Targeting", "Coupons", "RCT", "East Africa", "Kenya"] | null | [
{
"city": "Kisumu",
"country": "Kenya",
"facility": "Health and Demographic Surveillance System (HDSS sites)",
"geoPoint": {
"lat": -0.10221,
"lon": 34.76171
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"state": null
},
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"facility": "Health and Demographic Surveillance System (HDSS) sites",
"geoPoint": {
"lat": 0.06116,
"lon": 34.28823
},
"state": null
}
] | [
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"class": "OTHER",
"name": "Abdul Latif Jameel Poverty Action Lab"
},
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"description": null,
"measure": "Verified chlorine usage - 6 months",
"timeFrame": "The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch."
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"description": null,
"measure": "Verified chlorine usage - 12 months",
"timeFrame": "The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch."
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"measure": "Verified chlorine usage - 18 months",
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"measure": "Verified chlorine usage - 24 months",
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"measure": "Verified chlorine usage - 30 months",
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"measure": "Verified chlorine usage - 36 months",
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} | [
{
"affiliation": "University of Chicago",
"name": "Michael Kremer, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
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{
"affiliation": "Stanford University",
"name": "Pascaline Dupas, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT05665426 | null | Infrared Thermography-based Study of the Warming Effect Difference at Waist | Effect of Acupuncture or Moxibustion at Acupoints Weizhong (BL40) and Chize (LU5) on the Change in Lumbar Temperature in Healthy People | None | INTERVENTIONAL | RECRUITING | 2022-12-14T00:00:00 | null | 2023-12-13T00:00:00 | 2024-01-13T00:00:00 | [
"NA"
] | 140 | 18 | 60 | ALL | true | Low back pain is a common clinical condition, with up to 84% of adults experiencing varying degrees of low back pain. The most common form of low back pain is non-specific low back pain, which is often treated symptomatically in medicine due to its lack of etiology, which has many side effects. In contrast, acupuncture has the advantage of being practical and free of side effects.
The use of acupuncture points in the lumbar region has a long history of application, as early as the《Huangdi Neijing》thousands of years ago. In the Ming Dynasty, there were summaries of the experience of " Yaobei Weizhong Qiu" (Which means the Weizhong point is closely associated with the waist). Weizhong point's efficacy in lumbar diseases (e.g., lumbar disc herniation, lumbago, sciatica, etc.) is still confirmed. One of the mechanisms is closely related to the improvement of microcirculation, which can be visualized by observing changes in infrared thermal parameters. Acupuncture and moxibustion are the most common therapies at Weizhong point, but there is a lack of research on the differences in efficacy between the two. Therefore, this study aims to collect the temperature parameters of the lumbar region in healthy subjects after acupuncture/moxibustion to estimate the difference in the therapeutic effect on the lumbar region, which can help to reveal the effect differences between acupuncture and moxibustion. As well as to provide scientific evidence to enrich the connotation of the classical theory " Yaobei Weizhong Qiu." the investigators will test the following hypotheses:
1. Hypotheses for main effects of different point selection(LU 5 and BL 40)： H1: There is a significant difference in average temperature change at the waist at 30 minutes between the Weizhong(BL 40) group and the Chize(LU 5) group.
H0: There is no difference in average temperature change at the waist at 30 minutes between the Weizhong(BL 40) group and the Chize(LU 5) group.
2. Hypotheses for the main effects of different interventions (acupuncture and moxibustion) H1: There is a significant difference in average temperature change at the waist at 30 minutes between the acupuncture group and the moxibustion group.
H0: There is no difference in average temperature change at the waist at 30 minutes between the acupuncture and moxibustion groups. | the investigators will design a 2×2 randomized controlled trial, divided into four groups according to different acupoints (Weizhong and Chize) and different interventions (acupuncture and moxibustion). Patients will be randomized to one of the four treatment arms: (1) AW group: acupuncture at Weizhong point, (2) AC group: acupuncture at Chize point, (3) MW group: moxibustion at Weizhong point, (4) MC group: moxibustion at Chize point. All groups receive the intervention for 30 minutes. This trial will be carried out in the Third Affiliated Hospital of Zhejiang Chinese Medical University. the investigators will measure the average temperature difference of the lumbar region, the average temperature difference of the first lateral line of the Bladder meridian, and the average temperature difference of the second lateral line of the bladder meridian at different time nodes (Pre-intervention, 0, 5, 10, 15, 20, 25, 30 minutes) in all groups.
the investigators used the change of the average temperature (ΔT) in lumbar region from baseline to 30 minutes after intervention as the main effect indicator to estimate the sample size. Sample size calculations are performed to determine the number of participants needed to detect effect sizes. According to previously published results\[7, 8\] and our preliminary data, the mean and SD of the average temperature difference are μ1 = 0.84 μ2 = 0.34, μ3 = 0.70, and μ4 = 0.20 in the Acu-BL40 group, Acu-LU5 group, Mox-BL40 group and Mox-LU5 group, respectively, with SD σ = 0.26. k represents the number of groups and equals 4 in this trial. Type I error of 5% (α = 0.05) and 80% power (β = 0.20). Estimating a 20% dropout rate during the study, a minimum of 140 total participants is needed to reach the target of 35 participants per group. The investigators will undertake subgroup analysis in BL40 group, according to the pilot study performed previously, although there are about 40% participants can fell the warmth at lumbar region, the ΔT in lumbar region is more significant than others, therefore, the investigators decide not to expand the sample size.
the investigators will recruit 140 eligible participants from Zhejiang Chinese Medical University with age above 18 years. The eligible patients must meet the following inclusion criteria as well as the exclusion criteria. Anticipants will be recruited through an advertisement at the university, and through flyers at several locations of the internet. Interested participants can contact the project leader (PL) through their therapist, by phone or mail. If an applicant meets the study criteria, he or she will be invited to the research.
Temperature detection and measurement Thermal images were obtained using the FLIR E53 camera (FLIR Systems, Inc., Wilsonville, OR, USA). This thermal camera has an infrared resolution of 240×180 pixels and a visible light resolution of 640×480 pixels. The FLIR E53 camera has a scene range temperature range of -20 °C to 650 °C and can detect temperature differences as small as 0.04 °C.
Make the FLIR E53 camera perpendicular to the observing area (pre-marked area and acupoints), from 80 cm. Each participant will be evaluated in a room with a constant temperature of 26°C and 40%-60% humidity. The first photograph will be taken after the participants have rested for 20 min, other photographs will be sequentially taken at 0, 5, 10, 15, 20, 25 and 30 minutes once acupuncture/moxibustion has started and right after the intervention has ended. Heat lamps and other extraneous heat sources are switched off to prevent incorrect measurements.
Thermal images will be analyzed in the FLIR Tools application by two observers. The specific area of interest at the waist as well as the acupoints are predefined and outlined in the normal VGA photograph. The FLIR Tools application allows for calculating the mean temperature in a selected area or line. The mean temperature of certain areas will be compared at different time nodes. The temperature difference between both areas was expressed as ΔT (℃). the investigators will calculate the interobserver reliability by comparing the ΔT value of both researchers.
Interventions. For better observation of temperature changes in the acupoints, KSE36A0R thermometer (Keshun Instrument Co., Ltd., Ningbo, China) will be placed near the acupoint to record the temperature.
This trial will be designed with two interventions of acupuncture and moxibustion, with two acupoints Weizhong (BL 40) and Chize (LU 5) for each intervention. Both acupuncture and moxibustion will be performed by the licensed doctors of traditional Chinese medicine with at least 2 years of experience. Both acupuncture and moxibustion treatment will only consist of 1 session treatment with 30 minutes. Nee dles and moxa will be removed if the patients suffer from any adverse events (AEs).
Adverse Events and Safety All adverse events (AEs) associated with acupuncture and moxibustion would be recorded during the treatment; these AEs include bleeding, hematoma, burns, fainting, serious pain, local infection, etcetera. During the trial, all unexpected adverse events (AEs) will be observed in detail and documented in CRFs. All AEs reported should be analyzed regardless of the investigators' assessments of causality. If serious adverse events happen, the researchers should report to the PL and ethics committee immediately, who will decide on whether the participant needs to withdraw from the study.
Data collection and management Having sought consent, the demographic and baseline characteristic data in CRFs will be completed by a specific RA who is masked to treatment allocation and trained to administer questionnaires in a standardized way. The data consists Gender, age, weight, height, frequency (weekly) of recent low back discomfort, acupuncture/ moxibustion treatment experience and baseline temperature in the waist. Outcome measurement will be measured by the outcome assessors after the intervention. RAs will conduct quality control of data collection and be responsible for data entry. The PL will be responsible for initial data cleaning, identifying, coding, and conversion into the proper format for data analysis. All forms must be dated and signed by the responsible investigator or one of his/her authorized staff members.
Statistical analysis Intention-to-treat (ITT) analysis will be performed regardless of adherence. Microsoft Excel 2016 and IBM SPSS Statistics 23.0 (SPSS Inc., Chicago, IL, United States) will be used in data analysis. Continuous variables (e.g., age, body mass index, temperature, and intensity of warmth) will be represented as the mean ± standard deviation and compared using independent samples t tests. The investigators will use the chi-squared test to analyse the category variables (e.g., gender and sensation of warmth). A P-value alpha \< 0.05 (two-sided) will be used to determine statistical significance. After examining the data for normality (Kolmogorov-Smirnov test), the outcome measures will be analysed using ANOVA (assuming normal distribution) or Kruskal-Wallis (non-parametric). Demographic characteristics and other baseline values will be described using descriptive statistics for each group. Subgroup analysis stratified by warming sensation questionnaire (YES or NO). Significant group interactions will be analysed post hoc. | Inclusion criteria include:
1. aged 18-60 (either sex);
2. with a BMI of 18.5-23.9 kg/m2;
3. with no history of lower back pain;
4. with normal range of lumbar mobility (including flexion from 75-90 degrees, extension of 30 degrees, lateral bending from 20-35 degrees, and unilateral rotation of 90 degrees);
5. willing to participate in the trial and have signed the informed consent form.
Exclusion criteria:
1. participants with serious heart, liver, kidney, or hematological diseases;
2. women in menses, pregnancy, or lactation;
3. those unable to complete the imaging in prone position (about 40 minutes);
4. those with cognitive impairments;
5. those with a history of lower back trauma or whiplash within a week;
6. those with skin diseases or skin lesions, sensory impairments, scarring, or neoplasms at the test site;
7. those with metal allergies
8. those who have participated in other clinical trials that may affect the results of the study within the last three weeks. | The Third Affiliated hospital of Zhejiang Chinese Medical University | OTHER | {
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"date": "2023-07-10",
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"date": "2022-12-27",
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} | [
"ADULT"
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"interventionModel": "PARALLEL",
"interventionModelDescription": "2×2 factorial design",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The eligible patients will be given a sequential study number by research staff. Subsequently, their basic information will be entered into an internet-based and password-protected clinical research management system (ResMan Research Manager, supported by West China Hospital, Sichuan University, China), which will automatically generate a research code and randomly allocate participants to one of four groups (Acu-BL40 group, Acu-LU5 group, Mox-BL40 group or Mox-LU5 group) at a ratio of 1:1:1:1. Given the nature of the intervention, the participants and acupuncturists will be aware of the assignment. The research assistants responsible for data collection, biostatisticians and data analysis will be masked to study group allocation. Precise documentation of therapy will be recorded in the case report forms (CRFs) in an exclusive computer as well as on paper.",
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"primaryPurpose": "TREATMENT",
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} | [
"Health"
] | ["acupuncture; moxibustion; Weizhong; waist"] | null | [
{
"city": "Hangzhou",
"country": "China",
"facility": "the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University",
"geoPoint": {
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"timeFrame": "30 minutes after the intervention has begin"
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"timeFrame": "30 minutes after the intervention has begin"
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] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05118126 | null | Gut Microbiota in ITP | Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia | None | OBSERVATIONAL | UNKNOWN | 2021-11-01T00:00:00 | null | null | null | null | 240 | 18 | null | ALL | false | Prospective, observational study to explore the significance of gut microbiome in the diagnosis of ITP, and to identify the predictive value of baseline gut microbiome for GC resistance/relapse. | A prospective, observational study to (1) collect fecal samples from ITP patients at initial diagnosis (baseline) and after first-line GC treatment, (2) detect the composition of gut microbiome and related metabolites using metagenomic sequencing combined with metabolomics, (3) observe the impact of first-line treatment on gut microbiome, (4) explore the significance of gut microbiome in the diagnosis of ITP, and (5) identify the predictive value of baseline gut microbiome for GC resistance/relapse, thus to provide new ideas for clinical diagnosis and treatment of ITP. | Inclusion Criteria:
* 18 years or older;
* Isolated thrombocytopenia (platelet count of less than 100×10\^9/L);
* Normal leukocyte and erythrocyte counts according to routine blood tests;
* Did not receive any medication for thrombocytopenia for 6 months.
Exclusion Criteria:
* Secondary ITP such as drug-associated thrombocytopenia;
* Thrombocytopenia caused by viral infection (HIV, Hepatitis B virus or Hepatitis C virus);
* Nursing or pregnant women;
* Severe dysfunction of the heart, kidney, lung or liver;
* Active or previous malignancy;
* Patients with other diseases were undergoing treatment with immunosuppressants;
* Myelodysplastic disorder or myelofibrosis;
* Patients who were undergoing first - or second-line therapy for thrombocytopenia within 6 months. | Peking University People's Hospital | OTHER | {
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"date": "2021-11-11",
"type": "ACTUAL"
} | [
"ADULT",
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] | Patients with newly diagnosed ITP who would receive first-line therapy (glucocorticoid therapy with platelet infusion) according to the clinician's or patient's decision. | PROBABILITY_SAMPLE | true | {
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} | [
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"timeFrame": "6 months"
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"timeFrame": "6 months"
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"timeFrame": "6 months"
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NCT05332626 | null | Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women | Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal Osteoporosis in Women? | LaBon | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2022-03-23T00:00:00 | null | null | null | [
"NA"
] | 60 | 45 | 70 | FEMALE | false | This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study. | This study has three steps; namely, 1st step is to prepare the diet supplementation of probiotics and placebo. 2nd step is to perform the randomized, double-blind placebo-controlled clinical trial. 3rd step is to analyze the effects of L. acidophilus UALa-01™ in postmenopausal women. | Inclusion Criteria:
1. Women aged 45 to 70 years old with more than one year since last menstruation;
2. Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
3. All female participants who accepted bone densitometry measurement
Exclusion Criteria:
1. The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
2. Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
3. Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
4. Clinically significant acute inflammatory process (elevated hsCRP)
5. Abnormal kidney function (GFR \<60mL/min/1,73m2);
6. Participation in a body mass management study;
7. The use of drugs known to modify body mass or food intake;
8. Hormone replacement therapy;
9. History of following alternative diets (diets with the altered amount of macronutrients, vegan or vegetarian diets, high-fiber diet, a diet with high quantities of fermented food (\>400 g/day), diet fortified with prebiotics- and probiotics-functional food, elimination diets, low-calorie diets) within three months before the study;
10. History of use of any dietary supplements, including calcium, in the three months before the study;
11. History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
12. Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
13. Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
14. Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
15. Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
16. Diseases requiring nutritional requirement and chronic supplementation;
17. Alcohol (\>20g/d), nicotine or drug abuse;
18. Mental disorders, including eating disorders;
19. Cancer, autoimmune diseases;
20. Any other condition that, in the opinion of the investigators, would make participation not in the best interest of the subject, or could prevent, limit, or confound the efficacy of the study any diseases, disorders, and therapies, which may influence on final results of the study or pose a risk for subjects health. | Poznan University of Life Sciences | OTHER | {
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} | Unknown | {
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} | [
"Bone Loss",
"Post Menopausal Osteoporosis",
"Mineralization"
] | ["Probiotic", "Lactobacillus acidophilus", "Calcium status", "Bone resorption", "Bone formation", "Post Menopausal Osteoporosis"] | null | [
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"country": "Poland",
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{
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"measure": "calcium",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DXA",
"timeFrame": "2 years"
}
],
"secondary": [
{
"description": null,
"measure": "body mass",
"timeFrame": "2 years"
},
{
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"timeFrame": "2 years"
},
{
"description": null,
"measure": "calcium intake",
"timeFrame": "2 years"
},
{
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"measure": "biomarkers of bone turnover: CTX",
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},
{
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"measure": "biomarkers of bone turnover: TRAP5b",
"timeFrame": "2 years"
},
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"measure": "biomarkers of bone resorption: PINP",
"timeFrame": "2 years"
},
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"measure": "biomarkers of bone metabolism: PTH",
"timeFrame": "2 years"
},
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"measure": "biomarkers of bone metabolism: IGF 1",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "biomarkers of bone metabolism: high-molecular-weight adiponectin",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "gene polymorphism",
"timeFrame": "1 year"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001851",
"term": "Bone Diseases, Metabolic"
},
{
"id": "D001847",
"term": "Bone Diseases"
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{
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"term": "Musculoskeletal Diseases"
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{
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],
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],
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],
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{
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]
} | {
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{
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],
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],
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} |
NCT04488926 | null | Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients | Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial | None | INTERVENTIONAL | COMPLETED | 2020-07-20T00:00:00 | null | 2022-05-02T00:00:00 | 2022-05-02T00:00:00 | [
"PHASE4"
] | 21 | 18 | null | ALL | false | The onset of chronic Fibromyalgia symptomatology is due to central alterations, together with peripheral neuroimmune modifications. Using positron emission tomography (PET), it has been observed for the first time that fibromyalgia patients have a high activation of microglial cells compared to normal subjects. Experimental evidence in neuroinflammation models in vitro and in vivo have demonstrated the anti-inflammatory and neuroprotective effect of Palmitoylethanolamide (PEA), effects confirmed by observational clinical investigations conducted in patients with fibromyalgia in which micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA) reduced the intensity of pain improving the quality of life. The aim of this study is to investigate the efficacy and tolerability of PEA-m + PEA-um administered as an add-on therapy with a double-blind, randomized, placebo-controlled clinical investigation. | null | Inclusion Criteria:
* Diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology 2016 (symptoms for at least 3 months, Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI 4-6 and SS ≥ 9)
* Pain intensity assessed on the Visual Analogue Scale (VAS) ≥ 40
* PEA-naive patients
* Patients who agree to sign informed consent
Exclusion Criteria:
* Values of WPI \<7 and SS \<5
* Pain intensity assessed on the Visual Analogue Scale (VAS) \<40
* Patients who have already taken PEA in the past
* Allergic or hypersensitive subjects to the product and / or one or more of its excipients
* Patients who refuse to sign informed consent | Epitech Group SpA | INDUSTRY | {
"id": "MPS-FM",
"link": null,
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} | Unknown | {
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"nctId": null,
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} | 2020-07-24T00:00:00 | {
"date": "2023-09-07",
"type": "ACTUAL"
} | {
"date": "2020-07-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Fibromyalgia"
] | null | null | [
{
"city": "Verona",
"country": "Italy",
"facility": "Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona",
"geoPoint": {
"lat": 45.4299,
"lon": 10.98444
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"state": "VR"
}
] | [
{
"class": "OTHER",
"name": "Azienda Ospedaliera Universitaria Integrata Verona"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised",
"timeFrame": "90 days"
}
],
"secondary": [
{
"description": null,
"measure": "Pain Intensity assessed by Visual Analogue Scale",
"timeFrame": "90 days"
},
{
"description": null,
"measure": "Health assessed by Short form-12 Health Survey",
"timeFrame": "90 days"
},
{
"description": null,
"measure": "Sleep Disorders assessed by Pittsburgh Sleep Quality Index",
"timeFrame": "90 days"
},
{
"description": null,
"measure": "Rescue Drugs consumption assessed by a daily diary",
"timeFrame": "90 days"
},
{
"description": null,
"measure": "Incidence of Adverse Events",
"timeFrame": "90 days"
},
{
"description": null,
"measure": "Blood test",
"timeFrame": "90 days"
}
]
} | [
{
"affiliation": "Azienda Ospedaliera Universitaria Integrata di Verona",
"name": "Enrico Polati, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "30827269", "type": "BACKGROUND", "citation": "Schweiger V, Martini A, Bellamoli P, Donadello K, Schievano C, Balzo GD, Sarzi-Puttini P, Parolini M, Polati E. Ultramicronized Palmitoylethanolamide (um-PEA) as Add-on Treatment in Fibromyalgia Syndrome (FMS): Retrospective Observational Study on 407 Patients. CNS Neurol Disord Drug Targets. 2019;18(4):326-333. doi: 10.2174/1871527318666190227205359."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
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"term": "Musculoskeletal Diseases"
},
{
"id": "D012216",
"term": "Rheumatic Diseases"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
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{
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],
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],
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],
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},
{
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]
} | {
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{
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{
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],
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}
],
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]
} | {
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{
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"term": "Myofascial Pain Syndromes"
}
],
"interventions": [
{
"id": "C005958",
"term": "Palmidrol"
}
]
} |
NCT05653726 | null | Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF) | Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure | IMPACT-HF | INTERVENTIONAL | RECRUITING | 2022-11-28T00:00:00 | null | 2025-06-15T00:00:00 | 2025-12-31T00:00:00 | [
"NA"
] | 390 | 18 | null | ALL | false | The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are:
* Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure?
* Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients?
* Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team.
Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group. | null | Inclusion Criteria:
* Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months.
* Admitted for decompensation of chronic HF.
* Admitted for HF decompensation ≥30 days and ≤6 months.
* HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose.
* With previous optimized prognostic medical treatment.
* Under treatment with loop diuretic drugs.
* New York Heart Association functional class II, III or IV.
Exclusion Criteria:
* Inclusion in other intervention studies.
* Hemodynamic instability.
* Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days.
* Uncontrolled arrhythmias
* On waiting list for transplantation (any organ) or other cardiac surgery.
* Advanced mechanical circulatory support.
* Chronic renal disease on hemodialysis.
* Life expectancy less than 1 year.
* Moderate-severe cognitive impairment.
* Manifest inability to use a technological system.
* Institutionalized.
* Limiting psychiatric pathology. | Hospital Universitario 12 de Octubre | OTHER | {
"id": "HU12Octubre",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2022-12-07T00:00:00 | {
"date": "2024-11-27",
"type": "ACTUAL"
} | {
"date": "2022-12-16",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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"allocation": "RANDOMIZED",
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},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Heart Failure"
] | null | null | [
{
"city": "Madrid",
"country": "Spain",
"facility": "Hospital Universitario 12 de Octubre",
"geoPoint": {
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"lon": -3.70256
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] | [
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{
"class": "UNKNOWN",
"name": "Fundacion Investigacion Biomedica Hospital 12 de Octubre"
},
{
"class": "UNKNOWN",
"name": "Hospital Universitario Puerta de Hierro de Majadahonda"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Health care costs",
"timeFrame": "12 months"
}
],
"secondary": [
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"description": null,
"measure": "Non-health care costs",
"timeFrame": "12 months"
},
{
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"measure": "Symptoms",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Care burden of caregivers",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Number of hospital admissions",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Mortality",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Patient satisfaction with service",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Adherence to the telemonitoring protocolo",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Quality of life variation",
"timeFrame": "12 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
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"term": "Heart Diseases"
},
{
"id": "D002318",
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],
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"abbrev": "BC14",
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},
{
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],
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}
],
"meshes": [
{
"id": "D006333",
"term": "Heart Failure"
}
]
} | null | {
"conditions": [
{
"id": "D006333",
"term": "Heart Failure"
}
],
"interventions": null
} |
NCT02931526 | null | Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT) | Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy | None | OBSERVATIONAL | UNKNOWN | 2016-09-19T00:00:00 | null | null | null | null | 20 | 18 | 75 | ALL | false | The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.
The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT. | null | Inclusion Criteria:
* Aged 18-75 years,hospitalized ICU patients, male or female;
* having definitive diagnosis to treat with tigecycline for bacterial infection;
* receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function.
Exclusion Criteria:
* Patients with Child-Pugh C cirrhosis;
* Allergic to tetracycline or tigecycline;
* Patients received CRRT for \< 3 days or treated with tigecycline \< 3 days;
* Patients who are pregnant. | Zhujiang Hospital | OTHER | {
"id": "LCYJ1",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-10-10T00:00:00 | {
"date": "2016-10-13",
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"Critically Ill"
] | ["Tigecycline", "Continuous Renal Replacement Therapy", "Pharmacokinetics"] | null | [
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"facility": "Zhujiang Hospital,Southern Medical University",
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]
} | [
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}
] | [{"pmid": "32716292", "type": "DERIVED", "citation": "Zhao HH, Tang WJ, Yang YX, Cen ZR, Wang LQ. PK/PD study of tigecycline in severely infected patients with continuous renal replacement therapy. Int J Clin Pharmacol Ther. 2020 Oct;58(10):531-538. doi: 10.5414/CP203669."}] | {"versionHolder": "2025-06-18"} | {
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NCT01658826 | null | Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes | A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults. | None | INTERVENTIONAL | TERMINATED | 2012-08-03T00:00:00 | null | null | null | [
"PHASE2"
] | 91 | 18 | null | ALL | false | The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding. | Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days. | Inclusion Criteria:
* Adult, immunocompetent men and women in good health of any ethnic group
* Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
* History of recurrent episodes (\>=4 to \<=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day.
Exclusion Criteria:
* Present episode of genital herpes at time of randomization
* Clinically relevant acute or chronic infections (excluding HSV-2)
* Known intolerance to valacyclovir, acyclovir, or any component of the formulation
* Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir | AiCuris Anti-infective Cures AG | INDUSTRY | {
"id": "AIC316-01-II-02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-08-03T00:00:00 | {
"date": "2023-04-21",
"type": "ACTUAL"
} | {
"date": "2012-08-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
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},
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"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Genital Herpes"
] | ["AIC316", "Viral shedding"] | null | [
{
"city": "Indianapolis",
"country": "United States",
"facility": "Indiana University School of Medicine, IU Infectious Diseases Research",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana"
},
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"country": "United States",
"facility": "Westover Heights Clinic",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon"
},
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"city": "Houston",
"country": "United States",
"facility": "University of Texas Health Science Centre, Center for Clincial Studies",
"geoPoint": {
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"lon": -95.36327
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"state": "Texas"
},
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"facility": "University of Washington, Virology Research Clinic",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington"
}
] | [
{
"class": "INDUSTRY",
"name": "Medpace, Inc."
}
] | null | {
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"description": null,
"measure": "Within-subject Genital HSV Mucocutaneous Shedding Rate",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Overall Shedding Rate",
"timeFrame": "28 days"
}
],
"secondary": null
} | null | [{"pmid": "27997653", "type": "DERIVED", "citation": "Wald A, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Fife K, Selke S, Huang ML, Stobernack HP, Zimmermann H, Corey L, Birkmann A, Ruebsamen-Schaeff H. Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences: A Randomized Clinical Trial. JAMA. 2016 Dec 20;316(23):2495-2503. doi: 10.1001/jama.2016.18189."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Genital Diseases"
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NCT03939026 | null | Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma | A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma | ALPHA | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2019-04-04T00:00:00 | null | 2021-10-23T00:00:00 | null | [
"PHASE1"
] | 74 | 18 | null | ALL | false | The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647. | null | Inclusion Criteria:
* Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
* Relapse or refractory disease after at least 2 lines of chemotherapy
* At least 1 measurable lesion at time of screening.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate hematological, renal, liver, pulmonary, and cardiac functions.
Exclusion Criteria:
* Current or history of central nervous system (CNS) lymphoma.
* Clinically significant CNS dysfunction.
* ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
* Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
* Systemic anticancer therapy within 2 weeks prior to study entry.
* On-going treatment with immunosuppressive agents.
* Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
* Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
* Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
* Patients unwilling to participate in an extended safety monitoring period | Allogene Therapeutics | INDUSTRY | {
"id": "ALLO-501-201",
"link": null,
"type": null
} | Unknown | null | 2019-05-03T00:00:00 | {
"date": "2023-12-01",
"type": "ACTUAL"
} | {
"date": "2019-05-06",
"type": "ACTUAL"
} | [
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"OLDER_ADULT"
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"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Relapsed/Refractory Large B Cell Lymphoma",
"Relapsed/Refractory Follicular Lymphoma"
] | ["CAR T", "Cell Therapy", "Allogeneic Cell Therapy", "Cellular Immuno-therapy", "AlloCAR T", "ALLO-501", "ALLO-647", "LBCL", "Lymphoma", "Follicular Lymphoma", "Large B-Cell Lymphoma"] | null | [
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"facility": "Banner MD Anderson Cancer Center",
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"lon": -111.78903
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"state": "Arizona"
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"lon": -95.36327
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"state": "Texas"
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"secondary": null
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"term": "Molecular Mechanisms of Pharmacological Action"
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{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D019653",
"term": "Myeloablative Agonists"
}
],
"browseBranches": [
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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"abbrev": "ARhu",
"name": "Antirheumatic Agents"
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{
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"term": "Cyclophosphamide"
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{
"id": "C024352",
"term": "Fludarabine"
}
]
} | {
"conditions": [
{
"id": "D008223",
"term": "Lymphoma"
},
{
"id": "D008224",
"term": "Lymphoma, Follicular"
},
{
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"term": "Lymphoma, B-Cell"
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{
"id": "D003520",
"term": "Cyclophosphamide"
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{
"id": "C024352",
"term": "Fludarabine"
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} |
NCT05276726 | null | A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 | A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 | None | INTERVENTIONAL | RECRUITING | 2022-03-03T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 104 | 18 | null | ALL | false | Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation. | The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase.. | Inclusion Criteria:
1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
4. ECOG 0-1
Exclusion Criteria:
1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
2. Any severe and/or uncontrolled medical conditions
3. Active infection requiring systemic treatment within 7 days
4. Therapeutic radiation therapy within 3 weeks of study day 1 | Allist Pharmaceuticals, Inc. | INDUSTRY | {
"id": "JAB-21822-1003",
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"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-03-03T00:00:00 | {
"date": "2025-04-04",
"type": "ACTUAL"
} | {
"date": "2022-03-11",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
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"maskingInfo": {
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"maskingDescription": null,
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"observationalModel": null,
"primaryPurpose": "TREATMENT",
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} | [
"Non-small Cell Lung Cancer"
] | null | null | [
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"city": "Beijing",
"country": "China",
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"geoPoint": {
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"lon": 116.39723
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"state": "Beijing"
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{
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"geoPoint": {
"lat": 39.9075,
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"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
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"state": "Chongqing"
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{
"city": "Xiamen",
"country": "China",
"facility": "Research site05",
"geoPoint": {
"lat": 24.47979,
"lon": 118.08187
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"state": "Fujian"
},
{
"city": "Shenzhen",
"country": "China",
"facility": "Research site011",
"geoPoint": {
"lat": 22.54554,
"lon": 114.0683
},
"state": "Guangdong"
},
{
"city": "Nanning",
"country": "China",
"facility": "Research site016",
"geoPoint": {
"lat": 22.81667,
"lon": 108.31667
},
"state": "Guangxi"
},
{
"city": "Shijiazhuang",
"country": "China",
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"geoPoint": {
"lat": 38.04139,
"lon": 114.47861
},
"state": "Hebei"
},
{
"city": "Ha'erbin",
"country": "China",
"facility": "Research site018",
"geoPoint": {
"lat": 31.8696,
"lon": 101.742
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"state": "Heilongjiang"
},
{
"city": "Zhengzhou",
"country": "China",
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"geoPoint": {
"lat": 34.75778,
"lon": 113.64861
},
"state": "Henan"
},
{
"city": "Changsha",
"country": "China",
"facility": "Research site012",
"geoPoint": {
"lat": 28.19874,
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"state": "Hunan"
},
{
"city": "Changchun",
"country": "China",
"facility": "Research site015",
"geoPoint": {
"lat": 43.88,
"lon": 125.32278
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"state": "Jilin"
},
{
"city": "Shenyang",
"country": "China",
"facility": "Research site06",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
},
"state": "Liaoning"
},
{
"city": "Shenyang",
"country": "China",
"facility": "Research site07",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
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"state": "Liaoning"
},
{
"city": "Hohhot",
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"geoPoint": {
"lat": 40.81056,
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"state": "Neimenggu"
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{
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"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
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"state": "Shanxi"
},
{
"city": "Hubei",
"country": "China",
"facility": "Research site03",
"geoPoint": null,
"state": "Wuhan"
},
{
"city": "Hangzhou",
"country": "China",
"facility": "Research site019",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)",
"timeFrame": "At the end of Cycle 1 (each cycle is 21 days)"
},
{
"description": null,
"measure": "Dose Escalation phase: Number of participants with adverse events",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Expansion phase: Objective response rate (ORR)",
"timeFrame": "Up to 3 years - from baseline to confirmed Progressive Disease per RECIST."
}
],
"secondary": [
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"description": null,
"measure": "Dose Escalation phase: Objective response rate (ORR)",
"timeFrame": "Up to 3 years - from baseline to RECIST confirmed Progressive Disease"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Duration of response (DOR)",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Overall Survival (OS)",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Time to response (TTR)",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Expansion phase: Number of participants with adverse events",
"timeFrame": "Up to 3 years"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)",
"timeFrame": "Up to 3 Years"
},
{
"description": null,
"measure": "Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)",
"timeFrame": "Up to 3 Years"
},
{
"description": null,
"measure": "Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)",
"timeFrame": "Up to 3 Years"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012142",
"term": "Respiratory Tract Neoplasms"
},
{
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},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
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"term": "Neoplasms"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
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"term": "Carcinoma, Bronchogenic"
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],
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"id": "M5546",
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"relevance": "HIGH"
},
{
"asFound": null,
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},
{
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"relevance": "LOW"
},
{
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{
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"relevance": "LOW"
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{
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},
{
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"id": "M5540",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M5260",
"name": "Bronchial Neoplasms",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008175",
"term": "Lung Neoplasms"
},
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
}
]
} | null | {
"conditions": [
{
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"term": "Lung Neoplasms"
},
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
}
],
"interventions": null
} |
NCT00027326 | null | Collection of Blood and Urine From Patients Undergoing Radiation Therapy | Collection of Peripheral Blood and/or Urine From Patients Undergoing Radiation Therapy | None | OBSERVATIONAL | ENROLLING_BY_INVITATION | 2006-07-13T00:00:00 | null | null | null | null | 720 | 18 | 120 | ALL | false | Background:
-Research in NCI's Radiation Oncology Branch depends on the availability of blood and urine samples from patients receiving radiation therapy.
Objectives:
-To explore the effects of radiation therapy on gene expression in white blood cells, to measure radiation damage in red blood cells and to examine changes in hormone levels in the blood and urine after radiation therapy.
Eligibility:
-Patients 18 years of age and older who are receiving radiation therapy.
Design:
* Blood and urine samples are collected when participants enter the study.
* Additional samples may be collected at different times during and after treatment. Ideally, samples are obtained before, at the completion of, and 1 month following radiation therapy. Blood samples usually will be collected during routine patient monitoring procedures and will not require an additional needle stick.
* A total of 300 patients will be studied at the NCI in Bethesda, MD, Johns Hopkins University in Baltimore and the University of Pennsylvania in Philadelphia. | BACKGROUND:
Evolving research initiatives in the Radiation Oncology Branch (ROB) NCI, depend upon the availability of blood and urine samples from patients receiving radiotherapy.
Examples of planned studies include an exploration of the effects of radiotherapy on peripheral leukocyte phenotype, peripheral blood protein and metabolism changes as well as measurements of matrix metalloproteinases (MMP) in urine.
OBJECTIVES:
This protocol provides a means of acquiring blood and urine samples in patients receiving radiation therapy for a variety of conditions.
ELIGIBILITY:
Patients seen in the radiation oncology clinic will be asked to donate blood and/or urine before, during and after their treatment.
DESIGN:
This is a pilot, exploratory study to evaluate the effects of ionizing radiation in blood and/ or urine.
On most occasions, the blood samples will be obtained as a component of routine patient monitoring and will not necessitate an additional venipuncture.
Blood and urine samples will be processed and stored in the Radiation Oncology Branch and Basic Research Laboratory, CCR, NCI, for use in the research efforts of the branch. | * INCLUSION CRITERIA:
1. Patients must be co-enrolled in a NIH CC protocol in which radiation will be administered.
2. Patients must a candidate for, or currently receiving radiotherapy.
3. Age greater than or equal to 18 years.
4. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
1. Patients who have unobtainable data regarding previous radiation therapy. | National Institutes of Health Clinical Center (CC) | NIH | {
"id": "020064",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2001-11-30T00:00:00 | {
"date": "2025-06-05",
"type": "ACTUAL"
} | {
"date": "2001-12-03",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients currently a candidate or currently receiving radiotherapy. | NON_PROBABILITY_SAMPLE | null | {
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"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Carcinoma",
"Cancer",
"Tumor"
] | ["Blood", "Samples", "Radiation", "Urine", "Cancer", "Natural History"] | null | [
{
"city": "Bethesda",
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland"
}
] | null | null | {
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"description": null,
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"timeFrame": "At the time of the enrollment, a blood and/or a urine sample will be collected. Blood and/or urine will also be collected at the completion of radiotherapy and at 1 month follow- up."
}
],
"secondary": null
} | [
{
"affiliation": "National Cancer Institute (NCI)",
"name": "Kevin A Camphausen, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "All",
"name": "All Conditions"
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"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT06241326 | null | Immunotherapy for Hepatocellular Carcinoma | A Real-world Study of Immunotherapy-based Combination Therapies in Chinese Patients With Hepatocellular Carcinoma | IFHC | OBSERVATIONAL | RECRUITING | 2024-01-28T00:00:00 | null | 2026-12-31T00:00:00 | 2026-12-31T00:00:00 | null | 11,000 | 18 | null | ALL | null | This study is an observational real-world research conducted on Chinese hepatocellular carcinoma (HCC) patients. Its primary objective is to evaluate the safety and efficacy of immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions. | Hepatocellular carcinoma exhibits a significantly elevated incidence and mortality rate in China. Despite the Chinese population representing a mere 18.4% of the global population, the annual incidence of new liver cancer cases reaches a staggering 466,000 (55.4% of the global total), with 422,000 deaths (53.9% of the global total). Immunotherapy, particularly the implementation of immunotherapy-based combination treatment regimens, holds substantial therapeutic value in the management of hepatocellular carcinoma (HCC), leading to notable breakthroughs and advancements in the comprehensive treatment of liver cancer. The aim of this study is to evaluate the safety and efficacy of immunotherapy-based combination treatment regimens in Chinese hepatocellular carcinoma (HCC) patients under real-world clinical conditions. By collecting and analyzing data on the etiology, clinical characteristics, treatment modalities, and treatment outcomes of HCC patients receiving immunotherapy-based combination treatments in the clinical healthcare setting, the study seeks to provide valuable information regarding treatment patterns and effectiveness for hepatocellular carcinoma patients. | Inclusion Criteria:
1. Aged after 18 years (18 is included).
2. Hepatocellular carcinoma diagnosed by pathology or imaging.
3. Patients assessed by researchers as potentially benefiting from receiving immunotherapy-based combination regimens.
4. For participants who have previously received treatment according to this protocol, a comprehensive pre-treatment assessment is required, including demographic information, tumor history, medical history, and baseline imaging examinations.
5. Patients voluntarily enroll in this study.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Other conditions regimented at investigators' discretion. | The First Affiliated Hospital with Nanjing Medical University | OTHER | {
"id": "2023-SR-876",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-01-28T00:00:00 | {
"date": "2024-04-10",
"type": "ACTUAL"
} | {
"date": "2024-02-05",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Chinese hepatocellular carcinoma (HCC) patients | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
} | [
"Hepatocellular Carcinoma",
"Immunotherapy"
] | null | null | [
{
"city": "Nanjing",
"country": "China",
"facility": "Jiangsu Province Hospital",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu"
}
] | null | null | {
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"primary": [
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"measure": "Adverse events",
"timeFrame": "24 months"
}
],
"secondary": [
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"description": null,
"measure": "Progression free survival",
"timeFrame": "24 months"
},
{
"description": null,
"measure": "Disease control rate",
"timeFrame": "24 months"
},
{
"description": null,
"measure": "Objective response rate",
"timeFrame": "24 months"
},
{
"description": null,
"measure": "Duration of response",
"timeFrame": "24 months"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "24 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D009375",
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},
{
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},
{
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],
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],
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"term": "Carcinoma"
},
{
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]
} | {
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NCT00820326 | null | Efficacy of Dolasetron in Patients With Fibromyalgia | A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia | Dolastron | INTERVENTIONAL | COMPLETED | 2008-12-27T00:00:00 | null | null | null | [
"PHASE3"
] | 60 | 18 | 75 | ALL | false | This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.
This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).
Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.
This treatment will be renewed after one month, after 2 months and after 3 months.
If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.
Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment. | null | Inclusion Criteria:
* Patients aged 18 to 75
* Primitive Fibromyalgia according to ACR criteria
* Patient no responding to conventional treatment
* Women of childbearing age using an efficace contraception
* Signed consent
Exclusion Criteria:
* Inflammatory rheumatic diseases
* Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,
* Infectious diseases: hepatitis B and C, lyme disease, HIV,
* Hypothyroidism,
* Bone and mineral metabolism disorders
* Disorders of cardiac conduction
* Failure of Heart, of kidney or liver,
* Patient allergic to dolasetron
* Pregnant or nursing women
* Women without means of contraception,
* Age \<18 or \> 75 years. | University Hospital, Limoges | OTHER | {
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"facility": "Service de Rhumatologie, CHu de Limoges",
"geoPoint": {
"lat": 45.83153,
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"state": null
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] | null | null | {
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"description": null,
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"description": null,
"measure": "Improving visual analogue scale (VAS)",
"timeFrame": "Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12."
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"description": null,
"measure": "Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale",
"timeFrame": "Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12."
},
{
"description": null,
"measure": "Anxiety index",
"timeFrame": "Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12."
},
{
"description": null,
"measure": "Number of painful trigger points",
"timeFrame": "Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12."
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
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"id": "D009468",
"term": "Neuromuscular Diseases"
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{
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],
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"abbrev": "BC05",
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"abbrev": "BC10",
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"abbrev": "All",
"name": "All Conditions"
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}
],
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{
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"term": "Fibromyalgia"
},
{
"id": "D009209",
"term": "Myofascial Pain Syndromes"
}
]
} | {
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"term": "Peripheral Nervous System Agents"
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{
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"term": "Physiological Effects of Drugs"
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"id": "C060344",
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} |
NCT00677326 | null | Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer | Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer | None | INTERVENTIONAL | TERMINATED | 2008-05-12T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 1 | 20 | 85 | ALL | false | The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced breast cancer patients. | VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of the vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy. | Inclusion Criteria:
* Advanced or recurrent breast cancer
* Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*0201
* Laboratory values as follows
* 2000/mm3\<WBC\<15000/mm3
* Platelet count\>100000/mm3
* Bilirubin \< 3.0mg/dl
* Asparate transaminase \< 150IU/L
* Alanine transaminase \< 150IU/L
* Creatinine \< 3.0mg/dl
* Able and willing to give valid written informed consent
Exclusion Criteria:
* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Unhealed external wound
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal lesion(s)
* Decision of unsuitableness by principal investigator or physician-in-charge | Tokyo University | OTHER | {
"id": "Breast-A02-I, II",
"link": null,
"type": null
} | Difficulty in recruiting | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-05-12T00:00:00 | {
"date": "2009-12-29",
"type": "ESTIMATED"
} | {
"date": "2008-05-14",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Breast Cancer"
] | ["HLA-A*0201", "Peptide Vaccine", "VEGFR1", "VEGFR2"] | null | [
{
"city": "Minato-ku",
"country": "Japan",
"facility": "The Institute of Medical Science, the University of Tokyo",
"geoPoint": {
"lat": 34.2152,
"lon": 135.1501
},
"state": "Tokyo"
}
] | [
{
"class": "OTHER",
"name": "Human Genome Center, Institute of Medical Science, University of Tokyo"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)",
"timeFrame": "2 months"
}
],
"secondary": [
{
"description": null,
"measure": "To evaluate immunological responses",
"timeFrame": "2 months"
}
]
} | [
{
"affiliation": "Tokyo University",
"name": "Naohide Yamashita, MD/PhD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "12070285", "type": "BACKGROUND", "citation": "Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. doi: 10.1084/jem.20020072."}, {"pmid": "17020992", "type": "BACKGROUND", "citation": "Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750."}, {"pmid": "15930316", "type": "BACKGROUND", "citation": "Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
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],
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"abbrev": "BC04",
"name": "Neoplasms"
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"name": "All Conditions"
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],
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"term": "Breast Neoplasms"
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} | {
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],
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} |
NCT01719926 | null | Phase I Platinum Based Chemotherapy Plus Indomethacin | Phase I Study Evaluating Indomethacin in Combination With Platinum-based Chemotherapy | PIFA | INTERVENTIONAL | COMPLETED | 2012-10-30T00:00:00 | null | null | null | [
"PHASE1"
] | 13 | 18 | null | ALL | false | Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are recruited to the stroma of both the primary tumor and metastasis. Recent preclinical research has shown that in response to platinum-based chemotherapy, MSCs secrete two specific platinum-induced fatty acids (PIFAs) which induce resistance to a broad spectrum of chemotherapies. The secreted PIFAs are the fatty acid oxo-heptadecatetraenoic acid (KHT) and the omega-3 fatty acid hexadecatetraenoic acid (16:4). These PIFAs are produced via the COX-1 pathway. COX inhibitors, including indomethacin. This phase 1 study explores the safety of combining indomethacin with platinum containing chemotherapy. | null | Inclusion Criteria:
* Subjects with a histological proven malignancy receiving cisplatin combined with gemcitabine or 5FU/capecitabine. (cisplatin dose range 60-80 mg/m2) (Arm I) or CAPOX (oxaliplatin, capecitabine) (Arm II) in a 21 day cycle.
* Age ≥ 18 years
* Platinum-based chemotherapy naïve for at least 6 months.
* Subjects with at least one evaluable lesion.
* WHO Performance Status of 0 or 1.
* Female participants should be of non-child bearing potential either physiologic or by using adequate contraception, have a negative serum pregnancy test, and refrain from breast feeding.
* Written informed consent.
Exclusion Criteria:
* Known or suspected allergy or hypersensitivity to indomethacin or any agent given in association with this trial, in particular subjects who have a history of severe hypersensitivity reactions to anti-emetics (5-HT3 antagonists, metoclopramide or corticosteroids) and acetylsalicylic acid or other prostaglandin synthetase inhibitors.
* Symptomatic brain or meningeal tumors
* Subjects with seizure disorder requiring medication (such as corticosteroids or anti-epileptics).
* Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
* Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
* Unstable angina pectoris
* Symptomatic congestive heart failure NYHA class ≥ 3 (see appendix 13.6)
* Myocardial infarction ≤ 6 months prior to randomization
* Serious uncontrolled cardiac arrhythmia
* Active peptic ulcer disease, gastritis, inflammatory bowel disease.
* History of active gastrointestinal bleeding
* History of cerebrovascular disease
* Bleeding diathesis
* Chronic renal disease defined as GFR (MDRD) \<60 ml/min
* Absolute Neutrophil Count (ANC) \< 1.5 x 109/L (\< 1500/mm3)
* Platelets (PLT) \< 100 x 109/L (\< 100,000/mm3)
* Hemoglobin (Hgb) \< 6.0 mmol/l (patients may be transfused to achieve adequate Hb)
* Partial thromboplastin time (PTT) \> 1,5 x ULN
* Serum bilirubin \> 1.5 ULN
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \> 3.0 x ULN (\> 5 x ULN if liver metastases present)
* Patients who are unable or unwilling to comply with the protocol
* Chronic treatment with a corticosteroid agent (nebulized corticosteroids are allowed)
* Patients who received radiation therapy within 4 weeks of the start of the study
* Patients who received an experimental agent less than 4 weeks before start of the study.
* Patients who used Omega-3/omega-6 containing products, including fish oil products less than 2 weeks before start of the study.
* Chronic use of NSAID's and/or acetylsalicylic acid and/or other prostaglandin synthetase inhibitors.
* Use of anticoagulant therapy | UMC Utrecht | OTHER | {
"id": "NL40487.041.12",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-10-30T00:00:00 | {
"date": "2017-08-18",
"type": "ACTUAL"
} | {
"date": "2012-11-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Colorectal Neoplasms",
"Esophageal Neoplasms",
"Ovarian Neoplasms"
] | ["Colorectal", "Esophageal", "Indomethacin", "PIFA"] | null | [
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"city": "Amersfoort",
"country": "Netherlands",
"facility": "Meander Medisch Centrum",
"geoPoint": {
"lat": 52.155,
"lon": 5.3875
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"state": "Utrecht"
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"city": "Amsterdam",
"country": "Netherlands",
"facility": "the Netherlands Cancer Institute",
"geoPoint": {
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"state": null
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"country": "Switzerland",
"facility": "Oncology Institute of Southern Switzerland",
"geoPoint": {
"lat": 46.19278,
"lon": 9.01703
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Number of dose limiting toxicities at each dosage cohort",
"timeFrame": "From first dose of indomethacin until 28 days after last dose of indomethacin"
}
],
"secondary": [
{
"description": null,
"measure": "Pharmacodynamics",
"timeFrame": "During first 2 cycles of 3 weeks each"
},
{
"description": null,
"measure": "Efficacy",
"timeFrame": "From baseline to date of progressive disease according RECIST 1.1, approximately 9 to 18 weeks"
}
]
} | [
{
"affiliation": "UMC Utrecht",
"name": "F.Y.F.L. de Vos, MD/PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D007414",
"term": "Intestinal Neoplasms"
},
{
"id": "D005770",
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{
"id": "D004067",
"term": "Digestive System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
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"term": "Digestive System Diseases"
},
{
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"term": "Gastrointestinal Diseases"
},
{
"id": "D003108",
"term": "Colonic Diseases"
},
{
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"term": "Intestinal Diseases"
},
{
"id": "D012002",
"term": "Rectal Diseases"
},
{
"id": "D004701",
"term": "Endocrine Gland Neoplasms"
},
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"term": "Ovarian Diseases"
},
{
"id": "D000291",
"term": "Adnexal Diseases"
},
{
"id": "D005831",
"term": "Genital Diseases, Female"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D005833",
"term": "Genital Neoplasms, Female"
},
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"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
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"id": "D004700",
"term": "Endocrine System Diseases"
},
{
"id": "D006058",
"term": "Gonadal Disorders"
},
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NCT04962126 | null | Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy | Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy | FLUORO | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2021-06-29T00:00:00 | null | 2023-04-30T00:00:00 | null | [
"PHASE2"
] | 15 | 18 | null | ALL | false | This single-arm phase II interventional study aims to assess disease response to, and toxicity of, a combination of obinutuzumab and atezolizumab, with or without radiotherapy, in treatment naive Follicular Lymphoma.
The study will involve an induction phase and a maintenance phase for responding participants, for up to 24 months. Response to treatment will be monitored using medical imaging and clinical assessment. | This is a single-arm phase II study of obinutuzumab, atezolizumab with or without RT in treatment-naïve advanced FL. Participants will initially receive 2 cycles of induction treatment with obinutuzumab and atezolizumab. During cycle 2, participants will undergo disease assessment by PET/CT scan, results of which will determine further induction treatment. Participants in Complete Medical Response (CMR) according to Lugano criteria will receive an additional 4 cycles of induction treatment. Participants who achieve a partial response (PR), stable disease (SD) or deemed to have minor/asymptomatic progressive disease (PD) will also receive 4 further cycles of induction treatment, with the addition of involved-site RT to residual sites of disease (4Gy in 2 fractions), administered between cycle 3 and cycle 4. Participants with symptomatic PD following 2 cycles of induction treatment will not receive any further study treatment. Further treatment will be at the discretion of the treating clinician.
At the end of the induction phase, disease response will again be assessed by PET/CT scan. All participants in CR, PR or SD will move into the maintenance phase of the study and will receive obinutuzumab for 24 months (up to a total of 12 doses). Participants with PD at the end of induction will cease protocol treatment and further treatment will be as per local guidelines. | Inclusion Criteria:
1. Patient has provided written informed consent
2. Male or female aged ≥ 18 years or older at written informed consent
3. Histologically proven FL grade 1-3A according to the current World Health Organisation classification (2016) including all morphological variants. The B-cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody
4. No previous chemotherapy, or other investigational drug for this indication apart from focal RT
5. Stage I disease not amenable to single-agent definitive-dose RT, stage II, III or IV (as per Ann Arbor criteria - see appendix 1), suitable for treatment with non-curative intent
6. At least one site of radiographically measurable disease not previously irradiated (at least one bi-dimensionally measurable site of disease: nodal disease \>1.5 cm or an extranodal lesion \> 1.0 cm in longest perpendicular diameter)
7. Deemed to need treatment by treating Investigator. Reasons for treatment can include, but are not limited to:
* Any nodal or extranodal tumour mass \>7cm AND/OR multiple extranodal disease sites
* Involvement of at least 3 sites each with diameter \>3cm
* Symptomatic splenic enlargement
* Organ involvement/compression
* Ascites or pleural effusion
* (LDH) elevated
* Presence of systemic symptoms
* Disease progression in preceding 3 months
* Evidence of marrow infiltration with marrow compromise. (e.g. haemoglobin, WBC or platelet count below lower limit of institutional normal range)
8. Adequate bone marrow function within 7 days prior to registration defined as:
* ANC ≥1.0x109/L
* WBC ≥2.0x109/L
* Platelets ≥100x109/L (with no platelet transfusion in the preceding 14 days)
* Haemoglobin ≥90 g/L (with no red blood cell transfusion in the preceding 14 days) Unless these are attributed to bone marrow infiltration by lymphoma. In cases were one or more results are lower than those specified above due to bone marrow infiltration by FL, patient may be eligible following consultation with the CPI.
9. Adequate organ function within 7 days prior to registration, defined as
* Total bilirubin ≤1.5 x upper ULN with the exception of patients with known Gilbert's syndrome may be included if their total bilirubin is ≤3.0 x ULN and direct bilirubin ≤1.5 x ULN)
* AST and(ALT) ≤3 x ULN
* Adequate renal function with serum creatinine ≤1.5 x ULN or CrCl ≥ 40mL/min (using Cockroft-Gault formula, see Appendix 2)
* For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 x ULN
* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
10. ECOG performance status 0-2 (see Appendix 3)
11. Life expectancy greater than 6 months
12. Patients of childbearing potential must adhere to the following:
* Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration Note: A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\> 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
* Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the trial through to 18 months after the last dose of treatment. Women must refrain from donating eggs during this same period.
Note: The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
* Women must not be breastfeeding during study treatment and for 18 months after the last dose of obinutuzumab/study treatment.
* Male patients must agree to use an adequate method of contraception for the course of the trial through to 18 months after the last dose of treatment. Men must refrain from donating sperm during this same period.
13. Able to comply with the study protocol requirements and follow-up procedures.
Exclusion Criteria:
1. Patient has grade 3B FL, transformed FL or other indolent lymphoma
2. Requirement for urgent treatment due to life-threatening complications of the disease, for example: Compressive symptoms due to disease (which may or may not be bulky), such as superior vena caval obstruction; significant organ involvement causing compromise of organ function (including but not limited to liver/ renal obstruction, actual or impending spinal cord compression, uncontrolled pleural/pericardial effusions), malignant, symptomatic hypercalcaemia
3. Central nervous system, meningeal involvement, cord compression from lymphoma
4. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
5. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF- α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Medical Monitor confirmation has been obtained
* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids (≤ 10mg prednisolone for orthostatic hypotension or adrenal insufficiency are eligible for the study
6. Patients with active, known or suspected autoimmune disease, with the following exceptions:
* Well controlled type I diabetes mellitus
* Coeliac disease
* Residual hypothyroidism due to autoimmune condition only requiring hormone replacement
* Eczema or vitiligo or psoriasis not requiring systemic treatment and rash covering \<10% of body surface area
* Other conditions not expected to recur in the absence of an external trigger
7. Past history of pneumonitis or lung disease including idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organising pneumonia (i.e., bronchiolitis obliterans, cryptogenic organising pneumonia)
8. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to registration, unstable arrhythmia, or unstable angina
9. Prior organ transplantation or allogeneic bone marrow transplantation
10. Severe active infection with 4 weeks prior to registration , including, but not limited to, hospitalisation for complications of infection
11. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
12. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
13. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 18months after the last dose of trial treatment, for women and men respectively. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to registration.
14. History of HIV (HIV 1/2 antibodies)
15. Active Hepatitis B (Patients with a negative hepatitis B surface antigen (HBsAg) test and a positive total hepatitis B core antibody test (HBcAg) at screening are eligible for the study provided that the screening hepatitis B virus (HBV) DNA test is negative or undetectable). Patients with known hepatitis B on current antiviral therapy are excluded
16. Active Hepatitis C (Patients are eligible with a negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test)
17. Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example: approximately March to October in the Southern Hemisphere). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior registration or at any time during the study treatment or within 5 months after the last dose of protocol treatment. B-cell recovery should be documented prior to administration of live vaccines.
18. Has a known history of active TB (Bacillus Tuberculosis)
19. History of severe allergic anaphylactic reactions to chimeric or humanised antibodies or fusion proteins
20. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulations
21. Major surgical procedure, other than for diagnosis, within 4 weeks prior registration
22. History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer - | Olivia Newton-John Cancer Research Institute | OTHER | {
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"name": "Immune Checkpoint Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M1346",
"name": "Antineoplastic Agents, Immunological",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C000594389",
"term": "Atezolizumab"
},
{
"id": "C543332",
"term": "Obinutuzumab"
},
{
"id": "D019999",
"term": "Pharmaceutical Solutions"
}
]
} | {
"conditions": [
{
"id": "D008223",
"term": "Lymphoma"
},
{
"id": "D008224",
"term": "Lymphoma, Follicular"
}
],
"interventions": [
{
"id": "C000594389",
"term": "Atezolizumab"
},
{
"id": "C543332",
"term": "Obinutuzumab"
},
{
"id": "D019999",
"term": "Pharmaceutical Solutions"
}
]
} |
NCT04967326 | null | Role of Clinical Pharmacists in Epilepsy Management | Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study | None | INTERVENTIONAL | COMPLETED | 2021-07-08T00:00:00 | null | 2018-12-31T00:00:00 | 2018-12-31T00:00:00 | [
"PHASE4"
] | 141 | 18 | null | ALL | false | Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital. | Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.
However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam. | Inclusion Criteria:
* were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
* were treated for more than one month.
Exclusion Criteria:
* were pregnant or breastfeeding women.
* had a history of alcoholism.
* had liver or renal disease.
* were using drugs known to have an influence on cytochrome P450 enzymes. | Gia Dinh People Hospital | OTHER | {
"id": "23-2015/CN-HĐĐĐ",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-07-08T00:00:00 | {
"date": "2021-08-02",
"type": "ACTUAL"
} | {
"date": "2021-07-19",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Epilepsy"
] | ["epilepsy", "role of pharmacist", "adverse drug reaction", "antiepileptic drug", "Vietnam"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of patients with two seizures or less",
"timeFrame": "One year from the start of the study"
}
],
"secondary": [
{
"description": null,
"measure": "Number of patients who maintained an optimized concentration of antiepileptic drugs",
"timeFrame": "One year from the start of the study"
}
]
} | null | [{"pmid": "34930487", "type": "DERIVED", "citation": "Pham HT, Tran MH, Nguyen NQ, Tan Vo V, Tran MH. Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study. J Pharm Policy Pract. 2021 Dec 20;14(1):109. doi: 10.1186/s40545-021-00394-9."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC25",
"name": "Substance Related Disorders"
}
],
"browseLeaves": [
{
"asFound": "Epilepsy",
"id": "M7983",
"name": "Epilepsy",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M30303",
"name": "Drug-Related Side Effects and Adverse Reactions",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5204",
"name": "Brain Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D004827",
"term": "Epilepsy"
}
]
} | {
"ancestors": [
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D018682",
"term": "GABA Agents"
},
{
"id": "D018377",
"term": "Neurotransmitter Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018692",
"term": "Antimanic Agents"
},
{
"id": "D014149",
"term": "Tranquilizing Agents"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
},
{
"id": "D011619",
"term": "Psychotropic Drugs"
},
{
"id": "D018712",
"term": "Analgesics, Non-Narcotic"
},
{
"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D026941",
"term": "Sodium Channel Blockers"
},
{
"id": "D049990",
"term": "Membrane Transport Modulators"
},
{
"id": "D065701",
"term": "Cytochrome P-450 CYP3A Inducers"
},
{
"id": "D065693",
"term": "Cytochrome P-450 Enzyme Inducers"
},
{
"id": "D061567",
"term": "Voltage-Gated Sodium Channel Blockers"
},
{
"id": "D065694",
"term": "Cytochrome P-450 CYP1A2 Inducers"
}
],
"browseBranches": [
{
"abbrev": "AntiConv",
"name": "Anticonvulsants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "ChanBlk",
"name": "Channel Blockers"
},
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "PsychDr",
"name": "Psychotropic Drugs"
}
],
"browseLeaves": [
{
"asFound": "Diesel Exhaust",
"id": "M4246",
"name": "Anticonvulsants",
"relevance": "HIGH"
},
{
"asFound": "Botulinum Toxin Type A",
"id": "M5480",
"name": "Carbamazepine",
"relevance": "HIGH"
},
{
"asFound": "Com",
"id": "M13577",
"name": "Phenytoin",
"relevance": "HIGH"
},
{
"asFound": "Operator",
"id": "M17383",
"name": "Valproic Acid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20504",
"name": "Neurotransmitter Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14474",
"name": "Psychotropic Drugs",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4032",
"name": "Analgesics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20786",
"name": "Analgesics, Non-Narcotic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23177",
"name": "Sodium Channel Blockers",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30025",
"name": "Diuretics, Potassium Sparing",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002220",
"term": "Carbamazepine"
},
{
"id": "D010672",
"term": "Phenytoin"
},
{
"id": "D014635",
"term": "Valproic Acid"
},
{
"id": "D000927",
"term": "Anticonvulsants"
}
]
} | {
"conditions": [
{
"id": "D004827",
"term": "Epilepsy"
}
],
"interventions": [
{
"id": "D002220",
"term": "Carbamazepine"
},
{
"id": "D010672",
"term": "Phenytoin"
},
{
"id": "D014635",
"term": "Valproic Acid"
},
{
"id": "D000927",
"term": "Anticonvulsants"
}
]
} |
NCT06756126 | null | A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD) | A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-12-25T00:00:00 | null | 2025-06-30T00:00:00 | 2025-06-30T00:00:00 | [
"PHASE2"
] | 24 | 12 | 18 | ALL | false | This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis | This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks. | Inclusion Criteria:
* Male or female subjects aged ≥12 \<18 years old.
* Weight≥30kg at baseline.
* AD diagnosed at least half a year before screening.
* Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
Exclusion Criteria:
* Acute onset of AD in 4 weeks prior to enrollment.
* Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
* Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
* Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
* Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
* Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies. | Akeso | INDUSTRY | {
"id": "AK120-208",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-12-31T00:00:00 | {
"date": "2025-01-01",
"type": "ACTUAL"
} | {
"date": "2025-01-01",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Atopic Dermatitis"
] | null | null | [
{
"city": "Dongguan",
"country": "China",
"facility": "Dongguan People's Hospital",
"geoPoint": {
"lat": 23.01797,
"lon": 113.74866
},
"state": "Guangdong"
},
{
"city": "Guangzhou",
"country": "China",
"facility": "The Second Affiliated Hospital of Guangzhou Medical University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
},
{
"city": "Shenzhen",
"country": "China",
"facility": "The University of Hong Kong - Shenzhen Hospital",
"geoPoint": {
"lat": 22.54554,
"lon": 114.0683
},
"state": "Guangdong"
},
{
"city": "Changsha",
"country": "China",
"facility": "Hunan Pediatric Medical Union",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan"
},
{
"city": "Changsha",
"country": "China",
"facility": "Xiangya Hospital Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan"
},
{
"city": "Ningbo",
"country": "China",
"facility": "Ning Bo No.2 Hospital",
"geoPoint": {
"lat": 29.87819,
"lon": 121.54945
},
"state": "Zhejiang"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of adverse events(AE)",
"timeFrame": "week -4 to week 16"
}
],
"secondary": [
{
"description": null,
"measure": "PK evaluation: maximum plasma concentration (Cmax)",
"timeFrame": "Baseline till last follow-up visit ( up to day 113)"
},
{
"description": null,
"measure": "PK evaluation: time to maximum plasma concentration (Tmax)",
"timeFrame": "Baseline till last follow-up visit ( up to day 113)"
},
{
"description": null,
"measure": "PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17",
"timeFrame": "Baseline till last follow-up visit ( up to day 113)"
},
{
"description": null,
"measure": "Change in Eczema Area and Severity Index (EASI) scores",
"timeFrame": "week 0/2/4/8/12/16"
},
{
"description": null,
"measure": "Change in affected Body Surface Area (BSA) scores",
"timeFrame": "week 0/2/4/8/12/16"
},
{
"description": null,
"measure": "Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)",
"timeFrame": "week 0/2/4/8/12/16"
},
{
"description": null,
"measure": "Change in Children's Dermatology Life Quality Index (CDLQI) scores",
"timeFrame": "week 0/2/4/8/12/16"
},
{
"description": null,
"measure": "Change in Patient Oriented Eczema Measure (POEM) scores",
"timeFrame": "week 0/2/4/8/12/16"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D012873",
"term": "Skin Diseases, Genetic"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
},
{
"id": "D017443",
"term": "Skin Diseases, Eczematous"
},
{
"id": "D006969",
"term": "Hypersensitivity, Immediate"
},
{
"id": "D006967",
"term": "Hypersensitivity"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Atopic Dermatitis",
"id": "M7071",
"name": "Dermatitis, Atopic",
"relevance": "HIGH"
},
{
"asFound": "Dermatitis",
"id": "M7067",
"name": "Dermatitis",
"relevance": "HIGH"
},
{
"asFound": "Atopic Dermatitis",
"id": "M7655",
"name": "Eczema",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15676",
"name": "Skin Diseases, Genetic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19712",
"name": "Skin Diseases, Eczematous",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10018",
"name": "Hypersensitivity",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10020",
"name": "Hypersensitivity, Immediate",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003876",
"term": "Dermatitis, Atopic"
},
{
"id": "D003872",
"term": "Dermatitis"
},
{
"id": "D004485",
"term": "Eczema"
}
]
} | null | {
"conditions": [
{
"id": "D003876",
"term": "Dermatitis, Atopic"
},
{
"id": "D003872",
"term": "Dermatitis"
},
{
"id": "D004485",
"term": "Eczema"
}
],
"interventions": null
} |
NCT00958126 | null | A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA | A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older | None | INTERVENTIONAL | COMPLETED | 2009-08-12T00:00:00 | null | null | null | [
"PHASE2"
] | 1,313 | 18 | null | ALL | true | The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults | null | Inclusion Criteria:
* Male or female aged 18 and older, inclusive, at the time of providing informed consent.
* Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.
Exclusion Criteria:
* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine. | Seqirus | INDUSTRY | {
"id": "CSLCT-CAL-09-61",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-08-12T00:00:00 | {
"date": "2017-11-21",
"type": "ACTUAL"
} | {
"date": "2009-08-13",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Influenza"
] | null | null | [
{
"city": "Huntsville",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 34.7304,
"lon": -86.58594
},
"state": "Alabama"
},
{
"city": "San Diego",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California"
},
{
"city": "Melbourne",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 28.08363,
"lon": -80.60811
},
"state": "Florida"
},
{
"city": "Peoria",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 40.69365,
"lon": -89.58899
},
"state": "Illinois"
},
{
"city": "South Bend",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 41.68338,
"lon": -86.25001
},
"state": "Indiana"
},
{
"city": "Metairie",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 29.98409,
"lon": -90.15285
},
"state": "Louisiana"
},
{
"city": "Baltimore",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
},
{
"city": "Rockville",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 39.084,
"lon": -77.15276
},
"state": "Maryland"
},
{
"city": "Austin",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas"
},
{
"city": "Fort Worth",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 32.72541,
"lon": -97.32085
},
"state": "Texas"
},
{
"city": "Salt Lake City",
"country": "United States",
"facility": "Study Site",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Seroconversion Rate 21 Days After the First Vaccination",
"timeFrame": "21 days after the first vaccination"
},
{
"description": null,
"measure": "Seroconversion Rate 21 Days After the Second Vaccination",
"timeFrame": "21 days after the second vaccination"
},
{
"description": null,
"measure": "Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination",
"timeFrame": "21 days after the first vaccination"
},
{
"description": null,
"measure": "Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination",
"timeFrame": "21 days after the second vaccination"
}
],
"secondary": [
{
"description": null,
"measure": "Frequency and Intensity of Solicited Adverse Events After the First Vaccination",
"timeFrame": "During the 7 days after the first vaccination"
},
{
"description": null,
"measure": "Duration of Solicited Local Adverse Events After the First Vaccination",
"timeFrame": "During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs"
},
{
"description": null,
"measure": "Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)",
"timeFrame": "Up to 180 days after the last vaccination"
},
{
"description": null,
"measure": "Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination",
"timeFrame": "Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI"
}
]
} | [
{
"affiliation": "Seqirus",
"name": "Director, Vaccines Clinical Development",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "20874515", "type": "RESULT", "citation": "Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012141",
"term": "Respiratory Tract Infections"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D009976",
"term": "Orthomyxoviridae Infections"
},
{
"id": "D012327",
"term": "RNA Virus Infections"
},
{
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"term": "Virus Diseases"
},
{
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"term": "Respiratory Tract Diseases"
}
],
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"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC08",
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],
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"name": "Influenza, Human",
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"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
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}
],
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{
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"term": "Influenza, Human"
}
]
} | {
"ancestors": null,
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"abbrev": "All",
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"abbrev": "Coag",
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} | {
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{
"id": "D007251",
"term": "Influenza, Human"
}
],
"interventions": []
} |
NCT04945226 | null | A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 | A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending Dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants | None | INTERVENTIONAL | COMPLETED | 2021-06-25T00:00:00 | null | 2022-02-08T00:00:00 | 2022-02-08T00:00:00 | [
"PHASE1",
"PHASE2"
] | 40 | 18 | 55 | MALE | true | A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 | A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants | Inclusion Criteria:
* Healthy male, non-smoker or, if a moderate or occasional smoker (\< 10 cigarettes per day or nicotine equivalent) must agree to abstain from smoking from 48 h before first IP administration through to completion of the final EOS/ET visit, aged ≥ 18 to 55 years (inclusive at the time of informed consent)
* In good general health, in the opinion of the Investigator, with no significant medical history, and have no clinically significant abnormalities on complete physical examination, 12-lead ECG, heart rate, and BP, both at Screening and before administration of the initial dose of IP
* Body mass index (BMI) between ≥ 18 kg/m2 and ≤ 32 kg/m2 and a minimum weight ≥ 50 kg and ≤ 100 kg at Screening
* Clinical laboratory values within normal limits, with normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate
* Ability and willingness to attend the necessary visits to the CRU and be domiciled overnight
* Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol-specific study procedures
Exclusion Criteria:
* Prior or ongoing medical conditions, medical history, physical examination findings, or laboratory abnormalities that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant
* Presence or history of any clinically significant blood, kidney, endocrine, lung, gastrointestinal tract, cardiovascular, liver, or neurological condition
* Presence of any underlying physical or psychological (eg, depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. Mild depression and anxiety that has been resolved at least 6-12 months ago is accepted.
* Presence of any medical condition that may affect oral drug absorption (eg, gastrectomy, gall bladder removal, bariatric surgery, gastric bypass and sleeve, bowel resection)
* Hypersensitivity to finasteride or to any excipient of the IPs
* Age adjusted PSA between 0 2.5 ng/mL for subjects ≤ 50 years of age and between 0-4 ng/mL for subjects \> 50 years of age at Screening, unless deemed not clinically significant by the Investigator or delegate
* History or known presence of any prostatic problem (infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorder that might mimic BPH)
* Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), HIV antigen or antibody at Screening
* Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol \[THC\], amphetamines, benzodiazepines, opiates and cocaine), or a positive alcohol breath (or urine), or cotinine test
* History of alcohol or substance abuse or dependency, or history of recreational intravenous (IV) drug use over the last 1 year (by self-declaration)
* Regular alcohol consumption defined as \> 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine) within 6 months of Screening.
* Use of any IP or investigational medical device within 3 months prior to Screening, or five half-lives of the product (whichever is the longest), or participation in more than 4 investigational drug studies within 1 year prior to Screening
* Use of any drug known to significantly induce or inhibit drug absorption or metabolism within 30 days prior to dosing
* An employee, or relative of an employee, directly involved in the conduct of the study
* Unwilling to refrain from strenuous exercise from 48 hours prior to admission to the CRU at Day -1 and 48 hours prior to each follow-up
* Presence of sexual dysfunction such as decreased libido, erectile dysfunction, or ejaculation disorder
* Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2 at Screening
* Any reason which, in the opinion of the PI, would prevent the subject from participating in the study. | Inventage Lab., Inc. | INDUSTRY | {
"id": "IVL3001-001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-06-25T00:00:00 | {
"date": "2022-03-04",
"type": "ACTUAL"
} | {
"date": "2021-06-30",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Cohort 1 / Cohort 2 (Group 1, Group 2) / Cohort 3",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Androgenetic Alopecia"
] | null | null | [
{
"city": "Brisbane",
"country": "Australia",
"facility": "Nucleus Network",
"geoPoint": {
"lat": -27.46794,
"lon": 153.02809
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "AUClast of IVL3001",
"timeFrame": "Pre-dose, 1008 hours"
},
{
"description": null,
"measure": "AUCinf of IVL3001",
"timeFrame": "Pre-dose, 1008 hours"
},
{
"description": null,
"measure": "AUC0-1008h of IVL3001",
"timeFrame": "Pre-dose, 1008 hours"
},
{
"description": null,
"measure": "AUClast of Propecia",
"timeFrame": "Pre-dose, 816 hours"
},
{
"description": null,
"measure": "AUCinf of Propecia",
"timeFrame": "Pre-dose, 816 hours"
},
{
"description": null,
"measure": "AUC0-672h of Propecia",
"timeFrame": "Pre-dose, 672 hours"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007039",
"term": "Hypotrichosis"
},
{
"id": "D006201",
"term": "Hair Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D020763",
"term": "Pathological Conditions, Anatomical"
}
],
"browseBranches": [
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"asFound": "Androgenetic Alopecia",
"id": "M3846",
"name": "Alopecia",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M3847",
"name": "Alopecia Areata",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10089",
"name": "Hypotrichosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9293",
"name": "Hair Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22519",
"name": "Pathological Conditions, Anatomical",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000505",
"term": "Alopecia"
}
]
} | {
"ancestors": [
{
"id": "D058891",
"term": "5-alpha Reductase Inhibitors"
},
{
"id": "D065088",
"term": "Steroid Synthesis Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D006727",
"term": "Hormone Antagonists"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D064804",
"term": "Urological Agents"
}
],
"browseBranches": [
{
"abbrev": "Urol",
"name": "Urological Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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"asFound": "Amplification",
"id": "M20273",
"name": "Finasteride",
"relevance": "HIGH"
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"id": "M29274",
"name": "5-alpha Reductase Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9788",
"name": "Hormone Antagonists",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D018120",
"term": "Finasteride"
}
]
} | {
"conditions": [
{
"id": "D000505",
"term": "Alopecia"
}
],
"interventions": [
{
"id": "D018120",
"term": "Finasteride"
}
]
} |
NCT01331226 | null | Support Person Intervention to Promote a Smoking Helpline | Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline | ClearWay #4 | INTERVENTIONAL | COMPLETED | 2011-04-06T00:00:00 | null | null | null | [
"NA"
] | 1,020 | 18 | null | ALL | true | This study is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. In addition, the study will examine if the rate of smoker calls to the helpline is greater if the support person receives 3 intervention calls, 1 intervention call, or no calls (written materials only, control condition). | We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers. | Inclusion Criteria:
* The support person must
1. reside in Minnesota
2. be 18 years of age or older
3. provide written informed consent
4. be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
5. want to support a current cigarette smoker (has smoked a total of \>1 cigarettes during the past 7 days) who is 18 years of age or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months
6. be able and willing to participate in all aspects of the study
7. have access to a working telephone
8. have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration.
Exclusion Criteria:
* Support persons will be excluded if another support person from the same household has enrolled. | Mayo Clinic | OTHER | {
"id": "11-001796",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-04-06T00:00:00 | {
"date": "2015-04-10",
"type": "ESTIMATED"
} | {
"date": "2011-04-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Tobacco Cessation"
] | null | null | [
{
"city": "Rochester",
"country": "United States",
"facility": "Mayo CLinic",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "helpline utilization",
"timeFrame": "At 7 month follow-up"
}
],
"secondary": [
{
"description": null,
"measure": "smoker quit attempts and cessation",
"timeFrame": "7 month follow-up"
}
]
} | null | [{"pmid": "28854569", "type": "DERIVED", "citation": "Patten CA, Boyle R, Tinkelman D, Brockman TA, Lukowski A, Decker PA, D'Silva J, Lichtenstein E, Zhu SH. Linking smokers to a quitline: randomized controlled effectiveness trial of a support person intervention that targets non-smokers. Health Educ Res. 2017 Aug 1;32(4):318-331. doi: 10.1093/her/cyx050."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT01937026 | null | A Study of Baricitinib and Probenecid in Healthy Participants | A Study to Investigate the Potential Impact of Organic Anion Transporter 3 Inhibition by Probenecid on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects | None | INTERVENTIONAL | COMPLETED | 2013-09-03T00:00:00 | null | null | null | [
"PHASE1"
] | 18 | 18 | 65 | ALL | true | The purposes of this study are to assess how the body handles baricitinib when it is given with another drug called probenecid. The study doctor will measure the amount of baricitinib that is absorbed into the blood stream and the time that it takes to remove baricitinib from the body. The safety and tolerability of these drugs will be studied. The study will last about 18 days from the first dose to the end of the study (not including screening). | null | Inclusion Criteria:
* Male participants: agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
* Female participants: women not of childbearing potential due to surgical sterilization confirmed by medical history or menopause
* Have a body mass index of 18.0 to 29.0 kilograms per meter square (kg/m\^2), inclusive
* Have clinical laboratory test results within the normal reference range
* Have normal renal function
* Have normal blood pressure and pulse rate
Exclusion Criteria:
* Are currently enrolled in a clinical trial or are concurrently enrolled in any other type of medical research
* Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
* Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
* Have known allergies to baricitinib, probenecid, related compounds, or any components of the baricitinib or probenecid formulations, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
* Have a history of or current gout or gouty arthritis
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral, or mycobacterial infection
* Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C infection and/or positive hepatitis C antibody
* Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
* Are women who are lactating
* Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from first dose of study drug until discharge from the Clinical Research Unit (CRU)
* Have consumed or intend to consume grapefruit or grapefruit-containing products within 7 days prior to the first dose and throughout the study
* Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of organic anion transporter (OAT)3 or cytochrome P450 (CYP) 3A4
* Have donated or lost blood of more than 500 milliliter (mL) within the last 3 months
* Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of study
* History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (\>) 6 cups of coffee (or equivalent) per day
* Currently smoke more than 10 cigarettes per day | Eli Lilly and Company | INDUSTRY | {
"id": "14604",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-09-03T00:00:00 | {
"date": "2017-06-06",
"type": "ACTUAL"
} | {
"date": "2013-09-09",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Healthy Volunteers"
] | null | null | [
{
"city": "Leeds",
"country": "United Kingdom",
"facility": "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.",
"geoPoint": {
"lat": 53.79648,
"lon": -1.54785
},
"state": "West Yorkshire"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib",
"timeFrame": "Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose"
},
{
"description": null,
"measure": "PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib",
"timeFrame": "Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose"
}
],
"secondary": null
} | [
{
"affiliation": "Eli Lilly and Company",
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"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
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{
"id": "D014528",
"term": "Uricosuric Agents"
},
{
"id": "D006074",
"term": "Gout Suppressants"
},
{
"id": "D018501",
"term": "Antirheumatic Agents"
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],
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"abbrev": "ARhu",
"name": "Antirheumatic Agents"
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},
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"asFound": null,
"id": "M20604",
"name": "Antirheumatic Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011339",
"term": "Probenecid"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "D011339",
"term": "Probenecid"
}
]
} |
NCT05813626 | null | Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma | Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma | None | INTERVENTIONAL | RECRUITING | 2023-03-06T00:00:00 | null | 2024-10-30T00:00:00 | 2027-10-30T00:00:00 | [
"PHASE2"
] | 89 | 18 | 65 | ALL | false | Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced nasopharyngeal carcinoma | null | Inclusion Criteria:
1. Age: 18 to 65;
2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria);
3. Diagnosed with LANPC according to the 8th edition clinical staging system of the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\];
4. ECOG performance score: 0 to 1;
5. Normal bone marrow function: white blood cell count \> 4×109/L, hemoglobin \> 90g/L, platelet count \> 100×109/L;
6. Normal values of thyroid function, amylase and lipase examination, pituitary function, inflammation and infection indicators, myocardial enzymes, and ECG results. For patients older than 50 years with a smoking history, normal lung function are required. Patients with abnormal ECG and/or a history of vascular disease (but not meeting the exclusion criteria listed in the exclusion criteria 7) need further testing and require normal results of myocardial function and color Doppler ultrasound.
7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance rate ≥ 60 ml/min;
8. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
9. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.
Exclusion Criteria:
1. Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA \> 1×10E3 copies/ml; anti-hepatitis C virus positive;
2. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
3. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment; history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved;
4. Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
5. Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
6. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible;
7. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2) unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
8. Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
9. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
10. Allergy to macromolecular protein preparations, or any component of nivolumab;
11. Active infection requiring systemic treatment;
12. Receiving live vaccine within 30 days of the initial nivolumab;
13. History of organ transplantation;
14. History of psychotropic disease, alcoholism or drug abuse; other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors. | Zhejiang Cancer Hospital | OTHER | {
"id": "NPC-202301",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-04-02T00:00:00 | {
"date": "2023-04-14",
"type": "ACTUAL"
} | {
"date": "2023-04-14",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Nasopharyngeal Carcinoma"
] | null | null | [
{
"city": "Hangzhou",
"country": "China",
"facility": "Zhejiang Cancer Hospital",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Complete Response",
"timeFrame": "9 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Overall Survival(OS)",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Locoregional failure-free survival(LRRFS)",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Distant metastasis-free survival(DMFS)",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Number of participants with adverse events",
"timeFrame": "up to 3 years"
},
{
"description": null,
"measure": "Quality of life (QoL): questionnaire",
"timeFrame": "Week 1,9,16,28"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D009303",
"term": "Nasopharyngeal Neoplasms"
},
{
"id": "D010610",
"term": "Pharyngeal Neoplasms"
},
{
"id": "D010039",
"term": "Otorhinolaryngologic Neoplasms"
},
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009302",
"term": "Nasopharyngeal Diseases"
},
{
"id": "D010608",
"term": "Pharyngeal Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
},
{
"id": "D010038",
"term": "Otorhinolaryngologic Diseases"
}
],
"browseBranches": [
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"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
},
{
"abbrev": "BC09",
"name": "Ear, Nose, and Throat Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"id": "M5534",
"name": "Carcinoma",
"relevance": "HIGH"
},
{
"asFound": "Nasopharyngeal Carcinoma",
"id": "M1730",
"name": "Nasopharyngeal Carcinoma",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
"relevance": "LOW"
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"id": "M12962",
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"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
},
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"asFound": null,
"id": "M12017",
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"relevance": "LOW"
},
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"relevance": "LOW"
},
{
"asFound": "Nasopharyngeal Carcinoma",
"id": "T4047",
"name": "Nasopharyngeal Carcinoma",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D000077274",
"term": "Nasopharyngeal Carcinoma"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M6182",
"name": "Cisplatin",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2985",
"name": "Gemcitabine",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
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"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D000077274",
"term": "Nasopharyngeal Carcinoma"
}
],
"interventions": []
} |
NCT04911426 | null | Telehealth-Clinical Advocacy Project | Telehealth-Clinical Advocacy Project | (T-CAP) | INTERVENTIONAL | COMPLETED | 2021-04-05T00:00:00 | null | 2023-07-31T00:00:00 | 2023-07-31T00:00:00 | [
"NA"
] | 8 | 18 | null | ALL | false | The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program. | Participants in a police opioid diversion program will receive information about the research opportunity; those interested will be administered informed consent and randomized to either the (1) diversion program treatment as usual condition or (2) the enhanced condition, receiving the telehealth video call intervention with motivational interviewing and substance use treatment appointment reminders during the 12-week intervention. The study design has been modified to provide the enhanced condition with coaching and the T-CAP app to all individuals consented to the study beginning January 1, 2023. | Inclusion Criteria:
Individuals interested in joining the study will be
* Enrolled in the A Way Out Opioid Diversion Program (ODP),
* At least 18 years of age,
* Able to speak and understand English,
* Have a history of opioid, alcohol, or other substance use within last 12 months,
* Be willing to provide the research team with access to treatment records,
* Have access to a phone, tablet or computer for the informed consent activity, and
* Have a mailing address to receive a study phone issued to consented participants
Exclusion Criteria:
Individuals not eligible for the study are
* Not currently enrolled in the A Way Out Opioid Diversion Program on the day of consent,
* Under the age of 18 on the day of consent,
* Unable to speak and understand English,
* Have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months,
* Unwilling to authorize the research team to access treatment records,
* Without access to a phone, tablet or computer to complete the informed consent activity,
* Without a mailing address | Texas Christian University | OTHER | {
"id": "5R21DA048232-02",
"link": "https://reporter.nih.gov/quickSearch/5R21DA048232-02",
"type": "NIH"
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-05-27T00:00:00 | {
"date": "2025-04-18",
"type": "ACTUAL"
} | {
"date": "2021-06-03",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The two-arm randomization has been discontinued with new consented participants joining the study in 2023.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Substance Use"
] | ["Opioids", "Telehealth", "Police diversion program"] | null | [
{
"city": "Waukegan",
"country": "United States",
"facility": "Lake County Public Health Department",
"geoPoint": {
"lat": 42.36363,
"lon": -87.84479
},
"state": "Illinois"
}
] | [
{
"class": "NIH",
"name": "National Institute on Drug Abuse (NIDA)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percent of Participants Who Received One or More Referrals During the 12-week Intervention.",
"timeFrame": "12-week intervention period"
},
{
"description": null,
"measure": "Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12",
"timeFrame": "Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent."
}
],
"secondary": null
} | [
{
"affiliation": "Texas Christian University",
"name": "Jennifer Pankow, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D064419",
"term": "Chemically-Induced Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
{
"abbrev": "BC25",
"name": "Substance Related Disorders"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Substance Use",
"id": "M21837",
"name": "Substance-Related Disorders",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M30302",
"name": "Chemically-Induced Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D019966",
"term": "Substance-Related Disorders"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M4033",
"name": "Analgesics, Opioid",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D019966",
"term": "Substance-Related Disorders"
}
],
"interventions": []
} |
NCT00579826 | null | Study of Breast Cancer Prevention by Letrozole in High Risk Women | Study of Breast Cancer Prevention by Letrozole in High Risk Women | None | INTERVENTIONAL | COMPLETED | 2007-12-18T00:00:00 | null | null | null | [
"PHASE2"
] | 55 | 30 | 69 | FEMALE | false | This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of \>1.5%.
The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life. | Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker | Inclusion Criteria:
* Post-menopausal women at high risk for development of breast cancer
* stable dose of hormone replacement therapy
* have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression \>1.5% in benign breast epithelial cells acquired by RPFNA
* Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
* Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
Exclusion Criteria:
* Prior history of osteoporosis or osteoporotic fracture.
* Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
* Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs
* Receiving treatment for rheumatoid arthritis or fibromyalgia
* Current history of poorly controlled migraines or perimenopausal symptoms
* Currently receiving other investigational agents.
* Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past. | University of Kansas Medical Center | OTHER | {
"id": "10587",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-12-18T00:00:00 | {
"date": "2023-06-12",
"type": "ACTUAL"
} | {
"date": "2007-12-24",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Breast Cancer"
] | null | null | [
{
"city": "Kansas City",
"country": "United States",
"facility": "University of Kansas Medical Center",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas"
}
] | [
{
"class": "INDUSTRY",
"name": "Novartis"
},
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": [
{
"description": null,
"measure": "Change in Fibromyalgia Impact Questionnaire (FIQ) Score.",
"timeFrame": "Baseline to 6 months"
},
{
"description": null,
"measure": "Change in Brief Fatigue Inventory (BFI) Score.",
"timeFrame": "baseline to 6 months"
}
],
"primary": [
{
"description": null,
"measure": "Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months",
"timeFrame": "Baseline to 6 Months"
}
],
"secondary": [
{
"description": null,
"measure": "Assessment of Change in Morphology by the Masood Score.",
"timeFrame": "Baseline to 6 Months"
},
{
"description": null,
"measure": "Change in Mammographic Density From Baseline to 6 Months..",
"timeFrame": "Baseline to 6 Months"
}
]
} | [
{
"affiliation": "University of Kansas Medical Center",
"name": "Carol J Fabian, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D001941",
"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Breast Cancer",
"id": "M5220",
"name": "Breast Neoplasms",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5218",
"name": "Breast Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D047072",
"term": "Aromatase Inhibitors"
},
{
"id": "D065088",
"term": "Steroid Synthesis Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D004965",
"term": "Estrogen Antagonists"
},
{
"id": "D006727",
"term": "Hormone Antagonists"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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"asFound": "Docetaxel",
"id": "M1743",
"name": "Letrozole",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M25769",
"name": "Aromatase Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8116",
"name": "Estrogens",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8114",
"name": "Estrogen Antagonists",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30483",
"name": "Estrogen Receptor Antagonists",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9788",
"name": "Hormone Antagonists",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000077289",
"term": "Letrozole"
}
]
} | {
"conditions": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
],
"interventions": [
{
"id": "D000077289",
"term": "Letrozole"
}
]
} |
NCT05227326 | null | AOH1996 for the Treatment of Refractory Solid Tumors | First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors | None | INTERVENTIONAL | RECRUITING | 2022-01-11T00:00:00 | null | 2026-01-29T00:00:00 | 2026-01-29T00:00:00 | [
"PHASE1"
] | 92 | 18 | null | ALL | false | This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. | PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PCNA inhibitor AOH1996 (AOH1996).
II. To establish the recommended phase 2 dose (RP2D) of AOH1996.
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetics of AOH1996. II. To evaluate for preliminary efficacy of AOH1996. III. To evaluate response rate and disease control rate in solid tumors.
EXPLORATORY OBJECTIVE:
I. To determine pharmacodynamics parameters (alteration of gammaH2AX, downregulation of Myc) of AOH1996.
OUTLINE: This is a dose-escalation study.
Patients receive AOH1996 orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days. | Inclusion Criteria:
Informed Consent and Willingness to Participate
* 1. Documented informed consent by the participant
* 2. Willingness to permit study team to obtain and use archival tissue, if already existing
Age Criteria, Performance Status and Life Expectancy
* 3. Age: ≥ 18 years
* 4. ECOG performance status ≤ 2
* 5. Life expectancy of \> 3 months
Nature of Illness and Treatment History __6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR TKI + AOH1996) cohort: patients with stable disease or better on EGFR TKI for at least 2 months)
Contraception
__7. Agreement by females and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study medication. See Appendix B for guidelines.
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
Laboratory Criteria (to be performed within 14 days prior to Day 1)
* 8. ANC ≥ 1,500/mm3
* 9. Platelets ≥ 100,000/mm3 :
* 10. Total serum bilirubin ≤ 1.5 x ULN
* 11. AST =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
* 12. ALT =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
* 13. Creatinine clearance of ≥ 60 mL/min per 24 hour urine or the Cockcroft-Gault
* 14. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Exclusion Criteria
Concomitant Medications/Therapies __1. Dietary/herbal supplements
* 2. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
* 3. Warfarin
* 4. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
* 5. Strong inhibitors or inducers of CYP2C9
* 6. Strong inhibitors or inducers of CYP3A
Other Illnesses and Conditions
* 7. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
* 8. Women who are or are planning to become pregnant or breastfeed
* 9. Known allergy to any of the components within the study agents and/or their excipients.
* 10. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
* 11. Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection).
Noncompliance
__12. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
\*\*Eligibility should be confirmed per institutional policies. | City of Hope Medical Center | OTHER | {
"id": "21310",
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"type": null
} | Unknown | {
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"nctId": null,
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} | 2022-02-03T00:00:00 | {
"date": "2024-10-15",
"type": "ACTUAL"
} | {
"date": "2022-02-07",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
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} | [
"Refractory Malignant Solid Neoplasm",
"Osteosarcoma",
"Leiomyosarcomas",
"Synovial Sarcomas",
"Ovarian Cancer",
"Non-Small Cell Lung Cancer",
"Pancreatic Cancer"
] | null | null | [
{
"city": "Scottsdale",
"country": "United States",
"facility": "Honor Health Research and Innovation Institute",
"geoPoint": {
"lat": 33.50921,
"lon": -111.89903
},
"state": "Arizona"
},
{
"city": "Duarte",
"country": "United States",
"facility": "City of Hope Medical Center",
"geoPoint": {
"lat": 34.13945,
"lon": -117.97729
},
"state": "California"
}
] | [
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": [
{
"description": null,
"measure": "Levels of plasma gammaH2AX",
"timeFrame": "Up to 2 years"
}
],
"primary": [
{
"description": null,
"measure": "Incidence of adverse events (AEs)",
"timeFrame": "Up to 30 days after last study drug is given"
},
{
"description": null,
"measure": "Dose limiting toxicities",
"timeFrame": "Up to 28 days (cycle 1)"
}
],
"secondary": [
{
"description": null,
"measure": "Response rate",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Progression-free survival",
"timeFrame": "Assessed up to 2 years"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "Assessed up to 2 years"
},
{
"description": null,
"measure": "Time to treatment failure",
"timeFrame": "Assessed up to 2 years"
}
]
} | [
{
"affiliation": "City of Hope Medical Center",
"name": "Vincent Chung, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D012509",
"term": "Sarcoma"
},
{
"id": "D018204",
"term": "Neoplasms, Connective and Soft Tissue"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D018213",
"term": "Neoplasms, Bone Tissue"
},
{
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"term": "Neoplasms, Connective Tissue"
},
{
"id": "D009379",
"term": "Neoplasms, Muscle Tissue"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "BC17",
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},
{
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"name": "Rare Diseases"
}
],
"browseLeaves": [
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"id": "M11172",
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},
{
"asFound": null,
"id": "M5546",
"name": "Carcinoma, Non-Small-Cell Lung",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15327",
"name": "Sarcoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13110",
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},
{
"asFound": null,
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},
{
"asFound": null,
"id": "M1704",
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"relevance": "LOW"
},
{
"asFound": "Leiomyosarcoma",
"id": "M10902",
"name": "Leiomyosarcoma",
"relevance": "HIGH"
},
{
"asFound": "Synovial Sarcoma",
"id": "M16361",
"name": "Sarcoma, Synovial",
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},
{
"asFound": "Osteosarcoma",
"id": "M15334",
"name": "Osteosarcoma",
"relevance": "HIGH"
},
{
"asFound": null,
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"relevance": "LOW"
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{
"asFound": null,
"id": "M20359",
"name": "Neoplasms, Bone Tissue",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12317",
"name": "Neoplasms, Connective Tissue",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T5284",
"name": "Soft Tissue Sarcoma",
"relevance": "LOW"
},
{
"asFound": "Pancreatic Cancer",
"id": "T4387",
"name": "Pancreatic Cancer",
"relevance": "HIGH"
},
{
"asFound": "Ovarian Cancer",
"id": "T4352",
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},
{
"asFound": null,
"id": "T4354",
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},
{
"asFound": "Leiomyosarcoma",
"id": "T3367",
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"relevance": "HIGH"
},
{
"asFound": "Synovial Sarcoma",
"id": "T5553",
"name": "Synovial Sarcoma",
"relevance": "HIGH"
},
{
"asFound": "Osteosarcoma",
"id": "T4340",
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"relevance": "HIGH"
}
],
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{
"id": "D012516",
"term": "Osteosarcoma"
},
{
"id": "D007890",
"term": "Leiomyosarcoma"
},
{
"id": "D013584",
"term": "Sarcoma, Synovial"
}
]
} | null | {
"conditions": [
{
"id": "D012516",
"term": "Osteosarcoma"
},
{
"id": "D007890",
"term": "Leiomyosarcoma"
},
{
"id": "D013584",
"term": "Sarcoma, Synovial"
}
],
"interventions": null
} |
NCT03634826 | null | Monitoring of Circulating Tumor DNA and Its Aberrant Methylation in the Surveillance of Surgical Lung Cancer Patients (MEDAL, MEthylation Based Dynamic Analysis for Lung Cancer). | A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation | MEDAL | OBSERVATIONAL | UNKNOWN | 2018-08-05T00:00:00 | null | 2021-12-31T00:00:00 | 2022-01-01T00:00:00 | null | 200 | 18 | 80 | ALL | false | Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients. | Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients.
The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process. | Inclusion Criteria:
Aged 18 to 80 years
* Lung cancer was suspected preoperatively.
* Received curative surgical therapy
* No malignant tumor history within the past 5 years
* No being received any treatment prior to resection
* Patients must have given written informed consent
Exclusion Criteria:
* The pulmonary nodule is pure ground glass opacity
* Unable to comply with the study procedure
* The postoperative pathology is not NSCLC.
* Unqualified blood samples | Peking University People's Hospital | OTHER | {
"id": "PTHO1802",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-08-14T00:00:00 | {
"date": "2020-06-26",
"type": "ACTUAL"
} | {
"date": "2018-08-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Histologically confirmed lung cancer patients who received surgical therapy | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Carcinoma",
"Lung Cancer",
"NSCLC",
"Lung Neoplasm"
] | ["circulating tumor DNA", "ctDNA methylation", "lung cancer", "surveillance"] | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Peking University People's Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.",
"timeFrame": "3 years"
}
],
"secondary": [
{
"description": null,
"measure": "The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.",
"timeFrame": "3 years"
}
]
} | [
{
"affiliation": "Peking University People's Hospital Thoracic Surgery Department",
"name": "Jun Wang, M.D.",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "31195991", "type": "DERIVED", "citation": "Kang G, Chen K, Yang F, Chuai S, Zhao H, Zhang K, Li B, Zhang Z, Wang J. Monitoring of circulating tumor DNA and its aberrant methylation in the surveillance of surgical lung Cancer patients: protocol for a prospective observational study. BMC Cancer. 2019 Jun 13;19(1):579. doi: 10.1186/s12885-019-5751-9."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012142",
"term": "Respiratory Tract Neoplasms"
},
{
"id": "D013899",
"term": "Thoracic Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"asFound": "Lung Cancer",
"id": "M11172",
"name": "Lung Neoplasms",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14979",
"name": "Respiratory Tract Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16658",
"name": "Thoracic Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008175",
"term": "Lung Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D008175",
"term": "Lung Neoplasms"
}
],
"interventions": null
} |
NCT03565926 | null | Effects of Hipopressive Exercises in Nonspecific Low Back Pain | Effects of Hipopressive Exercises Versus Manual Therapy in Subjects with Nonspecific Low Back Pain | HPvsMT-LBP | INTERVENTIONAL | COMPLETED | 2018-05-30T00:00:00 | null | 2018-07-31T00:00:00 | 2018-08-15T00:00:00 | [
"NA"
] | 64 | 18 | 40 | ALL | false | Introduction Non-specific low back pain is very prevalent in our society. Different effective physiotherapy treatments have been performed in the reduction of pain and improvement of quality of life, however there are few studies that exist on the effectiveness of these treatments in protocol format based on manual therapy. On the other hand, there are no studies that implement a protocol of therapeutic exercises called abdominal hypopressives.
The aim of the study is to study the effect of a manual therapy protocol on non-specific low back pain and the implementation of hypopressive exercises in different areas such as disability, pain, flexibility and quality of life.
Material and methods
Participants The sample will consist of subjects with non-specific low back pain. Inclusion criteria
-Participants with nonspecific lumbar pain of at least 4 pain crises a month with recurrent low back pain.
Exclusion criteria
* Light acute.
* Lumbalgia after trauma.
* Presenting sciatica or musculoskeletal disorders or injuries within three months prior to the study.
* Contraindication of one of the two treatments.
* Participate in this period of no functional recovery program or physiotherapy treatment.
Study design A randomized clinical trial will be conducted. The sample will be divided into 2 groups: Group 1 will receive a manual therapy protocol that has previously shown its effectiveness in non-specific low back pain being 1 session a week, while group 2 will receive a protocol of hypopressive therapeutic exercises.
Evaluations
At the beginning of the study, a clinical interview will be carried out and, in addition, 3 evaluations will be carried out: at the beginning, at the end of the treatment and one follow-up per month. The investigators will use the following evaluation tools:
* Pain, through the Visual Analog Scale.
* Oswestry Low Back Pain Disability Scale.
* SF-36 quality of life scale.
* Visual Analog Scale.
* Algometry of spinous processes and lumbar muscles.
* Lumbar flexion with inclinometer and fingers test - floor. | null | Inclusion Criteria:
* Man between 18 and 40 years old
* Recurrent episodes of low back pain at least 4 times a month
* At least 3 months of evolution
* Non-specific low back pain
* Not having undergone surgery
Exclusion Criteria:
* Acute low back pain
* Lumbalgia operated surgically
* Low back pain after traumatism
* Episodes of sciatica
* Contraindication to any of the treatments
* Attend, during the study period, rehabilitation programs
* Serious injuries in the 3 months prior to the study
* Root pain
* Any breach of the inclusion criteria | University of Valencia | OTHER | {
"id": "ID0019",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-06-11T00:00:00 | {
"date": "2025-02-19",
"type": "ACTUAL"
} | {
"date": "2018-06-21",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Low Back Pain"
] | ["low back pain", "manual therapy", "hypopressive therapeutic exercises"] | null | [
{
"city": "Valencia",
"country": "Spain",
"facility": "Gemma v. Espí López",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Intensity of pain",
"timeFrame": "8 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Low Back Pain Disability",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Algometry of spinous processes and lumbar muscles.",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Lumbar flexion",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Health status",
"timeFrame": "8 weeks"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Back Pain",
"id": "M4714",
"name": "Back Pain",
"relevance": "HIGH"
},
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"asFound": "Low Back Pain",
"id": "M19433",
"name": "Low Back Pain",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
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"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001416",
"term": "Back Pain"
},
{
"id": "D017116",
"term": "Low Back Pain"
}
]
} | null | {
"conditions": [
{
"id": "D001416",
"term": "Back Pain"
},
{
"id": "D017116",
"term": "Low Back Pain"
}
],
"interventions": null
} |
NCT03827226 | null | Breech External Cephalic Version Intervention Trial | Breech External Cephalic Version Intervention Trial- A Prospective Study | BREXIT | OBSERVATIONAL | RECRUITING | 2019-01-29T00:00:00 | null | 2025-01-01T00:00:00 | 2025-06-01T00:00:00 | null | 200 | 18 | null | FEMALE | null | A prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy. | The primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks. | Inclusion Criteria:
* Presence of the written consent of the patients.
* The patients must be over 18 years old .
* No limit in the ability to consent.
Exclusion criteria:
* Age under 18
* Limited ability to consent
* Placenta previa
* Fetal abnormalities | Charite University, Berlin, Germany | OTHER | {
"id": "EA2/241/18",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-01-30T00:00:00 | {
"date": "2024-02-06",
"type": "ACTUAL"
} | {
"date": "2019-02-01",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | All patients presenting with breech presentation to the antenatal clinic | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Breech Presentation"
] | null | null | [
{
"city": "Berlin-Mitte",
"country": "Germany",
"facility": "Charité University Hospital",
"geoPoint": {
"lat": 52.52003,
"lon": 13.40489
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Success rate of external cephalic version",
"timeFrame": "4 hours after external cephalic version"
}
],
"secondary": [
{
"description": null,
"measure": "Sonographic Fetal Parameters: Head Circumference",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Sonographic Fetal Parameters: Abdominal Circumference",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Sonographic Fetal Parameters: Femur length",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Sonographic Fetal Parameters: Amniotic Fluid",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Fetal Doppler Indices middle cerebral",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Fetal Doppler Indices Umbilical Pulsatility Index",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Fetal Doppler Indices Umbilical Resistance Index",
"timeFrame": "30 Minutes after external cephalic version"
},
{
"description": null,
"measure": "Maternal Doppler Indices Uterine artery Right",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Maternal Doppler Indices Uterine artery Left",
"timeFrame": "30 Minutes after external cephalic version"
},
{
"description": null,
"measure": "Bladder volume",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Distance Symphysis to Breech",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Depression and Anxiety Stress scale score",
"timeFrame": "60 minutes before external cephalic version"
},
{
"description": null,
"measure": "Depression and Anxiety Stress scale score",
"timeFrame": "120 Minutes after external cephalic version"
},
{
"description": null,
"measure": "Fetal reflexes",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Mode of delivery",
"timeFrame": "6 weeks after delivery"
},
{
"description": null,
"measure": "Incidence of fetal extended legs",
"timeFrame": "30 Minutes before external cephalic version"
},
{
"description": null,
"measure": "Incidence of bleeding",
"timeFrame": "30 minutes after external cephalic version"
},
{
"description": null,
"measure": "Incidence of ruptured membranes",
"timeFrame": "30 minutes after external cephalic version"
},
{
"description": null,
"measure": "Incidence of pathological Cardiotocogram",
"timeFrame": "30 minutes after external cephalic version"
},
{
"description": null,
"measure": "Incidence of emergency delivery",
"timeFrame": "30 minutes after external cephalic version"
},
{
"description": null,
"measure": "Pain scores",
"timeFrame": "30 minutes after external cephalic version"
},
{
"description": null,
"measure": "Incidence of tocolysis",
"timeFrame": "30 minutes after external cephalic version"
},
{
"description": null,
"measure": "Incidence of umbilical cord looping",
"timeFrame": "30 Minutes before external cephalic version"
}
]
} | [
{
"affiliation": "Consultant in Obstetrics",
"name": "Larry Hinkson, FRCOG",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "10796122", "type": "BACKGROUND", "citation": "Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083."}, {"pmid": "26942387", "type": "RESULT", "citation": "American College of Obstetricians and Gynecologists' Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 161: External Cephalic Version. Obstet Gynecol. 2016 Feb;127(2):e54-61. doi: 10.1097/AOG.0000000000001312."}, {"pmid": "28299867", "type": "RESULT", "citation": "External Cephalic Version and Reducing the Incidence of Term Breech Presentation: Green-top Guideline No. 20a. BJOG. 2017 Jun;124(7):e178-e192. doi: 10.1111/1471-0528.14466. Epub 2017 Mar 16. No abstract available."}, {"pmid": "35344082", "type": "DERIVED", "citation": "Schauer M, Latartara E, Alonso-Espias M, Rossetti E, Gebert P, Henrich W, Hinkson L. Depression, anxiety and stress in women with breech pregnancy compared to women with cephalic presentation-a cross-sectional study. Arch Gynecol Obstet. 2023 Feb;307(2):409-419. doi: 10.1007/s00404-022-06509-0. Epub 2022 Mar 27."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007744",
"term": "Obstetric Labor Complications"
},
{
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"term": "Pregnancy Complications"
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{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
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"term": "Urogenital Diseases"
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],
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"abbrev": "BXS",
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],
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],
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{
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} | null | {
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],
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} |
NCT06462326 | null | A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers | A Phase 1, Randomized, Double-Blind Study to Compare the Effect of Omadacycline PO Versus Moxifloxacin PO on the Gut Microbiota in Healthy Adult Volunteers | None | INTERVENTIONAL | COMPLETED | 2024-04-29T00:00:00 | null | 2024-09-29T00:00:00 | 2024-09-29T00:00:00 | [
"PHASE1"
] | 24 | 18 | 40 | ALL | true | This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug. | The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug. | Inclusion Criteria:
1. Sign an Informed Consent Form (ICF) prior to the commencement of any study-related procedures.
2. Chinese healthy male and female subjects aged between 18 and 40 years (inclusive).
3. Body mass index (BMI) between 18.5 and 23.9 kg/m2 (inclusive).
4. Complete the stool sample collections required during screening.
Exclusion Criteria:
1. Subjects with clinically significant medical history of cardiovascular, hepatic, renal, gastrointestinal or psychiatric conditions, or any other condition as deemed by the investigators that may potentially jeopardize subject safety or impact study outcomes.
2. Subjects who have undergone any major surgery within 4 weeks prior to the first dose of study drug administration.
3. Subjects who have previously undergone gastrointestinal surgery that may affect the absorption of the study drug (eg. Intestinal resection surgery, fistula surgery).
4. During screening, subjects with positive tests for hepatitis C antibodies, hepatitis B surface antigen, or hepatitis B virus (HBV) DNA or HBV RNA, or known positive tests for human immunodeficiency virus (HIV).
5. Subjects with Fridericia-corrected QT interval (QTcF) \> 450 milliseconds (males) or \> 470 milliseconds (females); or known to have long QT syndrome; or using medications that may cause arrhythmia or prolong QT interval, and/or experiencing tachyarrhythmia.
6. Subjects with a history of irritable bowel syndrome (with or without constipation) - | Zai Lab (Hong Kong), Ltd. | INDUSTRY | {
"id": "ZL-2401-005",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-06-11T00:00:00 | {
"date": "2024-11-01",
"type": "ACTUAL"
} | {
"date": "2024-06-17",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"Healthy Volunteer"
] | null | null | [
{
"city": "Hangzhou",
"country": "China",
"facility": "The First Affiliated Hospital of Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Changes in the types of microbial resistomes.",
"timeFrame": "3months"
},
{
"description": null,
"measure": "Changes in the quantity of microbial resistomes.",
"timeFrame": "3months"
},
{
"description": null,
"measure": "Changes in the abundance of microbial resistomes.",
"timeFrame": "3months"
}
],
"secondary": [
{
"description": null,
"measure": "Changes in the microbial composition",
"timeFrame": "3months"
},
{
"description": null,
"measure": "Changes in the microbial functionality",
"timeFrame": "3months"
}
]
} | [
{
"affiliation": "Zhejiang University",
"name": "Jian Liu",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Zhejiang University",
"name": "Yonghong Xiao",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D000900",
"term": "Anti-Bacterial Agents"
},
{
"id": "D000890",
"term": "Anti-Infective Agents"
},
{
"id": "D059005",
"term": "Topoisomerase II Inhibitors"
},
{
"id": "D059003",
"term": "Topoisomerase Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
}
],
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Repr",
"name": "Reproductive Control Agents"
}
],
"browseLeaves": [
{
"asFound": "CBT",
"id": "M1722",
"name": "Moxifloxacin",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M266292",
"name": "Norgestimate, ethinyl estradiol drug combination",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4214",
"name": "Anti-Infective Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000077266",
"term": "Moxifloxacin"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "D000077266",
"term": "Moxifloxacin"
}
]
} |
NCT03802526 | null | Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 | Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers | None | INTERVENTIONAL | COMPLETED | 2019-01-10T00:00:00 | null | 2019-07-04T00:00:00 | 2019-09-27T00:00:00 | [
"PHASE1"
] | 37 | 19 | 45 | ALL | true | The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2 | pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2 | Inclusion Criteria:
* Male or female adults aged 19-45 years.
* BMI of \>18.5 kg/㎡ and \<27.0 kg/㎡ subject, weight more than 50kg.
* Voluntarily provided a witten consent to participate in this clinical study.
Exclusion Criteria:
* Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
* History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
* Pregnant or lactating women. | NVP Healthcare | INDUSTRY | {
"id": "NVP-1805_DDI",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-01-10T00:00:00 | {
"date": "2019-11-29",
"type": "ACTUAL"
} | {
"date": "2019-01-14",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Healthy"
] | null | null | [
{
"city": "Suwon-si",
"country": "Korea, Republic of",
"facility": "Navipharm",
"geoPoint": {
"lat": 37.29111,
"lon": 127.00889
},
"state": "Gyeonggi-do"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pharmacokinetic interaction",
"timeFrame": "0hours - 48hours"
}
],
"secondary": null
} | [
{
"affiliation": "Gachon University Gil Medical Center",
"name": "Dong Sung Shin, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "33326064", "type": "DERIVED", "citation": "Kim CH, Kang SI, Shin D. Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects. Adv Ther. 2021 Feb;38(2):1094-1105. doi: 10.1007/s12325-020-01592-8. Epub 2020 Dec 16."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05720026 | null | Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase Ⅲ Clinical Study to Compare the Efficacy and Safety of SYSA1901 vs Pertuzumab (Perjeta®) in the Neoadjuvant Therapy of HER2-Positive Breast Cancer | None | INTERVENTIONAL | RECRUITING | 2022-11-25T00:00:00 | null | 2025-08-29T00:00:00 | 2026-02-21T00:00:00 | [
"PHASE3"
] | 560 | 18 | null | ALL | false | This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor \> 2 cm. | This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the patients with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor \> 2 cm. The eligible patients will be randomized to treatment group (SYSA1901 + Trastuzumab + Docetaxel) or control group (Perjeta® + Trastuzumab + Docetaxel) at 1:1 ratio. The stratification factor is disease category (early-stage vs. locally advanced).
The primary endpoint is total pCR (tpCR). Secondary efficacy endpoints include breast pCR (bpCR), objective response rate (ORR)，pharmacokinetic (PK) and immunogenicity. | Inclusion Criteria:
1. Voluntary agreement to provide written informed consent;
2. Age ≥ 18 years;
3. Histologically confirmed invasive breast carcinoma, and breast cancer staging \[in accordance with the American Joint Committee on Cancer (AJCC) staging system (8th edition)\]: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2-3, M0; T4, any N, M0);
4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
5. HER2 positive, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with In Situ Hybridization (ISH) positive;
6. Estrogen receptor (ER) and progestin receptor (PR) negative; ER and PR negative is defined as \< 1% nuclear staining;
7. Agree to receive surgical treatment of breast cancer at the participating unit when the surgical criteria are met after neoadjuvant therapy;
8. Primary tumor size of \> 2 cm in diameter;
9. Left ventricular ejection fraction (LVEF)≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan;
10. Adequate major organ function, meeting the following criteria (have not received blood transfusion, EPO,G-CSF, other hematopoietic stimulating factors or medical supportive treatments within 14 days before the first dose of study drug): absolute neutrophil count (ANC) ≥1.5×10\^9 /L; Leukocyte count≥3.0×10\^9 /L, platelet (PLT) ≥100×10\^9 /L; hemoglobin ≥90 g/L; Serum creatinine ≤ 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; total bilirubin ≤1.5×ULN; international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, or activated partial thromboplastin time (APTT) ≤1.5×ULN (not receiving anticoagulation), or patients receiving anticoagulation need to be within treatment target range and at a stable dose;
11. Women of childbearing age must have a negative pregnancy test prior to the first dose;
12. Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug.
Exclusion Criteria:
1. Stage IV (metastatic) breast cancer, inflammatory breast cancer, and bilateral breast cancer;
2. Previous severe allergic reactions to any drug or its components in this trial (NCI-CTCAE 5.0 grade greater than 3);
3. Patients with any other malignant tumor within 2 years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer and other malignant tumors that have been radically removed and have not recurred);
4. Major surgery and incomplete recovery within 4 weeks prior to the first dose of study drug;
5. Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug;
6. Received chemotherapy, endocrine therapy, anti-HER2 biological therapy, breast surgery or local radiotherapy for breast cancer (except for diagnostic biopsy surgery or benign breast tumor surgery);
7. History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive, active syphilis;
8. History of severe cardiovascular disease, including previous coronary artery bypass grafting or coronary stent implantation, myocardial infarction or cerebrovascular accident within 6 months, history of congestive heart failure or unstable angina pectoris, uncontrolled severe hypertension and arrhythmia requiring drug treatment;
9. Any uncontrollable complication, infection, or other condition that may affect study compliance or interfere with efficacy evaluation;
10. History of drug abuse, or alcoholism, drug addicts;
11. History of neurological or psychiatric disorders and poor compliance, such as epilepsy and dementia;
12. Pregnant and breastfeeding women;
13. Other conditions that may affect the assessment of the primary endpoint or render the patient inappropriate for entry into this study in the opinion of the investigator. | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | INDUSTRY | {
"id": "SYSA1901-002",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-02-08T00:00:00 | {
"date": "2023-02-09",
"type": "ACTUAL"
} | {
"date": "2023-02-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"HER2-positive Breast Cancer"
] | null | null | [
{
"city": "Shanghai",
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Total pathologic complete response (tpCR) assessed by Independent Review Committee（IRC）",
"timeFrame": "Up to 5 months"
}
],
"secondary": [
{
"description": null,
"measure": "Percentage of patients with tpCR as assessed by the investigator",
"timeFrame": "Up to 5 months"
},
{
"description": null,
"measure": "Breast pathologic complete response (bpCR) assessed by IRC",
"timeFrame": "Up to 5 months"
},
{
"description": null,
"measure": "Breast pathologic complete response (bpCR) assessed by the investigator",
"timeFrame": "Up to 5 months"
},
{
"description": null,
"measure": "Percentage of patients with an objective response (BORR)",
"timeFrame": "Prior to surgery"
},
{
"description": null,
"measure": "Incidence of adverse event",
"timeFrame": "Up to approximately 30 months after randomization"
},
{
"description": null,
"measure": "Pharmacokinetic parameters of SYSA1901",
"timeFrame": "Up to approximately 30 months after randomization"
},
{
"description": null,
"measure": "Immunogenicity of SYSA1901",
"timeFrame": "Up to approximately 30 months after randomization"
}
]
} | [
{
"affiliation": "Fudan University",
"name": "Shao Zhimin, Professor",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D001941",
"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
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"abbrev": "BC04",
"name": "Neoplasms"
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"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
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"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"relevance": "HIGH"
},
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"asFound": null,
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"relevance": "LOW"
},
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"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
]
} | {
"ancestors": [
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"id": "D000970",
"term": "Antineoplastic Agents"
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{
"id": "D050257",
"term": "Tubulin Modulators"
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{
"id": "D050258",
"term": "Mitosis Modulators"
},
{
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"term": "Molecular Mechanisms of Pharmacological Action"
},
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"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
}
],
"browseBranches": [
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"name": "Antineoplastic Agents"
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"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
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"relevance": "HIGH"
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{
"asFound": "Women",
"id": "M1668",
"name": "Docetaxel",
"relevance": "HIGH"
},
{
"asFound": "Maintained",
"id": "M289243",
"name": "Pertuzumab",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M26197",
"name": "Tubulin Modulators",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M26196",
"name": "Antimitotic Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M1346",
"name": "Antineoplastic Agents, Immunological",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000077143",
"term": "Docetaxel"
},
{
"id": "D000068878",
"term": "Trastuzumab"
},
{
"id": "C485206",
"term": "Pertuzumab"
}
]
} | {
"conditions": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
],
"interventions": [
{
"id": "D000077143",
"term": "Docetaxel"
},
{
"id": "D000068878",
"term": "Trastuzumab"
},
{
"id": "C485206",
"term": "Pertuzumab"
}
]
} |
NCT06715826 | null | Target-specific immunoPET Imaging of Breast Cancer | Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer | None | INTERVENTIONAL | RECRUITING | 2024-11-29T00:00:00 | null | null | null | [
"NA"
] | 200 | 18 | 75 | FEMALE | false | The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated. | Enrolled patients will undergo whole-body \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4(Trop2-targeted imaging probes ) or \[68Ga\]Ga-DOTA-H2D3/\[18F\]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.
Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers. | Inclusion Criteria:
1. Aged 18-75 years old and of female gender；
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion Criteria:
1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals. | RenJi Hospital | OTHER | {
"id": "KY2024-095-A",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-11-29T00:00:00 | {
"date": "2024-12-04",
"type": "ACTUAL"
} | {
"date": "2024-12-04",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Breast Cancer",
"Breast Neoplasms",
"Breast Cancer Metastatic"
] | ["Trop2", "HER2", "Breast Cancer", "ImmunoPET"] | null | [
{
"city": "Shanghai",
"country": "China",
"facility": "Renji Hospital, School of Medicine, Shanghai Jiao Tong University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai"
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Biodistribution of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14",
"timeFrame": "1 day from injection of the tracer"
},
{
"description": null,
"measure": "Standardized uptake value (SUV)",
"timeFrame": "1 day from injection of the tracer"
},
{
"description": null,
"measure": "Radiation dosimetry of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14",
"timeFrame": "1 day from injection of the tracer"
},
{
"description": null,
"measure": "The correlation between Trop2 expression and [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4 uptake value",
"timeFrame": "60 days"
},
{
"description": null,
"measure": "The correlation between HER2 expression and [68Ga]Ga-DOTA-H2D3/[18F]F-RESCA-RB14 uptake value",
"timeFrame": "60 days"
},
{
"description": null,
"measure": "Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer",
"timeFrame": "30 days"
}
],
"secondary": [
{
"description": null,
"measure": "The predictive value of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14 in the course of targeted therapies",
"timeFrame": "3-6 months"
},
{
"description": null,
"measure": "Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer",
"timeFrame": "3-6 months"
}
]
} | [
{
"affiliation": "Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University",
"name": "Weijun Wei, Ph.D. & M.D.",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D001941",
"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
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"abbrev": "BC04",
"name": "Neoplasms"
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{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
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"name": "All Conditions"
}
],
"browseLeaves": [
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],
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}
]
} | null | {
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],
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} |
NCT03584126 | null | Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation | Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB | imATFIB | OBSERVATIONAL | COMPLETED | 2018-06-19T00:00:00 | null | 2020-08-31T00:00:00 | 2020-08-31T00:00:00 | null | 123 | 20 | 80 | ALL | true | The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent atrial fibrillation (AF). The result of the study is a diagnostic method which aids the medical work-up of patients suffering from this disease. | Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity and mortality in humans. Histopathological studies of persistent AF have reported extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation. The degree of the fibrosis might have a significant impact on wave propagation during AF. The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent AF. The obtained clinical parameters of patients and controls (electrocardiography, ecocardiography and MR imaging data) will be correlated with known markers in order to identify novel markers for AF diagnosis. | Inclusion Criteria:
* age: 20-80 years
* weight: 50-120 kg
* persistent, permanent or paroxysmal atrial fibrillation
* clinically stable patients: outside of an acute cardiac event with constant chronic medication
* optimum echographic window
Exclusion Criteria:
* patients with: rheumatic mitral disease; acute myocardial-pericarditis; chronic rheumatism, under chronic or immunomodulatory treatment; infectious-inflammatory process of any cause
* patients undergoing oncology treatment
* patients under medication in another study
* patients undergoing immunosuppressive therapy
* contraindication for magnetic resonance imaging (MRI)
* patients with valvular prosthesis, pacemaker of any type, metallic elements in the body (including metal particles accidentally in the body or as a result of exercising certain professions); pregnant patients; patients with known poly-allergy; patients with altered renal function (creatinine clearance \<40 mL/min determined by the Cockcroft-Gault formula). | County Clinical Emergency Hospital Cluj-Napoca | OTHER | {
"id": "20117/04.10.2016",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-07-10T00:00:00 | {
"date": "2020-09-11",
"type": "ACTUAL"
} | {
"date": "2018-07-12",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF). | PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
} | [
"Atrial Fibrillation"
] | null | null | [
{
"city": "Cluj-Napoca",
"country": "Romania",
"facility": "County Clinical Emergency Hospital of Cluj-Napoca",
"geoPoint": {
"lat": 46.76667,
"lon": 23.6
},
"state": "Cluj"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.",
"timeFrame": "2016-2020"
}
],
"secondary": [
{
"description": null,
"measure": "Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.",
"timeFrame": "2016-2020"
}
]
} | [
{
"affiliation": "County Clinical Emergency Hospital Cluj-Napoca",
"name": "Zoltán Bálint, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001145",
"term": "Arrhythmias, Cardiac"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
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"term": "Pathologic Processes"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"relevance": "HIGH"
},
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"id": "M4453",
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},
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"asFound": null,
"id": "M9419",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
]
} | null | {
"conditions": [
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
],
"interventions": null
} |
NCT05673226 | null | Organosilane for Surface Cleaning in Intensive Care Units | Organosilane for Surface Cleaning in Intensive Care Units: A Cluster Randomized, Controlled, Crossover, Clinical Trial | ORG-CLEAN | INTERVENTIONAL | RECRUITING | 2022-12-07T00:00:00 | null | 2024-11-04T00:00:00 | 2024-12-30T00:00:00 | [
"PHASE2",
"PHASE3"
] | 13,000 | 18 | null | ALL | false | The purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone. | null | Inclusion Criteria:
* All patients aged 18 years and older who will be admitted to the participating ICUs
Exclusion Criteria:
* Patients under 18 years
* ICUs that may use any organosilane formulation for surface disinfection | Hospital Israelita Albert Einstein | OTHER | {
"id": "52639521.1.1001.0071",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-01-05T00:00:00 | {
"date": "2024-01-09",
"type": "ACTUAL"
} | {
"date": "2023-01-06",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized, controlled, cluster, crossover, trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
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]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Infection, Hospital"
] | ["Infection Control", "Infections", "Intensive Care Units", "Pneumonia, Ventilator Associated", "Catheter-Related Infections", "Urinary Tract Infections", "Organosilanes", "Costs and Cost Analyses"] | null | [
{
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"facility": "Santa Casa de Misericórdia",
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},
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"facility": "Hospital Ernesto Dornelles",
"geoPoint": {
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"lon": -51.23
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},
{
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"country": "Brazil",
"facility": "Hospital Ana Nery",
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"lon": -38.51083
},
"state": null
},
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"city": "Santa Cruz Do Sul",
"country": "Brazil",
"facility": "Hospital Santa Cruz",
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"facility": "A.C. Camargo Cancer Center",
"geoPoint": {
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},
"state": null
},
{
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"country": "Brazil",
"facility": "Hospital do Coração",
"geoPoint": {
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"lon": -46.63611
},
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}
] | [
{
"class": "OTHER",
"name": "Hospital Sirio-Libanes"
},
{
"class": "OTHER",
"name": "Hospital Moinhos de Vento"
},
{
"class": "OTHER",
"name": "Hospital Alemão Oswaldo Cruz"
},
{
"class": "OTHER",
"name": "Hospital do Coracao"
},
{
"class": "OTHER",
"name": "Beneficência Portuguesa de São Paulo"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of healthcare associated infections",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Contamination of environmental surfaces by multi-resistant microorganisms",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Incidence of ventilator-associated pneumonia",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Incidence of central line-associated blood stream infections",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Incidence of catheter-associated urinary tract infection",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Intensive care unit length of stay costs",
"timeFrame": "6 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
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{
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}
],
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{
"abbrev": "BC01",
"name": "Infections"
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"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
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"name": "All Conditions"
},
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"id": "M13904",
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"relevance": "LOW"
},
{
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"relevance": "LOW"
},
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},
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},
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"relevance": "LOW"
},
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"name": "Oculocerebral Syndrome With Hypopigmentation",
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}
],
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{
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"term": "Infections"
},
{
"id": "D003428",
"term": "Cross Infection"
}
]
} | null | {
"conditions": [
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"term": "Infections"
},
{
"id": "D003428",
"term": "Cross Infection"
}
],
"interventions": null
} |
NCT05467826 | null | Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis | Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China | None | INTERVENTIONAL | UNKNOWN | 2022-07-18T00:00:00 | null | 2023-11-30T00:00:00 | 2023-12-31T00:00:00 | [
"PHASE4"
] | 100 | 18 | null | ALL | false | Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China. | Chronic hepatitis C virus (HCV) infection, which may lead to cirrhosis and hepatocellular carcinoma, is a major cause of chronic liver disease worldwide. Genotype 3 is the second most common genotype globally, accounting for approximately 18% of all adult HCV infections. Subjects with HCV genotype 3 infection, particularly genotype 3b, have a greater risk of developing hepatic steatosis, more rapid progression of hepatic fibrosis and cirrhosis, and hepatocellular carcinoma. Although there is only a small percentage of HCV subjects with genotype 3 in East Asia (5.4%) and China (8.7%), genotype 3b represents more than 50% of genotype 3 subjects in China,compared to most other regions of the world where genotype 3a predominates. In certain provinces of China, such as Yunnan Guizhou, and Chongqing, genotype 3b is the predominant HCV subtype among genotype 3 subjects.
Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China. | Inclusion Criteria:
1. Willing and able to provide written informed consent
2. Male or female, age ≥18 years
3. Body mass index (BMI) between 18.0-35.0kg/m2 and bodyweight ≥ 40 kg
4. Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
5. Anti-HCV positive at screening
6. HCV RNA 104 IU/mL at screening by the Central Laboratory
7. HCV genotype 3b assessed at screening by the Central Laboratory
8. DAA treatment naïve defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents. Pegylated interferon/interferon based prior treatment is allowed.
9. Cirrhosis Determination: cirrhosis is defined as any one of the following:
1. Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥5) in 24 months before screening, or
2. Fibroscan® with a result of \>12.5 kPa in 6 months before screening
10. The lab test at screening should meet all the criterion below: a) ALT ≤ 10 the upper limit of normal (ULN); b) AST ≤ 10 ULN; c) Total bilirubin ≤ 2 ULN; d) Platelets ≥ 60,000/L; e) Neutrophile ≥ 1,500/L; f) HbA1c ≤ 8.5%; g) Creatinine clearance (CLcr) ≥ 60 mL /min as calculated by the Cockcroft-Gault equation; h) Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects; i) Albumin ≥ 3 g/dL; j) INR ≤ 1.7 x ULN; k) AFP \<100ng/mL；if 20ng/mL≤AFP≤100ng/mL，HCC should be exclude by liver ultrasound
11. Females of childbearing potential must have a negative serum pregnancy test at screening
12. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
13. Male subjects must agree to avoid donating sperm in 6 months after the last dose of drug
14. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
15. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria:
1. Decompensated cirrhosis, including but not limited to: prior or current ascites, variceal hemorrhage and/or hepatic encephalopathy; prior or current Child-Pugh B or C
2. HBsAg posititve at screening
3. Anti-HIV positive at screening
4. Alcohol abuse
5. Contraindication of ribavirin, including but not limited to hemoglobinapathy
6. Pregnant or nursing female or male with pregnant female partner
7. Use of any prohibited concomitant medications as described in Section before screening
8. Known hypersensitivity to SOF, VEL, RBV or formulation excipients
9. Subjects who has any of the following history: a) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis); b) Solid organ transplantation; c) Significant pulmonary disease, significant cardiac disease or porphyria; d) Pancreatitis; e) Autoimmune diseases (e.g., systemic lupus erythematosus, sarcoidosis, psoriasis); f) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years; g) Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible; h) Significant drug allergy (such as anaphylaxis or hepatotoxicity).
10. Assessed as ineligible by investigators | Peking University People's Hospital | OTHER | {
"id": "PKU-HCV-3B",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-07-20T00:00:00 | {
"date": "2022-07-21",
"type": "ACTUAL"
} | {
"date": "2022-07-21",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Hepatitis C",
"Cirrhosis"
] | null | null | null | null | null | {
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NCT03897426 | null | Image Based Mobile System for Dietary Assessment and Coaching | Image Based Mobile System for Dietary Assessment and Coaching | None | INTERVENTIONAL | COMPLETED | 2017-12-31T00:00:00 | null | 2017-06-02T00:00:00 | 2017-08-31T00:00:00 | [
"NA"
] | 100 | 21 | 75 | ALL | true | Vignet partnered with The George Washington University Hospital to conduct a randomized control trial (RCT) with to evaluate the system's potential to improve health outcomes for patients with CVD. Results from the RCT have the potential to be applied to patients in other chronic disease contexts. | 84 million American adults (\>1 in 3) have cardiovascular disease, and cardiovascular disease accounts for 1 of every 3 deaths in the United States and has been the number one cause of deaths in every year since 1918. In addition, strokes, heart attacks, and uncontrolled hypertension are sources of significant disability. However, with control of known cardiovascular risk factors (i.e., smoking, body mass index, physical activity, healthy diet, total cholesterol, blood pressure, fasting plasma glucose), the risk of developing cardiovascular disease is markedly reduced. The most uncontrolled risk factor of these seven metrics for cardiovascular health amongst US adults is healthy dietary behaviors. 73 percent of Americans have a poor diet, and \<1 percent have an ideal diet. No other metric of cardiovascular risk comes close - by comparison, the second worst metric is body mass index for which 31 percent have an ideal score, and the remaining five risk factors are all greater than 40 percent with ideal control. The magnitude of the gap that needs closure is greatest with healthy dietary behaviors, yet it frequently receives the least amount of intervention, and the gap has worsened over the past quarter century. Fewer patients with hypertension today are adhering to healthy nutritional habits than patients a quarter century ago. These suboptimal dietary habits are the leading cause of mortality and disability-adjusted life-years lost, greater than smoking, obesity, physical inactivity, high cholesterol, hypertension, or diabetes.
Lifestyle modification is the cornerstone of cardiovascular disease prevention, and healthy nutritional habits are essential to reducing cardiovascular risk. Changes in diet alone are as effective as blood pressure medications, without side effects associated with pharmacologic intervention. Increase nut consumption lowers cholesterol, and reducing sugar-sweetened beverages reduces risk of weight gain.
More recently, greater attention has been brought to the Mediterranean diet. The Mediterranean diet lowers blood pressure, increases HDL cholesterol, and decreases glucose levels. The term "Mediterranean diet" was first coined by Ancel Keys, best known for the Seven Countries Study, which found lower cardiovascular mortality in Mediterranean vs. non-Mediterranean countries. Since Keys' seminal work, multiple observational studies and randomized controlled trials have demonstrated a diet characterized by abundant olive oil and nut consumption and enriched for fruits, vegetables and fatty fish to be the most likely to reduce risk of cardiovascular events, including myocardial infarction, stroke and death. The Mediterranean diet was speculated to have cardiovascular benefit after observational studies suggested benefit, and the evidence solidified after randomized controlled studies showed superiority of the Mediterranean diet in both high-risk primary prevention populations and secondary prevention populations. The PREDIMED study showed a 30 percent reduction in major adverse cardiovascular events, largely through a reduction in stroke, for those patients at high risk for the development of atherosclerotic disease on a Mediterranean diet enriched for olive oil and nut consumption. The Lyon Diet Heart Study enrolled patients after a first myocardial infarction, and those randomized to receiving a Mediterranean diet enriched with more bread, fish, root vegetables and fish had improved survival and fewer myocardial infarctions than those on a usual prudent diet. Neither study demonstrated any adverse effects of the diet. These studies, however, were conducted in Mediterranean countries, and whether this diet can be successfully implemented in a non-Mediterranean population (and whether the benefits would similarly translate) remains to be tested. Observational studies suggest its possibility in a non-Mediterranean population but this finding remains to be confirmed by randomized controlled trial. | Inclusion Criteria:
1. Consecutive patients with ongoing cardiology care with a cardiologist based at the GWU MFA and are expected to remain in the care of that cardiologist for at least 6 months.
2. Patients must own their own Android- or Apple iOS-based smartphone with a data plan.
3. Patients must give informed consent.
4. English language requirement.
5. At least 5th grade literacy level as assessed with Rapid Estimate of Adult Literacy in Medicine (REALM).\[ \]
6. Patients must demonstrate an ability to download and install the Vignet FitNinja app.
7. Patient must be at least 18 years of age.
8. Patient with evidence of prior acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, ischemic non-embolic stroke/TIA, or peripheral artery disease presumed to be of atherosclerotic origin.
9. Patient is on optimal medical therapy as determined by the primary cardiologist at time of enrollment.
Exclusion Criteria:
1. Clinical instability at time of enrollment.
2. Co-morbid medical disease that would preclude ability to participate in a nutrition intervention study (e.g., digestive disease with fat intolerance, life expectancy less than 5 years, severe neurologic, psychiatric or endocrine abnormalities).
3. Immunodeficiency or HIV-positive status.
4. Illegal drug use, alcoholism or daily alcohol intake \>80 g/d.
5. BMI\>40 kg/m2.
6. Inability or unwillingness to change dietary habits as predicted by the Prochaska and DiClemente stages of change model.\[ \]
7. Inability or unwillingness to adhere to a Mediterranean diet (e.g., religious/moral reasons, disorders or chewing or swallowing).
8. Allergies to major components of the Mediterranean diet (i.e., nuts, olive oil).
9. Participation in any drug trial or use of any investigational drug within the past one year.
10. Patients who are institutionalized, lack autonomy, are non-ambulatory, lack a stable address, or have a history of missing more than one appointment in the past 6 months.
11. Patients with an acute infection or inflammation (e.g., pneumonia) in the past 3 months.
12. Pregnancy. | Vibrent Health | INDUSTRY | {
"id": "HHSN261201400053C_SBIR 308",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-03-28T00:00:00 | {
"date": "2019-04-02",
"type": "ACTUAL"
} | {
"date": "2019-04-01",
"type": "ACTUAL"
} | [
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"name": "George Washington University"
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},
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"description": null,
"measure": "Compare the Mediterranean Diet Compliance Score at 6 months between the intervention and standard of care groups",
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NCT01340326 | null | The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling | null | VALID | INTERVENTIONAL | COMPLETED | 2011-04-20T00:00:00 | null | null | null | [
"PHASE4"
] | 800 | 18 | null | ALL | false | Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of those drugs used in previous clinical trials, therefore recommended in practical guidelines is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose is more efficacious compared to lower dose commonly used in clinical practice. In addition, the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has not been explored in the setting of post-MI remodeling.
Therefore, the investigators evaluate whether submaximal dose, which are lower than those in major pivotal trials but typically used in clinical practice, can offer similar benefit in post-MI ventricular remodeling. | A total of 1116 patients with left ventricular (LV) dysfunction following the first episode of acute ST-elevation MI are to be enrolled and randomized to maximal tolerable dose (up to 320 mg/day) or usual dose (80 mg/day) of valsartan for 12 months in 2:1 ratio. Echocardiographic analysis for quantifying post-MI ventricular remodeling and genotyping of blood samples are conducted in central core laboratory. Clinical assessment and laboratory test are performed at fixed times, and genetic polymorphisms of the patients are tested at the time of admission. | Inclusion Criteria:
* Both gender
* Age \> 18
* First episode of acute ST-elevation MI
* An echocardiographic left ventricular ejection fraction less than 50 %
* Patients who provide written informed consent
Exclusion Criteria:
* Contraindications for use of angiotensin receptor blockers (ARBs)(hypersensitivity, pregnancy, bilateral renal artery stenosis)
* Urgent need for revascularization procedure
* Severe heart failure (need for intravenous inotropic support)
* Persistent (\> 1 hour) severe hypotension (systolic blood pressure \< 90 mmHg)
* Refractory or potentially lethal arrhythmias
* Hemodynamically significant right ventricular infarction
* Primary valvular diseases
* Congenital heart disease
* Idiopathic hypertrophic cardiomyopathy
* Concomitant inflammatory cardiopathy
* Significant hepatic dysfunction
* Significant renal dysfunction
* Anemia (hemoglobin \< 10 mg/mL)
* Psychiatric disorders, alcohol or durg abuse
* Any concomitant disease that might interfere with drug evaluation (especially if life expectancy is less than 1 year)
* Participation in any other pharmacological study within 2 months
* Refusal or inability to provide informed consent | Dong-A University | OTHER | {
"id": "Donga 419",
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{
"city": "Busan",
"country": "Korea, Republic of",
"facility": "Department of Internal Medicine,Dong-A University College of Medicine",
"geoPoint": {
"lat": 35.10278,
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"measure": "left ventricular volume index",
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"measure": "clinical events",
"timeFrame": "during 12 months follow up"
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"description": null,
"measure": "clinical events",
"timeFrame": "at 12 months after myocardial infarction"
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]
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NCT05892926 | null | HER2-positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma in Russia | A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Russian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced/Metastatic Gastric and/or Gastroesophageal Junction (GEJ) Adenocarcinoma | None | OBSERVATIONAL | COMPLETED | 2023-05-29T00:00:00 | null | 2024-06-28T00:00:00 | 2024-06-28T00:00:00 | null | 204 | 18 | null | ALL | false | This study is a multicenter non-interventional observational retrospective study with secondary data collection | It will be multicenter study. Planned number of study sites is about 50 oncological centers specialized on anticancer chemotherapy in various regions of Russia. A multi-center collaborative effort will help to describe characteristics of patients with HER2-positive gastric and/or GEJ adenocarcinoma in different regions in the most comprehensive way and to capture more patients into database, not only limited to a single institution | Inclusion Criteria:
* Patients with locally advanced/metastatic gastric and/or gastroesophageal junction (GEJ) adenocarcinoma, with the diagnosis established between the 1st January 2022 and the 1st January 2023.
* Patients with documented HER2+ status based on IHC score ± ISH status.
* Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status by the reference laboratory.
* Age ≥ 18 years at the time of inclusion.
* Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted.
Exclusion Criteria:
* Patients receiving trastuzumab deruxtecan currently or in the anamnesis.
* The participation in any randomized controlled trial within period since diagnosis (between the 1st January 2022 and the 1st January 2023) until the timepoint of data collection | AstraZeneca | INDUSTRY | {
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] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To describe the clinical and demographic profiles of patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in the Russian Federation",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in routine practice in the Russian Federation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "To describe data on the treatment approach in patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in routine practice in the Russian Federation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "To assess the treatment outcomes of patients with HER2-positive locally advanced or metastatic gastric/GEJ adenocarcinoma in routine practice in the Russian Federation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "To characterize the concordance between HER2 IHC scores & ISH in local and reference laboratories",
"timeFrame": "6 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
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}
],
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}
],
"meshes": [
{
"id": "D000230",
"term": "Adenocarcinoma"
}
]
} | {
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"asFound": null,
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"name": "Mitogens",
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}
],
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} | {
"conditions": [
{
"id": "D000230",
"term": "Adenocarcinoma"
}
],
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} |
NCT00743626 | null | Pap Smear Research Study | Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening | None | INTERVENTIONAL | COMPLETED | 2008-08-28T00:00:00 | null | null | null | [
"NA"
] | 1,712 | 18 | null | FEMALE | true | The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear. | null | Inclusion Criteria:
* 18 years and older
* Ability to speak and clearly understand English
* Female patients
Exclusion Criteria:
* No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.)
* Women who have had Pap smears within the previous 10 months
* Women under the age of 18.
* Women who are pregnant.
* Inability to give informed consent in English | University Health Network, Toronto | OTHER | {
"id": "Pap Smear Study",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-08-28T00:00:00 | {
"date": "2018-02-22",
"type": "ACTUAL"
} | {
"date": "2008-08-29",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Cervical Cancer"
] | ["Pap test", "HPV", "Healthy patients screened for cervical cancer tests."] | null | [
{
"city": "Toronto",
"country": "Canada",
"facility": "University Health Network - Toronto Western Hospital",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required",
"timeFrame": "1st visit, 12 months, 18 months follow up"
}
],
"secondary": null
} | [
{
"affiliation": "University Health Network, Toronto",
"name": "Joan K Murphy, MD,FRCSC",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014594",
"term": "Uterine Neoplasms"
},
{
"id": "D005833",
"term": "Genital Neoplasms, Female"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D002577",
"term": "Uterine Cervical Diseases"
},
{
"id": "D014591",
"term": "Uterine Diseases"
},
{
"id": "D005831",
"term": "Genital Diseases, Female"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D000091662",
"term": "Genital Diseases"
}
],
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"abbrev": "BC04",
"name": "Neoplasms"
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{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
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"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M17342",
"name": "Uterine Neoplasms",
"relevance": "LOW"
},
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"asFound": null,
"id": "M8945",
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},
{
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},
{
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"id": "M27093",
"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14127",
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},
{
"asFound": null,
"id": "M8399",
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}
],
"meshes": [
{
"id": "D002583",
"term": "Uterine Cervical Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D002583",
"term": "Uterine Cervical Neoplasms"
}
],
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} |
NCT03829826 | null | Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS) | Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome | None | OBSERVATIONAL | UNKNOWN | 2019-01-07T00:00:00 | null | null | null | null | 22 | 18 | null | ALL | false | This is a pilot, proof-of concept investigator-initiated trial planned for 22 patients with the diagnosis of Stiff Person Syndrome (SPS). The study will compare efficacy of treatment using subcutaneous immunoglobulin therapy (SCIg) compared to intravenous immunoglobulin (IVIg) therapy. The majority of IVIg naïve subjects (those not already receiving IVIg) are typically managed with non-immunotherapy mostly Gamma Aminobutyric Acid (GABA) -enhancing drugs such as Baclofen or Diazepam. | Study Design:This is a proof of concept observational prospective, open label, study on the safety, efficacy and convenience of treatment with SCIg study of 22 patients at Thomas Jefferson University Hospital. Two cohorts of patients within the total of 22 will be included; half of them (11 patients) currently receiving and responding to IVIg and the other half starting de novo on SCIg. Patients diagnosed with SPS according to defined sets of symptoms will be eligible to enroll.
The primary clinical outcome will be based on clinical efficacy measures, as used before for the IVIg trial, based on changes in the Stiffness Index and Heightened Sensitivity scores, using the validated scales that the investigators have had previously utilized and validated (Dalakas et al 2001; see attached at the end of the protocol). These same measurements will be applied while on IVIg (weeks 0, 4, 8, 12) and will be compared to the measurements obtained during SCIg (weeks 16, 20, 24, 28). The secondary outcome will be Quality of Life (QoL) responses and patient preference for each treatment. | Inclusion Criteria:
* Men or women aged \>18 years
* Diagnosis of SPS based on standard criteria
* IVIg Group: Receiving the equivalent of 1-2 g/kg IVIg every 4 weeks with dependence\* on IVIg to maintain clinical response \*Dependence is clinically determined either by symptomatic worsening of condition at the end of the inter-dose interval or by worsening after dose reduction or discontinuation within the previous 3 months.
* IVIg-Naïve Group: Patients with symptomatic SPS and never treated with IVIg (IVIg-naïve group), poorly controlled with standard therapy
Exclusion Criteria:
* Pregnancy, planned pregnancy, breast-feeding or unwillingness to practice contraception
* Severe concurrent medical conditions, which would prevent treatment or assessment, including significant hematological, renal or liver dysfunction or malignancies
* Initiation of immunomodulatory treatment other than IVIg in the past 3 months
* Participation in a trial of an investigational medicinal product in the past 12 weeks
* Presence of any medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study. | Thomas Jefferson University | OTHER | {
"id": "18P.420",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-02-01T00:00:00 | {
"date": "2019-05-14",
"type": "ACTUAL"
} | {
"date": "2019-02-04",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Yes No Individuals with impaired decision-making capacity X Women of reproductive potential X Pregnant women/fetuses/neonates X Men of reproductive potential X Minorities X Prisoners X Economically or educationally disadvantaged persons X Students/employees X | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Stiff-Person Syndrome"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "A >50% change from baseline on the Stiffness Index scores ( scale from 0-6; each item adds one) after 12 weeks of treatment.",
"timeFrame": "24 MONTHS"
},
{
"description": null,
"measure": "A >50% change from baseline on the Heightened Sensitivity scores (scales from 1-7, each item adds one) after 12 weeks of treatment.",
"timeFrame": "24 months"
}
],
"secondary": [
{
"description": null,
"measure": "A meaningful change on Quality of Life (QoL) measures after 12 weeks of SCIg based on 6 sets of QoL Questionnaires (mobility, self-care, usual activities, pain, anxiety/depression, health state)",
"timeFrame": "24 MONTHS"
},
{
"description": null,
"measure": "If SCIg reduces the anti-GAD antibody titers measured in the patient's blood samples by more than 30%",
"timeFrame": "24 MONTHS"
},
{
"description": null,
"measure": "If >50% of patients prefer either SCIg or IVIg after 12 weeks of treatment based on a YES/NO questionnaire .",
"timeFrame": "24 MONTHS"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D004194",
"term": "Disease"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
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"term": "Autoimmune Diseases of the Nervous System"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D013118",
"term": "Spinal Cord Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
},
{
"id": "D001327",
"term": "Autoimmune Diseases"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
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"name": "Rare Diseases"
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} | {
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{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4225",
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},
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{
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"relevance": "LOW"
}
],
"meshes": null
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},
{
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}
],
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} |
NCT00488826 | null | Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants | An Open-Label Controlled Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine [DIPHTHERIA CRM197 PROTEIN] (PrevenarTM) in Healthy Infants | None | INTERVENTIONAL | COMPLETED | 2007-06-18T00:00:00 | null | null | null | [
"PHASE1"
] | 800 | 90 | 120 | ALL | true | This study is a combination of a Phase I and Phase III study design. The Phase I portion is an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants. The Phase III portion is an open-label, controlled, randomized study to evaluate the safety and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5 months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of age. | This study is a combination of a Phase I and Phase III study design. The Phase I portion is an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants. The Phase III portion is an open-label, controlled, randomized study to evaluate the safety and immunogenicity of 7vPnC in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and/or DTaP at about 3, 4, and 5 months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of age. A total of 822 healthy Chinese infants will be enrolled. The study will be conducted in 2 phases: Phase I and Phase III.
Phase I: 22 healthy infants will be enrolled first and receive a dose of 7vPnC at least 7 days prior to receiving DTaP and followed up on safety for 30 days post the immunization. If there are no adverse events of specific concern considered, in the opinion of the principal investigator, related to the study vaccine (including, though not limited to, infectious and allergic reactions as described in the China Immunization Handbook) within 4 days after the first dose immunization and no serious adverse event possibly, probably or definitely related to the study vaccine within 30 days after the first dose of immunization, Phase III can be initiated and the infants in Phase I will proceed to the next dose of the Primary Series. If such events occur, a medical review will be conducted by both the investigator and the Sponsor to decide if the study can proceed.
Phase III: 800 infants will be enrolled and randomized to one of 3 groups according to the administration regimen. Group 1: 300 infants will receive the primary 3 doses of 7vPnC separately at 3, 4 and 5 months of age. Group 2: 300 infants will receive the primary 3 doses of 7vPnC concurrently with DTaP at 3, 4 and 5 months of age. Group 3: 200 infants will receive DTaP only at 3, 4 and 5 months of age. The injection site is the left upper arm deltoid for 7vPnC and the right upper arm deltoid for DTaP.
Safety Evaluation: Each infant will have an initial physical examination and history obtained at the enrollment visit and a brief physical evaluation at each subsequent visit. Following immunization, each subject will be observed in the clinic for 30 minutes and evaluated for signs or symptoms of anaphylaxis and reactions at the injection sites. The parent or legal guardian will be required to take the infant's axillary temperature on the evening of immunization and for 3 consecutive evenings following the immunization. In addition, if the parent suspects that the infant may have a fever at any time in the four days following immunization, the temperature is to be taken and recorded. Thermometers for axillary temperature use and diary cards will be supplied by Wyeth for distribution to the parents.
The parent or legal guardian of each subject will be instructed to complete a diary card for 4 days \[day of immunization (day 0) and next 3 days\] following each immunization. Information collected will include: the subject's axillary temperature, local reactions at the 7vPnC injection site (All subjects in Phase I of the study and Group 1 and Group 2 of Phase III) and DTaP injection site (Group 2 and Group 3 of Phase III) (tenderness, presence and size of erythema and induration/swelling) and any systemic reactions (disrupted sleep, drowsiness, decreased appetite, irritability, vomiting, diarrhea and rash not limited to the injection site) occurring days 0-3. The subject will return to clinic or be visited at home on the day after immunization (Day 1) for local and systemic reaction observation by study personnel. The parent or legal guardian will be contacted by telephone or home visit at 2 and 3 days post-immunization to collect information on local and systemic events and the information will be recorded on the source data sheet by study personnel. On, or after, the fourth day after each immunization, the study personnel will collect the diary card. The data in the diary card will be reconciled with the data in the source data sheet. If there is discrepancy, it should be clarified with the parents and recorded.
At the visit of next immunization, the interim medical history since Day 4 post last immunization will be reviewed with the parent/legal guardian. If there is any adverse event, it should be collected and recorded in the case report form. The primary source of data on adverse events will be the parent or legal guardian of each subject, as well as any medical records from a health care provider sought as a result of an adverse event. The parent/legal guardian is instructed to contact the investigators immediately for any serious adverse events.
Assessment of Immunogenicity: Up to 3ml venous blood will be collected from 55 infants in Group 1, 55 infants in Group 2 and 55 infants in Group 3 of Phase III, immediately prior to the first dose and 30-40 days after the 3rd dose to assess the immunogenicity.
Booster Dose: All infants in Phase I and Group 1 and Group 2 of Phase III will receive the booster dose of 7vPnC at 12-15 months of age. Local/systemic reactions will be observed in the same way as after the primary dose.
Assessment of Immunogenicity: Up to 3ml venous blood will be collected from the same 55 infants in Group 1 and 55 infants in Group 2 as in the Primary Series of Phase III, immediately prior to the forth dose and 30-40 days after the 4th dose to assess the immunogenicity.
The statistical analysis of the two phases will be conducted separately. The statistical analysis of the primary series is planned when all subjects have received the 1st, 2nd and 3rd dose of 7vPnC and 3 doses of DTaP or 3 doses of DTaP alone and the 30-day safety follow-up period has terminated. The analysis of the booster dose is planned when all subjects have received the 4th dose of 7vPnC and the 30-day safety follow-up period has terminated. | Inclusion Criteria:
* Chinese infants, aged 3-4 months (90-120 days) at enrollment, and have not received their 1st dose of DTaP
* In good health determined by medical history, physical examination (axillary temperature and weight) and clinical judgment of the investigator
* An informed consent form must be signed by at least one of the parent/legal guardian. The parent or legal guardian are willing to adhere to the regimen of the study and are capable of using the thermometer, calipers and filling out the diary card
Exclusion Criteria:'
* Weight \< 2 SD for age
* History of neurological disorders including a personal and family history of convulsion and epilepsy (including febrile seizures)
* Receipt of blood products, including gamma globulin within 12 weeks prior to study entry
* Hypersensitivity to any component of 7vPnC, including diphtheria toxoid
* Known previous anaphylactic reactions to any vaccines or medicines
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
* Known or suspected impairment of immune function due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection or other cause
* History of culture-proven invasive disease caused by S. pneumoniae
* Any significant congenital deformity or serious chronic diseases
* Previous immunization with licensed or investigational pneumococcal vaccine
* Other investigational medicine is being administered or has been administered within 12 weeks before screening or participation in another investigational study | Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY | {
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NCT04934826 | null | Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass | Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese | RyDIGEST | INTERVENTIONAL | RECRUITING | 2021-02-24T00:00:00 | null | null | null | [
"NA"
] | 40 | 18 | 59 | ALL | false | The gastric bypass can reduce the bioavailability of food proteins. The bioavailability of hydrolyzed proteins may be higher than intact proteins. Thus, the use of hydrolyzed proteins could compensate for the decrease in protein bioavailability observed after gastric By-pass in morbidly obese patients.
The effectiveness of a hydrolyzed protein intake may be higher than that of an intact protein intake to improve the status of a By-pass.
The hypothesis would be that the use of hydrolyzed proteins would compensate for the decrease in bioavailability of food proteins caused by gastric By-pass. | Surgery is beneficial in terms of weight loss, correction of comorbidities and life expectancy but adverse effects can occur among which various nutritional deficiencies. Thus, in some cases, more or less marked protein undernutrition may be observed.
To overcome this protein undernutrition, protein supplements can be proposed. However, their effectiveness has not been satisfactorily assessed in this situation to date. Indeed, the protein malabsorption potentially induced by the By-pass limits its impact. The value of protein supplementation must also be considered in terms of overall efficacy, taking into account a possible decrease in spontaneous intake related to supplementation.
For the bioavailability studies, milk proteins will be presented in two different forms of the same origin: intact or hydrolyzed proteins. The proteins of the test meal are marked with 15N nitrogen.
For the three months daily supplementation period, the supplements will be intact proteins not marked with 15N nitrogen, provided to patients in the form of individual sachets. The purpose of this supplementation is to help the patient achieve the protein recommendations, which is 60 g/d. | Inclusion Criteria:
1. Patients with BMI \> 40 kg/m2 or BMI \> 35 kg/m2 associated with at least one comorbidity(s): hypertension, diabetes, cardiovascular disease, hyperlipidemia, sleep apnea, arthritis,hepatic steatosis.
2. Candidates for RY gastric By-pass bariatric surgery,
3. Over 18 and under 60 years of age
4. For women of childbearing age: effective contraception implemented for at least 3 months.
5. Failure of other medical cares (medical, nutritional, dietetic and psychotherapeutic treatment) well conducted for 6 to 12 months.
6. Patient affiliated to a social security system (excluding AME) or entitled to benefits.
7. Patient who agreed to participate by signing the informed consent of the study
Exclusion Criteria:
1. Pregnancy or breastfeeding in progress
2. Severe psychiatric disorder or other illness that may disrupt the study follow-up or to invalidate the proper understanding of the protocol information and the informed consent
3. Patient's foreseeable inability to participate in a clinical trial
4. Severe and unstable eating disorders
5. Patients with a contraindication to amino acid infusion
6. Dependence on alcohol or psychoactive substances such as drugs
7. Metabolic disease requiring a a low protein diet
8. Known allergy to milk proteins
9. Patient under guardianship or curatorship
10. Patient under the justice protection
11. Participation in another interventional research | Assistance Publique - Hôpitaux de Paris | OTHER | {
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} | 2021-06-14T00:00:00 | {
"date": "2023-11-18",
"type": "ACTUAL"
} | {
"date": "2021-06-22",
"type": "ACTUAL"
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"ADULT"
] | null | null | false | {
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"Morbid Obesity"
] | null | null | [
{
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"country": "France",
"facility": "Hôpital Avicenne",
"geoPoint": {
"lat": 48.9,
"lon": 2.45
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"state": null
}
] | null | null | {
"other": null,
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{
"description": null,
"measure": "Compare the evolution of the bioavailability of hydrolyzed milk proteins to the intact milk proteins in obese patients who have received a By-pass, using the Nitrogen-15 (15N) labelled test meal method",
"timeFrame": "6 months after By-pass"
}
],
"secondary": [
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"description": null,
"measure": "Evaluate the effect of daily milk protein supplementation administered for 3 months after a post-surgery recovery period of 3 months on protein status in obese patients who had a By-pass.",
"timeFrame": "6 months after By-pass"
},
{
"description": null,
"measure": "Evaluate the compliance with supplementation of an intact milk protein administered for 3 months after a post-surgery recovery period of 3 months, in obese patients who had a By-pass, as well as its contribution to daily protein intake.",
"timeFrame": "6 months after By-pass"
},
{
"description": null,
"measure": "Evaluate the compliance with supplementation of an intact milk protein administered for 3 months, after a post-surgery recovery period of 3 months, on spontaneous food consumption in obese patients who had a By-pass.",
"timeFrame": "6 months after By-pass"
},
{
"description": null,
"measure": "Evaluate the effect of an intact milk protein supplementation administered for 3 months after a post-surgery recovery period of 3 months, on the quality of life in obese patients who have undergone a By-pass surgery.",
"timeFrame": "6 months after By-pass"
},
{
"description": null,
"measure": "Evaluate post-prandial splanchnic sequestration of dietary amino acids",
"timeFrame": "6 months after By-pass"
},
{
"description": null,
"measure": "Evaluate the effect of an intact milk protein supplementation administered for 3 months after a post-surgery recovery period of 3 months, on the quality of life in",
"timeFrame": "6 month"
}
]
} | [
{
"affiliation": "Assistance Publique - Hôpitaux Paris",
"name": "Gheorghe AIRINEI, Doctor",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "21741734", "type": "BACKGROUND", "citation": "Airinei G, Gaudichon C, Bos C, Bon C, Kapel N, Bejou B, Raynaud JJ, Luengo C, Aparicio T, Levy P, Tome D, Benamouzig R. Postprandial protein metabolism but not a fecal test reveals protein malabsorption in patients with pancreatic exocrine insufficiency. Clin Nutr. 2011 Dec;30(6):831-7. doi: 10.1016/j.clnu.2011.06.006. Epub 2011 Jul 8."}, {"pmid": "26891123", "type": "BACKGROUND", "citation": "Aron-Wisnewsky J, Verger EO, Bounaix C, Dao MC, Oppert JM, Bouillot JL, Chevallier JM, Clement K. Nutritional and Protein Deficiencies in the Short Term following Both Gastric Bypass and Gastric Banding. PLoS One. 2016 Feb 18;11(2):e0149588. doi: 10.1371/journal.pone.0149588. eCollection 2016."}, {"pmid": "17311946", "type": "BACKGROUND", "citation": "Bos C, Airinei G, Mariotti F, Benamouzig R, Berot S, Evrard J, Fenart E, Tome D, Gaudichon C. The poor digestibility of rapeseed protein is balanced by its very high metabolic utilization in humans. J Nutr. 2007 Mar;137(3):594-600. doi: 10.1093/jn/137.3.594."}, {"pmid": "15640465", "type": "BACKGROUND", "citation": "Bos C, Juillet B, Fouillet H, Turlan L, Dare S, Luengo C, N'tounda R, Benamouzig R, Gausseres N, Tome D, Gaudichon C. Postprandial metabolic utilization of wheat protein in humans. Am J Clin Nutr. 2005 Jan;81(1):87-94. doi: 10.1093/ajcn/81.1.87."}, {"pmid": "26290008", "type": "BACKGROUND", "citation": "Oberli M, Marsset-Baglieri A, Airinei G, Sante-Lhoutellier V, Khodorova N, Remond D, Foucault-Simonin A, Piedcoq J, Tome D, Fromentin G, Benamouzig R, Gaudichon C. High True Ileal Digestibility but Not Postprandial Utilization of Nitrogen from Bovine Meat Protein in Humans Is Moderately Decreased by High-Temperature, Long-Duration Cooking. J Nutr. 2015 Oct;145(10):2221-8. doi: 10.3945/jn.115.216838. Epub 2015 Aug 19."}, {"pmid": "17093159", "type": "BACKGROUND", "citation": "Lacroix M, Bos C, Leonil J, Airinei G, Luengo C, Dare S, Benamouzig R, Fouillet H, Fauquant J, Tome D, Gaudichon C. Compared with casein or total milk protein, digestion of milk soluble proteins is too rapid to sustain the anabolic postprandial amino acid requirement. Am J Clin Nutr. 2006 Nov;84(5):1070-9. doi: 10.1093/ajcn/84.5.1070."}, {"pmid": "23576048", "type": "BACKGROUND", "citation": "Boutrou R, Gaudichon C, Dupont D, Jardin J, Airinei G, Marsset-Baglieri A, Benamouzig R, Tome D, Leonil J. Sequential release of milk protein-derived bioactive peptides in the jejunum in healthy humans. Am J Clin Nutr. 2013 Jun;97(6):1314-23. doi: 10.3945/ajcn.112.055202. Epub 2013 Apr 10."}] | {"versionHolder": "2025-06-18"} | {
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NCT01599026 | null | Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function | Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function | None | OBSERVATIONAL | UNKNOWN | 2012-05-14T00:00:00 | null | null | null | null | 120 | 20 | 45 | FEMALE | false | Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers | Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy | Inclusion Criteria:
* singleton pregnancy
* gestational age 36 weeks
Exclusion Criteria:
* congenital anomalies
* obstetric complications
* medical disorders other than diabetes | Ain Shams Maternity Hospital | OTHER | {
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"description": null,
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]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT00928226 | null | Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases | A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases | None | INTERVENTIONAL | COMPLETED | 2009-06-23T00:00:00 | null | 2017-10-31T00:00:00 | null | [
"NA"
] | 56 | 18 | null | ALL | false | The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined.
This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects). | Brain metastases are the most common intracranial tumors and occur in approximately 25% of patients with cancer. In the US, approximately 170,000 cancer patients a year are diagnosed with brain metastases.
The prognosis of patients with brain metastases is variable and depends on several factors, including performance status, age, control of the primary tumor, and extent of extracranial disease. Historically, patients with brain metastases who receive supportive care only have median survival of 1 to 2 months. However, a subgroup of patients with favorable prognosis who undergo treatment can enjoy an extended life expectancy with median survival of 10 to 16 months. Treatment options for brain metastases include medical management, surgery, and radiation therapy (radiotherapy). Both surgery and radiotherapy have an important role in management of brain metastases, and an optimized treatment plan may include both. It is well-established that surgery followed by conventional whole brain radiation (WBRT) decreases local recurrence and improves median survival compared to WBRT alone. Conventional WBRT is administered as radiotherapy to the whole cranium delivered in 10 to 20 daily treatments.
For this study, radiotherapy will be delivered using stereotactic radiosurgery (SRS) to treat individual metastases. SRS has the advantage of sparing normal brain tissue. In SRS, high energy radiation is precisely directed at the target lesion. Due to the steep fall-off of the radiation dose away from the target, the advantage of relative sparing of the normal brain may be realized. The present study is based on a rationale of treating brain metastases with surgical resection followed by adjuvant SRS to the resection cavity, while deferring conventional WBRT for salvage therapy.
WBRT is associated with a short-term decline in quality of life and long-term deficits in neurocognitive function ("late effects"). Late toxicity of WBRT, such as memory impairment and dementia, is usually irreversible and is likely due to demyelination, vascular damage, and necrosis. Following WBRT, the actuarial rate of neurocognitive toxicity at 2 years can be up to 49%. Recipients of WBRT may demonstrate a \> 2 standard deviation decline in their performance at 6 months. Compared to SRS alone, WBRT was reported to be associated with a marked decline in learning and memory function at 4 months (49% vs 23%, in favor of SRS).
To minimize the potential late effects of WBRT, investigators have explored the use of SRS alone, deferring the use of WBRT for salvage treatment if needed. Both retrospective analyses and a prospective randomized trial reported no apparent survival benefit to combining WBRT with SRS compared to SRS alone
Primary Objectives: Determine the maximum tolerated dose (MTD) of stereotactic radiosurgery (SRS).
Secondary Objectives:
1. Determine the local control rate as assessed on MRI and clinical exam.
2. Determine short- and long-term adverse effects.
3. Determine the distant intra-cranial control rate.
4. Determine the overall survival rate.
5. Assess the patient's health related quality of life.
Treatment Group assignment will be by SRS dose level. SRS will be administered as 3 fractions. Radiation dose is administered as "Greys" (or "Grays"; abbreviated Gy), a unit by which radiation is measured. Treatment Groups are as follows: Group 1 = 24 Gy (administered as 8 Gy x 3) Group 2 = 7 Gy (9 Gy x 3); Group 3 = 30 Gy (10 Gy x 3); Group 4 = 33 Gy (11 Gy x 3).
Within each Treatment Group, analysis may be stratified by tumor size and suitability for surgical resection, as below. For those participants eligible for surgical resection, the procedure will be conducted in advance of the SRS treatment.
* Strata A will be those with tumors 4.2 to 14.1 cm³, and suitable for resection.
* Strata B will be those with tumors 4.2 to 14.1 cm³, but not suitable for resection.
* Strata C will be those with tumors 14.2 to 33.5 cm³, and suitable for resection.
* Strata D will be those with tumors 14.2 to 33.5 cm³, but not suitable for resection. | INCLUSION CRITERIA
* Age 18 years and older
* Pathologically-proven solid tumor malignancy
* 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm³.
* Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
* Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS.
* Life expectancy of ≥ 12 weeks.
* Ability to understand and the willingness to sign a written informed consent.
EXCLUSION CRITERIA
* Previously treated with whole brain irradiation
* Target metastatic lesion previously been treated with SRS.
* \> 4 total brain metastases at the time of initial evaluation.
* Pregnant
* Unable to give informed consent. | Stanford University | OTHER | {
"id": "IRB-15107",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-06-24T00:00:00 | {
"date": "2024-01-30",
"type": "ACTUAL"
} | {
"date": "2009-06-25",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NON_RANDOMIZED",
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} | [
"Brain Cancer",
"Neoplasm Metastasis",
"Cancer of Brain and Nervous System",
"Metastatic Malignant Neoplasm to Brain"
] | null | null | [
{
"city": "Stanford",
"country": "United States",
"facility": "Stanford University School of Medicine",
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"lon": -122.16608
},
"state": "California"
}
] | null | null | {
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"description": null,
"measure": "Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)",
"timeFrame": "60 days"
}
],
"secondary": [
{
"description": null,
"measure": "Local Disease Control",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Distant Intra-cranial Disease Control",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Adverse Effects Within 30 Days",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Adverse Effects More Than 30 Days up to 1 Year",
"timeFrame": "after 30 days and up to 1 year"
},
{
"description": null,
"measure": "Overall Survival (OS)",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "Stanford University",
"name": "Clara Choi",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Stanford University",
"name": "Scott Soltys",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "34670228", "type": "DERIVED", "citation": "Rahimy E, Dudley SA, von Eyben R, Pollom EL, Seiger K, Modlin L, Wynne J, Fujimoto D, Jacobs LR, Chang SD, Gibbs IC, Hancock SL, Adler JR, Li G, Choi CYH, Soltys SG. Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases: Health-related Quality of Life Outcomes. Am J Clin Oncol. 2021 Nov 1;44(11):588-595. doi: 10.1097/COC.0000000000000868."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Nervous System Neoplasms"
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{
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{
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"term": "Neoplasm Metastasis"
},
{
"id": "D001932",
"term": "Brain Neoplasms"
}
]
} | null | {
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},
{
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"term": "Neoplasm Metastasis"
},
{
"id": "D001932",
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],
"interventions": null
} |
NCT00633126 | null | Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age | Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy | None | INTERVENTIONAL | COMPLETED | 2008-03-03T00:00:00 | null | null | null | [
"PHASE1"
] | 9 | 12 | 17 | ALL | false | The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects | The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects | Inclusion Criteria:
* Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
* Body mass index (weight \[kg\]/height squared \[m2\]) of no more than 30
* Males and females between 12 and 17 years of age, inclusive
Exclusion Criteria:
* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
* Past or current history of epilepsy or seizure disorder
* Critically ill or unstable patients | Forest Laboratories | INDUSTRY | {
"id": "P903-15",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-03-10T00:00:00 | {
"date": "2017-03-14",
"type": "ACTUAL"
} | {
"date": "2008-03-11",
"type": "ESTIMATED"
} | [
"CHILD"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Infection"
] | ["PK", "Pharmacokinetics"] | null | [
{
"city": "Louisville",
"country": "United States",
"facility": "Investigational Site",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky"
},
{
"city": "Durham",
"country": "United States",
"facility": "Investigational Site",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina"
},
{
"city": "Akron",
"country": "United States",
"facility": "Investigational site",
"geoPoint": {
"lat": 41.08144,
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},
"state": "Ohio"
},
{
"city": "Cleveland",
"country": "United States",
"facility": "Invetigational Site",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.",
"timeFrame": "12 hours after infusion"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).",
"timeFrame": "Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days)."
}
]
} | [
{
"affiliation": "Forest Laboratories",
"name": "Medical Monitor Cerexa",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC23",
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}
],
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},
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"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
}
],
"meshes": null
} | {
"ancestors": [
{
"id": "D000097902",
"term": "Beta Lactam Antibiotics"
},
{
"id": "D000900",
"term": "Anti-Bacterial Agents"
},
{
"id": "D000890",
"term": "Anti-Infective Agents"
}
],
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4224",
"name": "Antibiotics, Antitubercular",
"relevance": "LOW"
},
{
"asFound": "Negative control",
"id": "M3351",
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},
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},
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},
{
"asFound": null,
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},
{
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},
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}
],
"meshes": [
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"term": "Ceftaroline"
},
{
"id": "D002511",
"term": "Cephalosporins"
}
]
} | {
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"interventions": [
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"term": "Ceftaroline"
},
{
"id": "D002511",
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]
} |
NCT06412926 | null | A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants | A Crossover Treatment, Phase 1, Open-label, Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Single Doses of 2 Formulations of Emodepside (BAY 44-4400), and to Assess the Effect of Food in Healthy Male and Female Participants. | None | INTERVENTIONAL | COMPLETED | 2024-05-02T00:00:00 | null | 2024-08-27T00:00:00 | 2024-08-27T00:00:00 | [
"PHASE1"
] | 14 | 18 | 55 | ALL | true | Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly. Common symptoms include severe itching, skin problems, and eye problems including permanent blindness.
Soil-transmitted helminthiasis is an infection caused by various parasitic worms, such as whipworm, hookworm, and roundworm in the intestines. The infection spreads through eggs found in the feces of infected people. This contaminates the soil in areas with poor sanitation. Common symptoms include stomach pain, loose stools, loss of blood and proteins, delayed development in children, and reduced work performance in adults.
Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis. Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women. It works by activating a protein called 'SLO-1', which causes paralysis and death of the parasitic worms.
The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet, as a single dose. Researchers also want to find the effect of food on the absorption of the new emodepside tablet.
The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food.
The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food. The number of participants who experience medical problems during this study will be documented.
During this study, participants will receive 2 different types of emodepside tablets. These include the newly developed tablet and an existing tablet that has already been used in other clinical studies.
At the start of the study, the researchers will ask participants about their medical and surgical history. They will also perform a health check-up for all participants, and pregnancy tests for women.
During the study, participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood.
The study doctors will confirm that the participants can take part in the study. This may take up to 21 days.
This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each.
On Day 1 of each period, participants will receive the treatments, but the order of the treatment will be different.
• Periods 1 and 2: Each participant will receive a single oral dose of the new or the existing emodepside tablet without food.
After Period 2, an initial analysis will be performed. This analysis will help decide the doses for the next periods.
* Period 3: Participants will receive a selected dose of the new emodepside tablet either with or without food.
* Period 4 (optional): If needed, participants may receive a selected dose of the new emodepside tablet either with or without food. The decisions to conduct Period 4 will depend on the results of the initial analysis.
Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period (either Period 3 or 4).
Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up.
This study will include participants who are healthy and will gain no benefit from taking emodepside. However, the results of the study will provide useful information to support the further development of the new emodepside tablet. The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside. Participants will be closely monitored by the study doctors for any medical problems. | null | Inclusion Criteria:
* Men aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening
* Women that are not breastfeeding and are of non-childbearing potential aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening
* Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, vital signs, and laboratory tests.
* Ability to understand and follow study-related instructions.
Exclusion Criteria:
* Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study
* History of relevant eye or vision disorders (except myopia and hyperopia).
* History of diabetes mellitus or abnormalities in glucose homeostasis.
* Surgery, medical condition, or diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal
* Febrile illness within 2 weeks before the start of the first study intervention.
* Regular use of prescription drugs, over-the-counter drugs, supplements or herbal products.
* Use of any systemic or topical medicines or substances within 2 weeks or 5 half-lives (whichever is longer) before the start of the first administration until follow-up, in particular, use of CYP3A4 inducers (including St John's Wort) or inhibitors.
* Clinically relevant findings in the physical examination and vital signs (systolic blood pressure below 90 or above 140 mmHg, diastolic blood pressure below 60 or above 90 mmHg, pulse rate below 50 or above 90 beats per minute, as measured at screening).
* Clinically relevant deviations of safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges at screening.
* Suspicion of drug or alcohol abuse.
* Lack of compliance with study restrictions.
* Any vaccination received or planned during the period between 15 days before the first administration of study intervention and the last study visit. | Bayer | INDUSTRY | {
"id": "22534",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-05-13T00:00:00 | {
"date": "2024-09-27",
"type": "ACTUAL"
} | {
"date": "2024-05-14",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The study will be conducted in a single-center, randomized, open label, cross over design.\n\nThe study will investigate the relative bioavailability, pharmacokinetics, safety and tolerability of single doses of 2 formulations of emodepside and assess the effect of food on Test formulation (Formulation B) in healthy male participants and healthy female participants of non-childbearing potential.\n\nThe crossover design is used for intra-individual comparison of treatment effects to reduce impact of inter-individual variability. A preliminary PK analysis is planned after Period 2 to determine the appropriate dose to be tested for food effect.\n\nTreatment allocation is conducted in a randomized manner prior to Period 1 in order to reduce the likelihood of period or seasonal effects confounding the study assessments.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Soil-transmitted Helminth Infection",
"Onchocerciasis (River Blindness)"
] | ["Soil-transmitted helminth infection; Onchocerciasis (river blindness)"] | null | [
{
"city": "Neu-Ulm",
"country": "Germany",
"facility": "NUVISAN GmbH Neu-Ulm",
"geoPoint": {
"lat": 48.39279,
"lon": 10.01112
},
"state": "Bayern"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Maximum observed concentration (Cmax) (0-72 hrs)",
"timeFrame": "0-72 hrs post dose (per period)"
},
{
"description": null,
"measure": "Area under the concentration vs. time curve from zero to infinity after single dose (AUC) (0-72 hrs)",
"timeFrame": "0-72 hrs post dose (per period)"
}
],
"secondary": [
{
"description": null,
"measure": "Number of participants who experienced treatment-emergent adverse events (TEAEs)",
"timeFrame": "After first administration of study intervention through study completion, an average of 12 weeks"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"term": "Sensation Disorders"
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"term": "Neurologic Manifestations"
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"term": "Nervous System Diseases"
},
{
"id": "D005128",
"term": "Eye Diseases"
},
{
"id": "D005368",
"term": "Filariasis"
},
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"term": "Spirurida Infections"
},
{
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"term": "Secernentea Infections"
},
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"id": "D009349",
"term": "Nematode Infections"
},
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"term": "Parasitic Diseases"
},
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"id": "D012876",
"term": "Skin Diseases, Parasitic"
},
{
"id": "D012874",
"term": "Skin Diseases, Infectious"
},
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D015822",
"term": "Eye Infections, Parasitic"
},
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"id": "D000079426",
"term": "Vector Borne Diseases"
},
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"term": "Eye Infections"
}
],
"browseBranches": [
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"abbrev": "BC10",
"name": "Nervous System Diseases"
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"abbrev": "BC11",
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"name": "Symptoms and General Pathology"
},
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"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
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"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
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"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Blindness",
"id": "M5047",
"name": "Blindness",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": "Helminth Infections",
"id": "M9461",
"name": "Helminthiasis",
"relevance": "HIGH"
},
{
"asFound": "Onchocerciasis",
"id": "M12787",
"name": "Onchocerciasis",
"relevance": "HIGH"
},
{
"asFound": "River blindness",
"id": "M18381",
"name": "Onchocerciasis, Ocular",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17530",
"name": "Vision Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15490",
"name": "Sensation Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7771",
"name": "Elephantiasis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8498",
"name": "Filariasis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12296",
"name": "Nematode Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13185",
"name": "Parasitic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15679",
"name": "Skin Diseases, Parasitic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15677",
"name": "Skin Diseases, Infectious",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18371",
"name": "Eye Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2054",
"name": "Vector Borne Diseases",
"relevance": "LOW"
},
{
"asFound": "Helminth Infections",
"id": "T2684",
"name": "Helminthiasis",
"relevance": "HIGH"
},
{
"asFound": "Onchocerciasis",
"id": "T4245",
"name": "Onchocerciasis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T3528",
"name": "Lymphatic Filariasis",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009855",
"term": "Onchocerciasis"
},
{
"id": "D006373",
"term": "Helminthiasis"
},
{
"id": "D015827",
"term": "Onchocerciasis, Ocular"
},
{
"id": "D001766",
"term": "Blindness"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "All",
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}
],
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{
"asFound": null,
"id": "M259980",
"name": "Emodepside",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D009855",
"term": "Onchocerciasis"
},
{
"id": "D006373",
"term": "Helminthiasis"
},
{
"id": "D015827",
"term": "Onchocerciasis, Ocular"
},
{
"id": "D001766",
"term": "Blindness"
}
],
"interventions": []
} |
NCT06095726 | null | Peppermint Inhalation Versus Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia | Comparative Effect of Peppermint Inhalation and Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia. | None | INTERVENTIONAL | COMPLETED | 2023-10-04T00:00:00 | null | 2022-12-31T00:00:00 | 2022-12-31T00:00:00 | [
"NA"
] | 75 | 6 | 15 | ALL | false | Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage on chemotherapy induced-nausea and vomiting in children with leukemia. the main research hypotheses are:
* Children with leukemia who receive peppermint inhalation exhibit less chemotherapy induced- nausea and vomiting than those who don't receive.
* Children with leukemia who receive Swedish massage exhibit less chemotherapy induced-nausea and vomiting than those who don't receive.
* Children with leukemia who receive Swedish massage exhibit less chemotherapy induced- nausea and vomiting than those who receive peppermint inhalation. children divided into three groups of study ( control group, peppermint inhalation group and Swedish massage group) to identify its effect on chemotherapy induced nausea and vomiting. | null | Inclusion Criteria:
* Received first chemotherapy session
* Intact skin in the massage
Exclusion Criteria:
* Chronic and acute disorders such as respiratory, cardiovascular diseases...etc.
* Allergy from any essential oils. | Alexandria University | OTHER | {
"id": "CINV",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-10-17T00:00:00 | {
"date": "2023-10-23",
"type": "ACTUAL"
} | {
"date": "2023-10-23",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Leukemia"
] | ["leukemia", "Swedish Massage", "Peppermint Inhalation", "Nausea", "Vomiting", "Chemotherapy", "Children"] | null | [
{
"city": "Alexandria",
"country": "Egypt",
"facility": "Eman Arafa Badr",
"geoPoint": {
"lat": 31.21564,
"lon": 29.95527
},
"state": null
}
] | null | null | {
"other": [
{
"description": null,
"measure": "Child's age",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Gender",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Residence",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Level of education",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Onset of the disease",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Type of leukemia",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Prescribed chemotherapy medications",
"timeFrame": "Before data collection"
},
{
"description": null,
"measure": "Antiemetics prescribed medications",
"timeFrame": "Before data collection"
}
],
"primary": [
{
"description": null,
"measure": "Experience of anticipatory nausea",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Worst of anticipatory nausea",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Duration of anticipatory nausea",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Frequency of anticipatory nausea",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Experience of anticipatory vomiting",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Worst of anticipatory vomiting",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Amount of anticipatory vomiting",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Frequency of anticipatory vomiting",
"timeFrame": "assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions"
},
{
"description": null,
"measure": "Experience of acute nausea .",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Worst of acute nausea .",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Duration of acute nausea .",
"timeFrame": "Frst 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Frequency of acute nausea .",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Experience of acute vomiting.",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Worst of acute vomiting.",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Amount of acute vomiting.",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Frequency of acute vomiting.",
"timeFrame": "First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study."
},
{
"description": null,
"measure": "Experience of delayed nausea.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Worst of delayed nausea.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Duration of delayed nausea.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Frequency of delayed nausea.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Experience of delayed vomiting.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Worst of delayed vomiting.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Amount of delayed vomiting.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
},
{
"description": null,
"measure": "Frequency of delayed vomiting.",
"timeFrame": "On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration."
}
],
"secondary": null
} | null | [{"pmid": null, "type": "BACKGROUND", "citation": "Sowmiya Rajendran, Ruthrani Princely J, Kanchana S, Celina D., Effectiveness of Swedish Massage on the Level of Chemotherapy Induced Nausea and Vomiting (CINV) Among Children with Cancer at a Selected Hospital in North India, ICCRJNR, Jul - Dec 2016, 1(2): 20-38."}, {"pmid": "29947285", "type": "BACKGROUND", "citation": "Evans A, Malvar J, Garretson C, Pedroja Kolovos E, Baron Nelson M. The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):392-398. doi: 10.1177/1043454218782133. Epub 2018 Jun 27."}, {"pmid": null, "type": "BACKGROUND", "citation": "El-SayedYousef, Y., Zaki, N. A., AsmaaAbd-Alasis, Abdel-RazikSayed, H., & Elsayed, F. (2018). Effect of Therapeutic Massage on nausea and vomitingamong Children with Leukemia following Chemotherapy."}, {"pmid": null, "type": "RESULT", "citation": "Ahmad, M. (2016). Tool Development to Assess Nausea and Vomiting Among Patients Receiving Chemotherapy. International Journal of Cancer and Oncology, 3(1), 1-5. https://doi.org/10.15436/2377-0902.16.031"}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
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"term": "Neoplasms"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D012817",
"term": "Signs and Symptoms, Digestive"
},
{
"id": "D012120",
"term": "Respiration Disorders"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
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{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
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"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
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},
{
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"name": "Blood and Lymph Conditions"
}
],
"browseLeaves": [
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"id": "M12273",
"name": "Nausea",
"relevance": "HIGH"
},
{
"asFound": "Vomiting",
"id": "M17582",
"name": "Vomiting",
"relevance": "HIGH"
},
{
"asFound": "Inhalation",
"id": "M27137",
"name": "Respiratory Aspiration",
"relevance": "HIGH"
},
{
"asFound": "Leukemia",
"id": "M10945",
"name": "Leukemia",
"relevance": "HIGH"
},
{
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"relevance": "LOW"
},
{
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"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15622",
"name": "Signs and Symptoms, Digestive",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14957",
"name": "Respiration Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D053120",
"term": "Respiratory Aspiration"
},
{
"id": "D009325",
"term": "Nausea"
},
{
"id": "D014839",
"term": "Vomiting"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "AnEm",
"name": "Antiemetics"
},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "HB",
"name": "Herbal and Botanical"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M4251",
"name": "Antiemetics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M342681",
"name": "Peppermint oil",
"relevance": "LOW"
},
{
"asFound": "Rehabilitation therapy",
"id": "T251",
"name": "Peppermint",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T242",
"name": "Olive",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D053120",
"term": "Respiratory Aspiration"
},
{
"id": "D009325",
"term": "Nausea"
},
{
"id": "D014839",
"term": "Vomiting"
}
],
"interventions": []
} |
NCT05853926 | null | Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache | Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache: Randomized Controlled Trial | None | INTERVENTIONAL | UNKNOWN | 2023-03-18T00:00:00 | null | 2023-06-01T00:00:00 | 2023-08-31T00:00:00 | [
"NA"
] | 54 | 18 | 60 | ALL | false | To determine the effectiveness of spinal manipulation with laser therapy versus dry needling for pain, disability and fear of movement in chronic low backache | null | Inclusion Criteria:
* Those patients will be included in the study who have chronic low back pain (12 week duration).
both genders aged 18-60 years low back pain
Exclusion Criteria:
* Those patients will be excluded in the study who have needle phobia, any infection, cancer, dermal changings, heart transplant, pregnancy, rheumatic fever(25)fracture, cauda equina syndrome, arrhythmia, sensory deficiency, mental illness, surgery, osteoporosis, low term use of steroid | Superior University | OTHER | {
"id": "DPT/Batch-Fall18/530",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-05-02T00:00:00 | {
"date": "2023-05-11",
"type": "ACTUAL"
} | {
"date": "2023-05-11",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"Low Back Pain"
] | null | null | [
{
"city": "Lahore",
"country": "Pakistan",
"facility": "Chaudary Muhammad Akram Teaching Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Oswestry Disability Index scale",
"timeFrame": "6 Months"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001416",
"term": "Back Pain"
},
{
"id": "D010146",
"term": "Pain"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M4714",
"name": "Back Pain",
"relevance": "LOW"
},
{
"asFound": "Low Back Pain",
"id": "M19433",
"name": "Low Back Pain",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D017116",
"term": "Low Back Pain"
}
]
} | null | {
"conditions": [
{
"id": "D017116",
"term": "Low Back Pain"
}
],
"interventions": null
} |
NCT05064826 | null | ED Observation for Opioid Use Disorder | Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation | None | INTERVENTIONAL | RECRUITING | 2021-09-14T00:00:00 | null | 2025-06-01T00:00:00 | 2026-07-31T00:00:00 | [
"NA"
] | 230 | 18 | 100 | ALL | false | This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU). | In this hybrid implementation-effectiveness study, there is no direct research intervention. Rather, clinical care with well-documented effectiveness will be delivered at the discretion of clinical staff guided by clinical protocols for the management of OUD with MOUD (Medications for Opioid Use Disorder) introduced at each site prior to study enrollment. Enrolled patients will be randomized to ED vs. EDOU and to participate in assessments conducted at the index visit and at 30 days and 90 days. Patient level data will also be matched with Medicaid claims data for more robust analyses and to support the development of clinical quality measures. | Inclusion Criteria:
* Is 18 years of age or older
* Is able to speak English sufficiently to understand study procedures
* Has a history of non-medical opioid use
* Is a potential candidate for ED-based MOUD treatment initiation and referral at the site as confirmed by clinical staff
* s not receiving MOUD through ongoing formal addiction treatment or pain management at the time of index ED visit
* Is willing to receive either standard ED care or enhanced ED care in EDOU depending on random assignment
* Presents to the ED during study screening hours
Exclusion Criteria:
* Unwilling or unable to provide written/electronic informed consent/HIPAA Authorization for research procedures, including research visits at baseline and Day 30 and Day 90, and/or consent for the release of health records and data matching for a period of 2 years following enrollment and 1 year prior to enrollment.
* Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
* Presents from a medical-based extended care facility (e.g., skilled nursing facility)
* Previous participation in the current study
* Inadequate locator information (unable or unwilling to provide one unique mean of contact).
* Has acute, severe medical, psychiatric, or concurrent substance use problem or meets other criteria that would exclude the patient (clinically) from placement in EDOU according to EDOU placement clinical protocols. | NYU Langone Health | OTHER | {
"id": "20-01951",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-09-23T00:00:00 | {
"date": "2025-04-01",
"type": "ACTUAL"
} | {
"date": "2021-10-01",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Opiod Use Disorder"
] | null | null | [
{
"city": "Newark",
"country": "United States",
"facility": "Rutgers University-University Hospital",
"geoPoint": {
"lat": 40.73566,
"lon": -74.17237
},
"state": "New Jersey"
},
{
"city": "Brooklyn",
"country": "United States",
"facility": "NYULH-Brooklyn",
"geoPoint": {
"lat": 40.6501,
"lon": -73.94958
},
"state": "New York"
},
{
"city": "New Hyde Park",
"country": "United States",
"facility": "Northwell Health - Long Island Jewish Medical Center",
"geoPoint": {
"lat": 40.7351,
"lon": -73.68791
},
"state": "New York"
},
{
"city": "New York",
"country": "United States",
"facility": "Bellevue",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
},
{
"city": "New York",
"country": "United States",
"facility": "NYULH-Tisch",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
},
{
"city": "Staten Island",
"country": "United States",
"facility": "Northwell Health - Staten Island University Hospital",
"geoPoint": {
"lat": 40.56233,
"lon": -74.13986
},
"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Institutes of Health (NIH)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Proportion of participants initiated on BUP in ED directly via administration or prescription",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Proportion of participants initiated on BUP in ED directly via administration or prescription",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Proportion of participants initiated on BUP in ED directly via administration or prescription",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Proportion of participants initiated on BUP in ED directly via administration or prescription or indirectly via expedited referral",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week",
"timeFrame": "Day 90 Visit"
},
{
"description": null,
"measure": "Proportion of participants confirmed to be engaged in formal addiction treatment at 30 days",
"timeFrame": "Day 30 visit"
}
],
"secondary": [
{
"description": null,
"measure": "Days of opioid and other drug use",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Days of opioid and other drug use",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Proportion of participants who tested positive for illicit opioids/substances",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Number of overdose events and risk behaviors",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Number of overdose events and risk behaviors",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Number of overdose events and risk behaviors",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Score on EuroQol-5 Dimensions (EQ-5D) Scale",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Score on EuroQol-5 Dimensions (EQ-5D) cale",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Score on EuroQol-5 Dimensions (EQ-5D) Scale",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Score on Patient Health Questionnaire (PHQ)-9 Scale",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Score on Patient Health Questionnaire (PHQ)-9 Scale",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Score on Patient Health Questionnaire (PHQ)-9 Scale",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Score on Treatment Effectiveness Assessment (TEA) Scale",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Score on Treatment Effectiveness Assessment (TEA) Scale",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Score on Treatment Effectiveness Assessment (TEA) Scale",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Proportion of participants who reported treatment satisfaction",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Proportion of participants who reported treatment satisfaction",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Proportion of participants who reported treatment satisfaction",
"timeFrame": "Day 90 visit"
},
{
"description": null,
"measure": "Proportion of participants who reported changes in social determinants of health",
"timeFrame": "Day 1 visit"
},
{
"description": null,
"measure": "Proportion of participants who reported changes in social determinants of health",
"timeFrame": "Day 30 visit"
},
{
"description": null,
"measure": "Proportion of participants who reported changes in social determinants of health",
"timeFrame": "Day 90 visit"
}
]
} | [
{
"affiliation": "NYU Langone Health",
"name": "Ryan McCormack, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D000079524",
"term": "Narcotic-Related Disorders"
},
{
"id": "D019966",
"term": "Substance-Related Disorders"
},
{
"id": "D064419",
"term": "Chemically-Induced Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
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{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC25",
"name": "Substance Related Disorders"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
"browseLeaves": [
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"id": "M7796",
"name": "Emergencies",
"relevance": "LOW"
},
{
"asFound": "Opioid Use Disorder",
"id": "M12244",
"name": "Opioid-Related Disorders",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M2057",
"name": "Narcotic-Related Disorders",
"relevance": "LOW"
},
{
"asFound": null,
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},
{
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009293",
"term": "Opioid-Related Disorders"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M4033",
"name": "Analgesics, Opioid",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D009293",
"term": "Opioid-Related Disorders"
}
],
"interventions": []
} |
NCT00516126 | null | Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery | Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors | None | OBSERVATIONAL | COMPLETED | 2007-08-13T00:00:00 | null | null | null | null | 200 | 18 | null | ALL | false | Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer). | null | Inclusion Criteria:
* written consent
Exclusion Criteria:
* no written consent | University Hospital, Basel, Switzerland | OTHER | {
"id": "194/06",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-08-13T00:00:00 | {
"date": "2013-01-11",
"type": "ESTIMATED"
} | {
"date": "2007-08-14",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients undergoing cardiac surgery | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Coronary Artery Bypass Graft Triple Vessel",
"Blood Coagulation Disorders"
] | ["hemostasis monitoring", "perioperative blood loss"] | null | [
{
"city": "Basel",
"country": "Switzerland",
"facility": "University Hospital Basel",
"geoPoint": {
"lat": 47.55839,
"lon": 7.57327
},
"state": "CH"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Perioperative blood loss",
"timeFrame": "24 hours"
}
],
"secondary": [
{
"description": null,
"measure": "perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma",
"timeFrame": "24 hours and 7 days"
}
]
} | [
{
"affiliation": "Department of Anesthesia, University Hospital Basel, CH-4031 Basel, Switzerland",
"name": "Miodrag Filipovic, PhD, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D006474",
"term": "Hemorrhagic Disorders"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M9556",
"name": "Hemorrhage",
"relevance": "LOW"
},
{
"asFound": "Blood Coagulation Disorders",
"id": "M21977",
"name": "Hemostatic Disorders",
"relevance": "HIGH"
},
{
"asFound": "Blood Coagulation Disorders",
"id": "M5059",
"name": "Blood Coagulation Disorders",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9560",
"name": "Hemorrhagic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020141",
"term": "Hemostatic Disorders"
},
{
"id": "D001778",
"term": "Blood Coagulation Disorders"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Coag",
"name": "Coagulants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "PlAggInh",
"name": "Platelet Aggregation Inhibitors"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M9576",
"name": "Hemostatics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13865",
"name": "Platelet Aggregation Inhibitors",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D020141",
"term": "Hemostatic Disorders"
},
{
"id": "D001778",
"term": "Blood Coagulation Disorders"
}
],
"interventions": []
} |
NCT05326126 | null | Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis | Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis | None | INTERVENTIONAL | RECRUITING | 2021-10-08T00:00:00 | null | 2024-10-30T00:00:00 | 2025-10-30T00:00:00 | [
"NA"
] | 75 | 18 | 80 | ALL | false | Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis | Severe symptomatic aortic stenosis is commonly encountered in clinical practice, affecting close to 5% of individuals older than 65 years of age, and carries a dismal prognosis if left untreated.(1,2) Chronically increased left ventricular afterload triggers a compensatory myocardial response, ultimately leading to ventricular hypertrophy, aimed at reducing chronically increased wall tension an restore cardiac performance.(3) Hypertrophy ultimately results in maladaptive changes and ultimately leads to heart failure and eventually increased risk of cardiac mortality. Myocardial fibrosis and altered myocardial perfusion appear to play a role in progressive cardiac decompensation. | Inclusion Criteria:
• All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study
Exclusion Criteria:
* Age \<18 years
* Inability to express informed consent to take part in the present study.
* Pregnancy or lactation
* Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study
* Significant chronic kidney disease (estimated glomerular filtration rate \<30 ml/min)
* Known significant epicardial coronary artery stenosis
* Known contraindication to adenosine administration:
* Known allergic reactions
* Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker)
* Long QT syndrome
* Unstable angina
* Severe hypotension
* Acutely decompensated heart failure
* Chronic obstructive pulmonary disease with bronchospasm
* Concomitant use of dypiridamole | IRCCS San Raffaele | OTHER | {
"id": "TAVI IMR",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-04-08T00:00:00 | {
"date": "2024-03-06",
"type": "ACTUAL"
} | {
"date": "2022-04-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "TAVI's intervention will be performed as per current clinical indications and according to the hospital's clinical practice. To this will be added the evaluation of coronary physiology using Pressure Eire X and Coroventis software, which, although performed in accordance with the IFU of the aforementioned devices, is considered an experimental procedure. Adenosine will be required to complete the measurement of coronary physiology",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Patients will be assigned a univocal identification code. Medical personnel in charge of baseline, in-hospital and follow-up data acquisition will be allowed to know each patient identity.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Severe Symptomatic Aortic Stenosis"
] | null | null | [
{
"city": "Milan",
"country": "Italy",
"facility": "IRCCS San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The burden of myocardial fibrosis",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Index of microcirculatory resistance (IMR)",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Acute change in coronary flow reserve (CRF)",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Acute change in index of microcirculatory resistance (IMR)",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Computed tomography derived extracellular volume",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "All-cause death",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Cardiovascular death",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Any rehospitalization",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Cardiovascular rehospitalization",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "IRCCS San Raffaele",
"name": "Matteo montorfano, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020763",
"term": "Pathological Conditions, Anatomical"
},
{
"id": "D000082862",
"term": "Aortic Valve Disease"
},
{
"id": "D006349",
"term": "Heart Valve Diseases"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014694",
"term": "Ventricular Outflow Obstruction"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M8485",
"name": "Fibrosis",
"relevance": "LOW"
},
{
"asFound": "Stenosis",
"id": "M6475",
"name": "Constriction, Pathologic",
"relevance": "HIGH"
},
{
"asFound": "Aortic Stenosis",
"id": "M4340",
"name": "Aortic Valve Stenosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22519",
"name": "Pathological Conditions, Anatomical",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2379",
"name": "Aortic Valve Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9437",
"name": "Heart Valve Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17440",
"name": "Ventricular Outflow Obstruction",
"relevance": "LOW"
},
{
"asFound": "Aortic Stenosis",
"id": "T449",
"name": "Aortic Valve Stenosis",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D001024",
"term": "Aortic Valve Stenosis"
},
{
"id": "D003251",
"term": "Constriction, Pathologic"
}
]
} | null | {
"conditions": [
{
"id": "D001024",
"term": "Aortic Valve Stenosis"
},
{
"id": "D003251",
"term": "Constriction, Pathologic"
}
],
"interventions": null
} |
NCT00795626 | null | Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease. | Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease. | NERE-CR | INTERVENTIONAL | COMPLETED | 2008-11-20T00:00:00 | null | null | null | [
"NA"
] | 74 | 18 | null | ALL | false | Evaluate the impact of systematic nursing orientations in the reduction of predicted cardiovascular risk in patients with coronary artery disease during four nursing visits for a 1-year period and compare to a group of patients submitted to conventional treatment. | Assess 184 (two groups) patients during four nursing visits for a 1-year period and compare to a group of patients submitted to conventional treatment. We will evaluate the impact of systematic nursing orientations in the reduction of predicted cardiovascular risk in patients with coronary artery disease. | Inclusion Criteria:
* patients of both sexes;
* aged 18 years or older;
* diagnosed with ACS (unstable angina and acute myocardial infarction with ST segment elevation and without ST segment elevation) with CAD diagnosed by cardiac catheterization or electrocardiogram;
* patients have to agree to participate by signing a consent term
Exclusion Criteria:
* patients with cognitive deficits;
* neurological sequelae;
* who are not able to come for visits, or who do not consent to participate in the study. | Hospital de Clinicas de Porto Alegre | OTHER | {
"id": "UFRGS and HCPA 06570",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-11-20T00:00:00 | {
"date": "2013-02-05",
"type": "ESTIMATED"
} | {
"date": "2008-11-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Coronary Heart Disease"
] | ["nursing education", "cardiovascular risk factors", "coronary heart disease"] | null | [
{
"city": "Porto Alegre",
"country": "Brazil",
"facility": "Eneida Rejane Rabelo",
"geoPoint": {
"lat": -30.03306,
"lon": -51.23
},
"state": "Rio Grande do Sul"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Reduction of Predicted Cardiovascular Risk",
"timeFrame": "one year"
}
],
"secondary": [
{
"description": null,
"measure": "Knowledge of the risk factors and the adhesion to pharmacology treatment; Reduction of the modified risk factors in the previous knowledge of patients and their adhesion;",
"timeFrame": "one year"
}
]
} | [
{
"affiliation": "Federal University of Rio Grande do Sul Post Grad Prog",
"name": "Eneida R Rabelo, RN, ScD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D001161",
"term": "Arteriosclerosis"
},
{
"id": "D001157",
"term": "Arterial Occlusive Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Heart Disease",
"id": "M9419",
"name": "Heart Diseases",
"relevance": "HIGH"
},
{
"asFound": "Coronary Heart Disease",
"id": "M19506",
"name": "Myocardial Ischemia",
"relevance": "HIGH"
},
{
"asFound": "Coronary Artery Disease",
"id": "M6546",
"name": "Coronary Artery Disease",
"relevance": "HIGH"
},
{
"asFound": "Coronary Heart Disease",
"id": "M6549",
"name": "Coronary Disease",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10543",
"name": "Ischemia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4469",
"name": "Arteriosclerosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4465",
"name": "Arterial Occlusive Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003324",
"term": "Coronary Artery Disease"
},
{
"id": "D017202",
"term": "Myocardial Ischemia"
},
{
"id": "D003327",
"term": "Coronary Disease"
},
{
"id": "D006331",
"term": "Heart Diseases"
}
]
} | null | {
"conditions": [
{
"id": "D003324",
"term": "Coronary Artery Disease"
},
{
"id": "D017202",
"term": "Myocardial Ischemia"
},
{
"id": "D003327",
"term": "Coronary Disease"
},
{
"id": "D006331",
"term": "Heart Diseases"
}
],
"interventions": null
} |
NCT03406026 | null | Balance Systems Protocol for Subacute Phase Stroke Patients. | Evaluation of the Effect of the Protocol Focused on the Balance Systems in Patients Who Are in the Subacute Phase of the Stroke | BSPStroke | INTERVENTIONAL | COMPLETED | 2017-12-18T00:00:00 | null | 2018-06-30T00:00:00 | 2018-07-15T00:00:00 | [
"NA"
] | 65 | 18 | null | ALL | false | The aim of the study is to evaluate if the application of a protocol focused on the equilibrium systems versus the conventional treatments decreases the time to acquire equilibrium in standing, the risk of falls and favors the early initiation of treatments aimed at recovering the physiological gait. | In order to respond to the objectives, a randomized clinical trial was proposed on a total N of 70 stroke survivors (N = 35 patients in the control group and N = 35 patients in the intervention group), who Are in the subacute stage of the disease, meet the inclusion and exclusion criteria, and require hospitalization to perform the rehabilitative treatment.
For this, a rehabilitation treatment protocol was designed focusing on the equilibrium systems. The intervention of the study will be carried out during 4 weeks. The control group will receive conventional rehabilitation treatment for stroke patients, consisting of physiotherapy therapy for 60 minutes; While the intervention group will receive conventional rehabilitative treatment during the first 45 minutes and the last 15 minutes therapy will be based on the protocol designed.
The evaluation of the program will be carried out based on the stated objectives. In order to evaluate the improvement of the patients in terms of balance, gait, risk of falls and patient autonomy, these will be assessed at the beginning of the intervention at 15 days and at the end (30 days). After the intervention two more assessments will be made; At 3 months and at 6 months to follow up in time. | Inclusion Criteria:
* Patients ≥ 18 years, who are admitted to an intermediate care unit after an acute stroke, for functional recovery.
* Diagnosis of ischemic or hemorrhagic stroke confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
* Patients with no alteration on sitting balance: patients should be able to sit on the edge of the bed with the hip and knees on 90º flexion, feet flat on the floor and inclination forward 30º towards the healthy and paretic side and able to return to the vertical balance without any support of the back or upper limbs.
Exclusion Criteria:
* Patients with severe prior functional dependence (Barthel Index ≤60)
* Patients diagnosed with dementia or previous cognitive impairment
* Patients diagnosed with delirium.
* Patients diagnosed with Wernicke aphasia.
* Patients with previous visual deficit (retinopathy, cataract, etc.)
* Patient with a history of other causes of balance impairment.
* Patients with orthopedic conditions that difficult the performance of the proposed rehabilitation treatment. | Universitat Internacional de Catalunya | OTHER | {
"id": "3669 CEEAH",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-01-19T00:00:00 | {
"date": "2018-11-06",
"type": "ACTUAL"
} | {
"date": "2018-01-23",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Stroke Sequelae"
] | ["Stroke", "Balance rehabilitation", "Physiotherapy"] | null | [
{
"city": "Barcelona",
"country": "Spain",
"facility": "Centro Hospitalario Pere Virgili",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Institut Investigacio Sanitaria Pere Virgili"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline Balance",
"timeFrame": "At baseline, 15 days, 1 month"
}
],
"secondary": [
{
"description": null,
"measure": "Gait",
"timeFrame": "At baseline, 15 days, 1 month"
},
{
"description": null,
"measure": "Falling risk",
"timeFrame": "At baseline, 15 days, 1 month"
},
{
"description": null,
"measure": "Independence in basic activities of daily life",
"timeFrame": "At baseline, 15 days, 1 moth"
}
]
} | [
{
"affiliation": "Universitat Internacional de Catalunya",
"name": "Caritat Bagur, Physio",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D002561",
"term": "Cerebrovascular Disorders"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
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"abbrev": "BC10",
"name": "Nervous System Diseases"
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"abbrev": "BC14",
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"relevance": "LOW"
},
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"id": "M5204",
"name": "Brain Diseases",
"relevance": "LOW"
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"id": "M17400",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020521",
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}
]
} | null | {
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{
"id": "D020521",
"term": "Stroke"
}
],
"interventions": null
} |
NCT05205226 | null | Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment | Efficacy and Safety of Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment of Advanced Non-small Cell Lung Cancer: a Retrospective-real World Study | None | OBSERVATIONAL | COMPLETED | 2022-01-11T00:00:00 | null | 2021-06-05T00:00:00 | 2022-01-02T00:00:00 | null | 636 | 18 | null | ALL | null | This study aimed to confirmed that local radiotherapy for residual lesions can significantly prolong the efficacy of chemotherapy combined with immunotherapy in the initial treatment of advanced non-small cell lung cancer. | null | Inclusion Criteria:
* ≥18，Advanced Non-small Cell Lung Cancer Confirmed by Histopathology Patients received platinum-based chemotherapy combined with immunotherapy
Exclusion Criteria:
* EGFR/ALK/ROS1 driver gene mutation
* Chemotherapy only
* Concurrent radio-chemotherapy
* Surgery
* Single-agent immunotherapy
* No treatment information available | Hunan Province Tumor Hospital | OTHER | {
"id": "SPLENDOR",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-01-11T00:00:00 | {
"date": "2022-01-25",
"type": "ACTUAL"
} | {
"date": "2022-01-25",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with non driver mutation advanced non-small-cell lung cancer non driver mutation | PROBABILITY_SAMPLE | null | {
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"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
} | [
"Non Small Cell Lung Cancer"
] | null | null | [
{
"city": "Changsha",
"country": "China",
"facility": "Hunan Cancer Hospital",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "PFS",
"timeFrame": "January 2018 to June 2021"
}
],
"secondary": [
{
"description": null,
"measure": "RT",
"timeFrame": "January 2018 to June 2021"
}
]
} | [
{
"affiliation": "Hunan Cancer Hospital",
"name": "Yongchang C Zhang, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012142",
"term": "Respiratory Tract Neoplasms"
},
{
"id": "D013899",
"term": "Thoracic Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
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{
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"term": "Carcinoma, Bronchogenic"
},
{
"id": "D001984",
"term": "Bronchial Neoplasms"
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{
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"term": "Neoplastic Processes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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],
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"id": "M5546",
"name": "Carcinoma, Non-Small-Cell Lung",
"relevance": "HIGH"
},
{
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"id": "M5534",
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"relevance": "LOW"
},
{
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"relevance": "HIGH"
},
{
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"name": "Respiratory Tract Neoplasms",
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},
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},
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},
{
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"id": "M5540",
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"relevance": "LOW"
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{
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"id": "M5260",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M12330",
"name": "Neoplastic Processes",
"relevance": "LOW"
}
],
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"term": "Lung Neoplasms"
},
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
},
{
"id": "D018365",
"term": "Neoplasm, Residual"
}
]
} | null | {
"conditions": [
{
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"term": "Lung Neoplasms"
},
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
},
{
"id": "D018365",
"term": "Neoplasm, Residual"
}
],
"interventions": null
} |
NCT05023226 | null | Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS | Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS | ARDS | INTERVENTIONAL | UNKNOWN | 2021-08-21T00:00:00 | null | 2023-08-31T00:00:00 | 2023-08-31T00:00:00 | [
"NA"
] | 30 | 20 | 70 | ALL | false | The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS.
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality. | ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality. | Inclusion Criteria:
* Age 20 to 70 years old.
* Patients with hypoxemia receiving endotracheal mechanical ventilation therapy.
* The ARDS diagnostic criteria of Berlin Definition, arterial oxygen tension \[PaO2\]/fractional inspired oxygen \[FiO2\] ratio (PaO2/FiO2) \<200 mm Hg, recent appearance of bilateral pulmonary infiltrates consistent with edema and no clinical evidence of left atrial hypertension.
* Within 72 hours after ARDS diagnosis.
Exclusion Criteria:
* Pregnancy.
* Participate in other interventional trials at the same time during the acceptance period.
* Severe trauma combined with rib fracture or pneumothorax, subcutaneous emphysema, and mediastinal air accumulation within three months.
* Severe chronic respiratory diseases that require long-term use of oxygen therapy or home mechanical ventilation.
* Have a history of cachexia or terminal cancer.
* Use immunosuppressants, chemotherapy or radiation therapy.
* Contraindications for hypercapnia, such as patients with acute brain injury due to intracranial hypertension or craniotomy. | Asia University | OTHER | {
"id": "AUH-CT-ZK01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-08-25T00:00:00 | {
"date": "2023-02-01",
"type": "ACTUAL"
} | {
"date": "2021-08-26",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"ARDS"
] | ["Acute respiratory distress syndrome (ARDS)", "Recruitment maneuvers (RM)", "Oxygenation index(OI)", "Lung ultrasound score(LUS)"] | null | [
{
"city": "Taichung",
"country": "Taiwan",
"facility": "Asia University",
"geoPoint": {
"lat": 24.1469,
"lon": 120.6839
},
"state": "Wufeng"
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Oxygenation index(OI)",
"timeFrame": "Baseline - 72 hrs after enrollment"
},
{
"description": null,
"measure": "Lung ultrasound score(LUS)",
"timeFrame": "Baseline - 72 hrs after enrollment"
}
],
"secondary": [
{
"description": null,
"measure": "Ventilator days",
"timeFrame": "Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day"
},
{
"description": null,
"measure": "Length of stay in the ICU (days)",
"timeFrame": "Transfer out of ICU day - Admission to ICU day + 1 day"
},
{
"description": null,
"measure": "ICU mortality",
"timeFrame": "During ICU course"
}
]
} | [
{
"affiliation": "Asia University Hospital",
"name": "Zi-Tin Kuan, RN",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "28746224", "type": "RESULT", "citation": "Chung FT, Lee CS, Lin SM, Kuo CH, Wang TY, Fang YF, Hsieh MH, Chen HC, Lin HC. Alveolar recruitment maneuver attenuates extravascular lung water in acute respiratory distress syndrome. Medicine (Baltimore). 2017 Jul;96(30):e7627. doi: 10.1097/MD.0000000000007627."}] | {"versionHolder": "2025-06-18"} | {
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{
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"name": "All Conditions"
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{
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"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC16",
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{
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"name": "Rare Diseases"
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],
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},
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},
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},
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"name": "Acute Lung Injury",
"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
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"id": "T192",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "T170",
"name": "Acute Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": null
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Ot",
"name": "Other Dietary Supplements"
}
],
"browseLeaves": [
{
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"id": "M4854",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "T433",
"name": "Tannic Acid",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [],
"interventions": []
} |
NCT02808026 | null | Study of CS-3150 in Patients With Severe Hypertension | A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III) | None | INTERVENTIONAL | COMPLETED | 2016-06-17T00:00:00 | null | null | null | [
"PHASE3"
] | 20 | 20 | 80 | ALL | false | To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III). | null | Inclusion Criteria:
* Male and female subjects aged 20 to 80 years at informed consent
* Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)
Exclusion Criteria:
* Patients who are suspected hypertensive emergency
* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
* eGFR \< 60 mL/min/1.73 m\^2. | Daiichi Sankyo | INDUSTRY | {
"id": "CS3150-A-J304",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-06-17T00:00:00 | {
"date": "2018-12-21",
"type": "ACTUAL"
} | {
"date": "2016-06-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Severe Hypertension"
] | ["severe hypertension", "grade III hypertension", "mineralocorticoid receptor antagonist"] | null | [
{
"city": "Sapporo",
"country": "Japan",
"facility": null,
"geoPoint": {
"lat": 43.06667,
"lon": 141.35
},
"state": null
}
] | null | null | {
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"description": null,
"measure": "Change from baseline in sitting systolic and diastolic blood pressure",
"timeFrame": "Baseline to end of Week 8"
}
],
"secondary": [
{
"description": null,
"measure": "Time course of systolic and diastolic blood pressure",
"timeFrame": "Baseline to end of Week 8"
},
{
"description": null,
"measure": "Proportion of patients achieving blood pressure control",
"timeFrame": "Baseline to end of Week 8"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
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],
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"relevance": "HIGH"
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"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006973",
"term": "Hypertension"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
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"name": "Mineralocorticoids",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3797",
"name": "Mineralocorticoid Receptor Antagonists",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D006973",
"term": "Hypertension"
}
],
"interventions": []
} |
NCT06744426 | null | A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 Under Fasting Conditions | An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase I Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 in Healthy Volunteers | None | INTERVENTIONAL | COMPLETED | 2024-12-17T00:00:00 | null | 2025-03-12T00:00:00 | 2025-03-12T00:00:00 | [
"PHASE1"
] | 60 | 19 | null | ALL | true | The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fasting conditions | null | Inclusion Criteria:
* Those weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum.
* Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
Exclusion Criteria:
* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman. | Boryung Pharmaceutical Co., Ltd | INDUSTRY | {
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"date": "2024-12-20",
"type": "ACTUAL"
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"city": "Seoul",
"country": "Korea, Republic of",
"facility": "Clinical Research Center, H PLUS Yangji Hospital",
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"lon": 126.9784
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"state": "Gwanakgu"
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}
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NCT00200226 | null | Oral Misoprostol Before Endometrial Biopsy | Oral Misoprostol Before Endometrial Biopsy | None | INTERVENTIONAL | COMPLETED | 2005-09-12T00:00:00 | null | null | null | [
"PHASE3"
] | 72 | 19 | null | FEMALE | true | An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform. | null | Inclusion Criteria:
* women 19 years and older
* planned endometrial biopsy
Exclusion Criteria:
* known hypersensitivity or allery to prostaglandins
* seizure disorder
* liver disease
* known abnormal liver function tests
* pregnancy | Memorial University of Newfoundland | OTHER | {
"id": "HIC02.159",
"link": null,
"type": null
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"nctId": null,
"statusForNctId": null
} | 2005-09-12T00:00:00 | {
"date": "2007-09-21",
"type": "ESTIMATED"
} | {
"date": "2005-09-20",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
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"facility": "Women's Health Centre, Eastern Health",
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"facility": "Obstetrics and Gynecology Associates",
"geoPoint": {
"lat": 44.67134,
"lon": -63.57719
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"state": "Nova Scotia"
}
] | null | null | {
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"timeFrame": "during procedure"
}
],
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"description": null,
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{
"description": null,
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]
} | [
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"affiliation": "Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland",
"name": "Joan MG Crane, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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] | null | {"versionHolder": "2025-06-18"} | {
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NCT02484326 | null | Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction | Development and Validation of a Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction | None | OBSERVATIONAL | COMPLETED | 2015-06-22T00:00:00 | null | null | null | null | 3,779 | 18 | 80 | ALL | false | The purpose of this study is to validate a practical risk score to predict the mechanical complication of ST-elevation myocardial infarction (STEMI). | STEMI patients chewed 300 mg aspirin and 600 mg clopidogrel in the emergency department, followed by oral 100 mg aspirin and 75mg clopidogrel daily for at least 12 months. STEMI patients received low molecular weight heparin (LMWH), β-blockers, and angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) according to the STEMI guideline, unless there were contraindications to these drugs. Peripheral blood samples were collected from patients within 2 hours of admission for blood routines and blood biochemistry examinations. White blood cell counts and level of hemoglobin were assessed with automated cell counters via standard techniques. The investigators followed up patients in validation group for three month to observe the cardiac rupture events and other adverse cardiac events . | Inclusion Criteria:
ST-elevation myocardial infarction: concurrence of symptoms (chest pain or symptoms compatible with acute heart failure or unexplained syncope) and electrocardiogram findings (new onset left bundle branch block or ST-segment elevation≥1 mm in ≥2 inferior leads or ≥2 mm in ≥2 precordial leads)
Exclusion Criteria:
cancer mental illness | Chinese PLA General Hospital | OTHER | {
"id": "14FCJJ01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2015-06-24T00:00:00 | {
"date": "2015-06-29",
"type": "ESTIMATED"
} | {
"date": "2015-06-29",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
] | ST-elevation myocardial infarction patients who were admitted from January 2012 to January 2013 | NON_PROBABILITY_SAMPLE | true | {
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} | [
"Cardiac Rupture"
] | ["ST-elevation myocardial infarction", "Cardiac rupture", "Risk assessment"] | null | [
{
"city": "Peking",
"country": "China",
"facility": "Chinese People's Liberation Army General Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
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"state": "Beijing"
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] | null | null | {
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],
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} | null | [{"pmid": "20660803", "type": "RESULT", "citation": "Pouleur AC, Barkoudah E, Uno H, Skali H, Finn PV, Zelenkofske SL, Belenkov YN, Mareev V, Velazquez EJ, Rouleau JL, Maggioni AP, Kober L, Califf RM, McMurray JJ, Pfeffer MA, Solomon SD; VALIANT Investigators. Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. Circulation. 2010 Aug 10;122(6):597-602. doi: 10.1161/CIRCULATIONAHA.110.940619. Epub 2010 Jul 26."}, {"pmid": "20102891", "type": "RESULT", "citation": "French JK, Hellkamp AS, Armstrong PW, Cohen E, Kleiman NS, O'Connor CM, Holmes DR, Hochman JS, Granger CB, Mahaffey KW. Mechanical complications after percutaneous coronary intervention in ST-elevation myocardial infarction (from APEX-AMI). Am J Cardiol. 2010 Jan 1;105(1):59-63. doi: 10.1016/j.amjcard.2009.08.653."}, {"pmid": "20975001", "type": "RESULT", "citation": "Figueras J, Barrabes JA, Serra V, Cortadellas J, Lidon RM, Carrizo A, Garcia-Dorado D. Hospital outcome of moderate to severe pericardial effusion complicating ST-elevation acute myocardial infarction. Circulation. 2010 Nov 9;122(19):1902-9. doi: 10.1161/CIRCULATIONAHA.109.934968. Epub 2010 Oct 25."}, {"pmid": "20231153", "type": "RESULT", "citation": "Lopez-Sendon J, Gurfinkel EP, Lopez de Sa E, Agnelli G, Gore JM, Steg PG, Eagle KA, Cantador JR, Fitzgerald G, Granger CB; Global Registry of Acute Coronary Events (GRACE) Investigators. Factors related to heart rupture in acute coronary syndromes in the Global Registry of Acute Coronary Events. Eur Heart J. 2010 Jun;31(12):1449-56. doi: 10.1093/eurheartj/ehq061. Epub 2010 Mar 15."}, {"pmid": "24970335", "type": "RESULT", "citation": "Jones BM, Kapadia SR, Smedira NG, Robich M, Tuzcu EM, Menon V, Krishnaswamy A. Ventricular septal rupture complicating acute myocardial infarction: a contemporary review. Eur Heart J. 2014 Aug 14;35(31):2060-8. doi: 10.1093/eurheartj/ehu248. Epub 2014 Jun 26."}, {"pmid": "23897793", "type": "RESULT", "citation": "Qian G, Liu HB, Wang JW, Wu C, Chen YD. Risk of cardiac rupture after acute myocardial infarction is related to a risk of hemorrhage. J Zhejiang Univ Sci B. 2013 Aug;14(8):736-42. doi: 10.1631/jzus.B1200306."}, {"pmid": "25456862", "type": "RESULT", "citation": "Roberts WC, Burks KH, Ko JM, Filardo G, Guileyardo JM. Commonalities of cardiac rupture (left ventricular free wall or ventricular septum or papillary muscle) during acute myocardial infarction secondary to atherosclerotic coronary artery disease. Am J Cardiol. 2015 Jan 1;115(1):125-40. doi: 10.1016/j.amjcard.2014.10.004. Epub 2014 Oct 13."}, {"pmid": "28132793", "type": "DERIVED", "citation": "Qian G, Jin RJ, Fu ZH, Yang YQ, Su HL, Dong W, Guo J, Jing J, Guo YL, Chen YD. Development and validation of clinical risk score to predict the cardiac rupture in patients with STEMI. Am J Emerg Med. 2017 Apr;35(4):589-593. doi: 10.1016/j.ajem.2016.12.033. Epub 2016 Dec 15."}] | {"versionHolder": "2025-06-18"} | {
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NCT00685126 | null | Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD) | A Safety, Tolerability and Efficacy Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects Birth to 48 Months Old With Reactive Airways Disease in an Acute Setting | None | INTERVENTIONAL | COMPLETED | 2008-05-23T00:00:00 | null | null | null | [
"PHASE3"
] | 117 | null | 48 | ALL | false | The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old. | A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc. | Inclusion Criteria:
* Subject, male or female, must be between the ages of birth to 48 months inclusive at the time of consent.
* Subject must have experienced at least one previous episode or have a history of reactive airways disease.
* Subject must have an Oxygen saturation ≥ 90% at room air or with no more than 2 L/min supplemental Oxygen.
Exclusion Criteria:
* Subject who has participated in an investigational drug study within 30 days prior to study start, or who has previously participated in this study.
* Subject with a known sensitivity to levalbuterol or racemic albuterol, including Ventolin® or any of the excipients contained in any of these formulations.
* Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated. | Sumitomo Pharma America, Inc. | INDUSTRY | {
"id": "051-033",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-05-23T00:00:00 | {
"date": "2012-02-22",
"type": "ESTIMATED"
} | {
"date": "2008-05-28",
"type": "ESTIMATED"
} | [
"CHILD"
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} | [
"Reactive Airways Disease (RAD)"
] | ["RAD", "Reactive Airways Disease", "Levalbuterol", "Racemic albuterol"] | null | [
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"country": "United States",
"facility": null,
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"lon": -92.28959
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"state": "Arkansas"
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} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT04301726 | null | Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD | Efficacy of Deutetrabenazine in Huntington's Disease Patients with Dysphagia: a Randomised, Placebo-controlled Pilot Study | None | INTERVENTIONAL | TERMINATED | 2020-02-13T00:00:00 | null | 2023-08-18T00:00:00 | 2023-09-01T00:00:00 | [
"PHASE1"
] | 36 | 21 | null | ALL | false | To determine the efficacy of deutetrabenazine to control symptoms of dysphagia associated with HD. | The primary endpoint is the change in swallow function/dysphagia from baseline to maintenance therapy. | Inclusion Criteria:
* Confirmed diagnosis of HD
* Symptoms of dysphagia
* Must be able to swallow tablets
Exclusion Criteria:
* Other confounding diseases that affect swallowing
* Depression
* Hepatic impairment
* Renal impairment
* Dementia | Fundacion Huntington Puerto Rico | OTHER | {
"id": "2002027824",
"link": null,
"type": null
} | The study was terminated prematurely due to the lack of availability of the study drug. | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2020-03-06T00:00:00 | {
"date": "2025-02-27",
"type": "ACTUAL"
} | {
"date": "2020-03-10",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
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]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Huntington Disease"
] | null | null | [
{
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"country": "Puerto Rico",
"facility": "Fundacion Huntington Puerto Rico, Inc. - Huntington's disease Clinic",
"geoPoint": {
"lat": 18.46633,
"lon": -66.10572
},
"state": null
}
] | null | null | {
"other": [
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"description": null,
"measure": "Effect of deutetrabenazine on quality of life in HD patients.",
"timeFrame": "18 months"
}
],
"primary": [
{
"description": null,
"measure": "Efficacy of deutetrabenazine to control symptoms of dysphagia associated with Huntington's disease.",
"timeFrame": "18 months"
},
{
"description": null,
"measure": "Non-instrumental assessment of the efficacy of deutetrabenazine to control symptoms of dysphagia associated with Huntington's disease.",
"timeFrame": "18 months"
},
{
"description": null,
"measure": "Instrumental assessment of the efficacy of deutetrabenazine to control symptoms of dysphagia associated with Huntington's disease.",
"timeFrame": "18 months"
}
],
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"description": null,
"measure": "Effect of deutetrabenazine on body weight in HD patients.",
"timeFrame": "18 months"
},
{
"description": null,
"measure": "Effect of deutetrabenazine on body mass index in HD patients.",
"timeFrame": "18 months"
},
{
"description": null,
"measure": "Effect of deutetrabenazine on fat distribution in HD patients.",
"timeFrame": "18 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT06302426 | null | Trial of INI-4001 in Patients With Advanced Solid Tumours | An Open-label, Multiple-Ascending Dose, Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-01-16T00:00:00 | null | 2024-08-01T00:00:00 | 2026-04-30T00:00:00 | [
"PHASE1"
] | 50 | 18 | null | ALL | false | Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors. | This is a Phase Ia/Ib, open-label, dose-escalation, and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion). Phase Ia will initially seek to establish the MTD of INI-4001 administered as a monotherapy. Following identification of the MTD, any dose level at or below the MTD may be further expanded to further explore the safety, PK, PD, and preliminary efficacy of INI-4001 alone and in combination with a complementary therapy (Phase Ib).
Following cessation of INI-4001, patients will be requested to participate in long-term follow-up to assess overall survival. This long-term follow-up will continue for each patient until at least 1 year after their last dose of INI-4001, or until otherwise advised by the Sponsor. | Inclusion Criteria:
1. Patient has locally advanced or metastatic cancer (all solid tumours allowed except primary brain/CNS tumour or untreated spinal cord compression)
2. Patient has at least one extracranial measurable disease lesion per RECIST 1.1/ iRECIST criteria.
3. Patients with known brain metastases are eligible if they meet all the following criteria:
1. Patient has received definitive treatment of brain metastases with stereotactic body radiation therapy (SBRT) or surgery provided that the brain lesions are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study treatment)
2. Patient is neurologically stable and has had no persistent side effects / complications from prior treatment.
3. Patient has no evidence of new or enlarging brain metastases (confirmed by repeat imaging) and has not required steroids for at least 14 days prior to first dose administration on Day 1.
4. Female patients must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal
Exclusion Criteria:
1. Prior therapy with a TLR7 and/or TLR8 agonist, unless first approved by the medical monitor.
2. Has primary brain/CNS tumour or untreated spinal cord compression.
3. Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis.
4. Evidence of abnormal cardiac function
5. Clinically significant active infection within 2 weeks prior to commencement of treatment, or unexplained fever (temperature \> 38.1°C) within 7 days prior to first dose administration on Cycle 1 Day 1.
6. Known active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
7. History of other malignancy not meeting inclusion criterion #1 within the past 2 years
8. Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Day 1.
9. Received cancer-directed therapy
10. A history of autoimmune diseases that has caused terminal organ damage or required systemic immunosuppression / systemic disease modulating drugs within the past 2 years.
11. Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, (e.g., COPD) in dosing exceeding 10 mg daily of prednisone equivalent). Inhaled steroids are allowed.
12. History of prior organ allograft.
13. Known hypersensitivity to the study drug or its inactive ingredients. | Inimmune Corporation | INDUSTRY | {
"id": "INI-4001-101",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-03-04T00:00:00 | {
"date": "2024-03-08",
"type": "ACTUAL"
} | {
"date": "2024-03-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "This is a Phase Ia/Ib, open-label, dose-escalation and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Advanced Solid Tumor"
] | null | null | [
{
"city": "Albury",
"country": "Australia",
"facility": "The Border Cancer Hospital",
"geoPoint": {
"lat": -36.07482,
"lon": 146.92401
},
"state": "New South Wales"
},
{
"city": "Malvern",
"country": "Australia",
"facility": "Cabrini Hospital",
"geoPoint": {
"lat": -32.02849,
"lon": 151.32225
},
"state": "Victoria"
}
] | [
{
"class": "INDUSTRY",
"name": "Avance Clinical Pty Ltd."
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy",
"timeFrame": "Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21"
}
],
"secondary": [
{
"description": null,
"measure": "Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses",
"timeFrame": "Assessed at Screening, then daily from Cycle 1 Day 1 through to 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses",
"timeFrame": "Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21"
},
{
"description": null,
"measure": "Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Number of Participants with a Change from baseline in body weight after multiple ascending doses",
"timeFrame": "Assessed at Screening then pre-dose on Day 1 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first"
},
{
"description": null,
"measure": "Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first"
},
{
"description": null,
"measure": "Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first"
},
{
"description": null,
"measure": "Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first"
},
{
"description": null,
"measure": "Change from baseline in measurements of HR in beats per minute after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses",
"timeFrame": "Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses",
"timeFrame": "Screening, then Cycle 1 & Cycle 2 (each cycle is 21 days) on Day 1, Day 8 and Day 15 and then at 7 days and 30 days post last dose of INI-4001"
},
{
"description": null,
"measure": "Single dose PK Parameters - maximum observed concentration (Cmax)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - maximum observed concentration (Cmax)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Time to Cmax (Tmax)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - Time to Cmax (Tmax)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Total amount excreted in urine (Ae)",
"timeFrame": "Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Fraction excreted in the urine (Fe)",
"timeFrame": "Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Renal clearance (CLr)",
"timeFrame": "Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Area under the concentration-time curve (AUC0-t)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Half-life (t1/2)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - Half-life (t1/2)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Clearance (Cl)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - Clearance (Cl)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Single dose PK Parameters - Volume of distribution (Vz)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
},
{
"description": null,
"measure": "Multiple dose PK Parameters - Volume of distribution (Vz)",
"timeFrame": "Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)"
}
]
} | [
{
"affiliation": "Inimmune Corp",
"name": "Jon L Ruckle",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": null,
"browseLeaves": null,
"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D000082082",
"term": "Immune Checkpoint Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
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],
"browseBranches": [
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
"browseLeaves": [
{
"asFound": "Type",
"id": "M349416",
"name": "Pembrolizumab",
"relevance": "HIGH"
},
{
"asFound": "According",
"id": "M1854",
"name": "Nivolumab",
"relevance": "HIGH"
},
{
"asFound": "Static",
"id": "M302522",
"name": "Cemiplimab",
"relevance": "HIGH"
},
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"asFound": "Intravenous infusion",
"id": "M349417",
"name": "Atezolizumab",
"relevance": "HIGH"
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"asFound": "Powder",
"id": "M272500",
"name": "Durvalumab",
"relevance": "HIGH"
},
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"id": "M2342",
"name": "Immune Checkpoint Inhibitors",
"relevance": "LOW"
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"asFound": "Cystic",
"id": "M344580",
"name": "Avelumab",
"relevance": "HIGH"
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"name": "Antineoplastic Agents, Immunological",
"relevance": "LOW"
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],
"meshes": [
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"term": "Pembrolizumab"
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"term": "Nivolumab"
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"id": "C000613593",
"term": "Durvalumab"
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"term": "Atezolizumab"
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"id": "C000609138",
"term": "Avelumab"
},
{
"id": "C000627974",
"term": "Cemiplimab"
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]
} | {
"conditions": [
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],
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{
"id": "C582435",
"term": "Pembrolizumab"
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"term": "Nivolumab"
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{
"id": "C000609138",
"term": "Avelumab"
},
{
"id": "C000627974",
"term": "Cemiplimab"
}
]
} |
NCT03500926 | null | Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem | Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem | hype | INTERVENTIONAL | UNKNOWN | 2018-03-09T00:00:00 | null | 2022-03-09T00:00:00 | 2025-03-09T00:00:00 | [
"NA"
] | 160 | 18 | null | ALL | false | This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem. | This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software. | Inclusion Criteria:
* hip osteoarthritis requiring a total hip replacement
* \>18 years old
* agrees to participate
Exclusion Criteria:
* total hip replacement not indicated
* general anesthesia contraindicated
* previous surgery on the ipsilateral femur
* follow-up not possible | Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique | OTHER | {
"id": "2017-A03215-48",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-04-10T00:00:00 | {
"date": "2018-04-18",
"type": "ACTUAL"
} | {
"date": "2018-04-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized 1/1 comparison",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "implant",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Osteoarthritis, Hip"
] | null | null | [
{
"city": "Paris",
"country": "France",
"facility": "Hopital Cochin",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France"
}
] | null | null | {
"other": [
{
"description": null,
"measure": "intraoperative proportion of patients requiring a blood transfusion",
"timeFrame": "at time of hospital discharge, at approximately 2 days"
},
{
"description": null,
"measure": "postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge",
"timeFrame": "3 months, 1 year, 2 years, 5 years"
},
{
"description": null,
"measure": "postoperative Oxford hip score after hospital discharge",
"timeFrame": "3 months, 1 year, 2 years, 5 years"
},
{
"description": null,
"measure": "scar assessement",
"timeFrame": "3 months, 1 year, 2 years, 5 years"
},
{
"description": null,
"measure": "hip pain",
"timeFrame": "3 months, 1 year, 2 years, 5 years"
},
{
"description": null,
"measure": "thigh pain",
"timeFrame": "3 months, 1 year, 2 years, 5 years"
},
{
"description": null,
"measure": "revision of hip replacement",
"timeFrame": "at 5 years"
},
{
"description": null,
"measure": "radiological outcome - engh score",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "radiological outcome - ARA (AGORA Roentgenographic Assessment) score",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "in hospital morphine consumption",
"timeFrame": "postop day 1"
},
{
"description": null,
"measure": "in hospital blood transfusion",
"timeFrame": "until discharge from hospital, at approximately 2 days"
},
{
"description": null,
"measure": "duration of hospital stay",
"timeFrame": "until discharge from hospital, at approximately 2 days"
}
],
"primary": [
{
"description": null,
"measure": "stem subsidence",
"timeFrame": "2 years postop"
}
],
"secondary": [
{
"description": null,
"measure": "Intraoperative surgeon satisfaction",
"timeFrame": "intraoperative"
}
]
} | [
{
"affiliation": "Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique",
"name": "David BIAU, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010003",
"term": "Osteoarthritis"
},
{
"id": "D001168",
"term": "Arthritis"
},
{
"id": "D007592",
"term": "Joint Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D012216",
"term": "Rheumatic Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M12926",
"name": "Osteoarthritis",
"relevance": "LOW"
},
{
"asFound": "Osteoarthritis, Hip",
"id": "M17912",
"name": "Osteoarthritis, Hip",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M4476",
"name": "Arthritis",
"relevance": "LOW"
},
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"asFound": null,
"id": "M10621",
"name": "Joint Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15045",
"name": "Rheumatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
"name": "Collagen Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D015207",
"term": "Osteoarthritis, Hip"
}
]
} | null | {
"conditions": [
{
"id": "D015207",
"term": "Osteoarthritis, Hip"
}
],
"interventions": null
} |
NCT05760326 | null | Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients | Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients | DICAS | OBSERVATIONAL | UNKNOWN | 2023-02-27T00:00:00 | null | 2023-09-30T00:00:00 | 2024-09-30T00:00:00 | null | 13 | 18 | null | ALL | false | BACKGROUND AND RATIONALE OF THE STUDY
The analysis of the composition of the clot constitutes a promising tool for investigating the possible pathogenetic mechanisms underlying ischemic stroke. This analysis was made possible thanks to the numerous mechanical thrombectomy operations which have now become routine.
Several studies have attempted to explore the possible relationship between the primary site of thrombus formation and clot composition, reporting that cardioembolic stroke may have a higher percentage of platelet-rich areas than noncardioembolic thrombosis. However, the data are conflicting and do not seem to support an association between clot histology and etiology. Furthermore, thrombus composition appears to influence thrombolysis and the efficacy of thrombectomy. For example, fibrin-rich thrombi appear to reduce the effectiveness of thrombolytic treatment and require more steps with mechanical thrombectomy treatment.
Primary ENDPOINT:
Evaluate how clot composition relates to stroke etiology according to the TOAST classification.
Secondary ENDPOINT:
* relationship between different clot components and the degree of thrombectomy recanalization as defined by treatment modified cerebral ischemia score (mTICI).
* relationship between the different components of the clot and the number of steps required to achieve recanalization.
* relationship between the different clot components and outcome indicators (NIHSS score and mRS score).
TARGET POPULATION Patients with ischemic stroke with occlusion of large intracranial vessels will be included in the study if deemed suitable for mechanical thrombectomy therapy in accordance with national and international guidelines.
INCLUSION CRITERIA
* age \> 18 years;
* Patients diagnosed with large vessel occlusion stroke in the emergency room CT Angio-study, undergoing mechanical thrombectomy procedure.
* Recovered thrombus available for analysis
EXCLUSION CRITERIA
● Lack of written informed consent.
MATERIALS AND METHODS The clot will be portioned. Part of the sample will be fixed in a 10% formalin solution (3.7% formaldehyde), part will be frozen in liquid nitrogen. Within 24-48 hours of fixation, formalin-fixed thrombi will be dehydrated by increasing the concentration of ethanol (70%, -80%, -95%, 100%) and paraffin-embedded allowing good preservation of tissue morphology and easy long-term storage. The included samples will be sectioned along the major axis of the thrombus, in slices with a thickness between 4 and 5 µm.
Base staining will be used to visualize RBC, PLT and fibrin.
* Hematoxylin and Eosin (H\&E) will allow visualization of general thrombus structures and identification of aggregates of fibrin/platelets (colored pink), red blood cells (red), and nucleated cells (dark blue).
* Martius Scarlet Blue (MSB), selectively stains fibrin (dark pink/red), red blood cells (yellow) and collagen (blue
* Mallory-Azan for collagen and phosphotungstic acid hematoxylin for fibrin.
* immunohistochemistry to detect the presence of
* Platelets (CD42-Gp-Ib+, CD41a-Gp-IIb/IIIa+, CD61-GpIIIa),
* white blood cells (CD45+, common leukocyte antigen), or monocytes/macrophages (CD14+, CD1a+, CD68+),
* T lymphocytes (CD3+, CD8/CD4+), or natural killers (CD16+, CD56+), or mobile premature endothelial cells and blood progenitors (CD34+), or neutrophils (CD45+, CD16+), or fibrinogen or von Willebrand factor. | 2. BACKGROUND
Stroke is the second leading cause of death and the third cause of disability worldwide. The majority of strokes are ischemic, mainly caused by blood thrombi occluding a cerebral vessel1. According to the TOAST classification2, four cause of stroke due to large vessel occlusion (LVO) can be identified: atherosclerosis, cardioembolic, other determined etiology (like dissection) or other undetermined causes. Strokes without a defined etiology are now called "embolic stroke of undetermined nature" (ESUS)3. This definition implies the presence of an undefined embolic source as the cause of the stroke. Not knowing the origin of the embolus, the best medical therapy in these patients is actually matter of debate4-6. Research on this topic is focusing on finding a laboratory or radiologic marker capable of clearly identified the embolic source and guide in the choice of the best medical therapy7,8.
Revascularization strategy, such as thrombolysis and thrombectomy, represent the gold standard therapy during stroke acute phase, in particular for patients with large vessel occlusion (LVO). From 2015 a growing body of evidence showed the efficacy of endovascular procedures in stroke patients and, furthermore, allowed for the first time the opportunity to collect thrombus material for research purposes9,10.
3. OBJECTIVES
The objective of this study is to evaluate how clot composition is related to stroke etiology according to the TOAST classification. Furthermore, we will also study the relationship between different clot components and thrombectomy grade of recanalization as defined by the modified treatment in cerebral ischemia score (mTICI) and the number of required passes to achieve recanalization.
4. STUDY DESIGN Study population
Patients hospitalized in the - Catholic University of the Sacred Heart, Policlinico Gemelli - Catholic University - Rome, with a stroke due to LVO treated with mechanical thrombectomy will be presented the study.
Patient will be enrolled upon their presentation to the emergency department. The usual clinical practice will be followed.
Considering the emergency setting and the impossibility for most patients to provide a valid and informed consent before e immediately after the procedures, retrieved thrombi will be collected but not analyze. An informed consent to the study will be collect in the following day. Should the patient refuse the participation, the thrombus will be discarded and the patient will be considered as a drop out from the study.
Investigators plan to include 30 patients with acute ischemic stroke due to LVO treated with mechanical thrombectomy.
Patient's characteristics Ischemic stroke patients with LVO will be included in the study if considered suitable for mechanical thrombectomy therapy in accordance with national and international guidelines.
Inclusion criteria
* age \> 18 years;
* Patients with a diagnosis of large vessel occlusion stroke at the Angio-CT study performed in the ER, undergoing a mechanical thrombectomy procedure.
* Thrombus retrieved available for analysis
Exclusion criteria:
* Deny informed consent
5. ENDPOINTS Primary endpoint
* To evaluate the association between thrombus composition, studied through histological and immunohistochemical coloration, and stroke etiology according to the TOAST classification. In particular, TOAST voices for etiological category will be dichotomize between "cardioembolic" and "not cardioembolic" (the latter including "large vessel occlusion", "other determined etiologies" and "other undetermined etiologies").
Secondary endpoints
* To evaluate the association between thrombus composition and mechanical thrombectomy outcome.
* To evaluate the association between thrombus composition and number of passes needed to obtain recanalization.
"Correlation" endpoints
• To evaluate the correlation between thrombus composition and global outcome variable such as the National Institutes of Health Stroke Scale (NIHSS) at seven days and nineteen days after the event and the modified ranking scale (mRS) at three months.
6. METHODS AND ASSESSMENT
Clinical variables and neuroimaging studies The following data will be collected: medical history recording, demographic data (age, sex), potential vascular risk factors, (hypertension, diabetes mellitus, dyslipidemia, smoking, prior stroke/ transient ischemic attack (TIA), previous vascular diseases, previous antiplatelet treatment, congestive heart failure, hypertension, vascular disease, abnormal renal/liver function, bleeding history or predisposition, labile international normalized ratio, drugs/alcohol concomitantly), diagnosis of atrial fibrillation, Oxfordshire Community Stroke Project (OCSP) classification, previous treatment with thrombolysis, ASPECTS/pc-ASPECTS (based on TC scan performed 24 h after acute stroke), andHemorrhagic trasformation subtype. At three months follow-up, the following data will be collected: intracranial bleeding, major and minor bleeding, blood transfusion, hospitalization, deaths, modified Rankin Scale (mRS) score, adherence to treatment, stroke recurrence, and myocardial infarction. Laboratory tests, blood counts, biochemistry and coagulation tests, 12-lead ECG, chest radiography, carotid ultrasonography and Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) will be performed at admission and during the hospitalization.
To evaluate neurologic deficit, the National Institute of Health Stroke Scale (NIHSS) will be performed at admission, 24, 48, 72 h, 7 days and/or at discharge, and at 3 months.
Functional outcome will be evaluated at discharge and at 3 months by modified rankin scale (mRS). Stroke etiology will be classified according to TOAST criteria for ischemic stroke. TOAST voices for etiological category will be dichotomize between "cardioembolic" and "not cardioembolic" (the latter including "large vessel occlusion", "other determined etiologies" and "other undetermined etiologies").
To evaluate infarct volume, and control hemorrhagic evolution a CT will be performed between 24 ours from treatment. Infarct volume will be quantified in cubic centimeters (cm3) and assessed according to the formula 0.5xAxBxC, where A direction and C to the number of 10mm slices where infarct volume is present \[20\]. All neuroimaging evaluations will be made by the a neuroradiologist blinded to clinical and laboratory data.
Specimen fixation and sectioning Retrieved thrombi will be portioned. Part of the specimen will be fixed in a solution of 10% formalin (3,7% formaldehyde), part will be frozen in liquid azote. Within 24-48 hours from fixation, formalin-fixed thrombi will be dehydrated via increasing concentration of ethanol (70%, -80%, -95%, 100%) and embedded in paraffin allowing a good preservation of tissue morphology and easy long-term storage. Included samples will be sectioned along the major axis of the thrombus, in slice with a 4 to 5 µm of thickness.
Staining Base coloration will be employed to visualize RBC, PLT and fibrin. Hematoxylin and eosin staining (H\&E) will allow to visualize the general overall structures of the thrombus and the identification of fibrin/platelet aggregates (colored in pink), RBC (red) and nucleated cells (dark blue). The Martius Scarlet Blue (MSB) staining, instead, will selectively stain fibrin (Dark pink/red), RBC (yellow) and collagen (Blue). RBC-rich fibrin-poor material will appears red on H\&E staining and yellow on MSB, while RBC-poor/fibrin-rich areas will appear as light pink areas on H\&E staining and pink to red areas on MSB. Since platelets are only present in large amount in RBC-poor fibrin-rich areas, thrombi will be divided in: RBC-rich/Platelets-poor, mixed and platelets-rich/RBC-poor. Additional base coloration will include Mallory-Azan for collagen and phosphotungstic acid hematoxylin for fibrin. Furthermore, immunohistochemical staining will be employed to detect the presence of Platelets (CD42-Gp-Ib+, CD41a-Gp-IIb/IIIa+, CD61-GpIIIa), white blood cells (CD45+, leukocyte common antigen), monocyte/macrophages (CD14+, CD1a+, CD68+), T lymphocytes (CD3+, CD8/CD4+), Natural Killer cells (CD16+, CD56+), premature endothelial and blood progenitor cells (CD34+), Neutrophils (CD45+, CD16+), Fibrinogen and Von Willebrand factor.
Analysis Standardized quantification algorithms to calculate thrombus composition will be employed. Computational color-based segmentation analysis by the means of ImageJ (Rasband, W.S., ImageJ, U. S. National Institutes of Health, Bethesda, Maryland, USA, https://imagej.nih.gov/ij/, 1997-2018.) will allow to apply thresholds for color and thus selective quantification of specific colors/components, providing data in automated manner about the percentage of total thrombus areas.
7. STATISTICAL ANALYSIS
In this study 28 consecutive patients fulfilling selection criteria will be included. According to the analysis of Kim (2015) strong differences in mean percentages in clot composition between the two subgroups are reported, therefore it is possible to make an hypothesis of an effect size equal to or greater than 1; using the Student's t-test this sample size of 28 patients (increased to 30 for possible technical difficulties) included in one of the two groups determined by the TOAST classification will have a power of 80% to detect such differences at a significance level of 5% (two-tailed). Statistical analyses will be performed using the IBM-SPSS, Statistical Package for Social Science (SPSS) v.20. Kolmogorov-Smirnov test will be used to evaluate data distribution: in case of deviation from normality U test di Mann-Whitney or Kruskal-Wallis test will be used for comparisons among two or more groups; in case of respect of normality assumptions Students' t-test or analysis of variance will be considered. Association between dichotomomic items will be evaluated using the Fisher exact test or χ2, as appropriate. Due to the explorative approach of this study no adjustment will be made for multiple testing.
8. ETHICAL PRINCIPLES
This study will be conducted in accordance with the principles laid down by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies, and the ICH guidelines for good clinical practice (GCP).
9. INFORMED CONSENT
The Investigator should fully inform the patient of all pertinent aspects of the study including the written information giving approval/favorable opinion by the Ethics Committee (IRB/IEC). All participants should be informed to the fullest extent possible about the study, in language and terms they are able to understand.
Prior to thrombus analysis, the written informed consent form should be signed, name filled in and personally dated by the patient or by the patient's legally acceptable representative, and by the person who conducted the informed consent discussion. A copy of the signed and dated written informed consent form will be provided to the patient. | Inclusion Criteria:
* age \> 18 years;
* Patients with a diagnosis of large vessel occlusion stroke at the Angio-CT study performed in the ER, undergoing a mechanical thrombectomy procedure.
* Thrombus retrieved available for analysis
Exclusion Criteria:
• Deny informed consent | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER | {
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Patient will be enrolled upon their presentation to the emergency department. The usual clinical practice will be followed.
Considering the emergency setting and the impossibility for most patients to provide a valid and informed consent before e immediately after the procedures, retrieved thrombi will be collected but not analyze. An informed consent to the study will be collect in the following day. Should the patient refuse the participation, the thrombus will be discarded and the patient will be considered as a drop out from the study.
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NCT04217226 | null | Perfusion Index-derived Parameters as Predictors Post-induction Hypotension. | Evaluation of Perfusion Index-derived Parameters as Predictors of Hypotension After Induction of General Anaesthesia: a Prospective Cohort Study. | None | OBSERVATIONAL | COMPLETED | 2020-01-02T00:00:00 | null | 2020-06-05T00:00:00 | 2020-07-28T00:00:00 | null | 93 | 18 | 59 | ALL | null | The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension.
This study aims to evaluate the ability of preoperative plethysmographic variability index, perfusion index and the Dicrotic Plethysmography to predict post-induction hypotension. | The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension. Moreover, The PI has been described as a reliable tool for vascular tone assessment and monitoring.
Dicrotic Plethysmography (Dicpleth): is easily derived from the photoplethysmographic signal. It represents the relative height of the dicrotic wave compared with the maximum peak of the waveform, has been described as the amount of reflected wave, dependent on the vascular tone. M.Coutrot et al quantified Dicpleth variations to detect arterial hypotension and mentioned that Dicpleth and PI are both related to vascular tone and are easily derived from the photoplethysmographic signal. Moreover, Chowienczyk PJ et. al. demonstrated that the reduction in Dicpleth is related to the reduction of vascular tone caused by vasodilator drugs, such as salbutamol or glyceryl trinitrate | Inclusion Criteria:
* • Adult patients (18-59 years)
* ASA I-II
* Patients scheduled for elective surgeries under general anaesthesia
Exclusion Criteria:
* • Operations which will last for less than 15 minutes.
* Patients with cardiac morbidities (impaired contractility with ejection fraction \< 40% and tight valvular lesions, unstable angina).
* Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
* Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
* Patients with peripheral vascular disease or long standing DM affecting PVI readings.
* Pregnancy. | Cairo University | OTHER | {
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] | [{"pmid": "20236098", "type": "BACKGROUND", "citation": "Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10."}, {"pmid": "29307905", "type": "BACKGROUND", "citation": "Mehandale SG, Rajasekhar P. Perfusion index as a predictor of hypotension following propofol induction - A prospective observational study. Indian J Anaesth. 2017 Dec;61(12):990-995. doi: 10.4103/ija.IJA_352_17."}, {"pmid": "35359139", "type": "DERIVED", "citation": "Abdelhamid B, Yassin A, Ahmed A, Amin S, Abougabal A. Perfusion index-derived parameters as predictors of hypotension after induction of general anaesthesia: a prospective cohort study. Anaesthesiol Intensive Ther. 2022;54(1):34-41. doi: 10.5114/ait.2022.113956."}] | {"versionHolder": "2025-06-18"} | {
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NCT03456726 | null | Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation | A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation | None | INTERVENTIONAL | COMPLETED | 2018-03-06T00:00:00 | null | 2021-12-17T00:00:00 | 2021-12-17T00:00:00 | [
"PHASE2"
] | 20 | 20 | null | ALL | false | This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation. | null | Inclusion Criteria:
* Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows:
* Cohort 1: Follicular lymphoma (FL)
* Cohort 2: Diffuse large B-cell lymphoma (including primary mediastinal B-cell lymphoma and transformed FL)
* Participants who have confirmed EZH2 gene mutation of tumor in central laboratory
* Participants who have measurable disease
* Participants who had previous therapy with systemic chemotherapy and/or antibody therapy and for which no standard therapy exists
* Participants who had progressive disease or did not have response (complete response or partial response) in previous systemic therapy, or relapsed or progressed after previous systemic therapy
* Participants with Eastern Cooperative Oncology Group performance status of 0 to 1
* Participants with life expectancy of ≥3 months from starting study drug administration
* Participants with adequate renal, liver, and bone marrow function
* Male and female participants ≥20 years of age at the time of informed consent
* Participants who has provided written consent to participate in the study
Exclusion Criteria:
* Participants with prior exposure to EZH2 inhibitor
* Participants with a history or a presence of central nerves invasion
* Participants with malignant pleural effusion, cardiac effusion, or ascites retention
* Participants with allogeneic stem cell transplantation
* Participants with medical need for the continued use of potent inhibitors of Cytochrome P450 3A (CYP3A)or potent inducer of CYP3A (including St. John's wort)
* Participants with significant cardiovascular impairment
· Participants with prolongation of corrected QT interval using Fridericia's formula to \> 480 milliseconds (msec)
* Participants with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug
* Participants with complications of hepatic cirrhosis, interstitial pneumonia or pulmonary fibrosis
* Participants with active infection requiring systemic therapy
* Women of childbearing potential or man of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later (for males 90 days later) from last administration of study drug
* Woman who are pregnant or breastfeeding
* Participants who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
* Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myeloid malignancies, including myelodysplastic syndrome | Eisai Inc. | INDUSTRY | {
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"state": "Tokyo"
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"state": "Tokyo"
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"state": "Tokyo"
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"lon": 140.11667
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"lon": 130.41667
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"state": null
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"lat": 33.6,
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"state": null
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"lat": 34.4,
"lon": 132.45
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"state": null
},
{
"city": "Kumamoto",
"country": "Japan",
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"lon": 130.69182
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"state": null
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"lat": 35.02107,
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"lat": 35.02107,
"lon": 135.75385
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"state": null
},
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"city": "Nagasaki",
"country": "Japan",
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"geoPoint": {
"lat": 32.75,
"lon": 129.88333
},
"state": null
},
{
"city": "Okayama",
"country": "Japan",
"facility": "1009 Eisai Trial Site",
"geoPoint": {
"lat": 34.65,
"lon": 133.93333
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"state": null
},
{
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"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
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"state": null
},
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"city": "Yamagata",
"country": "Japan",
"facility": "1018 Eisai Trial Site",
"geoPoint": {
"lat": 38.23333,
"lon": 140.36667
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Objective Response Rate (ORR) Based on Independent Reviewer Assessment",
"timeFrame": "From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)"
},
{
"description": null,
"measure": "ORR Based on Investigator Assessment",
"timeFrame": "From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)"
}
],
"secondary": [
{
"description": null,
"measure": "Progression-free Survival (PFS) Based on Independent Reviewer Assessment",
"timeFrame": "From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)"
},
{
"description": null,
"measure": "PFS Based on Investigator Assessment",
"timeFrame": "From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)"
},
{
"description": null,
"measure": "Duration of Response (DOR) Based on Independent Reviewer Assessment",
"timeFrame": "From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months)"
},
{
"description": null,
"measure": "DOR Based on Investigator Assessment",
"timeFrame": "From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months)"
},
{
"description": null,
"measure": "Time to Response (TTR) Based on Independent Reviewer Assessment",
"timeFrame": "From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)"
},
{
"description": null,
"measure": "TTR Based on Investigator Assessment",
"timeFrame": "From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)"
},
{
"description": null,
"measure": "Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)",
"timeFrame": "From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
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{
"id": "D009369",
"term": "Neoplasms"
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{
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"term": "Lymphoproliferative Disorders"
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{
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"name": "Immune System Diseases"
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"name": "Lymphoma, B-Cell",
"relevance": "HIGH"
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"asFound": null,
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{
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"term": "Lymphoma, B-Cell"
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} | null | {
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},
{
"id": "D016393",
"term": "Lymphoma, B-Cell"
}
],
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} |
NCT02164526 | null | Registry for Pulmonary Hypertension Due to Left Heart Disease in China | National, Prospective, Multicenter,Observational Registry Study on Pulmonary Hypertension Due to Left Heart Disease in China | None | OBSERVATIONAL | UNKNOWN | 2014-06-04T00:00:00 | null | null | null | null | 520 | 18 | 80 | ALL | false | Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China. | null | Inclusion Criteria:
* Pulmonary Hypertension due to left heart disease
Exclusion Criteria:
* Other forms of Pulmonary Hypertension
* Heart failure due to valvular heart disease
* Hypertrophic obstructive cardiomyopathy
* Right ventricular outflow tract stenosis
* Pericardial disease
* Patients with chronic lung disease | Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER | {
"id": "CRPHDLHD",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-06-13T00:00:00 | {
"date": "2017-06-14",
"type": "ACTUAL"
} | {
"date": "2014-06-16",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Consecutive patients who were diagnosed as pulmonary hypertension due to the left heart disease in 35 participating institutions in China | PROBABILITY_SAMPLE | true | {
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} | [
"Pulmonary Hypertension Due to Left Heart Disease"
] | ["Pulmonary Hypertension", "Left Heart Disease", "Heart failure", "Registry", "China"] | null | [
{
"city": "Beijing",
"country": "China",
"facility": "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
},
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"city": "Beijing",
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"facility": "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "All cause death",
"timeFrame": "up to 5 years"
}
],
"secondary": null
} | null | [{"pmid": "36195993", "type": "DERIVED", "citation": "Huang L, Pang L, Gu Q, Yang T, Li W, Quan R, Su W, Wu W, Tang F, Zhu X, Shen J, Sun J, Shan G, Xiong C, Huang S, He J. Prevalence, risk factors, and survival associated with pulmonary hypertension and heart failure among patients with underlying coronary artery disease: a national prospective, multicenter registry study in China. Chin Med J (Engl). 2022 Aug 5;135(15):1837-1845. doi: 10.1097/CM9.0000000000002112."}, {"pmid": "36035936", "type": "DERIVED", "citation": "Lin Y, Pang L, Huang S, Shen J, Wu W, Tang F, Su W, Zhu X, Sun J, Quan R, Yang T, Han H, He J. Impact of borderline pulmonary hypertension due to left heart failure on mortality in a multicenter registry study: A 3-year survivorship analysis. Front Cardiovasc Med. 2022 Aug 12;9:983803. doi: 10.3389/fcvm.2022.983803. eCollection 2022."}, {"pmid": "35172722", "type": "DERIVED", "citation": "Quan R, Huang S, Pang L, Shen J, Wu W, Tang F, Zhu X, Su W, Sun J, Yu Z, Wang L, Zhu X, Xiong C, He J. Risk prediction in pulmonary hypertension due to chronic heart failure: incremental prognostic value of pulmonary hemodynamics. BMC Cardiovasc Disord. 2022 Feb 16;22(1):56. doi: 10.1186/s12872-022-02492-1."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
}
],
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"id": "M9421",
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},
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"id": "M9419",
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},
{
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"name": "Hypertension, Pulmonary",
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},
{
"asFound": null,
"id": "M17400",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
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},
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"asFound": null,
"id": "M14977",
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}
],
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"id": "D006976",
"term": "Hypertension, Pulmonary"
},
{
"id": "D006973",
"term": "Hypertension"
},
{
"id": "D006331",
"term": "Heart Diseases"
}
]
} | null | {
"conditions": [
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"id": "D006976",
"term": "Hypertension, Pulmonary"
},
{
"id": "D006973",
"term": "Hypertension"
},
{
"id": "D006331",
"term": "Heart Diseases"
}
],
"interventions": null
} |
NCT04759326 | null | Neurorehabilitation Through Hippotherapy of a Brain Stroke | Neurorehabilitation Through Hippotherapy on Neurofunctional Sequels of Brain Stroke: (i) Effect on Patient's Functional Independence, Sensorimotor and Cognitive Capacities and Quality of Life (ii) Effect on Caregivers' Quality of Life | HippoPostCVA | INTERVENTIONAL | RECRUITING | 2021-02-15T00:00:00 | null | null | null | [
"NA"
] | 52 | 18 | null | ALL | false | Cerebrovascular accident \[CVA\] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke.
The aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers.
A prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life.
Program evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life. | According to the WHO (2016), almost 1.1 million of Europeans suffer a stroke each year (17 million worldwide), which adds to a pool of 33 million stroke survivors. The case fatality rates are about 15% by 1 month, 25% by 1 year, and 50% by 5 years. Over one third of survivors are left disabled (modified Rankin Scale score 3-5) 5 years after stroke due to physical, cognitive, and/or emotional deficits. These deficiencies are often addressed in the hospital's acute care and/or during inpatient rehabilitation. Much of the scientific efforts to date have focused on medical programs involving acute care and hospital-based inpatient rehabilitation. However, many patients continue to experience difficulties beyond this period of recovery and long-term disability often occurs. In such cases, dealing with impairment is frequently ineffective, and when it is beneficial, the functional bases for recovery are mainly unclear.
Stroke is a brutal event in the course of a lifetime. It is a break in reality affecting the body and the psyche, not only for the individual but also for the family. It disrupts the many foundations that a person has built over the course of his or her life. Acceptance of the disease, medical care and its effects on daily life, global impairment, limitation of activity and restriction of participation, are a set of factors that the psyche cannot integrate at once. Following this event, the person and their caregivers must take the time to accept and rebuild themselves. A new sense of temporality is an essential factor in the management of a post-stroke patient and a question that must be addressed by the caregiver.
A body of scientific evidence has gradually emerged in recent years, reflecting the benefits of hippotherapy in various disabling neurological conditions. During hippotherapy, specific execution and repetition of a task are key elements of learning/strengthening/promoting a function and a robust backbone of neurorehabilitation through neural plasticity mechanisms. Hippotherapy is therefore slowly emerging as a cutting-edge method of neurorehabilitation. The post-injury experience is a powerful modulator of functional recovery following neurological disorders. Our method of hippotherapy has powerful effects on brain plasticity and neurological outcome. Beneficial results have been observed in a wide variety of brain disorders and include sensorimotor enhancement, cognitive enhancement, mental well-being, and delayed disease progression. Such an environment most likely promotes the synthesis of different neuroactive substances (e.g., BDNF, norepinephrine, acetylcholine, dopamine, serotonin), which reflect the level of arousal, motivation, attention, affection and emotion of a subject or directly drive the action (e.g., glutamate, or GABA). These endogenous molecules are strongly involved in the induction and maintenance of synaptic plasticity, namely long-lasting stable molecular, anatomical and functional modifications.
In this randomized interventional study, the effectiveness of neurological rehabilitation by hippotherapy will be studied and its scope compared in terms of functional recovery, autonomy and quality of life. Stroke patients will be included and treated from the end of the inpatient rehabilitation phase (starting 3-6 months post-stroke). They will be compared to a control group of patients undergoing conventional outpatient rehabilitation. Both groups will undergo the same qualitative and quantitative clinical tests. We will also compare the quality of life of the respective caregivers before and after the end of the program. | Inclusion Criteria:
* Age ≥ 18 years old
* Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 (30)
* Inclusion \> 3 months post-stroke
* Deficit still existing (Rankin score ≥ 3 and ≤ 4 at inclusion)
* Existing declaration of informed consent
* Affiliation of the patient to a social security scheme
* Minimal abduction of the hip of 25 degrees bilateral with no history of hip dislocation and/or dysplasia
* Certificate of non-contraindication issued by the referring physician
Exclusion Criteria:
* Major cognitive impairment affecting comprehension (Mini Mental State Examination test \< 24 points)
* Global or sensory aphasia
* Neurological or psychiatric co-morbidity (other than mild-to-moderate post-stroke depression)
* Evidence of an uncontrolled seizure disorder
* Substance abuse
* History of uncontrolled pain
* History of allergic reactions to dust and/or horsehair, or severe asthma
* Overweight (≥ 110 kg)
* Contraindications to physical activity
* Inability or medical contraindication to travel to the Equiphoria Institute by personal car or taxi
* History of horse riding or hippotherapy care during the last 6 months
* Pregnant or lactating women
* Patients participating in other biomedical research or in a period of exclusion | Alliance Equiphoria | OTHER | {
"id": "2020-A03172-37",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-02-15T00:00:00 | {
"date": "2024-07-31",
"type": "ACTUAL"
} | {
"date": "2021-02-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "We will use a randomized single-blinded prospective two-arms controlled clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone. To ensure that patients in the two arms of the trial are as homogeneous as possible in all respects except for the planned intervention, randomization will be stratified by age (18-59 years, 60-74 years, and ≥ 75 years), stroke type (ischemic versus hemorrhagic) and degree of disability (Rankin score). Stratified sampling reduces potential confusion by selecting homogeneous subgroups. In this case, matching will ensure a similar distribution of variables that could introduce a major imbalance potentially rendering the results unusable. The study will be single-blinded in order to rule out any possible bias introduced by the experimenter. We will use a fixed randomization defined by the allocation of each treatment (hippotherapy or neurorehabilitation alone).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Data will be collected at Centre Hospitalier Sud Francilien (CHSF) Corbeil-Essonnes (https://www.chsf.fr/nos-service/medecine/neurologie/), Centre Hospitalier of Béziers (CHB) (https://www.ch-beziers.fr/services/neurologie) and Centre Hospitalier Universitaire of Grenoble-Alpes (https://www.chu-grenoble.fr/patients-et-accompagnants/offre-de-soin/neurologie). The data will be duly anonymized and handled blindly. Data will be centralized on a secure server at the external subcontractor (Contract Research Organization - CRO) facilities. Their processing and analysis will be carried out blindly by the private service provider (CRO).",
"whoMasked": [
"INVESTIGATOR"
]
},
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"primaryPurpose": "TREATMENT",
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} | [
"Cerebrovascular Accident",
"Neurorehabilitation",
"Neuroplasticity",
"Hippotherapy",
"Silent Neurofunctional Barriers",
"Functional Deficit",
"Cognitive Deficit",
"Psychological Trauma",
"Autonomy",
"Quality of Life",
"Caregiver Burnout"
] | ["NeuroRehabilitation through hippotherapy", "Brain plasticity", "Functional recovery"] | null | [
{
"city": "La Canourgue",
"country": "France",
"facility": "Institut Equiphoria",
"geoPoint": {
"lat": 44.43133,
"lon": 3.21584
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"state": null
}
] | [
{
"class": "INDUSTRY",
"name": "Boehringer Ingelheim"
},
{
"class": "OTHER",
"name": "Centre Hospitalier Sud Francilien"
},
{
"class": "UNKNOWN",
"name": "Centre Hospitalier de Béziers"
},
{
"class": "OTHER",
"name": "University Hospital, Grenoble"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "For the patient: Change in Functional Independence Measure (FIM)",
"timeFrame": "Change from baseline to week 22; change from week 22 to week 48"
}
],
"secondary": [
{
"description": null,
"measure": "For the patient: Change in Modified Rankin Scale (MRS)",
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Epub 2016 Feb 28."}, {"pmid": "15562409", "type": "BACKGROUND", "citation": "Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297."}, {"pmid": "15838110", "type": "BACKGROUND", "citation": "Dobkin BH. Neurobiology of rehabilitation. Ann N Y Acad Sci. 2004 Dec;1038:148-70. doi: 10.1196/annals.1315.024."}, {"pmid": "11283749", "type": "BACKGROUND", "citation": "Raineteau O, Schwab ME. Plasticity of motor systems after incomplete spinal cord injury. Nat Rev Neurosci. 2001 Apr;2(4):263-73. doi: 10.1038/35067570."}, {"pmid": "20400552", "type": "BACKGROUND", "citation": "Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16."}, {"pmid": "21621674", "type": "BACKGROUND", "citation": "Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036."}, {"pmid": "21112434", "type": "BACKGROUND", "citation": "Combs SA, Dugan EL, Passmore M, Riesner C, Whipker D, Yingling E, Curtis AB. Balance, balance confidence, and health-related quality of life in persons with chronic stroke after body weight-supported treadmill training. Arch Phys Med Rehabil. 2010 Dec;91(12):1914-9. doi: 10.1016/j.apmr.2010.08.025."}, {"pmid": "32384678", "type": "BACKGROUND", "citation": "Viruega H, Gaillard I, Briatte L, Gaviria M. Inter-Day Reliability and Changes of Surface Electromyography on Two Postural Muscles Throughout 12 Weeks of Hippotherapy on Patients with Cerebral Palsy: A Pilot Study. Brain Sci. 2020 May 6;10(5):281. doi: 10.3390/brainsci10050281."}, {"pmid": "31569505", "type": "BACKGROUND", "citation": "Viruega H, Gaillard I, Carr J, Greenwood B, Gaviria M. Short- and Mid-Term Improvement of Postural Balance after a Neurorehabilitation Program via Hippotherapy in Patients with Sensorimotor Impairment after Cerebral Palsy: A Preliminary Kinetic Approach. Brain Sci. 2019 Sep 29;9(10):261. doi: 10.3390/brainsci9100261."}, {"pmid": "7678184", "type": "BACKGROUND", "citation": "Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35."}, {"pmid": "27091144", "type": "BACKGROUND", "citation": "Rannikmae K, Woodfield R, Anderson CS, Charidimou A, Chiewvit P, Greenberg SM, Jeng JS, Meretoja A, Palm F, Putaala J, Rinkel GJ, Rosand J, Rost NS, Strbian D, Tatlisumak T, Tsai CF, Wermer MJ, Werring D, Yeh SJ, Al-Shahi Salman R, Sudlow CL. Reliability of intracerebral hemorrhage classification systems: A systematic review. Int J Stroke. 2016 Aug;11(6):626-36. doi: 10.1177/1747493016641962. Epub 2016 Apr 18."}, {"pmid": "17901388", "type": "BACKGROUND", "citation": "Leys D, Ringelstein EB, Kaste M, Hacke W; Executive Committee of the European Stroke Initiative. Facilities available in European hospitals treating stroke patients. Stroke. 2007 Nov;38(11):2985-91. doi: 10.1161/STROKEAHA.107.487967. Epub 2007 Sep 27."}, {"pmid": "21733720", "type": "BACKGROUND", "citation": "Wissel J, Olver J, Sunnerhagen KS. Navigating the poststroke continuum of care. J Stroke Cerebrovasc Dis. 2013 Jan;22(1):1-8. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.021. Epub 2011 Jul 5."}, {"pmid": "23108248", "type": "BACKGROUND", "citation": "Ham TE, Sharp DJ. How can investigation of network function inform rehabilitation after traumatic brain injury? Curr Opin Neurol. 2012 Dec;25(6):662-9. doi: 10.1097/WCO.0b013e328359488f."}, {"pmid": "24382886", "type": "BACKGROUND", "citation": "Sale A, Berardi N, Maffei L. Environment and brain plasticity: towards an endogenous pharmacotherapy. Physiol Rev. 2014 Jan;94(1):189-234. doi: 10.1152/physrev.00036.2012."}, {"pmid": "25018713", "type": "BACKGROUND", "citation": "Kolb B, Muhammad A. Harnessing the power of neuroplasticity for intervention. Front Hum Neurosci. 2014 Jun 27;8:377. doi: 10.3389/fnhum.2014.00377. eCollection 2014."}, {"pmid": "17209981", "type": "BACKGROUND", "citation": "Sterba JA. Does horseback riding therapy or therapist-directed hippotherapy rehabilitate children with cerebral palsy? 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Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031."}, {"pmid": "22247403", "type": "BACKGROUND", "citation": "Silkwood-Sherer DJ, Killian CB, Long TM, Martin KS. Hippotherapy--an intervention to habilitate balance deficits in children with movement disorders: a clinical trial. Phys Ther. 2012 May;92(5):707-17. doi: 10.2522/ptj.20110081. Epub 2012 Jan 12."}, {"pmid": "14686913", "type": "BACKGROUND", "citation": "Diaz Heijtz R, Kolb B, Forssberg H. Can a therapeutic dose of amphetamine during pre-adolescence modify the pattern of synaptic organization in the brain? Eur J Neurosci. 2003 Dec;18(12):3394-9. doi: 10.1046/j.0953-816x.2003.03067.x."}, {"pmid": "14735114", "type": "BACKGROUND", "citation": "Horn G. Pathways of the past: the imprint of memory. Nat Rev Neurosci. 2004 Feb;5(2):108-20. doi: 10.1038/nrn1324. No abstract available."}, {"pmid": "24648655", "type": "BACKGROUND", "citation": "Lee CW, Kim SG, Yong MS. 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Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85."}, {"pmid": "25257153", "type": "BACKGROUND", "citation": "Karahan AY, Kucuksen S, Yilmaz H, Salli A, Gungor T, Sahin M. Effects of rehabilitation services on anxiety, depression, care-giving burden and perceived social support of stroke caregivers. Acta Medica (Hradec Kralove). 2014;57(2):68-72. doi: 10.14712/18059694.2014.42."}, {"pmid": "27598342", "type": "BACKGROUND", "citation": "Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6."}, {"pmid": "31699572", "type": "BACKGROUND", "citation": "Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4."}, {"pmid": "35625006", "type": "DERIVED", "citation": "Viruega H, Imbernon C, Chausson N, Altarcha T, Aghasaryan M, Soumah D, Lescieux E, Flamand-Roze C, Simon O, Bedin A, Smadja D, Gaviria M. Neurorehabilitation through Hippotherapy on Neurofunctional Sequels of Stroke: Effect on Patients' Functional Independence, Sensorimotor/Cognitive Capacities and Quality of Life, and the Quality of Life of Their Caregivers-A Study Protocol. Brain Sci. 2022 May 9;12(5):619. doi: 10.3390/brainsci12050619."}] | {"versionHolder": "2025-06-18"} | {
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* The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
* Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
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* Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
* Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
* Modified Hachinski Ischemia score greater than 4 at screening.
* Current evidence of clinically significant systemic disease
* Known or suspected history of alcoholism or drug abuse within the past 10 years.
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NCT03961126 | null | Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma. | Pilot Study of Vulvar Lichen Sclerosus (VLS) Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma (PRP). | None | INTERVENTIONAL | COMPLETED | 2019-05-17T00:00:00 | null | 2019-12-12T00:00:00 | 2019-12-12T00:00:00 | [
"PHASE2"
] | 20 | 18 | 70 | FEMALE | false | LIQUENIA clinical trial is a phase II, controlled, prospective and unicentric study to assess vulvar lichen sclerosus (VLS) treatment using adipose tissue associated with autologous platelet-rich plasma (PRP) coming from the inner side of the patients' thighs, which aims to restore the structure and elasticity of the affected vulvar subunits, and to improve vulvar subunits lesions and symptoms, therefore, patients' quality of life from the early phases of the treatment. | Randomized, prospective and unicentric study, in which the investigators evaluate patients with vulvar lichen sclerosus who undergo surgical treatment consisting of two separate infiltrations by intra and subdermal injection in each half vulvar of autologous fatty tissue associated with autologous platelet-rich plasma, in order to:
Main objective:
To estimate the population parameters of the study variables, as well as their variability, to be able to determine the sample size and statistical power for a future clinical trial whose main objective will be to demonstrate the efficacy of this treatment regarding the increase in the vulvar elasticity in patients with vulvar lichen sclerosus.
Secondary Objectives:
1. To evaluate if there is a structural improvement in the vulva areas treated at month, 3 months, 6 months and 12 months after the first infiltration and at 3 and 9 months after the second infiltration.
2. To analysis the improvement of fibrosis and inflammation 6 months after the first infiltration and 3 months after the second infiltration.
3. To study if there is an improvement in symptoms at month, 3 months, 6 months, 12 months after the first infiltration and at 3 months and 9 months after the second infiltration.
4. To examine whether there is an improvement in the quality of patients life.
5. Subsequent use of clinical and pain assessment scale in this study and in another lichen sclerosus vulvar studies with a greater number of patients.
6. To evaluate the adverse events derived from the treatment during the first year after the first infiltration through its registration in the CRD. | Inclusion Criteria:
* Adult women between 18 and 70 years old.
* Patients with clear clinical and/or histological diagnosis of vulvar lichen sclerosus (VLS).
* Moderate to severe affectation of the disease at genital level.
* Patients who have taken topical treatment for at least three months with 0.05% clobetasol propionate.
* Prior signed informed consent form.
Exclusion Criteria:
* Pregnant or lactating women.
* Alcoholic patients.
* Patients with malignant disease diagnosed in the last 5 years.
* Patients infected with HSV-II, HPV, HIV, HBV and HCV viruses.
* Injecting drug users.
* Patients with serious active infectious diseases.
* Patients with known allergy or intolerance to any of the aforementioned treatments.
* Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, psoriasis, eczema).
* Patients with unrealistic expectations regarding the final benefits of the treatment. | Instituto de Investigacion Sanitaria La Fe | OTHER | {
"id": "LIQUENIA",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-05-22T00:00:00 | {
"date": "2020-06-11",
"type": "ACTUAL"
} | {
"date": "2019-05-23",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Vulvar Lichen Sclerosus"
] | ["Vulvar Lichen Sclerosus", "Autologous Platelet-rich Plasma (PRP)"] | null | [
{
"city": "Valencia",
"country": "Spain",
"facility": "Hospital Universitario y Politécnico La Fe",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Vulvar elasticity measured by the cutometer-dualmpa®",
"timeFrame": "Month 1 after first infiltration."
},
{
"description": null,
"measure": "Vulvar elasticity measured by the cutometer-dualmpa®",
"timeFrame": "Month 3 after first infiltration."
},
{
"description": null,
"measure": "Vulvar elasticity measured by the cutometer-dualmpa®",
"timeFrame": "Month 6 after first infiltration."
},
{
"description": null,
"measure": "Vulvar elasticity measured by the cutometer-dualmpa®",
"timeFrame": "Year 1 after first infiltration."
},
{
"description": null,
"measure": "Vulvar elasticity measured by the cutometer-dualmpa®",
"timeFrame": "Month 3 after second infiltration."
},
{
"description": null,
"measure": "Vulvar elasticity measured by the cutometer-dualmpa®",
"timeFrame": "Month 9 after second infiltration."
}
],
"secondary": [
{
"description": null,
"measure": "Histological improvement measured by the scale for histological assessment.",
"timeFrame": "Month 6"
},
{
"description": null,
"measure": "Improvement in the quality of patients' life measured by skindex-29 questionnaire quality of life.",
"timeFrame": "Month 1, Month 3, Month 6, Year 1"
},
{
"description": null,
"measure": "Improvement in the clinical symptoms by clinical assessment scale.",
"timeFrame": "Month 1, Month 3, Month 6, Year 1"
},
{
"description": null,
"measure": "Improvement in the pruritus measured by 4D Pruritus Scale.",
"timeFrame": "Month 1, Month 3, Month 6, Year 1"
},
{
"description": null,
"measure": "Improvement in the pain measured by Pain Scale.",
"timeFrame": "Month 1, Month 3, Month 6, Year 1"
},
{
"description": null,
"measure": "Improvement in sexual performance by Sexual Functioning Index (SFI)",
"timeFrame": "Month 1, Month 3, Month 6, Year 1"
}
]
} | [
{
"affiliation": "Hospital La Fe",
"name": "Patricia Gutierrez Ontalvilla",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "22503028", "type": "BACKGROUND", "citation": "Tausch TJ, Peterson AC. Early aggressive treatment of lichen sclerosus may prevent disease progression. J Urol. 2012 Jun;187(6):2101-5. doi: 10.1016/j.juro.2012.01.071. Epub 2012 Apr 12."}, {"pmid": "26880944", "type": "BACKGROUND", "citation": "Giuseppina Onesti M, Carella S, Ceccarelli S, Marchese C, Scuderi N. The Use of Human Adipose-Derived Stem Cells in the Treatment of Physiological and Pathological Vulvar Dystrophies. Stem Cells Int. 2016;2016:2561461. doi: 10.1155/2016/2561461. Epub 2016 Jan 10."}, {"pmid": "26499935", "type": "BACKGROUND", "citation": "Boero V, Brambilla M, Sipio E, Liverani CA, Di Martino M, Agnoli B, Libutti G, Cribiu FM, Del Gobbo A, Ragni E, Bolis G. Vulvar lichen sclerosus: A new regenerative approach through fat grafting. Gynecol Oncol. 2015 Dec;139(3):471-5. doi: 10.1016/j.ygyno.2015.10.014. Epub 2015 Oct 21."}, {"pmid": "26848453", "type": "BACKGROUND", "citation": "Tamburino S, Lombardo GA, Tarico MS, Perrotta RE. The Role of Nanofat Grafting in Vulvar Lichen Sclerosus: A Preliminary Report. Arch Plast Surg. 2016 Jan;43(1):93-5. doi: 10.5999/aps.2016.43.1.93. Epub 2016 Jan 15. No abstract available."}, {"pmid": "23507004", "type": "BACKGROUND", "citation": "Focseneanu MA, Gupta M, Squires KC, Bayliss SJ, Berk D, Merritt DF. The course of lichen sclerosus diagnosed prior to puberty. J Pediatr Adolesc Gynecol. 2013 Jun;26(3):153-5. doi: 10.1016/j.jpag.2012.12.002. Epub 2013 Mar 16."}, {"pmid": "25919241", "type": "BACKGROUND", "citation": "Gale KL, Rakha EA, Ball G, Tan VK, McCulley SJ, Macmillan RD. A case-controlled study of the oncologic safety of fat grafting. Plast Reconstr Surg. 2015 May;135(5):1263-1275. doi: 10.1097/PRS.0000000000001151."}, {"pmid": "26910662", "type": "BACKGROUND", "citation": "Sinno S, Wilson S, Brownstone N, Levine SM. Current Thoughts on Fat Grafting: Using the Evidence to Determine Fact or Fiction. Plast Reconstr Surg. 2016 Mar;137(3):818-824. doi: 10.1097/01.prs.0000479966.52477.8b."}, {"pmid": "24559562", "type": "BACKGROUND", "citation": "Sehgal VN, Pandhi D, Khurana A. Nonspecific genital ulcers. Clin Dermatol. 2014 Mar-Apr;32(2):259-74. doi: 10.1016/j.clindermatol.2013.08.024."}, {"pmid": "22244661", "type": "BACKGROUND", "citation": "Fuh KC, Berek JS. Current management of vulvar cancer. Hematol Oncol Clin North Am. 2012 Feb;26(1):45-62. doi: 10.1016/j.hoc.2011.10.006."}, {"pmid": "26343349", "type": "BACKGROUND", "citation": "Erickson BA, Elliott SP, Myers JB, Voelzke BB, Smith TG 3rd, McClung CD, Alsikafi NF, Vanni AJ, Brant WO, Broghammer JA, Tam CA, Zhao LC, Buckley JC, Breyer BN; Trauma and Urologic Reconstructive Network of Surgeons. Understanding the Relationship between Chronic Systemic Disease and Lichen Sclerosus Urethral Strictures. J Urol. 2016 Feb;195(2):363-8. doi: 10.1016/j.juro.2015.08.096. Epub 2015 Sep 5."}, {"pmid": "24443652", "type": "BACKGROUND", "citation": "Arrowsmith S, Kendrick A, Wray S. Drugs acting on the pregnant uterus. Obstet Gynaecol Reprod Med. 2010 Aug;20(8):241-247. doi: 10.1016/j.ogrm.2010.05.001."}, {"pmid": "26610399", "type": "BACKGROUND", "citation": "Brauer M, van Lunsen R, Burger M, Laan E. Motives for Vulvar Surgery of Women with Lichen Sclerosus. J Sex Med. 2015 Dec;12(12):2462-73. doi: 10.1111/jsm.13052. Epub 2015 Nov 27."}, {"pmid": "23224274", "type": "BACKGROUND", "citation": "Kreuter A, Kryvosheyeva Y, Terras S, Moritz R, Mollenhoff K, Altmeyer P, Scola N, Gambichler T. Association of autoimmune diseases with lichen sclerosus in 532 male and female patients. Acta Derm Venereol. 2013 Mar 27;93(2):238-41. doi: 10.2340/00015555-1512."}, {"pmid": "23851740", "type": "BACKGROUND", "citation": "Mazzola RF, Mazzola IC. The fascinating history of fat grafting. J Craniofac Surg. 2013 Jul;24(4):1069-71. doi: 10.1097/SCS.0b013e318292c447. No abstract available."}] | {"versionHolder": "2025-06-18"} | {
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},
{
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},
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]
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NCT06126926 | null | Tertiary Prevention of Child Sexual Abuse | Mobilizing Evidence Into Tertiary Prevention of Child Sexual Abuse: A Pilot Study | None | INTERVENTIONAL | RECRUITING | 2023-10-16T00:00:00 | null | 2025-05-31T00:00:00 | 2025-12-31T00:00:00 | [
"NA"
] | 32 | 18 | null | MALE | false | This is a feasibility study designed to inform the development of a multinational study of the effectiveness of a tertiary prevention program for child sexual abuse. This study targets adult men who have engaged in child sexual abuse, and will be implemented within the Minnesota Department of Corrections. Data will include measures of the implementation process, short-terms changes in criminogenic factors, and staff and participant factors that could influence outcomes. | null | Inclusion Criteria:
* Male
* 18 or older
* Serving time in MnDOC facilities for Criminal Sexual Conduct in the first, second, or third degree, whose victims were less than 14 years old
* Individuals assigned moderate to high risk to reoffend as determined upon entrance to the Minnesota Correctional System by the DOC Risk Assessment/Community Notification Unit."
Exclusion Criteria:
* Diagnosed with an active, uncontrolled major mental disorder (e.g. bi-polar, schizophrenia, schizoaffective disorder, major depression with psychotic features)
* Unable to read English at the 5th grade level
* Unable to speak English
* IQ of less than 85 as measured by standard intelligence tests
* Diagnosis of intellectual disability
* Engaged in violent behavior while incarcerated, as indicated by disciplinary actions and/or segregation within 60 days of intake" | University of Minnesota | OTHER | {
"id": "FMCH-2023-32331",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-11-06T00:00:00 | {
"date": "2025-04-04",
"type": "ACTUAL"
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"date": "2023-11-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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"allocation": "RANDOMIZED",
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"interventionModelDescription": "Random assignment clinical trial. Participants are randomly assigned to the intervention group or treatment as usual.",
"maskingInfo": {
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} | [
"Child Sexual Abuse"
] | null | null | [
{
"city": "Minneapolis",
"country": "United States",
"facility": "University of Minnesota",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
},
"state": "Minnesota"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Violence Risk Scale-Sexual Offense Version (VRS:SO)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Coping Using Sex Inventory (CUSI)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Compulsive Sexual Behavior Inventory-13 (CSBI-13)",
"timeFrame": "7-days post-intervention"
},
{
"description": null,
"measure": "Types of Jealousy Scale (3 subscales; reactive, preventive, and anxious jealousy)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Faith in People Scale",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Trust in People Scale (Survey Research Center)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Aggression Questionnaire (AQ; Buss &) - Physical Aggression, Verbal Aggression, and Anger Subscales ONLY",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Revised UCLA Loneliness Scale (R-UCLA)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Self-Critical Rumination Scale (SCRS)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "External/Internal Shame Scale - Sense of Isolation/Exclusion Subscale ONLY (EISS)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Children and Sex Questionnaire Emotional Congruence Scale (CSQ:ECWC)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "The Openness to Men and Women Scales (OPM, OPWO)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Coping Strategy Indicator (CSI)",
"timeFrame": "7 days post-intervention"
},
{
"description": null,
"measure": "Aggression Inventory (AI)- Impulsive, Impatient, and Avoid subscales ONLY",
"timeFrame": "7 days post-intervention"
}
],
"secondary": [
{
"description": null,
"measure": "Group Climate Questionnaire - Short Form (GCQ-5)",
"timeFrame": "Every 14 days for first two months, than every four weeks for next four months"
},
{
"description": null,
"measure": "Curative Climate Instrument (CCI)",
"timeFrame": "Every 14 days for first two months, than every four weeks for next four months"
},
{
"description": null,
"measure": "Treatment Motivation Questionnaire-Revised (TMQ-R)",
"timeFrame": "Every 14 days for first two months, than every four weeks for next four months"
},
{
"description": null,
"measure": "Therapeutic Agency Inventory (TAI)",
"timeFrame": "Every 14 days for first two months, than every four weeks for next four months"
},
{
"description": null,
"measure": "Relationship Questionnaire (RQ)",
"timeFrame": "Every 14 days for first two months, than every four weeks for next four months"
},
{
"description": null,
"measure": "Working Alliance Inventory - Short Form (WAI- SR)",
"timeFrame": "Every 14 days for first two months, than every four weeks for next four months"
}
]
} | [
{
"affiliation": "University of Minnesota",
"name": "Michael Miner, Ph.D",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT04262726 | null | REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting | REMOTION: a Randomized Controlled Pilot Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting | REMOTION | INTERVENTIONAL | COMPLETED | 2020-02-06T00:00:00 | null | 2022-11-27T00:00:00 | 2022-11-27T00:00:00 | [
"NA"
] | 70 | 18 | 70 | ALL | false | Emotion regulation has been identified as an important transdiagnostic factor in the treatment of mental health disorders. This study aims to examine, for the first time, REMOTION, a novel blended therapy intervention aimed at reducing symptom severity and improving emotion regulation of patients in an outpatient psychotherapy setting. REMOTION is an internet based intervention that is administered as an add-on to psychotherapy. This study aims to investigate feasibility and also potential effectiveness of REMOTION in an outpatient setting. Participants will be randomly assigned to the study conditions. Outcomes are assessed at baseline, after six weeks and after twelve weeks. | null | Inclusion Criteria:
* 18 years or older
* In psychotherapeutic treatment at the outpatient clinic of the Department of Clinical Psychology at the University of Bern
* Mental disorder present
* Internet access available
* Written informed consent
Exclusion Criteria:
* Current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation
* Current or history of psychotic disorders or bipolar disorder
* Acute suicidality
* Insufficient mastery of German language | University of Bern | OTHER | {
"id": "2019-01929",
"link": null,
"type": null
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"measure": "Therapeutic alliance",
"timeFrame": "6 weeks, twelve weeks"
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{
"description": null,
"measure": "Self Compassion",
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},
{
"description": null,
"measure": "Negative effects of REMOTION",
"timeFrame": "six weeks, 12 weeks (REMOTION group only)"
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{
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"measure": "Therapist variables",
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{
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"measure": "Therapist variables specific to REMOTION",
"timeFrame": "6 weeks, 12 weeks (REMOTION group only)"
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{
"description": null,
"measure": "Patient emotion regulation difficulties as rated by the therapist",
"timeFrame": "baseline, 6 weeks,12 weeks"
},
{
"description": null,
"measure": "Patient emotion regulation competencies as rated by the therapist",
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}
],
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"description": null,
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"measure": "General symptom severity",
"timeFrame": "6 weeks"
},
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"measure": "General symptom severity",
"timeFrame": "12 weeks"
}
],
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{
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"measure": "Emotion competencies questionnaire",
"timeFrame": "baseline, 6 weeks, 12 weeks"
},
{
"description": null,
"measure": "Depressive Symptoms",
"timeFrame": "baseline, 6 weeks, 12 weeks"
},
{
"description": null,
"measure": "Anxiety symptoms",
"timeFrame": "baseline, 6 weeks, 12 weeks"
},
{
"description": null,
"measure": "Well-Being",
"timeFrame": "baseline, 6 weeks, 12 weeks"
},
{
"description": null,
"measure": "Health related quality of life",
"timeFrame": "baseline, 6 weeks, 12 weeks"
},
{
"description": null,
"measure": "Feasibility parameter: number of participants taking part in the study",
"timeFrame": "at randomization"
},
{
"description": null,
"measure": "Feasibility parameter: adherence",
"timeFrame": "6 weeks,12 weeks (REMOTION group only)"
},
{
"description": null,
"measure": "Feasibility parameter: adherence",
"timeFrame": "6 weeks,12 weeks (REMOTION group only)"
},
{
"description": null,
"measure": "Feasibility parameter: adherence",
"timeFrame": "6 weeks, 12 weeks (REMOTION group only)"
},
{
"description": null,
"measure": "Feasibility parameter: program usability",
"timeFrame": "6 weeks, 12 weeks (REMOTION group only)"
},
{
"description": null,
"measure": "Feasibility parameter: user experience",
"timeFrame": "6 weeks, 12 weeks (REMOTION group only)"
},
{
"description": null,
"measure": "Feasibility parameter: attitude toward psychological online interventions",
"timeFrame": "baseline, 6 weeks, 12 weeks"
},
{
"description": null,
"measure": "Feasibility parameter: satisfaction with the intervention",
"timeFrame": "6 weeks, 12 weeks (REMOTION group only)"
}
]
} | [
{
"affiliation": "Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern",
"name": "Thomas Berger, Prof. Dr.",
"role": "PRINCIPAL_INVESTIGATOR"
}
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NCT04218526 | null | Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease | Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease | DBS + FOG | INTERVENTIONAL | COMPLETED | 2019-12-02T00:00:00 | null | 2024-09-12T00:00:00 | 2024-09-12T00:00:00 | [
"NA"
] | 5 | 40 | 80 | ALL | false | The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease (PD). | null | Inclusion:
1. Confirmed Parkinson's Disease according to movement disorder neurologist with documented exclusion of other disorders such as fronto-temporal dementia (FTD)/ frontal gait disorder/normal pressure hydrocephalus (NPH)/progressive supranuclear palsy (PSP)
2. PD stage3 ON medication, with severe gait dysfunction and predominant axial symptoms: Movement Disorder Society-Unified Parkinson's Disease Rating Scale Tremor Dominant (MDS-UPDRS TD), Postural Instability Gait Difficulty (PIGD) ratio ≤ 0.90 and Freezing Of Gait Questionnaire (FOGQ) score \> 12.
3. Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in UPDRS score)
4. FOG refractory to LEVODOPA\>600 mg
5. 6. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS.
6. a) Poor candidate for STN or GPi DBS due to good control of tremor, bradykinesia, and rigidity symptoms with Levodopa b) or Post-operative STN/GPi DBS PD patients with significant residual non-levodopa responsive postural and gait instability
7. Must agree to full 6-month participation in study.
Exclusion:
1. Individuals with major executive dysfunction
2. Individuals with dementia, as defined by the Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
3. Individuals with other neurocognitive impairments
4. Individuals who have depression, as defined for example by the Beck Depression Inventory II (BDI-II) \> 25
5. Presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy
6. Individuals who require diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
7. Individuals with a history of prior intracranial surgery
8. Individuals with a metallic implant in their head that is not MRI compatible (e.g., aneurysm clip, cochlear implant)
9. Individuals with active implantable devices anywhere in the body (e.g. cardiac pacemaker, defibrillator, spinal cord stimulator, implanted medication pump)
10. Individuals who are pregnancy or desire to become pregnant during the study
11. Individuals who are breastfeeding12.
12. Individuals who are on investigational drugs and any other intervention (not part of the guidelines for management of Parkinson's Disease) known to have a potential impact on outcome
13. Subjects utilizing recreational drugs at the time of screening will be excluded from the study with the exception of medicinal marijuana | University of Miami | OTHER | {
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} | Unknown | {
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} | 2020-01-03T00:00:00 | {
"date": "2024-09-19",
"type": "ACTUAL"
} | {
"date": "2020-01-06",
"type": "ACTUAL"
} | [
"ADULT",
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} | [
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"city": "Miami",
"country": "United States",
"facility": "University of Miami",
"geoPoint": {
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"lon": -80.19366
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"class": "INDUSTRY",
"name": "Boston Scientific Corporation"
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"description": null,
"measure": "Percent Change in Gait Velocity",
"timeFrame": "Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op"
},
{
"description": null,
"measure": "Percent change in UPDRS Part III on/off stimulation",
"timeFrame": "Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op"
}
],
"secondary": [
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"description": null,
"measure": "Percent Change in FOG Questionnaire",
"timeFrame": "Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op"
},
{
"description": null,
"measure": "Percent Change in PDQ 39",
"timeFrame": "Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op"
},
{
"description": null,
"measure": "Percent Change in PDQ-L",
"timeFrame": "Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op"
},
{
"description": null,
"measure": "Percent Change in Muscle Amplitude",
"timeFrame": "Baseline, 24 weeks"
},
{
"description": null,
"measure": "Percent Change in number of Falls",
"timeFrame": "Baseline, 24 weeks"
}
]
} | [
{
"affiliation": "University of Miami",
"name": "Jonathan R Jagid, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "34168545", "type": "DERIVED", "citation": "Chang SJ, Cajigas I, Guest JD, Noga BR, Widerstrom-Noga E, Haq I, Fisher L, Luca CC, Jagid JR. MR Tractography-Based Targeting and Physiological Identification of the Cuneiform Nucleus for Directional DBS in a Parkinson's Disease Patient With Levodopa-Resistant Freezing of Gait. Front Hum Neurosci. 2021 Jun 8;15:676755. doi: 10.3389/fnhum.2021.676755. eCollection 2021."}, {"pmid": "34078477", "type": "DERIVED", "citation": "Chang SJ, Cajigas I, Guest JD, Noga BR, Widerstrom-Noga E, Haq I, Fisher L, Luca CC, Jagid JR. Deep brain stimulation of the Cuneiform nucleus for levodopa-resistant freezing of gait in Parkinson's disease: study protocol for a prospective, pilot trial. Pilot Feasibility Stud. 2021 Jun 2;7(1):117. doi: 10.1186/s40814-021-00855-7."}] | {"versionHolder": "2025-06-18"} | {
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NCT02291926 | null | Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect | Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee | None | INTERVENTIONAL | COMPLETED | 2014-11-07T00:00:00 | null | null | null | [
"PHASE1"
] | 20 | 18 | 75 | ALL | false | The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee. | Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.
To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation. | Inclusion Criteria:
* Patients must consent in writing to participate in the study by signing and dating an informed consent document
* Healthy patients with no major history of illness
* Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
* Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
* Patients must have had more than Grade 4 (0\~10 point numeric scale) pain at least for four months
* Patient's damaged cartilage area should be in the range of 2-6cm2
Exclusion Criteria:
* Pregnant women or lactating mothers
* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
* Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
* Patients who had participated in other clinical trials within three months prior to this study | Shenzhen Hornetcorn Bio-technology Company, LTD | INDUSTRY | {
"id": "HYK-Articular Cartilage Defect",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-11-12T00:00:00 | {
"date": "2017-05-10",
"type": "ACTUAL"
} | {
"date": "2014-11-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
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} | [
"Cartilage Diseases",
"Osteoarthritis"
] | ["Human Umbilical Cord Mesenchymal Stem Cell", "Mesenchymal Stem Cell", "Osteoarthritis"] | null | [
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"facility": "The Fifth Affiliated Hospital Immunotherapy center",
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"lon": 113.25
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"measure": "Severity of adverse events",
"timeFrame": "12 months"
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"timeFrame": "Before and 1,3,6,12 month after treatment"
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"description": null,
"measure": "Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)",
"timeFrame": "Before and 1,3,6,12 month after treatment"
}
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"affiliation": "Fifth Affiliated Hospital of Guangzhou Medical University",
"name": "Ping J Chen, Professor",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT06130826 | null | Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer | A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer | None | INTERVENTIONAL | RECRUITING | 2023-10-20T00:00:00 | null | 2026-09-05T00:00:00 | 2026-09-05T00:00:00 | [
"PHASE1"
] | 24 | 18 | null | ALL | false | This phase I trial studies the side effects and best dose of M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT) and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen (CEA) positive breast cancer that cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Carcinoembryonic Antigen (CEA) is a protein that is present in most colorectal cancers and in many other cancers, such as breast cancer, as well. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Cytokines are signaling proteins that help control inflammation in the body. They allow the immune system to mount a defense if germs or cancer or other substances that can make people sick enter the body. Interleukin-2 (IL-2) is a powerful cytokine able to regulate the immune responses that are important for anticancer immunity. Immunocytokines (also called antibody-cytokine fusion proteins) are small proteins that regulate the activity of immune cells. The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2. Giving M5A-ICK in combination with standard of care (SOC) SBRT may work better in treating patients with unresectable metastatic colorectal cancer or CEA positive metastatic breast cancer. | PRIMARY OBJECTIVE:
I. Identify the maximum tolerated dose (MTD) and recommend phase 2 dose (RP2D) and characterize toxicities associated with administration of the M5A-IL2 after fractionated SBRT.
SECONDARY OBJECTIVES:
I. Describe the therapeutic response to treatment of irradiated and unirradiated tumors per Criteria in Solid Tumors version 1.1 (RECIST v 1.1) guidelines.
II. Describe AEs by M5A-IL2 dose level, per Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0.
III. Describe the pharmacokinetics of M5A-IL2. IV. Describe the frequency of auto-antibody formation, overall and by dose of M5A-IL2.
EXPLORATORY OBJECTIVE:
I. If medically feasible, tumors targeted for SBRT will be biopsied pre-SBRT and 1-2 weeks post 3rd dose of M5A-IL2.
OUTLINE: This is a dose-escalation study of M5A-ICK.
Patients undergo SOC SBRT over 3 fractions on days 1, 3, and 5, followed by M5A-ICK subcutaneously (SC) on days 8, 9, and 10 once daily for a single cycle on study. Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT as well as blood sample collection throughout the trial. Patients may undergo magnetic resonance imaging or bone scan as clinically indicated on the trial. Additionally, patients may optionally undergo tissue biopsy during screening and on study.
After completion of study treatment, patients are followed-up at 3 months. | Inclusion Criteria:
* Patients should have a diagnosis of metastatic colon or rectal or breast cancer that is pathology proven
* Patients should have a CEA producing colorectal cancer or breast cancer defined as a baseline CEA or prior documented CEA level exceeding 5 ng/ml or evidence of CEA staining by Immunohistochemistry (IHC)
* Patients should 18 years of age or older
* Patients are willing and capable to consent to study and to adhere with all elements of the study
* Patients who have failed to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist, is not tolerable or was refused
* Patients should be at least 4 weeks from last receipt of a cytotoxic or biological agent prior to start of SBRT, with the exception of mitomycin C which requires a 6-week washout
* Patients should have unresectable disease or not be a candidate for surgical resection
* Patients must have a minimum of 1 and a maximum of 5 separate metastatic lesions planned for SBRT. (Patients may have \> 5 metastatic lesions overall, however only up to 5 lesions will be treated with SBRT.) SBRT sites must be equal to or less than 5 cm in greatest dimension. SBRT treated sites must be measurable per RECIST 1.1 and can include metastatic sites in the lung, liver, or soft tissue. Sites that are intracranial or in the bone are excluded. Sites deemed not appropriate for SBRT by the treating radiation oncologist are also excluded
* Patients should be at least 4 weeks from last radiation therapy prior to starting SBRT
* Patients should be at least 4 weeks from any investigational therapy prior to starting SBRT, with the exception of prior immunotherapy which would require a 3 month washout
* Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients should be considered clinically stable with an estimated overall survival of at least 3 months
* Neutrophil count \> 1500/mm\^3
* Lymphocyte count \> 500/mm\^3
* Hemoglobin \> 9 gm/dl
* Platelets count \> 100,000/mm\^3
* Aspartate transaminase (AST)/alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN)
* Bilirubin ≤ ULN
* Patients should have adequate kidney function defined as a serum creatinine \< ULN or calculated creatinine clearance of \> 60ml/min (Cockroft-Gault formula)
* Patients should have adequate cardiac function defined as:
* No history of acute coronary syndromes (including myocardial infarction, unstable angina, Coronary artery bypass grafting (CABG), coronary angioplasty, or stenting) \< 12 months prior to screening
* No impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
* Symptomatic chronic heart failure;
* Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities
* No uncontrolled arterial hypertension despite appropriate medical therapy (defined as systolic blood pressure \> 160 or diastolic blood pressure \>100)
* Electrocardiogram (EKG) showing normal sinus rhythm and a corrected QT (QTc) ≤ 450 ms for male and ≤ 470 ms for female patients
* Patients should have adequate pulmonary function defined as:
* Lack of uncontrolled pleural effusion requiring recurrent draining procedures (more than once per month)
* Lack of oxygen supplementation dependence
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* Screening 2-dimensional (2-D) echocardiogram (echo) shows a left ventricular ejection fraction (LVEF) \> 40%
* Urinalysis shows lack of proteinuria or a maximum of 1+ proteinuria
* Women of childbearing potential should use highly effective contraception while receiving the trial regimen and for at least 5 half-lives of M5A-IL2 from the last dose of M5A-IL2
Exclusion Criteria:
* Patients on immunosuppressive treatments including supra-physiological doses of corticosteroids
* Patients with history of auto-immune disease including history of inflammatory bowel disease
* Patients with active brain metastases
* Patients in the child-bearing ages who refuse to use adequate birth control measures (example: contraceptives, barrier method, or abstinence)
* Lactating females who do not agree to stop breastfeeding
* Known active hepatitis B or C
* Major surgical procedure within 4 weeks prior to SBRT
* Non-healed wound or surgical incisions
* Radiographic evidence of bowel obstruction
* Electrolyte disturbances (sodium, potassium, magnesium, calcium, and phosphorous) that are not correctable to at least CTCAE grade 1 with replacement therapy
* Known hypersensitivity of any of the study drug agents or components
* Patients should not have any uncontrolled illness including ongoing or active infection
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
* Pregnant women are excluded from this study because the investigational agents on this study are highly likely to exert teratogenic or abortifacient effects
* Patients with other active malignancies are ineligible for this study
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study | City of Hope Medical Center | OTHER | {
"id": "20510",
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"date": "2025-05-30",
"type": "ACTUAL"
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"date": "2023-11-14",
"type": "ACTUAL"
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"Breast Carcinoma",
"Colorectal Carcinoma"
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"state": "California"
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{
"class": "NIH",
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"description": null,
"measure": "Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK)",
"timeFrame": "At the end of cycle 1 (each cycle is 28 days)"
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NCT04171726 | null | Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation | Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation | REDOX-TAVI | INTERVENTIONAL | UNKNOWN | 2019-11-19T00:00:00 | null | 2023-06-01T00:00:00 | 2023-09-01T00:00:00 | [
"PHASE3"
] | 100 | 18 | null | ALL | false | A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after three months of edoxaban treatment. | Rationale: Thromboembolic- and bleeding events can occur after TAVI and can have great consequences. There is currently no evidence-based guideline on prevention of thromboembolic events after TAVI and the current standard of care with DAPT 3-6 months is based on expert opinion. Recently multislice computed tomography (MSCT) studies identified bioprosthesis leaflet thickening and impaired leaflet motion after TAVI. The goal of this study is to investigate whether in TAVI patients, treatment with edoxaban leads to a reduction in leaflet thickening incidence after 3 months and whether it is safe and clinically efficient.
Objective: To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.
Study design: A single-center, investigator-initiated, open-label, observational study.
Study population: Patients undergoing transfemoral transcatheter aortic valve replacement in the Erasmus University Medical Center with no formal novel oral anticoagulants/vitamin-K-antagonist (NOAC/VKA) indication.
Intervention (if applicable): Patients will be treated with edoxaban for a period of 3 months following TAVI. Afterwards they will switch to acetylsalicylic acid.
Main study parameters/endpoints: The incidence of leaflet thickening on MSCT 3 months after TAVI and edoxaban treatment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Thus far edoxaban has proven to be safe and non-inferior to treatment with warfarin in several indications. The role of anticoagulant agents in TAVI still has to be unravelled. Subjects participating in this trial are possibly at higher risk for bleeding complications than patients being treated with dual antiplatelet therapy after TAVI. | Inclusion Criteria:
* Completed successful elective TAVI for severe native aortic valve stenosis with any commercially-available transcatheter heart valve (THV).
* Correct positioning of a single prosthetic heart valve
* Device success, defined by:
* Mean aortic valve gradient \< 20 mmHg
* Peak transvalvular velocity \< 3.0 m/s
* Aortic valve regurgitation of 2 or less
* No periprocedural complications.
* No overt stroke
* No uncontrolled bleeding
* No major vascular complication defined by the Valve academic research committee 2 (VARC-2) consensus
* No formal indication for oral anticoagulation
* Prevention of thromboembolic complications in patients with atrial fibrillation
* Prevention for recurrent venous thromboembolism
* Prevention for recurrent pulmonary embolism
Exclusion Criteria:
* History of life-threatening or major bleeding event ≥ Bleeding academic research committee (BARC) 3b definitions within the last year.
* Conditions with a high risk of bleeding
* Active peptic ulcer or upper gastrointestinal bleeding (\< 3 months)
* Malignancy with high risk of bleeding
* Recent unresolved brain of spinal injury
* Spinal or ophthalmic surgery within last 3 months prior to enrolment
* Intracranial haemorrhage
* Esophagal varices
* Arteriovenous malformations with high risk of bleeding
* Vascular aneurysms
* Major intraspinal or intracerebral vascular abnormalities
* Hypersensitivity or contraindications to edoxaban
* No percutaneous coronary intervention within 6 months prior to randomization (requiring DAPT after TAVR)
* Dialysis-dependency or glomerular filtration rate \< 30 mL/min at time of enrollment
* Active bleeding or bleeding diathesis including thrombocytopenia (platelet count \< 50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease
* Patients unable to adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life-threatening disease
* Pregnant or breast-feeding subjects
* Current participation in clinical trials that potentially interfere with the current study | Erasmus Medical Center | OTHER | {
"id": "REDOX TAVI",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-11-19T00:00:00 | {
"date": "2022-07-27",
"type": "ACTUAL"
} | {
"date": "2019-11-21",
"type": "ACTUAL"
} | [
"ADULT",
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} | [
"Aortic Valve Stenosis"
] | ["Thrombosis", "Aortic Valve Stenosis", "Heart Valve Diseases", "Ventricular Outflow Obstruction", "Cardiovascular Diseases", "Embolism and Thrombosis", "Vascular Diseases", "Heart Diseases", "Factor Xa Inhibitors", "Anticoagulants"] | null | [
{
"city": "Rotterdam",
"country": "Netherlands",
"facility": "Erasmus MC",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": null
}
] | [
{
"class": "INDUSTRY",
"name": "Daiichi Sankyo"
}
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"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4D computed tomography scan (4DCT)",
"timeFrame": "3 months after TAVI"
}
],
"secondary": null
} | [
{
"affiliation": "Erasmusm MC",
"name": "Nicolas M Van Mieghem, MD, PhD",
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] | [{"pmid": "26436963", "type": "BACKGROUND", "citation": "Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5."}, {"pmid": "28838044", "type": "BACKGROUND", "citation": "Sondergaard L, De Backer O, Kofoed KF, Jilaihawi H, Fuchs A, Chakravarty T, Kashif M, Kazuno Y, Kawamori H, Maeno Y, Bieliauskas G, Guo H, Stone GW, Makkar R. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J. 2017 Jul 21;38(28):2201-2207. doi: 10.1093/eurheartj/ehx369."}, {"pmid": "28330690", "type": "BACKGROUND", "citation": "Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19."}, {"pmid": "35787831", "type": "DERIVED", "citation": "van Wiechen MP, El Azzouzi I, Knol WG, Adrichem R, Hokken TW, Ooms JF, de Ronde-Tillmans MJ, Daemen J, de Jaegere PP, Hirsch A, Budde RPJ, Van Mieghem NM. Leaflet Thickening and Motion After Transcatheter Aortic Valve Replacement: Design and Rationale of the Rotterdam Edoxaban Trial. Cardiovasc Revasc Med. 2022 Nov;44:67-70. doi: 10.1016/j.carrev.2022.06.011. Epub 2022 Jun 17."}] | {"versionHolder": "2025-06-18"} | {
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NCT00915226 | null | Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure | Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure. | None | INTERVENTIONAL | WITHDRAWN | 2009-06-03T00:00:00 | null | null | null | [
"NA"
] | 0 | 19 | 35 | MALE | true | Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve head (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure. The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments are designed to improve the investigators' knowledge of the physiology of regulatory mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow abnormalities in glaucoma. This is of importance, because there is an increased evidence, that vascular dysregulation plays a role in the development of glaucomatous damage. | null | Inclusion Criteria:
* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt
Exclusion Criteria:
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases | Medical University of Vienna | OTHER | {
"id": "OPHT-310505-2",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-06-04T00:00:00 | {
"date": "2014-11-14",
"type": "ESTIMATED"
} | {
"date": "2009-06-05",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
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"maskingInfo": {
"masking": "NONE",
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},
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"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Healthy"
] | ["Optic disk", "Regional blood flow", "Autoregulation"] | null | [
{
"city": "Vienna",
"country": "Austria",
"facility": "Department of Clinical Pharmacology, Medical University of Vienna",
"geoPoint": {
"lat": 48.20849,
"lon": 16.37208
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Ocular perfusion pressure - ONH blood flow relationship",
"timeFrame": "9 months"
}
],
"secondary": null
} | [
{
"affiliation": "Department of Clinical Pharmacology, Medical University of Vienna",
"name": "Elzbieta Polska, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT02900326 | null | Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer | Effect of a Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help to Improve Exercise Capacity and Quality of Life in Breast Cancer | MBSR | INTERVENTIONAL | COMPLETED | 2015-06-16T00:00:00 | null | 2015-05-12T00:00:00 | 2021-03-30T00:00:00 | [
"NA"
] | 100 | 18 | 65 | FEMALE | false | Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer. | null | Inclusion Criteria:
* Breast cancer
* Having completed the chemotherapy period
* Undergoing radiotherapy and/or hormono therapy
Exclusion Criteria:
* Regular physical activity higher than 4 hours per week.
* Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training ) | University Hospital, Strasbourg, France | OTHER | {
"id": "5970",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-09-13T00:00:00 | {
"date": "2022-05-25",
"type": "ACTUAL"
} | {
"date": "2016-09-14",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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"masking": "NONE",
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},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Breast Cancer"
] | ["Exercise capacity", "Mindfulness", "Quality of life"] | null | [
{
"city": "Strasbourg",
"country": "France",
"facility": "Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire",
"geoPoint": {
"lat": 48.58392,
"lon": 7.74553
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Evolution of V02 max between inclusion and 8 weeks",
"timeFrame": "8 weeks"
}
],
"secondary": null
} | [
{
"affiliation": "Hôpitaux Universitaires de Strasbourg",
"name": "LONSDORFER Evelyne",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D001941",
"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
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},
{
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"name": "Skin and Connective Tissue Diseases"
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},
{
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}
],
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],
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}
]
} | null | {
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{
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}
],
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} |
NCT02242526 | null | Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia | Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia | None | INTERVENTIONAL | UNKNOWN | 2014-09-03T00:00:00 | null | null | null | [
"PHASE4"
] | 312 | 18 | 80 | ALL | true | The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh. | Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh. | Inclusion Criteria:
* Male or female gender
* Age\>18 years
* Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
* Able to give informed consent
* Able and willing to participate in follow-up evaluations
* Upper GI with a documented hiatal hernia greater than 5cm
* Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.
Exclusion Criteria:
* Previous surgery of the esophagus and/or the stomach
* Emergent operation for acute gastric volvulus or strangulation
* Biopsy consistent with malignancy
* Body Mass Index (BMI) over 35kg/m2
* Inability to perform primary closure of crura
* Active smoking | Stony Brook University | OTHER | {
"id": "SB-568818",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-09-15T00:00:00 | {
"date": "2018-10-15",
"type": "ACTUAL"
} | {
"date": "2014-09-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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"maskingDescription": null,
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Hiatal Hernia"
] | ["hiatal hernia, recurrence, biologic mesh, synthetic mesh"] | null | [
{
"city": "Stony Brook",
"country": "United States",
"facility": "Stony Brook University Hospital",
"geoPoint": {
"lat": 40.92565,
"lon": -73.14094
},
"state": "New York"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Assess for reappearance of hiatal hernia and reflux",
"timeFrame": "6 months, 60 months"
}
],
"secondary": [
{
"description": null,
"measure": "Quality of Life questionnaire",
"timeFrame": "Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020763",
"term": "Pathological Conditions, Anatomical"
},
{
"id": "D006548",
"term": "Hernia, Diaphragmatic"
},
{
"id": "D000082122",
"term": "Internal Hernia"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"asFound": null,
"id": "M14850",
"name": "Recurrence",
"relevance": "LOW"
},
{
"asFound": "Hernia",
"id": "M9625",
"name": "Hernia",
"relevance": "HIGH"
},
{
"asFound": "Hiatal Hernia",
"id": "M9629",
"name": "Hernia, Hiatal",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22519",
"name": "Pathological Conditions, Anatomical",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9626",
"name": "Hernia, Diaphragmatic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M25675",
"name": "Hernia, Abdominal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2344",
"name": "Internal Hernia",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006547",
"term": "Hernia"
},
{
"id": "D006551",
"term": "Hernia, Hiatal"
}
]
} | null | {
"conditions": [
{
"id": "D006547",
"term": "Hernia"
},
{
"id": "D006551",
"term": "Hernia, Hiatal"
}
],
"interventions": null
} |
NCT02353026 | null | Phase I Study of Intravenous Artesunate for Solid Tumors | A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors | None | INTERVENTIONAL | COMPLETED | 2015-01-27T00:00:00 | null | null | null | [
"PHASE1"
] | 19 | 18 | null | ALL | false | This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity. | A rapid dose escalation design will be used, in which single patients will be enrolled to each dose level until a grade \>/= 2 treatment-related toxicity occurs during cycle 1; enrollment then will proceed using a classic 3+ 3 dose escalation design. If the toxicity was grade 2, then enrollment will continue on that dose level. If the toxicity was grade 3 or 4, then enrollment will continue on one dose level below that dose. Dose escalation with the 3+3 design will continue until \>/= 2 patients out of 6 experience a treatment-related dose-limiting toxicity. Then, the maximum tolerated dose and recommended Phase II dose of intravenous artesunate will be one dose level below the level at which the toxicities occurred. | Inclusion Criteria:
* At least one measurable lesion by RECIST criteria
* Willing to undergo pharmacogenetic testing
* Over the age of 18 years and able to provide informed consent
* No standard of care therapy available which has a proven overall survival benefit
* Adequate kidney, liver, and bone marrow function
* Life expectancy of greater than 3 months
* ECOG performance status less than or equal to 2
Exclusion Criteria:
* Chemotherapy or surgery within 4 weeks of treatment start
* Radiation treatment within 3 weeks prior to treatment start
* Untreated brain metastases or neurologically unstable CNS metastases
* Any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction \</= 6 months prior to study entry
* Previous diagnosis of alpha- or beta-thalassemia
* Patients on a medication or herbal therapy known to inhibit CYP2A6, UGT1A9, or UGT2B7
* Female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment
* Patients unwilling or unable to comply with the protocol, or provide informed consent | Georgetown University | OTHER | {
"id": "Pro028",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-01-27T00:00:00 | {
"date": "2016-11-18",
"type": "ESTIMATED"
} | {
"date": "2015-02-02",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Solid Tumors"
] | null | null | [
{
"city": "Washington",
"country": "United States",
"facility": "Georgetown Lombardi Comprehensive Cancer Center",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia"
}
] | [
{
"class": "FED",
"name": "United States Department of Defense"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Maximum Tolerated Dose",
"timeFrame": "1 year"
}
],
"secondary": null
} | [
{
"affiliation": "Georgetown University",
"name": "John F Deeken, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29392450", "type": "DERIVED", "citation": "Deeken JF, Wang H, Hartley M, Cheema AK, Smaglo B, Hwang JJ, He AR, Weiner LM, Marshall JL, Giaccone G, Liu S, Luecht J, Spiegel JY, Pishvaian MJ. A phase I study of intravenous artesunate in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Mar;81(3):587-596. doi: 10.1007/s00280-018-3533-8. Epub 2018 Feb 1."}] | {"versionHolder": "2025-06-18"} | {
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"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000962",
"term": "Antimalarials"
},
{
"id": "D000981",
"term": "Antiprotozoal Agents"
},
{
"id": "D000977",
"term": "Antiparasitic Agents"
},
{
"id": "D000890",
"term": "Anti-Infective Agents"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D000998",
"term": "Antiviral Agents"
},
{
"id": "D012556",
"term": "Schistosomicides"
},
{
"id": "D000980",
"term": "Antiplatyhelmintic Agents"
},
{
"id": "D000871",
"term": "Anthelmintics"
}
],
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "ABT-",
"id": "M1769",
"name": "Artesunate",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4280",
"name": "Antimalarials",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4298",
"name": "Antiprotozoal Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4294",
"name": "Antiparasitic Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4214",
"name": "Anti-Infective Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4314",
"name": "Antiviral Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4196",
"name": "Anthelmintics",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000077332",
"term": "Artesunate"
}
]
} | {
"conditions": [
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"term": "Neoplasms"
}
],
"interventions": [
{
"id": "D000077332",
"term": "Artesunate"
}
]
} |
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