protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Behavioural Experiments for Intolerance of Uncertainty"
}
]
},
"conditionsModule": {
"conditions": [
"Generalized Anxiety Disorder",
"Adolescent - Emotional Problem"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gatineau",
"contacts": [
{
"email": "[email protected]",
"name": "Sylvain C Lemay, B.A.",
"phone": "+1 819-595-3900",
"phoneExt": "2501",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Universite du Quebec en Outaouais",
"geoPoint": {
"lat": 45.47723,
"lon": -75.70164
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "J8X 3X7"
}
]
},
"descriptionModule": {
"briefSummary": "Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group.In the 1990s, a group of Canadian researchers developed a CBT protocol for GAD that included four components. Data from six clinical trials in adults suggest that one of the four components is particularly important for treatment success: exposing oneself to uncertainty rather than avoiding it in daily life. In other words, learning to tolerate and manage uncertainty seems to be the key to reducing worry and anxiety.Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Open trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "EC-II-Ado-P",
"briefTitle": "Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study",
"nctId": "NCT06282133",
"orgStudyIdInfo": {
"id": "2024-1862",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Intolerance of Uncertainty Scale (IUS)"
},
{
"measure": "Safety Behaviors Questionnaire (SBQ)"
},
{
"measure": "Treatment Acceptance and Adherence Scale (TAAS)"
},
{
"measure": "Working Alliance Inventory (WAI)"
}
],
"primaryOutcomes": [
{
"measure": "Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)"
}
],
"secondaryOutcomes": [
{
"measure": "Worry and Anxiety Questionnaire (WAQ)"
},
{
"measure": "Penn State Worry Questionnaire (PSWQ)"
},
{
"measure": "Beck Anxiety Inventory (BAI)"
},
{
"measure": "Beck Depression Inventory-II (BDI-II)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universite du Quebec en Outaouais"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Biliary Tract Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": [
{
"email": "[email protected]",
"name": "Huikai Li, Doctor",
"phone": "18622228639",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Xihao Zhang, Master",
"phone": "15510801035",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tianjin Cancer Hospital Airport Hospital",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": "Tianjin",
"status": "RECRUITING",
"zip": "300000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:* To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer",
"nctId": "NCT06282120",
"orgStudyIdInfo": {
"id": "CSPC-DNY-BTC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression Free Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival"
},
{
"measure": "Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1"
},
{
"measure": "EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "CSPC Ouyi Pharmaceutical Co., Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tianjin Medical University Cancer Institute and Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BiSAAE"
},
{
"name": "traditional triple antihypertensive treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Resistant Hypertension"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Hypertension is a common problem, affecting \\>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (SAAE) is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness and Safety of BiSAAE for Resistant Hypertension.",
"nctId": "NCT06282107",
"orgStudyIdInfo": {
"id": "BiSAAE-RHT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of 24-h average systolic blood pressure"
},
{
"measure": "Change of 24-h average systolic blood pressure"
},
{
"measure": "Change of 24-h average systolic blood pressure"
}
],
"secondaryOutcomes": [
{
"measure": "Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure"
},
{
"measure": "Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure"
},
{
"measure": "Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure"
},
{
"measure": "Change of home systolic and diastolic pressure"
},
{
"measure": "Change of home systolic and diastolic pressure"
},
{
"measure": "Change of home systolic and diastolic pressure"
},
{
"measure": "Difference in the change of office systolic and diastolic pressure between the intervention and control group"
},
{
"measure": "Difference in the change of office systolic and diastolic pressure between the intervention and control group"
},
{
"measure": "Difference in the change of office systolic and diastolic pressure between the intervention and control group"
},
{
"measure": "Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group"
},
{
"measure": "Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group"
},
{
"measure": "Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group"
},
{
"measure": "Change of plasma aldosterone"
},
{
"measure": "Change of plasma aldosterone"
},
{
"measure": "Change of plasma aldosterone"
},
{
"measure": "Change of plasma cortisol"
},
{
"measure": "Change of plasma cortisol"
},
{
"measure": "Change of plasma cortisol"
},
{
"measure": "Change of plasma renin measured"
},
{
"measure": "Change of plasma renin measured"
},
{
"measure": "Change of plasma renin measured"
},
{
"measure": "Change of liver enzymes"
},
{
"measure": "Change of liver enzymes"
},
{
"measure": "Change of liver enzymes"
},
{
"measure": "Change of kidney function"
},
{
"measure": "Change of kidney function"
},
{
"measure": "Change of kidney function"
},
{
"measure": "Change of fasting blood glucose"
},
{
"measure": "Change of fasting blood glucose"
},
{
"measure": "Change of fasting blood glucose"
},
{
"measure": "Change of lipids profiles"
},
{
"measure": "Change of lipids profiles"
},
{
"measure": "Change of lipids profiles"
},
{
"measure": "Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)"
},
{
"measure": "Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)"
},
{
"measure": "Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)"
},
{
"measure": "Change of 24-h urine microalbumin"
},
{
"measure": "Change of 24-h urine microalbumin"
},
{
"measure": "Change of 24-h urine microalbumin"
},
{
"measure": "Change of 24-h urine creatinine"
},
{
"measure": "Change of 24-h urine creatinine"
},
{
"measure": "Change of 24-h urine creatinine"
},
{
"measure": "Change of echocardiography parameters (LVEF)"
},
{
"measure": "Change of echocardiography parameters (LVEF)"
},
{
"measure": "Change of echocardiography parameters (LVEF)"
},
{
"measure": "Change of carotid intima-media thickness"
},
{
"measure": "Change of carotid intima-media thickness"
},
{
"measure": "Change of carotid intima-media thickness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital of Chengdu Medical College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Bariatric Surgery Candidate"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "York",
"contacts": [
{
"email": null,
"name": "Faiz Shariff",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "WellSpan",
"geoPoint": {
"lat": 39.9626,
"lon": -76.72774
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "17405"
}
]
},
"descriptionModule": {
"briefSummary": "This study investigates the new ViSiGi LUX."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ViSiGi LUX Bariatric Sizing and Calibration System",
"nctId": "NCT06282094",
"orgStudyIdInfo": {
"id": "LUX",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physician Feedback"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Boehringer Labs LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Serum Neurofilament Light"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis",
"Relapsing Remitting Multiple Sclerosis"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Serum Neurofilament Light in Multiple Sclerosis",
"nctId": "NCT06282081",
"orgStudyIdInfo": {
"id": "ML 45098",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received"
},
{
"measure": "Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice"
},
{
"measure": "Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements."
},
{
"measure": "Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements."
},
{
"measure": "Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale."
},
{
"measure": "Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale."
}
],
"secondaryOutcomes": [
{
"measure": "Describe patient demographics"
},
{
"measure": "Describe patient comorbidities"
},
{
"measure": "Describe patient concomitant medications"
},
{
"measure": "Describe patient MS medications"
},
{
"measure": "Describe patient reasons for MS medication changes"
},
{
"measure": "Describe patient MS relapses including date of relapse"
},
{
"measure": "Describe patient MS relapses including clinical findings"
},
{
"measure": "Describe patient MS relapses including radiologic findings"
},
{
"measure": "Describe patient MS relapses including severity"
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire."
},
{
"measure": "Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire."
},
{
"measure": "Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available."
},
{
"measure": "Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available."
},
{
"measure": "Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not."
},
{
"measure": "Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available."
},
{
"measure": "Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available."
},
{
"measure": "Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available."
},
{
"measure": "Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available."
},
{
"measure": "Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available."
},
{
"measure": "Describe changes in sNfL levels with magnetic resonance imaging disease activity where available."
},
{
"measure": "Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available."
},
{
"measure": "Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available."
},
{
"measure": "Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available."
},
{
"measure": "Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available."
},
{
"measure": "Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available."
},
{
"measure": "Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available."
},
{
"measure": "Compare changes in sNfL levels with magnetic resonance imaging disease activity where available."
},
{
"measure": "Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available."
},
{
"measure": "Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available."
},
{
"measure": "Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available."
},
{
"measure": "Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available."
},
{
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"zip": "29010"
},
{
"city": "Valladolid",
"contacts": [
{
"email": null,
"name": "Ignacio Amat-Santos, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Ignacio Amat-Santos, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Clínico Universitario de Valladolid",
"geoPoint": {
"lat": 41.65518,
"lon": -4.72372
},
"state": null,
"status": null,
"zip": "47003"
}
]
},
"descriptionModule": {
"briefSummary": "To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery.",
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"count": 250,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EMCAMI",
"briefTitle": "Early Transcatheter Mitral Valve Repair After Myocardial Infarction",
"nctId": "NCT06282042",
"orgStudyIdInfo": {
"id": "EMCAMI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "All-cause death or Cumulative Heart Failure hospitalizations"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Meditrial Europe Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundación para la Investigación Biosanitaria del Principado de Asturias"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Group Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Intracerebral Hemorrhage",
"Depressive Symptoms",
"Anxiety",
"Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bielefeld",
"contacts": [
{
"email": "[email protected]",
"name": "Simon Ladwig, PhD",
"phone": "017664716035",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Neuropsychological Outpatient Clinic",
"geoPoint": {
"lat": 52.03333,
"lon": 8.53333
},
"state": null,
"status": "RECRUITING",
"zip": "33607"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:* Is the group therapy feasible?* Is the group therapy accepted by stroke survivors and therapists?* Are there first indications on the efficacy of the group therapy to improve mental health?Participants will take part in 8 weekly group therapy sessions of 90 minutes each."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This pilot study includes a pre-/post test of a small intervention sample without control group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
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"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ACT-group for Stroke Survivors (Pilot Study)",
"nctId": "NCT06282029",
"orgStudyIdInfo": {
"id": "I-2720-0018-0003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Drop-out rate"
},
{
"measure": "Session adherence"
},
{
"measure": "Homework completion"
},
{
"measure": "Completion of outcome measures"
},
{
"measure": "Treatment fidelity"
},
{
"measure": "Group therapy session questionnaire - patients (Zoubek, 2013; Plain German)"
},
{
"measure": "Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German)"
},
{
"measure": "Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German)"
},
{
"measure": "Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German)"
}
],
"secondaryOutcomes": [
{
"measure": "Valuing Questionnaire (Smout, 2014; Plain German)"
},
{
"measure": "Self-as-context scale (Zettle, 2018; Plain German)"
},
{
"measure": "Patient Health Questionnaire-9 (Kroenke, 2001; Plain German)"
},
{
"measure": "Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bielefeld Young Researchers' Fund"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Bielefeld University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-02-12",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 260777,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-02-12T06:57"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Case-control study (no intervention)"
}
]
},
"conditionsModule": {
"conditions": [
"Neuroendocrine Neoplasm of Lung",
"Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
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"count": 7200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risk Factors for Neuroendocrine Neoplasms",
"nctId": "NCT06282016",
"orgStudyIdInfo": {
"id": "BKR-2024-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Depression/Persistent mood disorder"
},
{
"measure": "Obesity"
},
{
"measure": "Metabolic syndrome"
},
{
"measure": "Previous malignant neoplasm"
},
{
"measure": "Alcohol buse"
},
{
"measure": "Diabetes"
},
{
"measure": "Ulcerative colitis"
},
{
"measure": "Crohn disease"
},
{
"measure": "Allergic rhinitis"
},
{
"measure": "Asthma"
}
],
"secondaryOutcomes": [
{
"measure": "Area deprivation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bavarian Association of Statutory Health Insurance Accredited Physicians"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Bavarian Cancer Registry"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The procedure of protective lung ventilation"
}
]
},
"conditionsModule": {
"conditions": [
"Well-Being, Psychological"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zabok",
"contacts": [
{
"email": "[email protected]",
"name": "Maša Kontić, Medical Doctor",
"phone": "00385 98 97 95 648",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Croatia",
"facility": "General hospital Zabok",
"geoPoint": {
"lat": 46.02944,
"lon": 15.915
},
"state": null,
"status": "RECRUITING",
"zip": "49210"
}
]
},
"descriptionModule": {
"briefSummary": "Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "A crossover design should be utilized in addition to the randomization procedure to properly address outcome variability. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 53,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications",
"nctId": "NCT06282003",
"orgStudyIdInfo": {
"id": "380-59-10106-21-111/148",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Oxygentation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Prof.Dinko Tonković, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb"
},
{
"name": "Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar"
},
{
"name": "Prof. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb"
},
{
"name": "Prof. Anamarija Jazbec, Faculty of Forestry and Wood Technology, University of Zagreb"
},
{
"name": "Marijan Jedvaj, MD Anesthesiologist and ICU physician (Consultant), Head of Department of Anesthesia and IC, General Hospital Zabok"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Masa Kontic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Education"
}
]
},
"conditionsModule": {
"conditions": [
"Bariatric Surgeries",
"Education of Patients"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Balıkesir",
"contacts": null,
"country": "Turkey",
"facility": "Pınar Ongün",
"geoPoint": {
"lat": 39.64917,
"lon": 27.88611
},
"state": null,
"status": null,
"zip": "38000"
}
]
},
"descriptionModule": {
"briefSummary": "The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "There are two groups in the research: control and intervention groups.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded).",
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Education and Information for Bariatric Surgery Patients",
"nctId": "NCT06281990",
"orgStudyIdInfo": {
"id": "BAUN-SBF-PO-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Data collection form"
},
{
"measure": "Visual Analog Scale (VAS)"
},
{
"measure": "State-Trait Anxiety Inventory (STAI)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Scientific and Technological Research Council of Turkey"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Balikesir University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine"
},
{
"name": "Normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Ventricular Tachycardia",
"Ventricular Arrhythmias",
"Ventricular Fibrillation",
"Recurrent Ventricular Tachycardia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Double-blind",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 192,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SEDATE",
"briefTitle": "Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm",
"nctId": "NCT06281977",
"orgStudyIdInfo": {
"id": "ES613",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation."
}
],
"secondaryOutcomes": [
{
"measure": "All-cause in-hospital death"
},
{
"measure": "Ventricular arrhythmia requiring treatment after study drug initiation"
},
{
"measure": "Resuscitated cardiac arrest after study drug initiation"
},
{
"measure": "Renal failure requiring new initiation of renal replacement therapy after study drug initiation"
},
{
"measure": "Intubation following study drug initiation"
},
{
"measure": "Length of stay in the intensive care unit"
},
{
"measure": "Length of stay in hospital"
},
{
"measure": "Need for mechanical circulatory support device after study drug initiation"
},
{
"measure": "Ventricular Arrhythmia requiring treatment only during active study drug treatment"
},
{
"measure": "Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ottawa Heart Institute Research Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PLB1004"
},
{
"name": "Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab"
}
]
},
"conditionsModule": {
"conditions": [
"Non-Small-Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 327,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.",
"nctId": "NCT06281964",
"orgStudyIdInfo": {
"id": "PLB1004-III-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "intracranial Progression-Free Survival（PFS）"
},
{
"measure": "second progression-free survival (PFS2)"
},
{
"measure": "Assess the Quality of Healthy Living About Patients"
},
{
"measure": "EGFR Ex20ins status in tumor tissues and its relevance to the clinical efficacy of drugs"
},
{
"measure": "Gene mutation status in plasma ctDNA before and after medication, and its correlation with clinical efficacy"
}
],
"primaryOutcomes": [
{
"measure": "Progression-Free Survival (PFS) by BICR"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-Free Survival (PFS) by the investigator"
},
{
"measure": "Intracranial Overall Response Rate（ORR）"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Disease Control Rate (DCR)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Incidence of Treatment-Emergent Adverse Events (TEAEs)"
},
{
"measure": "Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies"
}
]
},
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"collaborators": null,
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"class": "INDUSTRY",
"name": "Avistone Biotechnology Co., Ltd."
}
},
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"date": "2026-12-30"
},
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},
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"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fentanyl - Inhalation by facial nebulization"
},
{
"name": "Fentanyl - Nebulisation"
}
]
},
"conditionsModule": {
"conditions": [
"Analgesia",
"Emergencies"
]
},
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{
"city": "Rouen",
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]
},
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},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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},
"eligibilityModule": {
"maximumAge": "68 Years",
"minimumAge": "18 Years",
"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AEROfen",
"briefTitle": "Nebulized Fentanyl in Healthy Volunteers",
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"id": "2022/0271/HP",
"link": null,
"type": null
},
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},
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"measure": "Measurement of [F] bioavailability via facial nebulization and intranasal inhalation."
}
],
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"measure": "Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation."
},
{
"measure": "Measurement of the difference between observed and predicted PUAL values by a PK/PD model."
},
{
"measure": "Time required to achieve >30% decrease in PUAL compared to baseline."
},
{
"measure": "Measurement of dose required to achieve >30% decrease in PUAL compared to baseline."
},
{
"measure": "Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless)."
}
]
},
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}
},
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},
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"date": "2026-03-01"
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"date": "2024-04-01"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Weight estimation using 3D camera"
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{
"name": "Standard care weight estimation"
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]
},
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},
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"measure": "Weight estimation accuracy"
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{
"measure": "Time to obtain weight estimate"
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{
"measure": "Drug dosing accuracy"
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{
"measure": "Correct dosing scalar used"
}
],
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{
"measure": "Accuracy of in-bed scales"
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"name": "Florida Atlantic University"
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},
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}
} | false | null |
{
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{
"name": "Cryotherapy Gloves"
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]
},
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},
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{
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},
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"briefTitle": "Cryotherapy & Oxaliplatin",
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"measure": "Proportion of Participants with Peripheral Neuropathy at Visit 2"
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"measure": "Proportion of Participants with Peripheral Neuropathy at Visit 3"
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{
"measure": "Proportion of Participants with Peripheral Neuropathy at Visit 4"
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{
"measure": "Proportion of Participants with Peripheral Neuropathy at Visit 5"
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}
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{
"armsInterventionsModule": {
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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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]
},
"descriptionModule": {
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},
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"eligibilityModule": {
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},
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"briefTitle": "Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients",
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"link": null,
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"measure": "rate of objective response"
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}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dapagliflozin 10 mg Tab"
},
{
"name": "Low protein diet"
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]
},
"conditionsModule": {
"conditions": [
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},
"contactsLocationsModule": {
"locations": [
{
"city": "Bucharest",
"contacts": [
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"email": "[email protected]",
"name": "Liliana Garneata, Assoc Prof",
"phone": "+40722619358",
"phoneExt": null,
"role": "CONTACT"
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{
"email": "[email protected]",
"name": "Elena Cuiban, MD",
"phone": "+40748975315",
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"role": "CONTACT"
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"facility": "Carol Davila University of Medicine and Pharmacy Bucharest",
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]
},
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},
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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},
"identificationModule": {
"acronym": "PRODAPA-CKD",
"briefTitle": "Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus",
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"id": "01/2022",
"link": null,
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},
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"otherOutcomes": [
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"measure": "Compliance to the protein intake"
},
{
"measure": "Compliance to the energy intake"
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{
"measure": "Compliance to carbohydrate intake"
}
],
"primaryOutcomes": [
{
"measure": "Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of decline in the estimated Glomerular Filtration Rate"
},
{
"measure": "Variation of albuminuria"
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{
"measure": "Variation of HbA1C"
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{
"measure": "Variation of serum cholesterol levels"
},
{
"measure": "Variation of serum bicarbonate levels"
},
{
"measure": "Variation of serum potassium levels"
},
{
"measure": "Variation of serum sodium levels"
},
{
"measure": "Variation of hemoglobin levels"
},
{
"measure": "Variation of hematocrit levels"
},
{
"measure": "All cause hospitalizations"
},
{
"measure": "Variation in body weight"
},
{
"measure": "Variation in BMI"
},
{
"measure": "Variation in handgrip strength"
},
{
"measure": "Variation in serum albumin levels"
},
{
"measure": "Variation in CRP levels"
},
{
"measure": "Changes in the quality of life"
}
]
},
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"collaborators": [
{
"name": "Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania"
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{
"name": "Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania"
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{
"name": "Carol Davila University of Medicine and Pharmacy"
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},
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}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Induction Immunotherapy-Toripalimab"
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{
"name": "Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin"
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{
"name": "Radiotherapy"
},
{
"name": "Apatinib"
},
{
"name": "Capecitabine"
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},
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"conditions": [
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"Toxicity"
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},
"contactsLocationsModule": {
"locations": [
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"city": "Guangzhou",
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{
"email": "[email protected]",
"name": "Bo Qiu, Professor",
"phone": "+86-020-87343031",
"phoneExt": null,
"role": "CONTACT"
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"country": "China",
"facility": "Sun yat-sen University Cancer Center",
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"zip": "510060"
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]
},
"descriptionModule": {
"briefSummary": "This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma"
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
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"orgStudyIdInfo": {
"id": "GASTO-10107",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
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{
"measure": "Progression free survival rate"
}
],
"secondaryOutcomes": [
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"measure": "Overall survival"
},
{
"measure": "Objective response rate"
},
{
"measure": "Local-regional progression-free survival"
},
{
"measure": "Incidence of Treatment-related Adverse Events"
},
{
"measure": "Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer)"
},
{
"measure": "Distant metastasis-free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "closure by PRF membrane"
}
]
},
"conditionsModule": {
"conditions": [
"Oroantral Fistula"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alexandria",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Dentistry",
"geoPoint": {
"lat": 31.21564,
"lon": 29.95527
},
"state": null,
"status": null,
"zip": "562589"
}
]
},
"descriptionModule": {
"briefSummary": "the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 9,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy",
"nctId": "NCT06281873",
"orgStudyIdInfo": {
"id": "0645",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the soft tissue wound's healing"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary radiographic outcomes, assessment of bone formation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Alexandria University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cisplatine Teva®"
}
]
},
"conditionsModule": {
"conditions": [
"Mesothelioma, Malignant",
"Carcinoma, Non-Small-Cell Lung",
"Carcinoma Breast Stage IV",
"Ovarian Cancer",
"Esophageal Cancer",
"Gastric Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": [
{
"email": null,
"name": "Jean-Yannis PERENTES",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jean Yannis PERENTES",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Centre Hospitalier Universitaire Vaudois",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 39,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PITHAC",
"briefTitle": "Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration",
"nctId": "NCT06281860",
"orgStudyIdInfo": {
"id": "PITHAC",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "BASEC",
"id": "2023-00099",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Dose Escalation and MTD determination (Part A):Exploratory outcomes"
},
{
"measure": "Expansion phase (Part B):Exploratory outcomes"
}
],
"primaryOutcomes": [
{
"measure": "Dose Escalation and Maximum Tolerated Dose determination (Part A):"
},
{
"measure": "Expansion phase (Part B):"
}
],
"secondaryOutcomes": [
{
"measure": "Dose Escalation and MTD determination (Part A):"
},
{
"measure": "Expansion phase (Part B):"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dr Jean Yannis PERENTES"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-24"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CCTx-001"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Myeloid Leukemia, in Relapse",
"Acute Myeloid Leukemia Refractory"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Besançon Cedex",
"contacts": [
{
"email": null,
"name": "Eric Deconinck",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eric Deconinck",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Besançon Regional and University Hospital",
"geoPoint": {
"lat": 47.24878,
"lon": 6.01815
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Nicolas Boissel",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nicolas Boissel",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hospital Saint Louis",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Munich",
"contacts": [
{
"email": null,
"name": "Marion Subklewe",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marion Subklewe",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Ludwig-Maximilians University of Munich",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Ulm",
"contacts": [
{
"email": null,
"name": "Elisa Sala",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elisa Sala",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University Hospital Ulm",
"geoPoint": {
"lat": 48.39841,
"lon": 9.99155
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Barcelona",
"contacts": [
{
"email": null,
"name": "Pere Barba",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Pere Barba",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Vall d'Hebron University Hospital",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Stockholm",
"contacts": [
{
"email": null,
"name": "Stephan Mielke",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Stephan Mielke",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Karolinska University Hospital",
"geoPoint": {
"lat": 59.33258,
"lon": 18.0649
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r/r AML and provide a potential novel treatment option."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The study comprises 4 periods:* The pre-treatment period will consist of screening for eligibility, leukapheresis and a pre-treatment evaluation (prior to Lymphodepleting Chemotherapy (LDC)).* The treatment period will start with LDC, followed by CCTx-001 infusion 2 to 7 days after completion of LDC. A first response evaluation will be performed at approximately 28 days after CCTx-001 infusion.* The post-treatment period will consist of further clinical activity and safety follow-up visits at regular timepoints after CCTx-001 infusion, starting after the Month 3 visit up to the Month 24 visit.* The long-term follow-up period will start after the Month 24 visit up to 15 years post CCTx-001 infusion.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 143,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RESOLVE AML001",
"briefTitle": "An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia",
"nctId": "NCT06281847",
"orgStudyIdInfo": {
"id": "CCTx-001-AML-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001"
},
{
"measure": "Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001"
}
],
"secondaryOutcomes": [
{
"measure": "Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001"
},
{
"measure": "Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001"
},
{
"measure": "Phase 2: To assess the safety of CCTx-001"
},
{
"measure": "Phase 2: To assess HRQoL for patients treated with CCTx-001"
},
{
"measure": "Phase 2: To assess HRQoL for patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001"
},
{
"measure": "Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Advesya SAS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2041-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rifapentine"
},
{
"name": "Dolutegravir"
}
]
},
"conditionsModule": {
"conditions": [
"Pediatric HIV Infection",
"Latent Tuberculosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective single-arm, open-label, pharmacokinetic and safety study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "4 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention",
"nctId": "NCT06281834",
"orgStudyIdInfo": {
"id": "2024P000306",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dolutegravir AUC during weekly rifapentine/isoniazid"
}
],
"secondaryOutcomes": [
{
"measure": "Rifapentine AUC"
},
{
"measure": "Proportion of participants experiencing severe (grade 3 or 4) clinical or laboratory adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "APIN Public Health Initiatives"
},
{
"name": "University of Cape Town"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Brigham and Women's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "mhealth-pc"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Drinking",
"Chronic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": null,
"name": "Maya Kratzer, BA",
"phone": "857-225-8843",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Boston University",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Compare an intervention to an assessment only control condition",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Outcomes assessor at follow-up timepoint is masked to condition. Baseline assessment occurs prior to randomization",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study",
"nctId": "NCT06281821",
"orgStudyIdInfo": {
"id": "4947 [Study 2]",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale"
},
{
"measure": "Time Line Follow-Back-30 Day Weekly Drinking"
}
],
"secondaryOutcomes": [
{
"measure": "Time Line Follow-Back 30-Day Heavy Episodic Drinking"
},
{
"measure": "Perceptions of Treatment Questionnaire"
},
{
"measure": "Systems Usability Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Alcohol Abuse and Alcoholism (NIAAA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Boston University Charles River Campus"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Photon Counting Detector CT"
}
]
},
"conditionsModule": {
"conditions": [
"Diagnostic Imaging",
"Tomography, X Ray Computed"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Photon Counting Detector CT Image Quality",
"nctId": "NCT06281808",
"orgStudyIdInfo": {
"id": "R490",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Image Quality PCD CT"
},
{
"measure": "Diagnostic Accuracy PCD CT"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Reto Sutter, MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
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"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-09-01"
},
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"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "tVNS"
}
]
},
"conditionsModule": {
"conditions": [
"Efficacy, Self",
"Fatigue; Muscle, Heart",
"Fatigue, Mental",
"Fatigue; Combat"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Krasnodar",
"contacts": null,
"country": "Russian Federation",
"facility": "Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION",
"geoPoint": {
"lat": 45.04484,
"lon": 38.97603
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "1:1 randomization of active stimulation vs. sham stimulation",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 125,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "NANSA",
"briefTitle": "Neuromodulation of the Autonomic Nervous System in Athletes",
"nctId": "NCT06281795",
"orgStudyIdInfo": {
"id": "1.24.",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dynamics of maximum oxygen consumption (VO2max)."
},
{
"measure": "The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism."
}
],
"secondaryOutcomes": [
{
"measure": "Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism."
},
{
"measure": "The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism."
},
{
"measure": "The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism."
},
{
"measure": "The dynamics of RMSSD."
},
{
"measure": "HF dynamics"
},
{
"measure": "Dynamics of the LF/HF ratio."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION"
},
{
"name": "Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Bakulev Scientific Center of Cardiovascular Surgery"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "topical retinoids and platalet rich plasma"
}
]
},
"conditionsModule": {
"conditions": [
"Acne Vulgaris"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assiut",
"contacts": [
{
"email": "[email protected]",
"name": "Howida Abdalla",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Medicine",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
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},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris",
"nctId": "NCT06281782",
"orgStudyIdInfo": {
"id": "PRP with topical retinoids",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "change of acne lasions"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
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"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "3D multi-parametric ultrasound targeted biopsy pathway using PcaVision"
},
{
"name": "MRI targeted biopsy pathway"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amsterdam",
"contacts": null,
"country": "Netherlands",
"facility": "Amsterdam UMC - location VUmc",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Baarn",
"contacts": null,
"country": "Netherlands",
"facility": "Andros Clinics",
"geoPoint": {
"lat": 52.21167,
"lon": 5.2875
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hoofddorp",
"contacts": null,
"country": "Netherlands",
"facility": "Spaarne Gasthuis",
"geoPoint": {
"lat": 52.3025,
"lon": 4.68889
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Nieuwegein",
"contacts": null,
"country": "Netherlands",
"facility": "St. Antonius",
"geoPoint": {
"lat": 52.02917,
"lon": 5.08056
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Rotterdam",
"contacts": null,
"country": "Netherlands",
"facility": "Fransiscus Gasthuis",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 438,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision",
"nctId": "NCT06281769",
"orgStudyIdInfo": {
"id": "NL82101.000.22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI."
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway."
},
{
"measure": "Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway)."
},
{
"measure": "Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway."
},
{
"measure": "Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Angiogenesis Analytics"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-15",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 1638356,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-01-12T04:56"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cognitive Behavioral Treatment for Insomnia (CBT-I)"
},
{
"name": "Trazodone"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Insomnia",
"Insomnia Chronic",
"Insomnia, Primary",
"Blood Pressure",
"Blood Pressure, High"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Denver",
"contacts": [
{
"email": "[email protected]",
"name": "Roxane Horberg",
"phone": "303-270-2850",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rachel Johnson",
"phone": "303 398-1058",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "National Jewish Health",
"geoPoint": {
"lat": 39.73915,
"lon": -104.9847
},
"state": "Colorado",
"status": "NOT_YET_RECRUITING",
"zip": "80206-2761"
},
{
"city": "Hershey",
"contacts": [
{
"email": "[email protected]",
"name": "Carrie Criley",
"phone": "717-531-4123",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Penn State University",
"geoPoint": {
"lat": 40.28592,
"lon": -76.65025
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "17033"
},
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Laurie Brar",
"phone": "412-723-7998",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Pittsburgh",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": "NOT_YET_RECRUITING",
"zip": "15213-3203"
},
{
"city": "Quebec",
"contacts": [
{
"email": "[email protected]",
"name": "Manon Lamy",
"phone": "418 656-2131",
"phoneExt": "412467",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Université Laval",
"geoPoint": {
"lat": 46.81228,
"lon": -71.21454
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "G1V 0A6"
}
]
},
"descriptionModule": {
"briefSummary": "Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Both prescribing physicians and participants will be blind to phenotype and treatment groups.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia",
"nctId": "NCT06281756",
"orgStudyIdInfo": {
"id": "STUDY00022285",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1UG3HL161342-01A1",
"link": "https://reporter.nih.gov/quickSearch/1UG3HL161342-01A1",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)"
},
{
"measure": "Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)"
},
{
"measure": "Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Insomnia Severity Index (ISI) Score following CBT-I"
},
{
"measure": "Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)"
},
{
"measure": "Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)"
},
{
"measure": "Evening Cortisol levels following CBT-I"
},
{
"measure": "Insomnia Severity Index (ISI) Score following RCT"
},
{
"measure": "PSG Total Sleep Time (TST) following RCT"
},
{
"measure": "Actigraphy Total Sleep Time (TST) following RCT"
},
{
"measure": "Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)"
},
{
"measure": "Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)"
},
{
"measure": "Evening Cortisol levels following RCT"
},
{
"measure": "Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Milton S. Hershey Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Survey"
}
]
},
"conditionsModule": {
"conditions": [
"Pediatric Disorder",
"Critical Illness",
"Ethics, Narrative"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LSTPedSurvey",
"briefTitle": "Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children",
"nctId": "NCT06281743",
"orgStudyIdInfo": {
"id": "LST-Ped Survey",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Attitudes and experiences -questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Göteborg University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Karl Storz New Generation Fetoscope - curved 11508AAK"
},
{
"name": "Karl Storz New Generation Fetoscope - straight 11506AAK"
}
]
},
"conditionsModule": {
"conditions": [
"In Utero Procedure Affecting Fetus or Newborn"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": null,
"country": "United States",
"facility": "Mayo Clinic Minnesota",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy",
"nctId": "NCT06281730",
"orgStudyIdInfo": {
"id": "23-009197",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse events"
},
{
"measure": "Serious Adverse Events"
},
{
"measure": "Device malfunctions"
}
],
"secondaryOutcomes": [
{
"measure": "Mean gestational age at delivery"
},
{
"measure": "Successful Completion"
},
{
"measure": "Satisfaction scores"
},
{
"measure": "Live births"
},
{
"measure": "Neonatal deaths"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2044-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2044-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fetal Endotracheal Occlusion (FETO)"
}
]
},
"conditionsModule": {
"conditions": [
"Congenital Diaphragmatic Hernia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Brittany Gudanowski",
"phone": "617-919-6658",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maternal Fetal Care Center",
"phone": "617-355-6512",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alireza Shamshirsaz, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Eyal Krispin, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Boston Children's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia",
"nctId": "NCT06281717",
"orgStudyIdInfo": {
"id": "IRB-P00045047",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Successful Ballon Placement"
},
{
"measure": "Successful Balloon Removal"
},
{
"measure": "Balloon placement operative time"
},
{
"measure": "Balloon removal operative time"
},
{
"measure": "Type of FETO release"
},
{
"measure": "Maternal Complications"
},
{
"measure": "Gestational age at delivery"
}
],
"secondaryOutcomes": [
{
"measure": "Fetal lung volume"
},
{
"measure": "O/E LHR"
},
{
"measure": "Infant survival"
},
{
"measure": "Oxygen dependency"
},
{
"measure": "Number of infants requiring ECMO"
},
{
"measure": "NICU stay"
},
{
"measure": "Ventilator support"
},
{
"measure": "Presence of periventricular leukomalacia"
},
{
"measure": "Presence of neonatal sepsis"
},
{
"measure": "Presence of intraventricular hemorrhage"
},
{
"measure": "Retinopathy of prematurity"
},
{
"measure": "Presence of gastro-esophageal reflux"
},
{
"measure": "CDH repair type"
},
{
"measure": "Pulmonary function"
},
{
"measure": "Infant Neurodevelopment"
},
{
"measure": "Route of delivery"
},
{
"measure": "Maternal hospitalization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Alireza Shamshirsaz"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AK101 IV"
},
{
"name": "AK101 SC"
},
{
"name": "Placebo"
},
{
"name": "AK101 IV/AK101 SC"
}
]
},
"conditionsModule": {
"conditions": [
"Ulcerative Colitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bengbu",
"contacts": null,
"country": "China",
"facility": "The First Affiliated Hospital of Bengbu Medical College",
"geoPoint": {
"lat": 32.94083,
"lon": 117.36083
},
"state": "Anhui",
"status": null,
"zip": "233099"
},
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100730"
},
{
"city": "Fuzhou",
"contacts": null,
"country": "China",
"facility": "The First Affiliated Hospital of Fujian Medical University",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": null,
"zip": "350004"
},
{
"city": "Guangzhou",
"contacts": null,
"country": "China",
"facility": "Nanfang Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510515"
},
{
"city": "Guanzhou",
"contacts": null,
"country": "China",
"facility": "The Sixth Affiliated Hospital of Sun Yat-Sen University",
"geoPoint": null,
"state": "Guangdong",
"status": null,
"zip": "510665"
},
{
"city": "Shijiazhuang",
"contacts": null,
"country": "China",
"facility": "The Second Hospital of Hebei Medical University",
"geoPoint": {
"lat": 38.04139,
"lon": 114.47861
},
"state": "Hebei",
"status": null,
"zip": "050004"
},
{
"city": "Wuhan",
"contacts": null,
"country": "China",
"facility": "People's Hospital of Wuhan University",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430060"
},
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "Nanjing First Hospital",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": "210012"
},
{
"city": "Xuzhou",
"contacts": null,
"country": "China",
"facility": "The Affiliated Hospital of Xuzhou Medical University",
"geoPoint": {
"lat": 34.18045,
"lon": 117.15707
},
"state": "Jiangsu",
"status": null,
"zip": "221004"
},
{
"city": "Shengyang",
"contacts": null,
"country": "China",
"facility": "Shengjing Hospital of China Medical University",
"geoPoint": null,
"state": "Liaoning",
"status": null,
"zip": "110000"
},
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Ruijin Hospital, Shanghai Jiaotong University School of Medicine",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200025"
},
{
"city": "Tianjing",
"contacts": null,
"country": "China",
"facility": "Tianjing People's Hospital",
"geoPoint": null,
"state": "Tianjing",
"status": null,
"zip": "300122"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis",
"nctId": "NCT06281704",
"orgStudyIdInfo": {
"id": "AK101-102",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse Events"
},
{
"measure": "Adverse Events"
},
{
"measure": "Elimination half-life (T1/2) of AK101"
},
{
"measure": "Mean residence time (MRT) of AK101"
},
{
"measure": "Area under curve (AUC) of AK101"
},
{
"measure": "Apparent distribution volume (VD/F) of AK101"
},
{
"measure": "Systemic clearance (CL/F) of AK101"
},
{
"measure": "Maximum (peak) plasma concentration (Cmax) of AK101"
},
{
"measure": "Time to maximum plasma concentration (Tmax) of AK101"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment)."
},
{
"measure": "Proportion of subjects with clinical response at Week8(per the Mayo score)."
},
{
"measure": "Immunogenicity index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Akeso"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-05-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-11-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Xpert® Bladder Cancer Detection Test"
}
]
},
"conditionsModule": {
"conditions": [
"Urinary Bladder Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aarhus",
"contacts": null,
"country": "Denmark",
"facility": "Department of Urology, Aarhus University Hopsital",
"geoPoint": {
"lat": 56.15674,
"lon": 10.21076
},
"state": null,
"status": null,
"zip": "8000"
},
{
"city": "Nuuk",
"contacts": null,
"country": "Greenland",
"facility": "Queen Ingrid's Hospital",
"geoPoint": {
"lat": 64.18347,
"lon": -51.72157
},
"state": null,
"status": null,
"zip": "3900"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit",
"nctId": "NCT06281691",
"orgStudyIdInfo": {
"id": "GreenBladder",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Cepheid"
},
{
"name": "Laborie Medical Technologies Inc."
},
{
"name": "Vingmed Danmark A/S"
},
{
"name": "OneMed A/S"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Jørgen Bjerggaard Jensen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IBI363"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fairway",
"contacts": [
{
"email": "[email protected]",
"name": "Saqib Abbasi",
"phone": "913-945-7545",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Kansas Medcial Center Research Institute",
"geoPoint": {
"lat": 39.02223,
"lon": -94.6319
},
"state": "Kansas",
"status": null,
"zip": "66205"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of IBI363 in Subjects With Advanced Solid Malignancies",
"nctId": "NCT06281678",
"orgStudyIdInfo": {
"id": "CIBI363A202",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse Event （AE）"
},
{
"measure": "Dose-limiting Toxicity （DLT）"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Innovent Biologics (Suzhou) Co. Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low-dose aspirin"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertensive Disorder of Pregnancy",
"Pre-Eclampsia",
"Hypertension",
"Eclampsia",
"Gestational Hypertension",
"Cardiovascular Diseases",
"Toxemia",
"Pregnancy Complications",
"Vascular Diseases",
"Hypertension, Pregnancy Induced",
"Hypertension;Pre-Eclamptic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Sila Yavan, MS",
"phone": "412-417-4981",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alisse K Hauspurg, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pittsburgh Magee-Womens Hospital",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15213"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a pilot randomized, single-center, double-blind placebo-control study of low-dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or similar-appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two additional study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants, Investigators and outcomes assessors will be blinded.",
"whoMasked": [
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "TAP",
"briefTitle": "Treatment With Aspirin After Preeclampsia: TAP Trial",
"nctId": "NCT06281665",
"orgStudyIdInfo": {
"id": "STUDY23080099",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "K23HL168356",
"link": "https://reporter.nih.gov/quickSearch/K23HL168356",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percent of participants eligible, enrolled and retained (feasibility)"
}
],
"secondaryOutcomes": [
{
"measure": "Study visit systolic BP"
},
{
"measure": "Study visit diastolic BP"
},
{
"measure": "Study visit systolic BP"
},
{
"measure": "Study visit diastolic BP"
},
{
"measure": "Study visit mean arterial pressure"
},
{
"measure": "Study visit mean arterial pressure"
},
{
"measure": "Anti-hypertensive medication use"
},
{
"measure": "Anti-hypertensive medication use"
},
{
"measure": "Therapeutic intensity score"
},
{
"measure": "Therapeutic intensity score"
},
{
"measure": "Mean home systolic blood pressure"
},
{
"measure": "Mean home diastolic blood pressure"
},
{
"measure": "Mean home mean arterial pressure"
},
{
"measure": "Mean daytime systolic blood pressure"
},
{
"measure": "Mean nocturnal systolic blood pressure"
},
{
"measure": "Mean daytime diastolic blood pressure"
},
{
"measure": "Mean nocturnal diastolic blood pressure"
},
{
"measure": "Mean nocturnal mean arterial pressure"
},
{
"measure": "Mean daytime mean arterial pressure"
},
{
"measure": "Mean overall mean arterial pressure"
},
{
"measure": "Mean overall systolic blood pressure"
},
{
"measure": "Mean overall diastolic blood pressure"
},
{
"measure": "Classification of hypertension"
},
{
"measure": "Classification of hypertension"
},
{
"measure": "Endothelial function EC50%"
},
{
"measure": "Endothelial function EC50%"
},
{
"measure": "Endothelial function Emax"
},
{
"measure": "Endothelial function Emax"
},
{
"measure": "Endothelial function change in Emax"
},
{
"measure": "Endothelial function change in EC50%"
},
{
"measure": "Change in systolic blood pressure"
},
{
"measure": "Change in diastolic blood pressure"
},
{
"measure": "Change in mean arterial pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Alisse Hauspurg"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Go classes"
},
{
"name": "Chess classes"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Cognitive Impairment",
"Subjective Cognitive Decline"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Monza",
"contacts": [
{
"email": "[email protected]",
"name": "Lucio Tremolizzo, MD, PhD",
"phone": "+390392339082",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Federico Emanuele Pozzi, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS San Gerardo dei Tintori",
"geoPoint": {
"lat": 45.58005,
"lon": 9.27246
},
"state": "Lombardia",
"status": "RECRUITING",
"zip": "20900"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial\\]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:* Do Go and Chess improve cognition?* Is a game better than the other? Is the effect of both games on cognition synergistic?* Do Go and Chess improve quality of life?* Do Go and Chess improve mood?* Do Go and Chess improve lifestyle?Participants will be randomized to one of four groups:* Group intervention with Go, once a week, for 12 weeks* Group intervention with Chess, once a week, for 12 weeks* Group intervention with Go and Chess, twice a week, for 12 weeks* Control group"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Cognichess",
"briefTitle": "Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline",
"nctId": "NCT06281652",
"orgStudyIdInfo": {
"id": "Cognichess",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "General cognition"
}
],
"secondaryOutcomes": [
{
"measure": "Digit Span Forward"
},
{
"measure": "Digit Span Backwards"
},
{
"measure": "Trail Making Test - part A"
},
{
"measure": "Trail Making Test - part B"
},
{
"measure": "Semantic fluency"
},
{
"measure": "Quality of life indicator"
},
{
"measure": "Depression"
},
{
"measure": "Lifestyle"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Milano Bicocca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RAPID"
}
]
},
"conditionsModule": {
"conditions": [
"Congenital Heart Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minneapolis",
"contacts": [
{
"email": "[email protected]",
"name": "Gwenyth Fischer, MD",
"phone": "612-625-6678",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Minnesota",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
},
"state": "Minnesota",
"status": null,
"zip": "55414"
}
]
},
"descriptionModule": {
"briefSummary": "The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \\<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "1 Year",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging",
"nctId": "NCT06281639",
"orgStudyIdInfo": {
"id": "RAPID",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "RAPID imaging quality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Minnesota"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Data collection"
}
]
},
"conditionsModule": {
"conditions": [
"Comdom"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Reims",
"contacts": null,
"country": "France",
"facility": "Ufr Medecine Urca",
"geoPoint": {
"lat": 49.25,
"lon": 4.03333
},
"state": null,
"status": null,
"zip": "51100"
},
{
"city": "Reims",
"contacts": null,
"country": "France",
"facility": "Université de Reims Champagne Ardenne",
"geoPoint": {
"lat": 49.25,
"lon": 4.03333
},
"state": null,
"status": null,
"zip": "51100"
}
]
},
"descriptionModule": {
"briefSummary": "For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Préservatif",
"briefTitle": "Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25",
"nctId": "NCT06281626",
"orgStudyIdInfo": {
"id": "2024_RIPH_01_Preservatif",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "use of free male condoms"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Université de Reims Champagne-Ardenne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AMCOP group"
},
{
"name": "High-pull headgear"
}
]
},
"conditionsModule": {
"conditions": [
"Skeletal Malocclusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pavia",
"contacts": null,
"country": "Italy",
"facility": "Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": "Lombardy",
"status": null,
"zip": "27100"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients",
"nctId": "NCT06281613",
"orgStudyIdInfo": {
"id": "2024-AMCOPTEO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in cephalometric angular measurements"
},
{
"measure": "Linear regressions"
},
{
"measure": "Change in cephalometric linear measurements"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pavia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Human milk oligosaccharide"
},
{
"name": "Maltodextrin placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Irritable Bowel Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Reading",
"contacts": [
{
"email": "[email protected]",
"name": "Patricia Sanz Morales",
"phone": "+447843865554",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Glenn Gibson, Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "The University of Reading",
"geoPoint": {
"lat": 51.45625,
"lon": -0.97113
},
"state": "Berkshire",
"status": "RECRUITING",
"zip": "RG6 6LA"
}
]
},
"descriptionModule": {
"briefSummary": "There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as \"a substrate that is selectively utilised by host microorganisms conferring a health benefit\" \\[8\\]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens \\[9\\]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. We aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Every individual involved in undertaking this trial will be blinded.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "GUT-HEAL-IBS",
"briefTitle": "An Intervention Study Using HMOs to Improve IBS Symptoms",
"nctId": "NCT06281600",
"orgStudyIdInfo": {
"id": "REC: 23/SW/0042",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRAS ID",
"id": "326109",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "IBS-SSS"
}
],
"secondaryOutcomes": [
{
"measure": "Change in anxiety and depression scores (ADS)"
},
{
"measure": "Improvement of the Pittsburgh Sleep Quality Index (PSQI)."
},
{
"measure": "Changes in faecal microbiota e.g. Bifidobacterium"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Royal Berkshire NHS Foundation Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Glenn Gibson"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "penetrating keratoplasty"
}
]
},
"conditionsModule": {
"conditions": [
"Graft Rejection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Krasnodar",
"contacts": null,
"country": "Russian Federation",
"facility": null,
"geoPoint": {
"lat": 45.04484,
"lon": 38.97603
},
"state": null,
"status": null,
"zip": "350012"
}
]
},
"descriptionModule": {
"briefSummary": "There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection.Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 93,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pathogenetic Risk Factors for Corneal Graft Rejection",
"nctId": "NCT06281587",
"orgStudyIdInfo": {
"id": "SNFyodorov",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cohort group Kaplan-Meier survival analysis (clear graft engraftment)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "The S.N. Fyodorov Eye Microsurgery State Institution"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2011-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaires"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Arthroplasty"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leuven",
"contacts": null,
"country": "Belgium",
"facility": "UZ Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": "Vlaams-Brabant",
"status": null,
"zip": "3000"
}
]
},
"descriptionModule": {
"briefSummary": "Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "63 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "RTW after SA",
"briefTitle": "What Are the Determinants for RTW After SA",
"nctId": "NCT06281574",
"orgStudyIdInfo": {
"id": "S67346",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Return to work"
}
],
"secondaryOutcomes": [
{
"measure": "Type of shoulder arthroplasty"
},
{
"measure": "WORQ-UP (work-related questionnaire for upper extremity disorders)"
},
{
"measure": "SSV (Subjective Shoulder Value)"
},
{
"measure": "SST (Dutch translation of the Simple Shoulder Test)"
},
{
"measure": "OSS (Oxford Shoulder Score)"
},
{
"measure": "Self-made questionnaire"
},
{
"measure": "Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Normal Saline"
},
{
"name": "Dexmedetomidine"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Sleep Disturbance"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "23 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance",
"nctId": "NCT06281561",
"orgStudyIdInfo": {
"id": "FirstAHXiamenU-YB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline sleep quality at after intervention"
},
{
"measure": "Pittsburgh sleep quality index(PSQI)"
}
],
"secondaryOutcomes": [
{
"measure": "Early recovery evaluated by Aldrete rating scale"
},
{
"measure": "Later Recovery evaluated by QoR-40 questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Xiamen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RESTART"
}
]
},
"conditionsModule": {
"conditions": [
"Stigma, Social",
"Substance Use"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Portsmouth",
"contacts": [
{
"email": "[email protected]",
"name": "Adams L Sibley, MPH",
"phone": "423-227-9198",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Abby Spears",
"phone": "740-357-9773",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "SHRPS Syringe Service Program",
"geoPoint": {
"lat": 38.73174,
"lon": -82.99767
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "45662"
}
]
},
"descriptionModule": {
"briefSummary": "Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs",
"nctId": "NCT06281548",
"orgStudyIdInfo": {
"id": "23-2937",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1F31DA058452",
"link": "https://reporter.nih.gov/quickSearch/1F31DA058452",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Stigma Resistance Scale (SRS) Score"
},
{
"measure": "Change in Substance Abuse Self-Stigma Scale (SASSS) Score"
},
{
"measure": "Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)"
},
{
"measure": "Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment)"
},
{
"measure": "Time to Sample Saturation (Feasibility - Recruitment)"
},
{
"measure": "Percentage of Participants Retained in Study (Feasibility - Retention)"
},
{
"measure": "Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)"
},
{
"measure": "Percentage of Participants with High Text Message Frequency (Feasibility - User)"
},
{
"measure": "Percentage of Participants with High Text Messaging Comfort (Feasibility - User)"
},
{
"measure": "Percentage of Participants with Cell Phone Device Challenges (Feasibility - User)"
},
{
"measure": "Percentage of Participants with Cell Phone Plan Challenges (Feasibility - User)"
},
{
"measure": "Percentage of Participants who Read Messages Daily (Feasibility - User)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Adult Dispositional Hope Scale Score"
},
{
"measure": "Change in Rosenberg Self-Esteem Scale Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Implant loading"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Implant"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Early Versus Conventional Loading for Fully Guided Immediate Implant Placement",
"nctId": "NCT06281535",
"orgStudyIdInfo": {
"id": "21789",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Implant stability"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Assiut University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Operated patients with hydatid cyst of the lung"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Hydatid Cyst"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Van",
"contacts": null,
"country": "Turkey",
"facility": "University of Health Sciences, Van Training and Research Hospital",
"geoPoint": {
"lat": 38.49457,
"lon": 43.38323
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the role of these laboratory findings in the differential diagnosis and management of pulmonary hydatid cyst (PHC) by examining the number of euzonophils, neutrophils, lymphocytes, platelets and neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune inflammatory index values in the peripheral blood of patients diagnosed with pulmonary hydatid cyst (PHC) in the preoperative period and post-operative 3rd month. Although we have extensive data on hydatid liver cysts, there is limited information in the literature on the laboratory values of patients with PHC. This study aims to provide more scientific basis for the diagnosis and management of PHC and is considered as an inexpensive, reproducible and easily calculable method to improve the accurate diagnosis and management of AKH in clinical practice."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "83 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Echinococcusis",
"briefTitle": "The Importance of Inflammatory Markers Calculated From Preoperative and Postoperative Peripheral Blood Results in the Diagnosis and Treatment of Patients Operated for Hydatid Cyst of the Lung (Lung Echinococcus Granulosus)",
"nctId": "NCT06281522",
"orgStudyIdInfo": {
"id": "University of Health Sciences",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Calculation of laboratory markers"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Abdullah Adiyaman"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands."
},
{
"name": "Ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Dupuytren's Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leuven",
"contacts": [
{
"email": "[email protected]",
"name": "Ilse Degreef, Prof. Dr.",
"phone": "+32 16 33 88 43",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anna Tarasiuk",
"phone": "+32 16 33 88 18",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Universitaire Ziekenhuizen KU Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": "Vlaams-Brabant",
"status": "RECRUITING",
"zip": "3000"
}
]
},
"descriptionModule": {
"briefSummary": "Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups: Patients with Dupuytren Disease and healthy control group. They will be age matched (50 years of age or higher) with the objective to have a proportionate division (50/50) between the genders.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "No masking will be done in this study",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Palmaris",
"briefTitle": "Palmaris Longus Muscle and Dupuytren",
"nctId": "NCT06281509",
"orgStudyIdInfo": {
"id": "S68374",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PLM in the DD versus control"
},
{
"measure": "PML in mild versus severe DD-group"
}
],
"secondaryOutcomes": [
{
"measure": "PLM presence in DD affected group"
},
{
"measure": "PLM presence in control group"
},
{
"measure": "Dominant versus non-dominant hand"
},
{
"measure": "Male versus female population"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AlloCare"
}
]
},
"conditionsModule": {
"conditions": [
"Hematological Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Mette Schaufuss Engedal, MSc",
"phone": "+45 51896699",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mary Jarden, Professor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Rigshospitalet",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": "2100"
}
]
},
"descriptionModule": {
"briefSummary": "A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "One site, two arm randomized controlled trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AlloCare",
"briefTitle": "AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation",
"nctId": "NCT06281496",
"orgStudyIdInfo": {
"id": "Rigshospitalet, Hematology",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)"
}
],
"secondaryOutcomes": [
{
"measure": "Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Danish Cancer Society"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "platelet-rich plasma"
},
{
"name": "platelet-rich fibrin"
},
{
"name": "Surgical debridement, normal saline washing and dressing coverage"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Non-healing Skin Ulcers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Mohamed Aboshabana Hussein, Assistant Lecturer",
"phone": "01007981008",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Badr Hospital - Helwan University and Kafrelseikh University Hospital",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers",
"nctId": "NCT06281483",
"orgStudyIdInfo": {
"id": "APCs in chronic skin ulcers",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective assessment of ulcer size for effectiveness, using Image J software."
},
{
"measure": "Pain assessment"
},
{
"measure": "Any adverse effects related to treatment modality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Helwan University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kafrelsheikh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "WS016 Single Dose(6g)"
},
{
"name": "WS016 Single Dose(12g)"
},
{
"name": "WS016 Single Dose(24g)"
},
{
"name": "WS016 Single Dose(36g)"
},
{
"name": "WS016 Single Dose(48g)"
},
{
"name": "SAD matching placebo"
},
{
"name": "WS016 Multiple Dose(12g)"
},
{
"name": "WS016 Multiple Dose(24g)"
},
{
"name": "WS016 Multiple Dose(48g)"
},
{
"name": "MAD matching placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Hyperkalemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "Zhejiang Xiaoshan Hospital",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": null,
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Safety and Tolerability of WS016 in Healthy Chinese Volunteers",
"nctId": "NCT06281470",
"orgStudyIdInfo": {
"id": "WS016-Ⅰ-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Waterstone Pharmaceutical (Wuhan) Co., LTD."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stimulus properties: task-defining feature"
}
]
},
"conditionsModule": {
"conditions": [
"Basic Science: Visual Attention in Healthy Participants",
"Basic Science: Neural Representations of Location"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santa Barbara",
"contacts": [
{
"email": "[email protected]",
"name": "Melodie Blakemore",
"phone": "805-893-4286",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tommy C Sprague, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of California, Santa Barbara",
"geoPoint": {
"lat": 34.42083,
"lon": -119.69819
},
"state": "California",
"status": "RECRUITING",
"zip": "93117"
}
]
},
"descriptionModule": {
"briefSummary": "How does one know what to look at in a scene? Imagine a \"Where's Waldo\" game - it's challenging to find Waldo because there are many 'salient' locations in the picture, each vying for one's attention. One can only attend to a small location on the picture at a given moment, so to find Waldo, one needs to direct their attention to different locations. One prominent theory about how one accomplishes this claims that important locations are identified based on distinct feature types (for example, motion or color), with locations most unique compared to the background most likely to be attended. An important component of this theory is that individual feature dimensions (again, color or motion) are computed within their own 'feature maps', which are thought to be implemented in specific brain regions. However, whether and how specific brain regions contribute to these feature maps remains unknown.The goal of this study is to determine how brain regions that respond strongly to different feature types (color and motion) and which encode spatial locations of visual stimuli transform 'feature dimension maps' based on stimulus properties as a function of task instructions. The investigators hypothesize that feature-selective brain regions act as neural feature dimension maps, and thus encode representations of relevant location(s) based on their preferred feature dimension, such that the stimulus representation in the most relevant feature map is up-regulated to support adaptive behavior. The investigators will scan healthy human participants using functional MRI (fMRI) in a repeated-measures design while they view visual stimuli made relevant based on a cued feature dimension (e.g., color or motion). The investigators will employ state-of-the-art multivariate analysis techniques that allow them to reconstruct an 'image' of the stimulus representation encoded by each brain region to dissect how neural tissue identifies salient locations. Each participant will perform a challenging discrimination task based on the cued feature (report motion direction or color of stimulus dots) of a stimulus presented in the periphery, which are identical across trial types. Across trials the investigators will manipulate the attended feature value (color, motion, or fixation point). This manipulation will help the investigators fully understand these critical relevance computations in the healthy human visual system."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns).",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Probing the Role of Feature Dimension Maps in Visual Cognition: Impact of Task Demands (Expt 2.1)",
"nctId": "NCT06281457",
"orgStudyIdInfo": {
"id": "5-24-0030: 2.1",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01EY035300",
"link": "https://reporter.nih.gov/quickSearch/R01EY035300",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood Oxygenation Level Dependent (BOLD) fMRI signal"
},
{
"measure": "Gaze position"
},
{
"measure": "Behavioral response (button press)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Eye Institute (NEI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Santa Barbara"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ESWT"
},
{
"name": "Sham-ESWT"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Birkan Sonel Tur, Prof. Dr.",
"phone": "+903125956331",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Taha Can Başar, Dr.",
"phone": "+90312595 6331/2822",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Birkan Sonel Tur, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Taha Can Başar, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Ankara University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Altındağ",
"status": "RECRUITING",
"zip": "06230"
}
]
},
"descriptionModule": {
"briefSummary": "Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Patients who meet the study conditions and agree to participate in this study will not know whether they are in the first group or the second group.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis",
"nctId": "NCT06281444",
"orgStudyIdInfo": {
"id": "i07-453-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in pain [by using the Visual Analogue Scale(VAS)]"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline in functionality and walking distance"
},
{
"measure": "Change from baseline in walking distance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Echogenic nerve block needle"
},
{
"name": "Non-echogenic nerve block needle"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Postoperative Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": [
{
"email": "[email protected]",
"name": "He Huang, ph.D",
"phone": "13708385559",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "He Huang",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Chongqing",
"status": "RECRUITING",
"zip": "4000000"
}
]
},
"descriptionModule": {
"briefSummary": "Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. \\>20% of patients suffer from chronic postoperative pain. China has \\>70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain",
"nctId": "NCT06281431",
"orgStudyIdInfo": {
"id": "CPSP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Chronic postoperative pain"
},
{
"measure": "Moderate to severe pain"
}
],
"secondaryOutcomes": [
{
"measure": "Acute postoperative pain"
},
{
"measure": "Acute postoperative pain"
},
{
"measure": "Acute postoperative pain"
},
{
"measure": "Puncture operation time"
},
{
"measure": "Number of needle passes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Second Affiliated Hospital of Chongqing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Granisetron 1 Mg/mL Intravenous Solution"
},
{
"name": "Normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Post Operative Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Hoda Mohamed Bayoumi, Bachelor's",
"phone": "01126143971",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "National Hepatology and Tropical Research Institute",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": "11617"
}
]
},
"descriptionModule": {
"briefSummary": "Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy",
"nctId": "NCT06281418",
"orgStudyIdInfo": {
"id": "5-24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS score"
}
],
"secondaryOutcomes": [
{
"measure": "Time to analgesic request"
},
{
"measure": "Quality of life (QoL) after laparoscopic cholecystectomy (LC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Future University in Egypt"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PD-1 antibody"
},
{
"name": "Capecitabine"
},
{
"name": "Short-course radiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Locally Advanced Rectal Cancer",
"Neoadjuvant Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 198,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TORCH-iTNT",
"briefTitle": "CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer",
"nctId": "NCT06281405",
"orgStudyIdInfo": {
"id": "FDRT-2023-290-3409",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complete response (CR) rate"
}
],
"secondaryOutcomes": [
{
"measure": "Grade 3-4 adverse effects rate"
},
{
"measure": "3 year anal preservation rate"
},
{
"measure": "3 year disease free survival rate"
},
{
"measure": "3 year local recurrence free survival rate"
},
{
"measure": "3 year overall survival rate"
},
{
"measure": "Rate of surgical complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CADe system"
},
{
"name": "NBI"
}
]
},
"conditionsModule": {
"conditions": [
"Inflammatory Bowel Diseases",
"Dysplasia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Valencia",
"contacts": [
{
"email": "[email protected]",
"name": "Antonio López-Serrano, Ph.D.",
"phone": "0034656495490",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Antonio López-Serrano",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": "RECRUITING",
"zip": "46017"
}
]
},
"descriptionModule": {
"briefSummary": "Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 122,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)",
"nctId": "NCT06281392",
"orgStudyIdInfo": {
"id": "CEIm: 106/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "\"Per lesion\" dysplasia detection rate (DDR)"
},
{
"measure": "\"Per patient\" dysplasia detection rate (DDR)"
}
],
"secondaryOutcomes": [
{
"measure": "Duration of endoscopic examination"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Valencia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Total mesogastrectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer",
"Gastric Neoplasm",
"Gastric Cancer Stage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Yigit Duzkoylu",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34480"
}
]
},
"descriptionModule": {
"briefSummary": "Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.Study design:Randomised-controlled studyPlace and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:",
"nctId": "NCT06281379",
"orgStudyIdInfo": {
"id": "Basaksehir City Hospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative outcome"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Başakşehir Çam & Sakura City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Pregnancy Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Manel Mendoza, PhD",
"phone": "+34934893085",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Erika Bonacina, PhD",
"phone": "+34934893264",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Erika Bonacina, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Manel Mendoza, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mireia Armengol, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Manel Mendoza",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08035"
}
]
},
"descriptionModule": {
"briefSummary": "In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Diamine Oxidase and Adverse Pregnancy Outcomes",
"nctId": "NCT06281366",
"orgStudyIdInfo": {
"id": "PR(AMI)470-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diamine oxidase activity first trimester"
},
{
"measure": "Diamine oxidase gene polymorphisms"
}
],
"secondaryOutcomes": [
{
"measure": "Blood Diamine oxidase activity at delivery"
},
{
"measure": "Placental Diamine oxidase activity at delivery"
},
{
"measure": "Blood histamine levels at delivery"
},
{
"measure": "Placental histamine levels at delivery"
},
{
"measure": "Urine histamine levels at delivery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "DR Healthcare"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hospital Universitari Vall d'Hebron Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Curcumin Oral Capsule"
},
{
"name": "Trichloroacetic acid"
},
{
"name": "Blood sample collection"
},
{
"name": "Cotton swab"
}
]
},
"conditionsModule": {
"conditions": [
"Anogenital Wart"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta Pusat",
"contacts": null,
"country": "Indonesia",
"facility": "Cipto Mangunkusumo Hospital",
"geoPoint": {
"lat": -6.1818,
"lon": 106.8223
},
"state": "DKI Jakarta",
"status": null,
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include:* To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and* To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin.The main questions it aims to answer are:* Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)?* Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls?* Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW?Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ACTUAL"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue",
"nctId": "NCT06281353",
"orgStudyIdInfo": {
"id": "22-07-0754",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical improvement in patients with AGW"
}
],
"secondaryOutcomes": [
{
"measure": "Level of IFN-γ in lesions of AGW patients"
},
{
"measure": "Level of FOXP3+Treg in lesions of AGW patients"
},
{
"measure": "Level of NFĸB in lesions of AGW patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manual therapy"
},
{
"name": "Placebo therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Hemophilia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oviedo",
"contacts": null,
"country": "Spain",
"facility": "University of Oviedo",
"geoPoint": {
"lat": 43.36029,
"lon": -5.84476
},
"state": "Asturias",
"status": null,
"zip": "33006"
}
]
},
"descriptionModule": {
"briefSummary": "Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Randomization will be performed using a computerized randomization procedure by permuted blocks of 4 subjects in each recruitment center. The 6 possible sequence alternatives will be modified in each block. This task will be carried out by a person who is not involved in the study and who will not know the identity of the subjects.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "30 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy",
"nctId": "NCT06281340",
"orgStudyIdInfo": {
"id": "He-ankle US",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline sonographic changes after 4 hours"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline joint pain after 4 hours"
},
{
"measure": "Change from baseline joint damage after 4 hours"
},
{
"measure": "Change from baseline degree of joint inflammation after 4 hours"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Investigación en Hemofilia y Fisioterapia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Avatrombopag"
}
]
},
"conditionsModule": {
"conditions": [
"Immune Thrombocytopenia",
"Treatment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": [
{
"email": "[email protected]",
"name": "Lei Zhang, MD",
"phone": "+8602223909009",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ting Sun, MD",
"phone": "+8602223909009",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia",
"nctId": "NCT06281327",
"orgStudyIdInfo": {
"id": "TX-ITP-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall efficacy response after AVA treatment within 12 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment response-1"
},
{
"measure": "Treatment response-2"
},
{
"measure": "Time to Response"
},
{
"measure": "Persistent response"
},
{
"measure": "Emergency treatment"
},
{
"measure": "Reduction of concomitant drug"
},
{
"measure": "Number of participants with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale."
},
{
"measure": "Number of participants with clinically significant bleeding as assessed using the bleeding scale for pediatric patients with ITP."
},
{
"measure": "Health-related quality of life survey of subjects(HRQoL)-1"
},
{
"measure": "Health-related quality of life survey of subjects(HRQoL)-2"
},
{
"measure": "Health-related quality of life survey of subjects(HRQoL)-3"
},
{
"measure": "Health-related quality of life survey of subjects(HRQoL)-4"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Henan Cancer Hospital"
},
{
"name": "Tianjin Medical University Second Hospital"
},
{
"name": "Tianjin Children's Hospital"
},
{
"name": "The Second Affiliated Hospital of Kunming Medical University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Institute of Hematology & Blood Diseases Hospital, China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vespa software"
}
]
},
"conditionsModule": {
"conditions": [
"Neurodegenerative Diseases",
"Cognitive Decline",
"Parkinson Disease Dementia",
"Alzheimer Disease",
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Messina",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Centro Neurolesi Bonino Pulejo",
"geoPoint": {
"lat": 38.19394,
"lon": 15.55256
},
"state": "Sicily",
"status": null,
"zip": "98124"
}
]
},
"descriptionModule": {
"briefSummary": "VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"masking": "NONE",
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"whoMasked": null
},
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},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment",
"nctId": "NCT06281314",
"orgStudyIdInfo": {
"id": "VESPA 2.0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Montreal cognitive assessment (MoCA)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Centro Neurolesi \"Bonino-Pulejo\""
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "education tool"
},
{
"name": "no additional information"
}
]
},
"conditionsModule": {
"conditions": [
"Macrosomia, Fetal"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Kristen Cagino, MD",
"phone": "713-500-6412",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Suneet Chauhan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Texas Health Science Center at Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 176,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Improving Patient Understanding of Macrosomia",
"nctId": "NCT06281301",
"orgStudyIdInfo": {
"id": "HSC-MS-23-1023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants that showed Macrosomia knowledge greater than 50 percent as assessed by the score on a survey"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas Health Science Center, Houston"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cognitive-Behavioral Therapy"
},
{
"name": "Exercise Training"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Suez",
"contacts": null,
"country": "Egypt",
"facility": "doaa Tammam Atia",
"geoPoint": {
"lat": 29.97371,
"lon": 32.52627
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptomsBACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and \"silent killers\" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and \"silent killers\"RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms",
"nctId": "NCT06281288",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004754",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Center for Epidemiological Studies Depression Scale for Children (CES-DC),"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Doaa Tammam Atia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Frailty",
"Acute Postoperative Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": null,
"country": "China",
"facility": "Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430030"
}
]
},
"descriptionModule": {
"briefSummary": "To gain a clearer understanding of the association between frailty and postoperative acute pain in elderly thoracoscopic surgery patients and its underlying mechanisms, to provide new solution ideas to reduce the level of postoperative acute pain and improve the debilitating state of elderly thoracoscopic surgery patients, and consequently improve their quality of life and mental status."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients",
"nctId": "NCT06281275",
"orgStudyIdInfo": {
"id": "TJ-IRB202402008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "All patients' Numerical Rating Scale （NRS） scores for most significant pain at rest in the 48h postoperative period"
},
{
"measure": "Numerical Rating Scale （NRS） scores for the most pronounced pain in the patient's coughing state in the 48h postoperative period"
}
],
"secondaryOutcomes": [
{
"measure": "PCA pump consumption"
},
{
"measure": "Number of PCA pump presses"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Huazhong University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Peripheral blood collection"
},
{
"name": "Swab sample collection"
}
]
},
"conditionsModule": {
"conditions": [
"Preterm Birth",
"Preeclampsia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Prague",
"contacts": [
{
"email": "[email protected]",
"name": "Zdeněk Laštůvka, MUDr., Ph.D.",
"phone": "+420777724640",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Michal Koucký, Doc., MUDr., Ph.D.",
"phone": "+420603219916",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Department of Gynaecology, Obstetrics and Neonatology of the First Faculty of Medicine of the Charles University and General University Hospital in Prague",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": null,
"status": "RECRUITING",
"zip": "128 08"
}
]
},
"descriptionModule": {
"briefSummary": "The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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},
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"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "19 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PRIME",
"briefTitle": "Selected Immunological Indicators and Microbiota in Patients With Premature Birth and Preeclampsia",
"nctId": "NCT06281262",
"orgStudyIdInfo": {
"id": "GIP-23-L-04-223",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth"
},
{
"measure": "Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia"
}
],
"secondaryOutcomes": [
{
"measure": "Association of maternal microbiota and maternal T regulatory cell populations."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Charles University, Czech Republic"
},
{
"name": "Institute of Hematology and Blood Transfusion, Czech Republic"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "General University Hospital, Prague"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound placement device"
}
]
},
"conditionsModule": {
"conditions": [
"Labor Pain",
"Cesarean Delivery Regional Anesthesia Induction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stanford",
"contacts": null,
"country": "United States",
"facility": "Stanford University",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
},
"state": "California",
"status": null,
"zip": "94305"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neuraxial Ultrasound Device Study",
"nctId": "NCT06281249",
"orgStudyIdInfo": {
"id": "73172",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of difficult block placement"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of failed block"
},
{
"measure": "Incidence of post-dural puncture headache"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Rivanna Medical, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Prednisolone"
},
{
"name": "SPI-62"
}
]
},
"conditionsModule": {
"conditions": [
"Polymyalgia Rheumatica"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Wieczorek",
"phone": "+49 30 439741221",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Frank Zollmann",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Emovis Gmbh",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Hannover",
"contacts": [
{
"email": "[email protected]",
"name": "Matilde Planer",
"phone": "+49 511 169 7650",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jan Wagner",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Klinische Forschung Hannover Mitte GmbH/Pratia",
"geoPoint": {
"lat": 52.37052,
"lon": 9.73322
},
"state": null,
"status": null,
"zip": "30159"
},
{
"city": "Schwerin",
"contacts": [
{
"email": "[email protected]",
"name": "Julia Grindel",
"phone": "+49 385 557 740",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Charlotte von Engelhardt",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Klinische Forschung Schwerin GmbH/Pratia",
"geoPoint": {
"lat": 53.62937,
"lon": 11.41316
},
"state": null,
"status": null,
"zip": "19055"
}
]
},
"descriptionModule": {
"briefSummary": "This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)",
"nctId": "NCT06281236",
"orgStudyIdInfo": {
"id": "SPI-62-CL-1002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Erythrocyte sedimentation rate"
},
{
"measure": "C-reactive protein"
},
{
"measure": "Plasma fibrinogen"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sparrow Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "intraoperative neuroelectrophysiological monitoring"
}
]
},
"conditionsModule": {
"conditions": [
"Spasticity, Muscle"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "MOVE",
"briefTitle": "Study of Brain-spinal Cord Neural Connectivity in Spasticity",
"nctId": "NCT06281223",
"orgStudyIdInfo": {
"id": "JBR_2023_9",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "variation in \"spontaneous/resting\" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Fondation Ophtalmologique Adolphe de Rothschild"
}
},
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"date": "2026-05"
},
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},
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"date": "2026-05"
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"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Omission of surgical treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Triple Negative Breast Cancer",
"HER2-positive Breast Cancer",
"Neoadjuvant Chemotherapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Candiolo",
"contacts": [
{
"email": null,
"name": "Antonio Toesca, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto di Candiolo IRCCS",
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"lat": 44.95858,
"lon": 7.59812
},
"state": "Turin",
"status": "NOT_YET_RECRUITING",
"zip": "10060"
},
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Elisabetta Rossi, MD",
"phone": "+390294372191",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mara Negri",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elisabetta Rossi, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "European Institute of Oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20141"
}
]
},
"descriptionModule": {
"briefSummary": "This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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},
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},
"enrollmentInfo": {
"count": 77,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BETTY-CRASY",
"briefTitle": "Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery",
"nctId": "NCT06281210",
"orgStudyIdInfo": {
"id": "IEO 2034",
"link": null,
"type": null
},
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},
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{
"measure": "Event-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Positive predictive value of MRI"
},
{
"measure": "Contrast-Enhanced Mammography (CEM) positive predictive value"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
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"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
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"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Conventional"
},
{
"name": "Subspinal"
}
]
},
"conditionsModule": {
"conditions": [
"Maxillofacial Abnormalities"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": null,
"country": "Turkey",
"facility": "Selin Çelebi",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": "Meligazi",
"status": null,
"zip": "38320"
}
]
},
"descriptionModule": {
"briefSummary": "After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"interventionModelDescription": "double blind",
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"OUTCOMES_ASSESSOR"
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},
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},
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"count": 47,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume",
"nctId": "NCT06281197",
"orgStudyIdInfo": {
"id": "2021/48",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of Septum Deviation"
},
{
"measure": "Evaluation of Nasal Airway"
}
],
"secondaryOutcomes": [
{
"measure": "nasal obstruction scale evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-05-15"
},
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"date": "2024-02-28"
},
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"date": "2021-08-15"
},
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"startDateStruct": {
"date": "2021-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Methotrexate"
},
{
"name": "No treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Hand Osteoarthritis",
"Erosive Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oslo",
"contacts": [
{
"email": "[email protected]",
"name": "Ida Løchting",
"phone": "+4722451500",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alexander Mathiessen, MD PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Norway",
"facility": "Diakonhjemmet Hospital",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null,
"status": null,
"zip": "0319"
}
]
},
"descriptionModule": {
"briefSummary": "In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\\&#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression."
},
"designModule": {
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},
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"type": "ESTIMATED"
},
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},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MERINO:2",
"briefTitle": "A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA.",
"nctId": "NCT06281184",
"orgStudyIdInfo": {
"id": "DIA2024.1",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Regional committee for medical and health research ethics",
"id": "715758",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effect of MTX on radiographic progression of erosive hand OA."
}
],
"secondaryOutcomes": [
{
"measure": "Effect of MTX on pain, function and life quality"
},
{
"measure": "Effect of MTX on radiographic progression of hand OA."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Diakonhjemmet Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
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"date": "2027-02-01"
},
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"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SkillTalk for Autistic Young Adults"
},
{
"name": "Flyer Library"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santa Cruz",
"contacts": null,
"country": "United States",
"facility": "Virtual Study",
"geoPoint": {
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},
"state": "California",
"status": null,
"zip": "95060"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.The main questions it aims to answer are:* Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?* Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?* Does using SkillTalk increase interpersonal competence?* Does using SkillTalk increase ability to cope with rejection?* Does using SkillTalk improve mental health and wellbeing?Participants will be asked to:* Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up* Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up* Watch a minimum of 85% of the 60 minutes of video assigned"
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
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"eligibilityModule": {
"maximumAge": "28 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of SkillTalk for Autistic Young Adults",
"nctId": "NCT06281171",
"orgStudyIdInfo": {
"id": "90BISB0022",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Demonstrated Skill Score in communication skills."
}
],
"secondaryOutcomes": [
{
"measure": "Participant Confidence & Satisfaction in their communication skills"
},
{
"measure": "Interpersonal Competence Score"
},
{
"measure": "Coping with Rejection, Jealousy and Relationship Anxiety"
},
{
"measure": "Mental Health and Wellbeing"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "dfusion Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "[14C]-DNL343"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madison",
"contacts": null,
"country": "United States",
"facility": "Clinical Site",
"geoPoint": {
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"lon": -89.40123
},
"state": "Wisconsin",
"status": "RECRUITING",
"zip": "53704"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343."
},
"designModule": {
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"interventionModel": "SINGLE_GROUP",
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants",
"nctId": "NCT06281158",
"orgStudyIdInfo": {
"id": "DNLI-F-0009",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PK Parameter: AUC0-∞"
},
{
"measure": "PK Parameter: AUC0-tlast"
},
{
"measure": "PK Parameter: Cmax"
},
{
"measure": "PK Parameter: Tmax"
},
{
"measure": "PK Parameter: t1/2"
},
{
"measure": "Total radioactivity in plasma and whole blood"
},
{
"measure": "Total radioactivity in blood-to-plasma ratio"
},
{
"measure": "Extent and rate of recovery of total radioactivity in urine and feces"
}
],
"secondaryOutcomes": [
{
"measure": "PK Parameter: AUC0-∞"
},
{
"measure": "PK Parameter: AUC0-tlast"
},
{
"measure": "PK Parameter: Cmax"
},
{
"measure": "PK Parameter: Tmax"
},
{
"measure": "PK Parameter: t1/2"
},
{
"measure": "DNL343 and a DNL343 metabolite recoveries in urine"
},
{
"measure": "Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Denali Therapeutics Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "RECRUITING",
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"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Heart-rate variability biofeedback intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Colon Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bratislava",
"contacts": [
{
"email": "[email protected]",
"name": "Bela Mrinakova, MD",
"phone": "00421232249111",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Miriam Hancinova, MD",
"phone": "00421232249111",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bela Mrinakova",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Miriam Hancinova",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Slovakia",
"facility": "St. Elizabeth Cancer Institute",
"geoPoint": {
"lat": 48.14816,
"lon": 17.10674
},
"state": null,
"status": "RECRUITING",
"zip": "81250"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SRI-BrCa_CRC",
"briefTitle": "Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer",
"nctId": "NCT06281145",
"orgStudyIdInfo": {
"id": "RSV-SK001/UC-SK004/OUSA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary endpoint - inflammation"
},
{
"measure": "Primary endpoint - QoL"
},
{
"measure": "Primary endpoint - executive functions"
},
{
"measure": "Primary endpoint- salivary cortisol slopes"
},
{
"measure": "Primary endpoint- sleep quality"
},
{
"measure": "Primary endpoint - heart rate variability (HRV)"
},
{
"measure": "Primary endpoint - Working memory"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A"
},
{
"measure": "Secondary endpoint - Relapse-free Survival (RFS)"
},
{
"measure": "Secondary endpoint - Overall survival (OS)"
},
{
"measure": "Secondary endpoint - Serious Adverse Events (SAE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Comenius University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CKD-341, D956"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jeonju",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Jeonbuk National University Hospital",
"geoPoint": {
"lat": 35.82194,
"lon": 127.14889
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults",
"nctId": "NCT06281132",
"orgStudyIdInfo": {
"id": "A126_03BE2316",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "area under curve(AUC) of CKD-341, D956"
},
{
"measure": "Cmax of CKD-341, D956"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Chong Kun Dang Pharmaceutical"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cervavac as three dose regimen"
},
{
"name": "Cervavac as two dose regimen"
},
{
"name": "Gardasil as three dose regimen"
}
]
},
"conditionsModule": {
"conditions": [
"Human Papillomavirus Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nairobi",
"contacts": [
{
"email": "[email protected]",
"name": "Nelly Mugo",
"phone": "+254733629665",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Kenya",
"facility": "Centre For Clinical Research, Kemri",
"geoPoint": {
"lat": -1.28333,
"lon": 36.81667
},
"state": null,
"status": null,
"zip": "54840-00200"
},
{
"city": "Thika",
"contacts": [
{
"email": "[email protected]",
"name": "Nelly Mugo",
"phone": "+254733629665",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Kenya",
"facility": "Partners in Health and Research Development (Phrd)",
"geoPoint": {
"lat": -1.03326,
"lon": 37.06933
},
"state": null,
"status": null,
"zip": "19865-00202"
},
{
"city": "Manhiça",
"contacts": [
{
"email": "[email protected]",
"name": "Tacilta Nhampossa",
"phone": "+258 21 810 181",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Mozambique",
"facility": "Manhiça Health Research Center - Manhiça Foundation (CISM-FM)",
"geoPoint": null,
"state": null,
"status": null,
"zip": "1929"
},
{
"city": "Johannesburg",
"contacts": [
{
"email": "[email protected]",
"name": "Carla Chibwesha",
"phone": "+27 072 744 7899",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Clinical HIV Research Unit (CHRU), Helen Joseph Hospital",
"geoPoint": {
"lat": -26.20227,
"lon": 28.04363
},
"state": null,
"status": null,
"zip": "2092"
}
]
},
"descriptionModule": {
"briefSummary": "Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 450,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "15 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years",
"nctId": "NCT06281119",
"orgStudyIdInfo": {
"id": "SII-qHPV/MC-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion"
},
{
"measure": "Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage"
},
{
"measure": "CD4+ cell count, HIV viral load, and HIV clinical staging"
}
],
"primaryOutcomes": [
{
"measure": "Geometric mean titers of anti HPV 16 and 18 IgG antibodies"
}
],
"secondaryOutcomes": [
{
"measure": "Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies"
},
{
"measure": "Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion"
},
{
"measure": "Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bill and Melinda Gates Foundation"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Serum Institute of India Pvt. Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Deucravacitinib"
}
]
},
"conditionsModule": {
"conditions": [
"Psoriasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": [
{
"email": "[email protected]",
"name": "Franziska Stuber, RN",
"phone": "+41 21 3143427",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Curdin Conrad, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Centre hospitalier universitaire vaudois (CHUV)",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": "VD",
"status": null,
"zip": "1011"
}
]
},
"descriptionModule": {
"briefSummary": "Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "During 4 weeks the patients of the 2 arms receive either Deucravacitinib 6mg 1x/day or an identically looking placebo.At Week 4, Patients with underlying disease of Crohn's disease, colitis ulcerosa, uveitis will stop the study, to avoid that they are too long without efficient treatment for their underlying disease.Patients with underlying disease of psoriasis or psoriatic arthritis will have the possiblity to continue in Part 2, where they all will receive Deucravacitinib 6mg 1x/day, open label for 3 months",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Lab personnel",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 26,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TYPP",
"briefTitle": "TYK2 Inhibition in Paradoxical Psoriasis",
"nctId": "NCT06281106",
"orgStudyIdInfo": {
"id": "IM011-1118",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CER-VD",
"id": "KOFAM 2023-01731",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Nanostring"
}
],
"primaryOutcomes": [
{
"measure": "Paradoxical Psoriasis Investigator Global Assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Paradoxical Psoriasis Body Surface Area"
},
{
"measure": "Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index"
},
{
"measure": "Paradoxical Psoriasis Scalp Investigator General Assessment"
},
{
"measure": "Psoriasis Area and Severity Index (PASI)"
},
{
"measure": "American College of Rheumatology (ACR) Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Centre Hospitalier Universitaire Vaudois"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Prof Curdin Conrad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "questionary"
},
{
"name": "Daily continuous recording of radiofrequency exposure levels"
},
{
"name": "Follow-up of daily infants clinical parameters"
},
{
"name": "recording of cerebral (EEG)"
},
{
"name": "autonomic nervous (ECG) activity"
}
]
},
"conditionsModule": {
"conditions": [
"Preterm Newborn"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amiens",
"contacts": [
{
"email": "[email protected]",
"name": "Pierre Tourneux, MD",
"phone": "+33 3 22 66 82 86",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Erwan STÉPHAN-BLANCHARD, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Stéphane DELANAUD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Frédéric TELLIEZ, Pr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Karen CHARDON, Pr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Brahim SELMAOUI, Dr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Débora TUKA",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jean-Michel ROUÉ, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Marine BUTIN, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Pierre KUHN, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Géraldine GASCOIN, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Amiens University Hospital",
"geoPoint": {
"lat": 49.9,
"lon": 2.3
},
"state": "Picardie",
"status": "RECRUITING",
"zip": "80054"
}
]
},
"descriptionModule": {
"briefSummary": "Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "1 Month",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "CHARLINE",
"briefTitle": "Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System",
"nctId": "NCT06281093",
"orgStudyIdInfo": {
"id": "PI2022_843_0089",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Variation of the spectral power in the α band (8-12 Hz) of the EEG"
}
],
"secondaryOutcomes": [
{
"measure": "variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Hospital, Brest"
},
{
"name": "CHU LYON"
},
{
"name": "University Hospital, Strasbourg, France"
},
{
"name": "University Hospital, Toulouse"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire, Amiens"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "En-Bloc Resection of Bladder Tumours"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours",
"nctId": "NCT06281080",
"orgStudyIdInfo": {
"id": "CRE2023.589-T",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Successful en-bloc tumour resection by the robotic system"
}
],
"secondaryOutcomes": [
{
"measure": "Dissection time and speed"
},
{
"measure": "Total procedure time"
},
{
"measure": "Surgeon Console time"
},
{
"measure": "Presence of detrusor muscle in specimen"
},
{
"measure": "Resection Margin"
},
{
"measure": "Intra-operative bladder perforation event"
},
{
"measure": "Post-operative complications"
},
{
"measure": "Need of bladder irrigation"
},
{
"measure": "Residual tumour or upstaging of tumour after second look TURBT"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Agilis Robotics Limited"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "\"full-physiology approach\" arm"
},
{
"name": "\"standard approach\" arm"
}
]
},
"conditionsModule": {
"conditions": [
"Myocardial Bridge"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Acquaviva Delle Fonti",
"contacts": null,
"country": "Italy",
"facility": "Ospedale Generale Regionale F. Miulli",
"geoPoint": {
"lat": 40.89704,
"lon": 16.8433
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Alessandria",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo",
"geoPoint": {
"lat": 44.90924,
"lon": 8.61007
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Arezzo",
"contacts": null,
"country": "Italy",
"facility": "Ospedale San Donato",
"geoPoint": {
"lat": 43.46276,
"lon": 11.88068
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Bergamo",
"contacts": null,
"country": "Italy",
"facility": "ASST Papa Giovanni XXIII",
"geoPoint": {
"lat": 45.69601,
"lon": 9.66721
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Biella",
"contacts": null,
"country": "Italy",
"facility": "Ospedale degli Infermi di Biella",
"geoPoint": {
"lat": 45.56304,
"lon": 8.05796
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Bologna",
"contacts": null,
"country": "Italy",
"facility": "Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Caserta",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano",
"geoPoint": {
"lat": 41.07262,
"lon": 14.33231
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Cotignola",
"contacts": null,
"country": "Italy",
"facility": "Villa Maria Cecilia Hospital",
"geoPoint": {
"lat": 44.38572,
"lon": 11.93852
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Ferrara",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria di Ferrara",
"geoPoint": {
"lat": 44.83804,
"lon": 11.62057
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Firenze",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Careggi",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Genova",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliera Universitaria Policlinico San Martino",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
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}
],
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},
{
"measure": "Incidence of MACE"
},
{
"measure": "Rate of cardiac death"
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{
"measure": "Rate of MI"
},
{
"measure": "Rate of cardiac hospitalization"
},
{
"measure": "Rate of TLR"
}
]
},
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"name": "Università degli Studi del Piemonte Orientale \"Amedeo Avogadro\""
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"date": "2023-12-15"
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"date": "2024-02-28"
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}
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{
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"conditions": [
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},
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{
"measure": "Revascularization"
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{
"measure": "Hospitalization for heart failure"
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{
"measure": "Stroke"
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{
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}
]
},
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}
} | false | null |
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{
"name": "Antiplatelet Agents"
}
]
},
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"conditions": [
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},
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},
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"acronym": "NHIS",
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"measure": "Major adverse cardiac and cerebrovascular events"
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{
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{
"measure": "Myocardial infarction"
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{
"measure": "Unplanned revascularization"
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{
"measure": "Stroke"
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{
"measure": "Major bleeding"
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{
"measure": "Gastrointestinal bleeding necessitated hospitalization without documented transfusion"
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{
"measure": "Intracranial hemorrhage"
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]
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}
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{
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"interventions": [
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{
"name": "HYDROLINK-NVU/SOLACEA-H"
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]
},
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"conditions": [
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]
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"locations": [
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"email": "[email protected]",
"name": "Maxime HOFFMANN, MD",
"phone": "6 86 70 91 23",
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}
} | false | null |
{
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]
},
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]
},
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"contacts": null,
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},
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"briefSummary": "This study aimed to determine whether the whole-body bone Single Photon Emission Computed Tomography (SPECT) recording times of around 10 minutes, routinely provided by a high-sensitivity 360 degrees cadmium and zinc telluride (CZT) camera, can be further reduced by a deep learning noise reduction (DLNR) algorithm."
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{
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{
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"briefTitle": "Trueness of Full Arch Scans and Generated Digital Implant Models",
"nctId": "NCT06281002",
"orgStudyIdInfo": {
"id": "FDASU-RecIM112323",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies."
}
],
"secondaryOutcomes": [
{
"measure": "Trueness of the generated 3D-printed digital implant models."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "kinesio taping"
},
{
"name": "myofascial release technique"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": [
{
"email": "[email protected]",
"name": "hala ma morsy, Bachelor",
"phone": "00201028616865",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Hala mohamed ahmed morsy",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": null,
"zip": "12511"
}
]
},
"descriptionModule": {
"briefSummary": "the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "kinesio taping and myofascial release technique",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Kinesio Taping Versus Myofascial Release on Menstrual Low Back Pain",
"nctId": "NCT06280989",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004768",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pain intensity"
},
{
"measure": "pain pressure threshold"
}
],
"secondaryOutcomes": [
{
"measure": "severity of dysmenorrhea"
},
{
"measure": "Assess the function disability level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Statin"
},
{
"name": "Aspirin tablet"
},
{
"name": "Nexlizet"
},
{
"name": "LEQVIO"
},
{
"name": "Vascepa"
},
{
"name": "Jardiance"
},
{
"name": "Colchicine"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease",
"Atherosclerosis",
"Heart Attack"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Louisville",
"contacts": [
{
"email": "[email protected]",
"name": "Dinesh Kalra, MD",
"phone": "502-588-7010",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Muhammad Umer, MD",
"phone": "502-588-7010",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Louisville School of Medicine, Division of Cardiovascular Diseases",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky",
"status": "RECRUITING",
"zip": "40202"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "PROBE design: Prospective Randomized Open Label Blinded End-point",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ARTCAP",
"briefTitle": "Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)",
"nctId": "NCT06280976",
"orgStudyIdInfo": {
"id": "23.0001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plaque quantification"
},
{
"measure": "Characterization of plaque to evaluate for high-risk features - positive remodeling"
},
{
"measure": "Quantification of stenosis"
},
{
"measure": "Quantification of pericoronary fat attenuation."
},
{
"measure": "Characterization of plaque to evaluate for high-risk features - low CT attenuation"
},
{
"measure": "Characterization of plaque to evaluate for high-risk features - napkin-ring sign"
},
{
"measure": "Quantification of epicardial fat attenuation."
}
],
"secondaryOutcomes": [
{
"measure": "Major adverse cardiac and cardiovascular events (MACCE)"
},
{
"measure": "Polygenic risk score (PRS)"
},
{
"measure": "Next generation sequencing (NGS)"
},
{
"measure": "Change in Lipoprotein (a)"
},
{
"measure": "Change in myeloperoxidase (MPO) activity"
},
{
"measure": "Change in trimethylamine-N-oxide (TMAO) levels"
},
{
"measure": "Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels"
},
{
"measure": "Change in interleukin-6 (IL-6) levels"
},
{
"measure": "Change in high sensitivity C-creative protein (HS-CRP) levels"
},
{
"measure": "Buffy coat for chromatin immunoprecipitation (ChIP)"
},
{
"measure": "Change in high sensitivity Troponin (HS-Tn)"
},
{
"measure": "Change in natriuretic peptide (BNP, NT-pro BNP"
},
{
"measure": "Change in levels of open reading frame 1 protein (ORF1p)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Louisville"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "muscle energy technique"
},
{
"name": "posterior innominate mobilization"
},
{
"name": "conventional treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Sacroiliac Joint Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dokki",
"contacts": [
{
"email": "[email protected]",
"name": "Haytham M Elhafez, PhD",
"phone": "+201001909630",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Physical Therapy",
"geoPoint": {
"lat": 30.03823,
"lon": 31.2113
},
"state": "Giza",
"status": "RECRUITING",
"zip": "12612"
}
]
},
"descriptionModule": {
"briefSummary": "the goal of this clinical trial study is to compare between posterior innominate mobilization and muscle energy techniqueon lumbopelvic angles in sacroiliac joint dysfunction patients.the main questions they aim to answer are1. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on lumbopelvic angles in sacroiliac joint dysfunction patients ?2. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on pain intensity level in sacroiliac joint dysfunction patients ? * purpose of the study is to measure the effect of muscle energy technique versus posterior innominate mobilization on lumbopelvic angles in sacroiliac joint dysfunction"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "group one will receive muscle energy technique group two will receive posterior innominate mobilization group three will receive conventional treatment ( TENS , US , stertching exercises and strenghening exercises )",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MET",
"briefTitle": "Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction",
"nctId": "NCT06280963",
"orgStudyIdInfo": {
"id": "012/005532",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "lumbopelvic angles"
}
],
"secondaryOutcomes": [
{
"measure": "pain intensity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mahmoud Yousry Rashwan Hefny"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Everolimus"
},
{
"name": "Tacrolimus (continued reduction)"
},
{
"name": "Tacrolimus (maintain 50% reduction)"
},
{
"name": "Everolimus"
}
]
},
"conditionsModule": {
"conditions": [
"Liver Transplant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phoenix",
"contacts": [
{
"email": null,
"name": "Hugo Vargas, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic Hospital Arizona (Site #: 71144)",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": null,
"zip": "85054"
},
{
"city": "San Francisco",
"contacts": [
{
"email": "[email protected]",
"name": "Joanna Kwan",
"phone": "415-476-2574",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sandy Feng, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of California, San Francisco (Site #: 71108)",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": null,
"zip": "94143"
},
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Dania Jahangir",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Justin Boike, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Northwestern University (Site #: 71110)",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60611"
},
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Bharathi Ramesh",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Thomas Schiano, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Icahn School of Medicine at Mount Sinai (Site #: 71115)",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10029"
},
{
"city": "Durham",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Perry",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carl Berg, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Duke University Medical Center (Site #: 71139)",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27710"
},
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Lexi Tumblety",
"phone": "267-441-1800",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Abraham Shaked, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pennsylvania (Site #: 71111)",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
},
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Lois Kipling",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Scott Biggins, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pittsburgh Medical Center (Site #: 71162)",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15260"
},
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Angela Roy",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sumeet Asrani, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Baylor Medical Center (Site #: 71153)",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75246"
}
]
},
"descriptionModule": {
"briefSummary": "This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 340,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ELIMINATE",
"briefTitle": "Expanding Liver Transplant Immunosuppression Minimization Via Everolimus",
"nctId": "NCT06280950",
"orgStudyIdInfo": {
"id": "DAIT CTOT-43",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2"
},
{
"measure": "Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2"
}
],
"secondaryOutcomes": [
{
"measure": "Percent change in Estimated Glomerular Filtration Rate (eGFR) in Renal function"
},
{
"measure": "Percentage of subjects with treated Biopsy Proven Acute Rejection (tBPAR) in Liver Function"
},
{
"measure": "Changes in liver graft function: Total bilirubin"
},
{
"measure": "Changes in liver graft function: Direct bilirubin"
},
{
"measure": "Changes in liver graft function: Alanine Aminotransaminase (ALT)"
},
{
"measure": "Changes in liver graft function: Aspartate Aminotransferase (AST)"
},
{
"measure": "Changes in liver graft function: Alkaline Phosphatase"
},
{
"measure": "Time to graft failure in liver function defined as relisting for transplantation, re-transplantation itself or death with failed graft"
},
{
"measure": "Time to all-cause mortality"
},
{
"measure": "Proportion of subjects experiencing a Major Adverse Cardiac Event (MACE)"
},
{
"measure": "Proportion of subjects experiencing infection requiring hospitalization"
},
{
"measure": "Proportion of subjects experiencing any malignancy"
},
{
"measure": "Proportion of subjects developing severe Estimated Glomerular Filtration Rate (eGFR) deterioration >40 percent from baseline using the CKD-EPI 2021 equation"
},
{
"measure": "Proportion of subjects developing any major immunosuppressive therapy complications"
},
{
"measure": "Proportion of subjects developing new onset peripheral edema"
},
{
"measure": "Proportion of subjects developing new onset cytopenia deemed WBC <3.0x10^9 /L, Hb <8.0 g/dL, or platelets <50 x 10^9/L."
},
{
"measure": "Proportion of subjects developing new onset oral/gastrointestinal ulcerations"
},
{
"measure": "Proportion of subjects developing new onset gastrointestinal symptoms (nausea, vomiting, abdominal pain, or diarrhea) related to everolimus therapy."
},
{
"measure": "Proportion of subjects developing new onset pneumonitis"
},
{
"measure": "Proportion of subjects developing new onset hepatic artery thrombosis"
},
{
"measure": "Proportion of subjects developing other adverse events deemed"
},
{
"measure": "Proportion of subjects developing any adverse events related to everolimus therapy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute of Allergy and Infectious Diseases (NIAID)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wearing a tie"
}
]
},
"conditionsModule": {
"conditions": [
"Musculoskeletal Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bitlis",
"contacts": null,
"country": "Turkey",
"facility": "Bitlis Eren University",
"geoPoint": {
"lat": 38.40115,
"lon": 42.10784
},
"state": "Merkez",
"status": null,
"zip": "13000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized controlled study is to assess the short term effect of wearing a ties on musculoskeletal system. In this scope viscoelastic properties and the mechanosensitivity of the muscles, and cervical range of motion will be measured. In addition to these measurements activity limitation due to wearing a tie and trunk mobility will be assessed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Control group will go on their routine daily activities. Study group will wear a tie during one office working day.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Interventions and assessment will be performed by separate researchers.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Short Term Effect of Wearing a Tie",
"nctId": "NCT06280937",
"orgStudyIdInfo": {
"id": "BEUFTR-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Change in the Viscoelastic Properties of the Muscles"
},
{
"measure": "The Change in the Pressure Pain Threshold of the Spine and Upper Trapezius"
},
{
"measure": "Cervical Range of Motion"
}
],
"secondaryOutcomes": [
{
"measure": "Activity Limitation"
},
{
"measure": "Global Rating of Change"
},
{
"measure": "Trunk Forward Bending Mobility"
},
{
"measure": "Trunk Lateral Bending Mobility"
},
{
"measure": "Neck Circumference"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bitlis Eren University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Supported Exercise"
},
{
"name": "Standard Care"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Myeloma",
"Exercise",
"Prehabilitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Edmonton",
"contacts": null,
"country": "Canada",
"facility": "University of Alberta/ Cross Cancer Institute",
"geoPoint": {
"lat": 53.55014,
"lon": -113.46871
},
"state": "Alberta",
"status": null,
"zip": "T6G 2G4"
}
]
},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MOTIVATE",
"briefTitle": "Prehab Prior to Stem Cell Transplantation in Multiple Myeloma",
"nctId": "NCT06280924",
"orgStudyIdInfo": {
"id": "HREBA.CC-23-0220",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Study completion rate"
}
],
"secondaryOutcomes": [
{
"measure": "Recruitment rate"
},
{
"measure": "Attendance rate"
},
{
"measure": "Edmonton Symptom Assessment System"
},
{
"measure": "Functional Assessment of Cancer Therapy Multiple Myeloma"
},
{
"measure": "Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)"
},
{
"measure": "Body weight"
},
{
"measure": "Body height"
},
{
"measure": "Grip Strength"
},
{
"measure": "Calf muscle size"
},
{
"measure": "Thigh muscle thickness"
},
{
"measure": "Short Physical Performance Battery"
},
{
"measure": "Six-minute walk test"
},
{
"measure": "One leg stance balance"
},
{
"measure": "Shoulder flexion range of motion"
},
{
"measure": "Sit and reach test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Alberta"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Date Fruit group"
},
{
"name": "Nipple group"
}
]
},
"conditionsModule": {
"conditions": [
"Augmentation",
"Induction",
"Labor",
"Stimulation, Self"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Zeynep Kamil Women's and Children's Diseases Training and Research Hospital",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study was designed to be randomly controlled.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 198,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy",
"nctId": "NCT06280911",
"orgStudyIdInfo": {
"id": "098",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The spontaneous onset of labor"
},
{
"measure": "Induction and augmentation of labor"
}
],
"secondaryOutcomes": [
{
"measure": "Mode of delivery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Selcuk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2017-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-04"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2014-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remote ischemic conditioning"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Injuries",
"Kidney Transplant; Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul St. Mary's hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": "06591"
}
]
},
"descriptionModule": {
"briefSummary": "Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using , and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 539,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Perioperative Factors and Early Postoperative Kidney Graft Function Recovery",
"nctId": "NCT06280898",
"orgStudyIdInfo": {
"id": "KC22RISI0395",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Troponin I"
}
],
"secondaryOutcomes": [
{
"measure": "Troponin T"
},
{
"measure": "QTc interval"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Seoul St. Mary's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-03-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-03-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
},
{
"name": "Health Behaviour Change (Pedometer)"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dublin",
"contacts": null,
"country": "Ireland",
"facility": "St James's Hospital",
"geoPoint": {
"lat": 53.33306,
"lon": -6.24889
},
"state": null,
"status": null,
"zip": "8"
}
]
},
"descriptionModule": {
"briefSummary": "The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Feasibility randomised controlled trial using a 2:1 randomisation",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Not indicated for this feasibility study.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FIERCE",
"briefTitle": "A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy",
"nctId": "NCT06280885",
"orgStudyIdInfo": {
"id": "FIERCE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility: Recruitment rates"
},
{
"measure": "Feasibility: Adherence rates"
},
{
"measure": "Feasibility: Attendance rates"
},
{
"measure": "Feasibility: Retention Rates"
},
{
"measure": "Feasibility: Reason for drop0out"
}
],
"secondaryOutcomes": [
{
"measure": "Cardiorespiratory Fitness"
},
{
"measure": "Muscular Strength"
},
{
"measure": "Body Mass Index"
},
{
"measure": "Mid-arm circumference"
},
{
"measure": "Waist Circumference"
},
{
"measure": "Bioimpedance Analysis"
},
{
"measure": "Health Related Quality of Life"
},
{
"measure": "Fatigue"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "St. James's Hospital, Ireland"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Dublin, Trinity College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physiological Based Cord Clamping"
},
{
"name": "Differed Cord Clamping"
}
]
},
"conditionsModule": {
"conditions": [
"Premature Birth",
"Respiratory Distress Syndrome in Premature Infant",
"Sepsis",
"Intraventricular Hemorrhage of Prematurity",
"Bronchodysplasia",
"Jaundice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussels",
"contacts": [
{
"email": "[email protected]",
"name": "Andrew CARLIN",
"phone": "+3224773295",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andrew CARLIN, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "CHU Brugmann",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "RECRUITING",
"zip": "1020"
},
{
"city": "Brussels",
"contacts": [
{
"email": "[email protected]",
"name": "Anna AMORUSO, MD",
"phone": "+3224773250",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anna AMORUSO",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Hôpital Universitaire Des Enfants Reine Fabiola",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "RECRUITING",
"zip": "1020"
}
]
},
"descriptionModule": {
"briefSummary": "Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way.A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "36 Weeks",
"minimumAge": "32 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PhyCordPrem",
"briefTitle": "Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns",
"nctId": "NCT06280872",
"orgStudyIdInfo": {
"id": "P2023/Neonat/PhyCordPrem",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Duration of non-invasive or invasive respiratory support."
}
],
"secondaryOutcomes": [
{
"measure": "Rate of neonatal mortality"
},
{
"measure": "Rate of neonatal resuscitation"
},
{
"measure": "Rate of neonatal respiratory morbidity"
},
{
"measure": "Number of admission to the NICU or special care baby unit"
},
{
"measure": "Length of hospitalization"
},
{
"measure": "Gestational age corrected at discharge"
},
{
"measure": "Changes in physiological variables during neonatal transition"
},
{
"measure": "Early neonatal parameters"
},
{
"measure": "Hemoglobin level"
},
{
"measure": "Bilirubin level"
},
{
"measure": "Occurrence of Neonatal adverse events"
},
{
"measure": "Biological markers of oxidative stress"
},
{
"measure": "Maternal perioperative parameters"
},
{
"measure": "Maternal postoperative hemoglobin level"
},
{
"measure": "Number of maternal adverse events"
},
{
"measure": "Maternal-infant bonding"
},
{
"measure": "Maternal-infant bonding"
},
{
"measure": "Maternal-infant bonding"
},
{
"measure": "Rate of Maternal-infant bonding"
},
{
"measure": "Rate of Maternal-infant bonding"
},
{
"measure": "Rate of Maternal-infant bonding"
},
{
"measure": "Maternal-infant bonding"
},
{
"measure": "Parental satisfaction survey"
},
{
"measure": "Child development assessment"
},
{
"measure": "Success of PBCC"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Belgian Kids Fund"
},
{
"name": "Fonds IRIS-Recherche"
},
{
"name": "Ars Statistica"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Queen Fabiola Children's University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hoosier Sport"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Sedentary Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bloomington",
"contacts": null,
"country": "United States",
"facility": "Indiana University",
"geoPoint": {
"lat": 39.16533,
"lon": -86.52639
},
"state": "Indiana",
"status": null,
"zip": "47405"
}
]
},
"descriptionModule": {
"briefSummary": "The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Students enrolled in physical education (PE) class will be eligible to enroll in the study, and serve as the intervention group. Those not enrolled in PE that semester will be recruited as the control group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "9 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana",
"nctId": "NCT06280859",
"orgStudyIdInfo": {
"id": "18784",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of Intervention Measure (FIM)"
},
{
"measure": "Acceptability of Intervention Measure (IAM)"
},
{
"measure": "Intervention Appropriateness Measure (AIM)"
}
],
"secondaryOutcomes": [
{
"measure": "Daily Steps of Participants"
},
{
"measure": "Daily Moderate to Vigorous Physical Activity of Participants"
},
{
"measure": "Heart Rate of Participants"
},
{
"measure": "Blood Pressure of Participants"
},
{
"measure": "Basic Psychological Needs of Participants in Intervention Environment"
},
{
"measure": "Physical Literacy of Participants"
},
{
"measure": "Cardiovascular Fitness Levels of Participants"
},
{
"measure": "Muscular Endurance Levels of Participants"
},
{
"measure": "Self-Reported Weekly Moderate to Vigorous Physical Activity of Participants"
},
{
"measure": "Nutrition Knowledge of Participants"
},
{
"measure": "Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "United States Department of Agriculture (USDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Indiana University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "high-intensity laser acupuncture and Exercise therapy program"
},
{
"name": "low-intensity laser acupuncture and Exercise therapy program"
},
{
"name": "Sham laser acupuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Nonspecific Low-back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": [
{
"email": "[email protected]",
"name": "Doaa A Elimy, lecturer",
"phone": "00201066474654",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Doaa Ayoub Elimy",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": "RECRUITING",
"zip": "11251"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "high-intensity laser acupuncture, low-intensity laser acupuncture and exercise therapy program",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "random generator",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain",
"nctId": "NCT06280846",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004878",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "peak torque"
},
{
"measure": "peak torque"
},
{
"measure": "Fatigue"
},
{
"measure": "Fatigue"
}
],
"secondaryOutcomes": [
{
"measure": "Pain Intensity"
},
{
"measure": "Pain Intensity"
},
{
"measure": "lumbar flexion ROM assessment"
},
{
"measure": "lumbar flexion ROM assessment"
},
{
"measure": "Disability"
},
{
"measure": "Disability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "King Khalid University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
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