protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Polycaprolactone (PCL) Based Facial Injectable"
}
]
},
"conditionsModule": {
"conditions": [
"Forehead Contouring"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Shengkang Luo",
"phone": "02089168071",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "WEIJIN HONG",
"phone": "02089168071",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "shengkang luo",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "weijin hong",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "Guangdong Second Provincial General Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510317"
}
]
},
"descriptionModule": {
"briefSummary": "A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 189,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour",
"nctId": "NCT06380972",
"orgStudyIdInfo": {
"id": "HDM6009A-301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)"
}
],
"secondaryOutcomes": [
{
"measure": "The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)"
},
{
"measure": "The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS)"
},
{
"measure": "The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "AQTIS Medical B.V."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Art Based Activity"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bornova",
"contacts": null,
"country": "Turkey",
"facility": "Ege University",
"geoPoint": {
"lat": 38.47921,
"lon": 27.2399
},
"state": "İzmir",
"status": null,
"zip": "35100"
}
]
},
"descriptionModule": {
"briefSummary": "Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using \"Individual Introduction Form\", \"Herth Hope Index\", \"Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomised Controlled",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Art-based Activities in Stroke Patients",
"nctId": "NCT06380959",
"orgStudyIdInfo": {
"id": "223K879",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Herth Hope Index"
},
{
"measure": "Generalized Self-Efficacy Scale"
},
{
"measure": "Individual Introduction Form"
}
],
"secondaryOutcomes": [
{
"measure": "Art Object Concretization Form"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ege University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "iPRF"
}
]
},
"conditionsModule": {
"conditions": [
"Effect of Platelet Rich FibrinDuring Clear Aligner Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "AlAzhar university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "22 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy",
"nctId": "NCT06380946",
"orgStudyIdInfo": {
"id": "978/91",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Al-Azhar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "experimental group"
}
]
},
"conditionsModule": {
"conditions": [
"Sleep Quality",
"Comfort"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chiayi City",
"contacts": null,
"country": "Taiwan",
"facility": "Hsu Mei-Lian",
"geoPoint": {
"lat": 23.47917,
"lon": 120.44889
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 94,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort",
"nctId": "NCT06380933",
"orgStudyIdInfo": {
"id": "B11103008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Richards-Campbell Sleep Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Numerical Rating of Comfort"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dalin Tzu Chi General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "\"AI Mindful Eating\" App"
},
{
"name": "Outpatient regular follow-up"
}
]
},
"conditionsModule": {
"conditions": [
"Weight Loss",
"Body Fat Rate Loss",
"Body Composition Change"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an \"AI Mindful Eating\" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on \"gut-brain-axis\", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention."
},
"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": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example",
"nctId": "NCT06380920",
"orgStudyIdInfo": {
"id": "Digital Health App",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "weight change"
}
],
"secondaryOutcomes": [
{
"measure": "Parameters of Metabolic syndrome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Cheng-Kung University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ZL-1102 1% w/w gel BID for 16 weeks"
},
{
"name": "ZL-1102 3% w/w gel BID for 16 weeks"
},
{
"name": "ZL-1102 3% w/w gel QD for 16 weeks"
},
{
"name": "Placebo ZL-1102 0% w/w gel BID for 16 weeks"
},
{
"name": "Placebo ZL-1102 0% w/w gel QD for 16 weeks"
}
]
},
"conditionsModule": {
"conditions": [
"Plaque Psoriasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phillip",
"contacts": null,
"country": "Australia",
"facility": "Zai Lab Site 5013",
"geoPoint": {
"lat": -31.13333,
"lon": 150.85
},
"state": "Australian Capital Territory",
"status": null,
"zip": "2606"
},
{
"city": "Kotara",
"contacts": null,
"country": "Australia",
"facility": "Zai Lab Site 5016",
"geoPoint": {
"lat": -32.95,
"lon": 151.68333
},
"state": "New South Wales",
"status": null,
"zip": "2289"
},
{
"city": "Woolloongabba",
"contacts": null,
"country": "Australia",
"facility": "Zai Lab Site 5017",
"geoPoint": {
"lat": -27.48855,
"lon": 153.03655
},
"state": "Queensland",
"status": null,
"zip": "4102"
},
{
"city": "Carlton",
"contacts": null,
"country": "Australia",
"facility": "Zai Lab Site 5014",
"geoPoint": {
"lat": -37.8,
"lon": 144.96667
},
"state": "Victoria",
"status": null,
"zip": "3053"
},
{
"city": "Melbourne E.",
"contacts": null,
"country": "Australia",
"facility": "Zai Lab Site 5002",
"geoPoint": {
"lat": -37.81667,
"lon": 144.9879
},
"state": "Victoria",
"status": null,
"zip": null
},
{
"city": "Melbourne",
"contacts": null,
"country": "Australia",
"facility": "Zai Lab Site 5015",
"geoPoint": {
"lat": -37.814,
"lon": 144.96332
},
"state": "Victoria",
"status": null,
"zip": "3124"
}
]
},
"descriptionModule": {
"briefSummary": "A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis"
},
"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": 250,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis",
"nctId": "NCT06380907",
"orgStudyIdInfo": {
"id": "ZL-1102-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16."
}
],
"secondaryOutcomes": [
{
"measure": "The proportion of patients achieving IGA treatment success."
},
{
"measure": "The proportion of patients achieving IGA score of 0 or 1."
},
{
"measure": "The percent change from baseline in mPASI score."
},
{
"measure": "The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20."
},
{
"measure": "The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20."
},
{
"measure": "Time to achieve mPASI 50/75/90."
},
{
"measure": "Time to achieve IGA score of 0 or 1."
},
{
"measure": "Time to achieve 1- or 2-point improvement in IGA."
},
{
"measure": "Incidence of Treatment Related Adverse Events through Week 20."
},
{
"measure": "Mean local tolerability scores (LTS)"
},
{
"measure": "Serum concentration of ZL-1102."
},
{
"measure": "Anti-drug antibody (ADA) of ZL-1102."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Zai Lab (US) LLC"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Zai Lab (Hong Kong), Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual Reality Cognitive Training"
},
{
"name": "Active Control"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Cognitive Impairment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": null,
"country": "Singapore",
"facility": "Changi General Hospital",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Virtual Reality Cognitive Training for Mild Cognitive Impairment",
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"measure": "Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11"
},
{
"measure": "Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11"
},
{
"measure": "Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11"
},
{
"measure": "Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11"
},
{
"measure": "Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11"
}
],
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}
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{
"armsInterventionsModule": {
"interventions": [
{
"name": "SHR-2017"
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]
},
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"conditions": [
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]
},
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],
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}
]
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},
"designModule": {
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},
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"measure": "The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax"
},
{
"measure": "The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax"
},
{
"measure": "The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t"
},
{
"measure": "The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞"
},
{
"measure": "The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2"
},
{
"measure": "The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F"
},
{
"measure": "The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr"
},
{
"measure": "The pharmacodynamic parameter of SHR-2017 after administration include β-CTX"
},
{
"measure": "The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time"
}
],
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{
"measure": "Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing"
},
{
"measure": "Incidence of skeletal-related event"
},
{
"measure": "Average daily total opioids consumption"
}
]
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"name": "Suzhou Suncadia Biopharmaceuticals Co., Ltd."
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"name": "Intravascular imaging-guided PCI"
},
{
"name": "Angiography-guided PCI group"
}
]
},
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"conditions": [
"Diabetes"
]
},
"contactsLocationsModule": {
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{
"city": "Nanjing",
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"facility": "Nanjing First Hospital",
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"lon": 118.77778
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"state": "Jiangsu",
"status": null,
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]
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"briefSummary": "Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial."
},
"designModule": {
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"maskingInfo": {
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"acronym": "IVI-DIABETES",
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"id": "Nanjing-2",
"link": null,
"type": null
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{
"measure": "Rate of target vessel failure (TVF)"
}
],
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{
"measure": "Rate of target vessel failure without procedure-related MI"
},
{
"measure": "Rate of cardiac death"
},
{
"measure": "Rate of all-cause death"
},
{
"measure": "Rate of procedure-related myocardial infarction (PMI)"
},
{
"measure": "Rate of spontaneous myocardial infarction (SMI)"
},
{
"measure": "Rate of clinically-driven revascularization"
},
{
"measure": "Rate of stent thrombosis"
}
]
},
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"collaborators": [
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"name": "Shanxi Provincial People's Hospital"
}
],
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"class": "OTHER",
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}
},
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"date": "2027-07-20"
},
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"date": "2024-06-10"
},
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} | false | null |
{
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"interventions": [
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"name": "Flexible colonoscope assisted hybrid transanal total mesorectal resection"
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]
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},
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"name": "Liang Kang, MD, PhD",
"phone": "008613602886833",
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],
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"briefSummary": "The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury."
},
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"measure": "Success rate of operation"
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}
} | false | null |
{
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]
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]
},
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"briefSummary": "The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy."
},
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],
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"measure": "incidence of a composite of major complications"
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{
"measure": "Incidence of ICU mortality"
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{
"measure": "Incidence of hospital mortality"
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{
"measure": "Incidence of 28-day mortality"
},
{
"measure": "Incidence of one year mortality"
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{
"measure": "ICU length of hospital stay"
},
{
"measure": "Length of hospital stay"
},
{
"measure": "The pancreatic symptoms score"
},
{
"measure": "The levels of inflammatory factor CRP"
},
{
"measure": "The levels of inflammatory cytokines IL-6"
},
{
"measure": "The levels of inflammatory procalcitonin"
}
]
},
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"name": "Chunling Jiang"
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"startDateStruct": {
"date": "2024-04-15"
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}
} | false | null |
{
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"interventions": [
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"name": "Questionnaire"
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]
},
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"conditions": [
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"Self Care"
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},
"contactsLocationsModule": {
"locations": [
{
"city": "Aydın",
"contacts": null,
"country": "Turkey",
"facility": "Bircan Kahraman Berberoğlu",
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"state": null,
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"descriptionModule": {
"briefSummary": "This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale?"
},
"designModule": {
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},
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"briefTitle": "Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form",
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"id": "Adnan Menderes",
"link": null,
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},
"studyFirstPostDateStruct": {
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} | false | null |
{
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"Squamous Cell Carcinoma of Head and Neck",
"Carcinoma, Non-Small-Cell Lung",
"Colorectal Neoplasms",
"Triple Negative Breast Neoplasms",
"Carcinoma, Renal Cell (Clear Cell Only)",
"Esophageal Neoplasms",
"Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors)",
"Uterine Cervical Neoplasms",
"Ovarian Neoplasms",
"Pancreatic Neoplasms"
]
},
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{
"city": "Manchester",
"contacts": [
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"email": "[email protected]",
"name": "Fiona Thistlethwaite, Prof",
"phone": "+44 (0)161 9187672",
"phoneExt": null,
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],
"country": "United Kingdom",
"facility": "The Christie NHS Foundation Trust",
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{
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"contacts": [
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"email": "[email protected]",
"name": "Ioannis Karydis, Prof",
"phone": null,
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"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "University Hospital Southampton NHS Foundation Trust",
"geoPoint": {
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"lon": -1.40428
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"state": null,
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},
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"briefSummary": "This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.The four main aims of the clinical trial are to find out:1. The best dose of UCB4594 that can be given safely to participants in the trial.2. What the side effects of UCB4594 are and how they can be managed.3. What happens to UCB4594 inside the body and how it affects cancer cells.4. Whether UCB4594 can cause cancer to shrink."
},
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},
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"measure": "Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles)."
}
],
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"measure": "Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules)."
},
{
"measure": "Maximum concentration of UCB4594 (monotherapy modules; Modules A and B)."
},
{
"measure": "Minimum concentration of UCB4594 (monotherapy modules; Modules A and B)."
},
{
"measure": "Area under the curve of UCB4594 (monotherapy modules; Modules A and B)."
},
{
"measure": "Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B)."
},
{
"measure": "Clearance of UCB4594 (monotherapy modules; Modules A and B)."
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{
"measure": "Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period)."
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"studyFirstPostDateStruct": {
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}
} | false | null |
{
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"Surgical Procedure, Unspecified"
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},
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"briefSummary": "The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery.The main question\\[s\\]it aims to evaluate :* Satisfaction questionnaire of a educational program* NASA-TLX of a educational program* global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiencyParticipants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX.The tutor evaluates GEARS for 15 minutes at the beginning and end of training.After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ROMCAPO+AI",
"briefTitle": "Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence",
"nctId": "NCT06380803",
"orgStudyIdInfo": {
"id": "4-2020-1385",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Satisfaction questionnaire of a educational program"
},
{
"measure": "NASA-Task Load index of a educational program"
},
{
"measure": "Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency"
}
],
"secondaryOutcomes": [
{
"measure": "The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide"
},
{
"measure": "The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide"
},
{
"measure": "The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Research Foundation of Korea"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Severance Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Laser-aided csf"
},
{
"name": "placebo laser-aided csf"
}
]
},
"conditionsModule": {
"conditions": [
"Orthodontics"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Cairo University",
"phone": "0223638755",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of dentistry cairo university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment"
},
"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": 26,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding",
"nctId": "NCT06380790",
"orgStudyIdInfo": {
"id": "8423",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of tooth movement"
}
],
"secondaryOutcomes": [
{
"measure": "Pain level"
},
{
"measure": "Periodontal health"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Sarcopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Kang Yu, MD",
"phone": "+86 010-69155550",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.Research aims:Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.Participants will:Engage in screening and assessment based on inclusion and exclusion criteria.Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia",
"nctId": "NCT06380777",
"orgStudyIdInfo": {
"id": "DDT system for sarcopenia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Concentration of insulin"
},
{
"measure": "Concentration of adiponectin"
},
{
"measure": "Concentration of leptin"
},
{
"measure": "Concentration of insulin like growth factor -1(IGF-1)"
},
{
"measure": "Concentration of interleukin 18 (IL-18)"
},
{
"measure": "Concentration of tumor necrosis factor - α (TNF-α)"
},
{
"measure": "Concentration of TNF-like weak inducer of apoptosis (TWEAK)"
},
{
"measure": "Concentration of fibroblast growth factor -19 (FGF-19)"
},
{
"measure": "Concentration of myostatin"
},
{
"measure": "Concentration of chemoattractant protein-1 (MCP-1)"
},
{
"measure": "Concentration of activin"
}
],
"primaryOutcomes": [
{
"measure": "Appendicular skeletal muscle mass index"
}
],
"secondaryOutcomes": [
{
"measure": "Hand grip strength"
},
{
"measure": "Gait speed"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Greater Occipital Nerve Block"
},
{
"name": "Bilateral suboccipital intramuscular injection"
},
{
"name": "Epidural Blood Patch"
},
{
"name": "Normal Saline 10 mL Injection"
},
{
"name": "Lidocaine 2% Injectable Solution"
}
]
},
"conditionsModule": {
"conditions": [
"Postdural Puncture Headache"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banhā",
"contacts": null,
"country": "Egypt",
"facility": "Benha university",
"geoPoint": {
"lat": 30.45906,
"lon": 31.17858
},
"state": "El Qalyoubia",
"status": null,
"zip": "13511"
}
]
},
"descriptionModule": {
"briefSummary": "Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 152,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache",
"nctId": "NCT06380764",
"orgStudyIdInfo": {
"id": "RC.11.3.2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The extent of reduction of consumed analgesia"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Benha University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Saruparib (AZD5305)"
},
{
"name": "Camizestrant"
},
{
"name": "Abemaciclib"
},
{
"name": "Ribociclib"
},
{
"name": "Palbociclib"
},
{
"name": "Fulvestrant"
},
{
"name": "Letrozole"
},
{
"name": "Anastrozole"
},
{
"name": "Exemestane"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": null,
"country": "Canada",
"facility": "Research Site",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5G 2M9"
},
{
"city": "Montreal",
"contacts": null,
"country": "Canada",
"facility": "Research Site",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H3T 1E2"
},
{
"city": "Montréal",
"contacts": null,
"country": "Canada",
"facility": "Research Site",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H2X 0A9"
},
{
"city": "Saskatoon",
"contacts": null,
"country": "Canada",
"facility": "Research Site",
"geoPoint": {
"lat": 52.13238,
"lon": -106.66892
},
"state": "Saskatchewan",
"status": null,
"zip": "S7N 4H4"
},
{
"city": "Toronto",
"contacts": null,
"country": "Canada",
"facility": "Research Site",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": null,
"status": null,
"zip": "M4N 3M5"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Open label",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "130 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EvoPAR-BR01",
"briefTitle": "Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer",
"nctId": "NCT06380751",
"orgStudyIdInfo": {
"id": "D9722C00001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-Free Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival"
},
{
"measure": "Progression Free Survival 2"
},
{
"measure": "Time to chemotherapy"
},
{
"measure": "Objective Response Rate"
},
{
"measure": "Duration of Response"
},
{
"measure": "Participant-reported tolerability"
},
{
"measure": "Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)"
},
{
"measure": "Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)"
},
{
"measure": "Plasma concentrations of saruparib (AZD5305)"
},
{
"measure": "Plasma concentrations of camizestrant"
},
{
"measure": "Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AstraZeneca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-07-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Metastatic Castration-resistant Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aschaffenburg",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 49.97704,
"lon": 9.15214
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Berlin",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Berlin",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Duisburg",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 51.43247,
"lon": 6.76516
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Franckfurt",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": null,
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Halle",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 51.48159,
"lon": 11.97948
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Herzogenaurach",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 49.56798,
"lon": 10.88565
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Leipzig",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 51.33962,
"lon": 12.37129
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Lueneburg",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 53.2509,
"lon": 10.41409
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Muhlheim",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 50.11667,
"lon": 8.83333
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Nurnberg",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 49.45421,
"lon": 11.07752
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Russelsheim",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 49.98955,
"lon": 8.42251
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Speyer",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 49.32083,
"lon": 8.43111
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Wetzlar",
"contacts": null,
"country": "Germany",
"facility": "Research Site",
"geoPoint": {
"lat": 50.56109,
"lon": 8.50495
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROceed",
"briefTitle": "Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)",
"nctId": "NCT06380738",
"orgStudyIdInfo": {
"id": "D0817R00074",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "AstraZeneca",
"id": "D0817R00074",
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]
},
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"primaryOutcomes": [
{
"measure": "Time to treatment discontinuation"
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{
"measure": "Time to first subsequent therapy"
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]
},
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"name": "Merck Sharp & Dohme LLC"
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"date": "2027-01-31"
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"date": "2027-01-31"
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"date": "2024-02-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcranial alternating current stimulation(real stimulation)"
},
{
"name": "Transcranial alternating current stimulation(sham stimulation)"
}
]
},
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"conditions": [
"Alzheimer's Disease",
"Mild Cognitive Impairment",
"Dementia"
]
},
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"locations": null
},
"descriptionModule": {
"briefSummary": "Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment."
},
"designModule": {
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"allocation": "RANDOMIZED",
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"maskingInfo": {
"masking": "TRIPLE",
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"count": 60,
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"phases": [
"NA"
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"studyType": "INTERVENTIONAL"
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"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease",
"nctId": "NCT06380725",
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"id": "jshim8zay6vd",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
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{
"measure": "Cognitive appraisal"
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{
"measure": "Global Cognitive appraisal"
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{
"measure": "Psychobehavioral assessment"
}
],
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{
"measure": "Near-infrared spectroscopy"
},
{
"measure": "Event related potential measurement"
},
{
"measure": "Peripheral blood biomarkers"
},
{
"measure": "Magnetic Resonance Imaging"
},
{
"measure": "Incidence of side effects"
}
]
},
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"collaborators": null,
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"class": "OTHER_GOV",
"name": "Anhui Provincial Hospital"
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"completionDateStruct": {
"date": "2024-12"
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"date": "2024-04-24"
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"date": "2024-08"
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"startDateStruct": {
"date": "2024-04"
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"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
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"conditionsModule": {
"conditions": [
"Hypertension"
]
},
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"locations": [
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "Andrea Flex, MD, PhD",
"phone": "+ 39 06 3015 4293",
"phoneExt": null,
"role": "CONTACT"
}
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"country": "Italy",
"facility": "Fondazione Policlinico Universitario A. Gemelli., IRCCS",
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"lon": 12.51133
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"state": null,
"status": null,
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"briefSummary": "Background: Hypertension is the primary cause of cardiovascular diseases and premature death in the world. Hypertension management starts with the control of blood pressure, whatever it is the type and severity. The optimum control of blood pressure requires regular and frequent auto-monitoring of blood pressure values, adherence to medication plan, and modification of lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a pilot project to assess acceptance ad usability of a digital health solution to be used by patients diagnosed with hypertension. Materials and methods: Prior to the development of the solution, a literature research was performed, then focus group meetings were conducted with senior experts in the digital field, physicians treating hypertension, and patients. A mobile app and web platform were created to help patients in monitoring and reporting data about health status and lifestyle. In order to execute the study, first the physicians in charge of the study will register in the webApp, creating a personal account. Then, patients who meet the inclusion criteria are proposed to participate to the study and, in case of agreement, will be asked to sign the informed consent (IC) statement and the privacy policy. After the phase of profile setting and onboarding, the patient will start to use the mobile App for hypertension management. Once the patient has used the App for the observation period, the physician will be allowed to analyze the data to understand the level of acceptance and regular usage from each patient. This physician will perform this analysis using a web-based portal which is part of the digital solution. Results: During the study, data about usage patterns will be collected. Specific data about usability and acceptance will be gathered through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests. After each patient has completed the observation period, all the data will be analysed using mainly descriptive statistics to obtain metrics related to usage patterns, usability and adherence. The study results from this pilot phase will be used to modify the digital solution, leveraging an incremental, iterative logic following a co-design and agile methodology. After incorporating the feedback from this pilot and further enriching the solution, next phases of the study are forseen in order to assess the care benefit of such technology in terms of improved treatment outcomes, due to better adherence, higher motivation in practicing healthy lifestyle, better information, and personalized support from HCP."
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"minimumAge": "18 Years",
"sex": "ALL",
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"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "HYPERTESSA \"HyperTessa User Experience Study (HTUX)\"",
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"id": "6509",
"link": null,
"type": null
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"measure": "User Experience / User Acceptance Indicators for patients"
}
],
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{
"measure": "User Experience / User Acceptance Indicators for Healthcare Professionals"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
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},
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"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
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"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-09-30"
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"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "QHRD106 Injection"
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{
"name": "Yurekline"
},
{
"name": "placebo"
}
]
},
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"conditions": [
"Acute Ischemic Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "Nanjing Drum Tower Hospital",
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"lon": 118.77778
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"state": "Jiangsu",
"status": null,
"zip": "210008"
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]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses."
},
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"enrollmentInfo": {
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"type": "ACTUAL"
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"phases": [
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"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Assess PK, Safety and Tolerability in Healthy Subjects",
"nctId": "NCT06380699",
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"id": "HJG-CZQH-QHRD106-I",
"link": null,
"type": null
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"measure": "Safety as assessed by incidence, severity, and causality of adverse events"
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{
"measure": "Plasma measurements of QHRD106"
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{
"measure": "Concentration of bradykinin in plasma"
}
],
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"collaborators": null,
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"name": "Changzhou Qianhong Bio-pharma Co., Ltd."
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},
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"completionDateStruct": {
"date": "2023-12-25"
},
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"date": "2024-04-26"
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"date": "2023-11-16"
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"startDateStruct": {
"date": "2023-03-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
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"interventions": [
{
"name": "data collection"
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]
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"conditions": [
"Squamous Cell Carcinoma of the Oral Cavity",
"Squamous Cell Carcinoma of the Oropharynx",
"Squamous Cell Carcinoma of the Hypopharynx",
"Squamous Cell Carcinoma of the Larynx"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Essen",
"contacts": [
{
"email": "[email protected]",
"name": "Victor Grünwald, Prof. Dr.",
"phone": "+49 201 723 85584",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Universitätsklinikum Essen",
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"lon": 7.01228
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"state": null,
"status": null,
"zip": "45147"
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]
},
"descriptionModule": {
"briefSummary": "Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients."
},
"designModule": {
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"sex": "ALL",
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]
},
"identificationModule": {
"acronym": "HEAT",
"briefTitle": "Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome",
"nctId": "NCT06380686",
"orgStudyIdInfo": {
"id": "AIO-KHT-0322/ass",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Sociodemographic factors"
},
{
"measure": "Treatments"
},
{
"measure": "Response rates"
},
{
"measure": "Treatment decision"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Time-to-treatment-failure"
},
{
"measure": "Overall survival"
}
],
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},
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"collaborators": [
{
"name": "Merck Sharp & Dohme LLC"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "AIO-Studien-gGmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-05"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Implementation of cow's milk in decreasingly heated forms"
},
{
"name": "Implementation of heated cow's milk"
},
{
"name": "No intervention"
}
]
},
"conditionsModule": {
"conditions": [
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"Cow Milk Allergy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bonheiden",
"contacts": [
{
"email": null,
"name": "Katrien Coppens, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Imelda Hospital Bonheiden",
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"lon": 4.54714
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Brugge",
"contacts": [
{
"email": null,
"name": "Kate Sauer, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "AZ Sint-Jan",
"geoPoint": {
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"lon": 3.22424
},
"state": null,
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"zip": null
},
{
"city": "Ghent",
"contacts": [
{
"email": null,
"name": "Jasmine Leus, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "AZ Maria Middelares",
"geoPoint": {
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"lon": 3.71667
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"state": null,
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"zip": null
},
{
"city": "Hasselt",
"contacts": [
{
"email": null,
"name": "Sophie Verelst, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Jessa Hospital",
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"lon": 5.33781
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"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Leuven",
"contacts": [
{
"email": "[email protected]",
"name": "Dominique MA Bullens, Prof. Dr.",
"phone": "+32016343801",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UZ Leuven Gasthuisberg",
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"lon": 4.70093
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"zip": null
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]
},
"descriptionModule": {
"briefSummary": "This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only)."
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
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"ADULT"
]
},
"identificationModule": {
"acronym": "TEHITI",
"briefTitle": "Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy",
"nctId": "NCT06380673",
"orgStudyIdInfo": {
"id": "s68299",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
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"measure": "Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction"
}
],
"secondaryOutcomes": [
{
"measure": "Time to complete tolerance in all three arms"
},
{
"measure": "Quality of life in all three arms"
},
{
"measure": "Clinical reactions"
},
{
"measure": "Side effects"
},
{
"measure": "IL-10-producing cow's milk specific regulatory T and B cells"
},
{
"measure": "BATs to mimic the outcome of cow's milk provocation tests"
}
]
},
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"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
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"date": "2029-12-30"
},
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"date": "2024-04-24"
},
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"date": "2028-12-30"
},
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"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
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"interventions": [
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"name": "ACE-86225106 tablet"
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]
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"conditions": [
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"BRCA1 Mutation",
"BRCA2 Mutation",
"Ovarian Cancer",
"Breast Cancer",
"Prostate Cancer"
]
},
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"locations": [
{
"city": "Fuzhou",
"contacts": null,
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"facility": "Fujian Cancer Hospital",
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"lon": 119.30611
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"zip": null
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{
"city": "Guangzhou",
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"facility": "Sun Yat-Sen University Cancer Center",
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"lon": 113.25
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"zip": null
},
{
"city": "Wuhan",
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"country": "China",
"facility": "Hubei Cancer Hospital",
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"lon": 114.26667
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"zip": null
},
{
"city": "Wuhan",
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"country": "China",
"facility": "Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",
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"lon": 114.26667
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"state": "Hubei",
"status": "NOT_YET_RECRUITING",
"zip": null
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{
"city": "Changsha",
"contacts": null,
"country": "China",
"facility": "Hunan Cancer Hospital",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
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"zip": null
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{
"city": "Shanghai",
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"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
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"lon": 121.45806
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{
"city": "Hangzhou",
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"country": "China",
"facility": "Zhejiang Cancer Hospital",
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"lon": 120.16142
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"state": "Zhejiang",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors."
},
"designModule": {
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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"PHASE2"
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors",
"nctId": "NCT06380660",
"orgStudyIdInfo": {
"id": "ACE-106-001",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)"
},
{
"measure": "The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol"
},
{
"measure": "Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Duration of Response (DoR) and Time to Response (TTR)"
},
{
"measure": "Progression Free Survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change"
},
{
"measure": "Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "INDUSTRY",
"name": "Acerand Therapeutics (Shanghai) Limited"
}
},
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"date": "2029-03-21"
},
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"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
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"date": "2028-12-21"
},
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"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intravenous Acyclovir"
}
]
},
"conditionsModule": {
"conditions": [
"Herpes Virus Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "department of pediatric surgery King Edward Medical University",
"geoPoint": {
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"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals.Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "parents were blinded to group allocation",
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]
},
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},
"enrollmentInfo": {
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"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "13 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "childburn",
"briefTitle": "Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns",
"nctId": "NCT06380647",
"orgStudyIdInfo": {
"id": "0004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Number of participants with positive Tzanck smear"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "King Edward Medical University"
}
},
"statusModule": {
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"date": "2020-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
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"date": "2020-09-30"
},
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"startDateStruct": {
"date": "2019-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental group- Motivational Interview"
}
]
},
"conditionsModule": {
"conditions": [
"Motivational Interview",
"Cosmetic Product Causing Toxic Effect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul University Cerrahpasa",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 130,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "43 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy",
"nctId": "NCT06380634",
"orgStudyIdInfo": {
"id": "NYalcinbas",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation Form for Use of Domestic Chemicals and Personal Care Products"
},
{
"measure": "Self Efficacy Competence Scale"
},
{
"measure": "Endocrine Disruptors Attitude Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University - Cerrahpasa (IUC)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-02-05",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 142041,
"typeAbbrev": "Prot",
"uploadDate": "2024-04-17T16:09"
},
{
"date": "2024-02-05",
"filename": "SAP_001.pdf",
"hasIcf": false,
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"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 234444,
"typeAbbrev": "SAP",
"uploadDate": "2024-04-17T16:13"
},
{
"date": "2023-12-30",
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"label": "Informed Consent Form",
"size": 75804,
"typeAbbrev": "ICF",
"uploadDate": "2024-04-17T16:05"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Totally Extra Peritoneal repair (TEP) repair"
}
]
},
"conditionsModule": {
"conditions": [
"Inguinal Hernia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dharān Bāzār",
"contacts": null,
"country": "Nepal",
"facility": "Bikash Kumar Sah",
"geoPoint": {
"lat": 26.81248,
"lon": 87.28355
},
"state": "Koshi",
"status": null,
"zip": "56700"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.The main questions it aims to answer are:* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia",
"nctId": "NCT06380621",
"orgStudyIdInfo": {
"id": "IRC/1386/018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair."
},
{
"measure": "To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "B.P. Koirala Institute of Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2018-03-15",
"filename": "Prot_ICF_000.pdf",
"hasIcf": true,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol and Informed Consent Form",
"size": 450800,
"typeAbbrev": "Prot_ICF",
"uploadDate": "2024-04-21T09:41"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Local anesthesia"
},
{
"name": "General anesthesia"
}
]
},
"conditionsModule": {
"conditions": [
"Wisdom Teeth Extraction or Jaw Implant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Be'er Ya'aqov",
"contacts": [
{
"email": "[email protected]",
"name": "sara Bar Yehuda, MD",
"phone": "972528981004",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Shamir (Asaf Harofe) Medical center",
"geoPoint": {
"lat": 31.93864,
"lon": 34.83749
},
"state": null,
"status": "RECRUITING",
"zip": "60930"
}
]
},
"descriptionModule": {
"briefSummary": "Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia.A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly.The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia",
"nctId": "NCT06380608",
"orgStudyIdInfo": {
"id": "0047-23-ASF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fear and anxiety"
},
{
"measure": "Wound heeling"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Zoya Haitov Ben Zikri"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Complex endovascular aortic repair (cEVAR)"
}
]
},
"conditionsModule": {
"conditions": [
"Inflammatory Abdominal Aortic Aneurysm",
"Aneurysm, Infected",
"Aneurysm, Mycotic",
"Abdominal Aortic Aneurysm",
"Thoracoabdominal Aortic Aneurysm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": null,
"country": "United States",
"facility": "University of Colorado Healthcare",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": null,
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CEVARII",
"briefTitle": "Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms",
"nctId": "NCT06380595",
"orgStudyIdInfo": {
"id": "23 -1533",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Graft Patency"
},
{
"measure": "Bowel Ischemia"
},
{
"measure": "Presence of aortic aneurysm endoleak after surgery"
},
{
"measure": "Aneurysm-related mortality (ARM)"
},
{
"measure": "Conversion to Open Surgical Repair (OSR)"
},
{
"measure": "Aortic rupture"
},
{
"measure": "Post-operative infection-related complication (IRC)"
},
{
"measure": "The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies."
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of Adverse Events (AEs) described in the protocol."
},
{
"measure": "All Cause Mortality"
},
{
"measure": "Continued Aortic sac growth."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Iowa"
},
{
"name": "University of Colorado, Denver"
},
{
"name": "University of Trieste"
},
{
"name": "University of Copenhagen"
},
{
"name": "University of Colorado, Colorado Springs"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "CEVARII"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Temperature and Airflow combination"
}
]
},
"conditionsModule": {
"conditions": [
"Indoor Air Quality, Temperature and Cognitive Performance"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Study design: A cross-over single-blinded treatment design will be used. Participants will undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3) high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the air quality level; however, it is not possible to blind them to the temperature condition, as they will be able to perceive it as different.Study population: The population consists of healthy young and middle-aged adults of both sexes between 18 and 40 years.Intervention (if applicable): Each participant undergoes 4 conditions in randomized order. Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or 35°C temperature, respectively."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "AEOLUS",
"briefTitle": "Indoor Air Quality, Temperature and Cognitive Performance",
"nctId": "NCT06380582",
"orgStudyIdInfo": {
"id": "NL85595.068.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Temperature (C)"
},
{
"measure": "Humidity %"
},
{
"measure": "Carbon dioxide (CO2) concentration (ppm)"
}
],
"primaryOutcomes": [
{
"measure": "Cognition"
},
{
"measure": "Cognition"
}
],
"secondaryOutcomes": [
{
"measure": "Heart Rate (bpm)"
},
{
"measure": "Metabolic Rate (ml/kg/min)"
},
{
"measure": "Blood Pressure (mmHg)"
},
{
"measure": "Blood samples"
},
{
"measure": "Saliva samples"
},
{
"measure": "Breathing rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Maastricht University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "KF-STRIDE®"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "We are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. We are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Kessler Foundation Strength Identification and Expression (KF-STRIDE®)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "26 Years",
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting",
"nctId": "NCT06380569",
"orgStudyIdInfo": {
"id": "E-1139-21 Community Setting",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mock Job Interview"
},
{
"measure": "Employment Status"
},
{
"measure": "Time-to-reach Employment"
},
{
"measure": "Strength Knowledge and Strengths Use Scale (SKUS)"
},
{
"measure": "Youth Interview- Self Efficacy and Anxiety"
},
{
"measure": "Job Search Behavior Scale"
},
{
"measure": "Work Readiness Scale"
},
{
"measure": "Global Assessment of Character Strengths (GACS)"
}
],
"secondaryOutcomes": [
{
"measure": "Rosenberg Self-Esteem Scale (RSES)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kessler Foundation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ShotBlocker"
},
{
"name": "Mechanical vibration"
}
]
},
"conditionsModule": {
"conditions": [
"Procedural Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Medeniyet University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Kadıköy",
"status": null,
"zip": "34720"
}
]
},
"descriptionModule": {
"briefSummary": "This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Using the block randomization technique, participants were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding).Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind.To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (statistician blinding).",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 108,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "42 Weeks",
"minimumAge": "38 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates",
"nctId": "NCT06380556",
"orgStudyIdInfo": {
"id": "25.05.2022/68",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Procedural pain score- Neonatal Infant Pain Scale (NIPS)"
}
],
"secondaryOutcomes": [
{
"measure": "Crying time"
},
{
"measure": "Procedure time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Medeniyet University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Biliary Tract Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": null,
"name": "Alberto Mariani, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS OSpedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BILINCE",
"briefTitle": "ERCP Biliary Cannulation Success Using ESGE Algorithm",
"nctId": "NCT06380543",
"orgStudyIdInfo": {
"id": "BILINCE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Success of ERCP biliary cannulation rate"
}
],
"secondaryOutcomes": [
{
"measure": "ERCP complication rates"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Societa Italiana di Endoscopia Digestiva"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-12-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Deformity correction"
}
]
},
"conditionsModule": {
"conditions": [
"Musculoskeletal Deformity",
"Musculoskeletal Abnormalities",
"Musculoskeletal Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Grazia Chiara Menozzi",
"phone": "0516266",
"phoneExt": "484",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Ortopedico Rizzoli",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": "BO",
"status": null,
"zip": "40136"
},
{
"city": "Rozzano",
"contacts": null,
"country": "Italy",
"facility": "Istituto Clinico Humanitas",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": "MI",
"status": null,
"zip": null
},
{
"city": "Genova",
"contacts": [
{
"email": "[email protected]",
"name": "Giorgio Marrè Brunenghi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Giannina Gaslini",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Fabio Verdoni, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Galeazzi Orthopedic Institute",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Pavia",
"contacts": [
{
"email": null,
"name": "Gianluigi Pasta, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Policlinico San Matteo",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Roberto Biagini, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Nazionale Tumori Regina Elena",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Pier Francesco Costici, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale Pediatrico Bambino Gesù",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice.One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes.The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions.The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through \"in-silico\" medicine (ISM) principles.At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI.The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures."
},
"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": "40 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "SIMULA",
"briefTitle": "Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities",
"nctId": "NCT06380530",
"orgStudyIdInfo": {
"id": "SIMULA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Cost analysis"
}
],
"primaryOutcomes": [
{
"measure": "Achieved skeletal corrections"
},
{
"measure": "Achieved skeletal corrections"
}
],
"secondaryOutcomes": [
{
"measure": "Operating room times"
},
{
"measure": "Fluoroscopy times"
},
{
"measure": "Blood loss"
},
{
"measure": "Intra- and peri-operative complications"
},
{
"measure": "Suitability of PSIs"
},
{
"measure": "Suitability of GSIs"
},
{
"measure": "Suitability of bone graft"
},
{
"measure": "Clinical-functional outcome"
},
{
"measure": "Clinical-functional outcome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ospedale Pediatrico Bambino Gesù"
},
{
"name": "Istituto Giannina Gaslini"
},
{
"name": "Galeazzi Orthopedic Institute"
},
{
"name": "Istituto Nazionale Tumori Regina Elena"
},
{
"name": "Policlinico San Matteo"
},
{
"name": "Istituto Clinico Humanitas"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Ortopedico Rizzoli"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Luminopia"
},
{
"name": "Eye Patch"
}
]
},
"conditionsModule": {
"conditions": [
"Amblyopia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 238,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "7 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "ATS23",
"briefTitle": "Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age",
"nctId": "NCT06380517",
"orgStudyIdInfo": {
"id": "ATS23",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2UG1EY011751",
"link": "https://reporter.nih.gov/quickSearch/2UG1EY011751",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in amblyopic eye logMAR distance VA between randomization and 26 weeks"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Eye Institute (NEI)"
},
{
"name": "Pediatric Eye Disease Investigator Group"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Jaeb Center for Health Research"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-04-01",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 715474,
"typeAbbrev": "Prot",
"uploadDate": "2024-04-18T09:58"
},
{
"date": "2024-04-17",
"filename": "SAP_001.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 4154847,
"typeAbbrev": "SAP",
"uploadDate": "2024-04-18T15:02"
},
{
"date": "2024-04-17",
"filename": "ICF_002.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 248300,
"typeAbbrev": "ICF",
"uploadDate": "2024-04-18T09:59"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "R-SWITCH integrated intervention package"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Malnutrition, Severe",
"Malnutrition, Child",
"Wasting"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Evaluator teams will be blinded from intervention allocation",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1080,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "R-SWITCH",
"briefTitle": "Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia",
"nctId": "NCT06380504",
"orgStudyIdInfo": {
"id": "RSWITCH-Ethiopia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Period prevalence of SAM OTP treatment coverage in children 6-59 months of age"
}
],
"secondaryOutcomes": [
{
"measure": "Point prevalence of SAM OTP treatment coverage in children 6-59 months of age"
},
{
"measure": "Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age"
},
{
"measure": "Screening coverage of SAM"
},
{
"measure": "Screening coverage of severe underweight"
},
{
"measure": "Platform specific screening coverage of SAM"
},
{
"measure": "Growth Monitoring Promotion (GMP) consultation attendance"
},
{
"measure": "AFD group meeting attendance"
},
{
"measure": "AFD home visit coverage"
},
{
"measure": "Prevalence of SAM"
},
{
"measure": "Prevalence of wasting"
},
{
"measure": "Prevalence of stunting"
},
{
"measure": "Prevalence of underweight and severe underweight"
},
{
"measure": "Mean height-for-age Z-score (HAZ)"
},
{
"measure": "Mean weight-for-height Z-score (WHZ)"
},
{
"measure": "Mean weight-for-age Z-score (WAZ)"
},
{
"measure": "Mean mid-upper arm circumference (MUAC)"
},
{
"measure": "Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting"
},
{
"measure": "Vaccination coverage"
},
{
"measure": "Introduction of (semi) solid and soft complementary foods"
},
{
"measure": "Minimum dietary diversity in infants and young children (6-23 mo)"
},
{
"measure": "Nr of food groups consumed by infants and young children (6-59 mo)"
},
{
"measure": "Minimum meal frequency in infants and young children"
},
{
"measure": "Minimum acceptable diet in infants and young children"
},
{
"measure": "Continuous breastfeeding 12-23 months"
},
{
"measure": "Egg and/or flesh food consumption"
},
{
"measure": "Sweet beverage consumption"
},
{
"measure": "Zero vegetable or fruit consumption consumption"
},
{
"measure": "Minimum milk feeding frequency for non-breastfed children"
},
{
"measure": "Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP)"
},
{
"measure": "SAM OTP adherence"
},
{
"measure": "Weight gain rate during SAM OTP"
},
{
"measure": "SAM OTP outcomes (drop-out, death, transfer, non-response rates)"
},
{
"measure": "SAM OTP duration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ethiopian Public Health Association"
},
{
"name": "UNICEF"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "International Food Policy Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Melatonin 3 MG Oral Tablet"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea of Adult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mexico City",
"contacts": null,
"country": "Mexico",
"facility": "National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)",
"geoPoint": {
"lat": 19.42847,
"lon": -99.12766
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.The main question it aims to answer is:Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MEBP-OSA",
"briefTitle": "Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)",
"nctId": "NCT06380491",
"orgStudyIdInfo": {
"id": "REF.2338",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Universidad Nacional Autonoma de Mexico (UNAM)",
"id": "UNAM-PAPIIT 32-IN216919",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universidad Nacional Autonoma de Mexico"
},
{
"name": "Emory University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "aspicio Monofocal IOL"
}
]
},
"conditionsModule": {
"conditions": [
"Cataract"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taoyuan",
"contacts": [
{
"email": "[email protected]",
"name": "Lisa Chen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yih-Shiou Hwang, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Taiwan",
"facility": "Chang Gung University Hospital",
"geoPoint": {
"lat": 24.95233,
"lon": 121.20193
},
"state": "Guishan District",
"status": "RECRUITING",
"zip": "333"
}
]
},
"descriptionModule": {
"briefSummary": "This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Efficacy of the Bi-Aspheric Monofocal IOL",
"nctId": "NCT06380478",
"orgStudyIdInfo": {
"id": "CPRO-000012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "CDVA"
},
{
"measure": "Defocus curve"
}
],
"secondaryOutcomes": [
{
"measure": "UDVA"
},
{
"measure": "UIVA"
},
{
"measure": "CIVA"
},
{
"measure": "IOL glistening"
},
{
"measure": "PCO"
},
{
"measure": "Satisfaction questionnaire"
},
{
"measure": "AE"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AST Products, Inc."
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "ICARES Medicus, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The water extract of \"Biang\" variety purple sweet potato"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Small Vessel Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease.Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo.The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groups/arms consisting of 2 treatments (1 group getting the water extract pf purple sweet potato) and 1 control group that got placebo.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease",
"nctId": "NCT06380465",
"orgStudyIdInfo": {
"id": "23-11-1838",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Breath Holding Index"
},
{
"measure": "Nitric Oxide"
},
{
"measure": "L-Arginine"
},
{
"measure": "Adiponectin"
},
{
"measure": "Cognitive"
},
{
"measure": "Gait"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fakultas Kedokteran Universitas Indonesia"
},
{
"name": "Universitas Padjadjaran"
},
{
"name": "Institut Pertanian Bogor"
},
{
"name": "School of Science and technology, Kwansei Gakuin University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-02",
"filename": "ICF_000.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 332637,
"typeAbbrev": "ICF",
"uploadDate": "2024-04-18T03:49"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "5% Permethrin Creme"
},
{
"name": "10% Permethrin Creme"
}
]
},
"conditionsModule": {
"conditions": [
"Scabies"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "double-blind",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SKABUP",
"briefTitle": "Therapy for Scabies With Two Differently Concentrated Permethrin Creams",
"nctId": "NCT06380452",
"orgStudyIdInfo": {
"id": "SKABUP",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU-Trial-Nr. (EMA)",
"id": "2023-507925-41-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "clinical efficacy (yes/no)"
}
],
"secondaryOutcomes": [
{
"measure": "effectiveness at Visit 1"
},
{
"measure": "frequency of therapy success"
},
{
"measure": "itching"
},
{
"measure": "patients with evidence of mites"
},
{
"measure": "patients with use of antiscabiosa not compliant with the protocol"
},
{
"measure": "patients with new scabies efflorescences"
},
{
"measure": "patients with \"additional confirmed\" treatment failure"
},
{
"measure": "AEs, SAEs, ADRs, SUAWs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Winicker Norimed GmbH"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Infectopharm Arzneimittel GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "wrist ankle acupuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Postoperative",
"Hip Osteoarthritis",
"Hip Fractures",
"Hip Injuries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta Pusat",
"contacts": [
{
"email": null,
"name": "Cipto Mangunkusumo Hospital",
"phone": "1 500 135",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Cipto Mangunkusumo Hospital",
"geoPoint": {
"lat": -6.1818,
"lon": 106.8223
},
"state": "Jakarta",
"status": "RECRUITING",
"zip": "10430"
},
{
"city": "Jakarta",
"contacts": [
{
"email": null,
"name": "Fatmawati Hospital",
"phone": "0217501524",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Fatmawati Hospital",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": null,
"status": "RECRUITING",
"zip": "12430"
},
{
"city": "Jakarta",
"contacts": [
{
"email": null,
"name": "Persahabatan Hospital",
"phone": "(021) 4891708",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Persahabatan Hospital",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": null,
"status": "RECRUITING",
"zip": "13230"
}
]
},
"descriptionModule": {
"briefSummary": "Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture"
},
"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": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain",
"nctId": "NCT06380439",
"orgStudyIdInfo": {
"id": "23-10-1763",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale"
}
],
"secondaryOutcomes": [
{
"measure": "recovery rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Monogenic Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Emilie GUILLON",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sarra POCHON",
"phone": "+33(1)42167574",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75013"
}
]
},
"descriptionModule": {
"briefSummary": "Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways.More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS).The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications.Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches.In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications.GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity.The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 175,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ObGeSema",
"briefTitle": "Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema)",
"nctId": "NCT06380426",
"orgStudyIdInfo": {
"id": "APHP230441",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "IDRCB : 2023-A02003-42",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in weight and Body Mass Index (BMI)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in weight and Body Mass Index (BMI)"
},
{
"measure": "Reduction of body weight equal to or above 5%"
},
{
"measure": "Change in Hunger score"
},
{
"measure": "Change in eating behaviour measured by Food Craving questionnaire"
},
{
"measure": "Change in eating behaviour measured by the Binge Eating Scale (BES)"
},
{
"measure": "Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ)"
},
{
"measure": "Change in eating behaviour measured by the Dykens questionnaire"
},
{
"measure": "Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ)"
},
{
"measure": "Change in the International physical activity questionnaire (IPAQ - short form)"
},
{
"measure": "Change in Digestive disorders (GIQLI )"
},
{
"measure": "Change in sleep disorder (MCTQ score)"
},
{
"measure": "Change in score of quality of life scores (patient and parents)"
},
{
"measure": "Change in anxiety and depression score"
},
{
"measure": "Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tai Chi Chuan Plus Walking"
},
{
"name": "Walking"
}
]
},
"conditionsModule": {
"conditions": [
"Aging"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pelotas",
"contacts": [
{
"email": null,
"name": "Cristine L Alberton, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Brazil",
"facility": "Escola Superior de Educação Física e FIsioterapia",
"geoPoint": {
"lat": -31.77194,
"lon": -52.3425
},
"state": "Rio Grande Do Sul",
"status": null,
"zip": "96055630"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults",
"nctId": "NCT06380413",
"orgStudyIdInfo": {
"id": "78972024.7.0000.5313",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Body mass"
},
{
"measure": "Height"
},
{
"measure": "Waist and hip circumferences"
},
{
"measure": "Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10)"
},
{
"measure": "Follow-up questionnaire"
},
{
"measure": "Adherence assessments"
},
{
"measure": "Health Questionnaire"
},
{
"measure": "Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version"
},
{
"measure": "Cognitive screening - Mini-mental state examination (MMSE)"
}
],
"primaryOutcomes": [
{
"measure": "Maximal dynamic strength"
},
{
"measure": "Functional test - 30-s Chair-stand test"
}
],
"secondaryOutcomes": [
{
"measure": "Dynamic muscular endurance"
},
{
"measure": "Isometric handgrip strength"
},
{
"measure": "Isometric back-leg-chest strength"
},
{
"measure": "Functional tests - arm curl"
},
{
"measure": "Functional tests - 8-ft Up-and-Go"
},
{
"measure": "Functional tests - Chair Sit-and-Reach"
},
{
"measure": "Functional tests - Back Scratch"
},
{
"measure": "Funcional tests - 6-min Walk"
},
{
"measure": "Static balance - 30-second single-leg stance test"
},
{
"measure": "Quadriceps muscle thickness"
},
{
"measure": "Quadriceps muscle quality"
},
{
"measure": "Objective cognitive function - Trail Making Test (TMT)"
},
{
"measure": "Objective cognitive function - Controlled Oral Word Association Test (COWAT)"
},
{
"measure": "Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref)"
},
{
"measure": "Sleep quality - Pittsburgh Sleep Quality Index"
},
{
"measure": "Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Federal University of Pelotas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Foot bath"
}
]
},
"conditionsModule": {
"conditions": [
"Parturition"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": [
{
"email": "[email protected]",
"name": "Habibe Bay Ozcalik",
"phone": "05424469343",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Habibe Bay Ozcalik",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": null,
"status": "RECRUITING",
"zip": "42250"
}
]
},
"descriptionModule": {
"briefSummary": "Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means \"a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment\". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 196,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Foot Bath on Birth Pain and Birth Comfort",
"nctId": "NCT06380400",
"orgStudyIdInfo": {
"id": "0000-0001-5786-4385",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visuell analog scale score of the pregnant woman"
}
],
"secondaryOutcomes": [
{
"measure": "Birth comfort scale score of the pregnant woman"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Selcuk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Meal"
}
]
},
"conditionsModule": {
"conditions": [
"CNS Tumor, Childhood"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Mette Cathrine Ørngreen, MD, DMSc",
"phone": "35455935",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mette Cathrine Ørngreen, MD, DMSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Denmark",
"facility": "Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": "Copenhagen Ø",
"status": "RECRUITING",
"zip": "2100"
}
]
},
"descriptionModule": {
"briefSummary": "At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis."
},
"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": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Whole Body Metabolism in Children Before and After Treatment of CNS Tumor",
"nctId": "NCT06380387",
"orgStudyIdInfo": {
"id": "H-21046543",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Protein breakdown"
},
{
"measure": "Protein synthesis"
},
{
"measure": "Phenylalanine concentration"
},
{
"measure": "Phe oxidation to TYR"
},
{
"measure": "Whole-body protein synthesis"
},
{
"measure": "Whole-body protein degradation"
},
{
"measure": "Netto protein balance"
},
{
"measure": "Glucose Rate of appearance"
},
{
"measure": "Total glucose Rate of appearance"
},
{
"measure": "Total glucose Rate of disappearance"
},
{
"measure": "Endogenous glucose"
},
{
"measure": "Oral phenylalanine Rate of appearance"
},
{
"measure": "Phenylalanine oxidation"
},
{
"measure": "Rate of Appearance of Palmitate in Plasma"
},
{
"measure": "Rate of Disappearance of Palmitate"
},
{
"measure": "Concentration of ketones"
}
],
"secondaryOutcomes": [
{
"measure": "Glucose"
},
{
"measure": "Quality of Skeletal Muscle"
},
{
"measure": "Protein synthesis rate"
},
{
"measure": "Pain score"
},
{
"measure": "Life quality score"
},
{
"measure": "Muscle biopsy"
},
{
"measure": "Incretins"
},
{
"measure": "Glucagon"
},
{
"measure": "Liver parameters ALT, AST, GGT"
},
{
"measure": "Bilirubin"
},
{
"measure": "International normalized ratio (INR)"
},
{
"measure": "LDH"
},
{
"measure": "Insulin"
},
{
"measure": "catecholamines"
},
{
"measure": "Blood pressure"
},
{
"measure": "Waist- and hip circumference"
},
{
"measure": "Lipids"
},
{
"measure": "Concentration of Plasma Amino Acids"
},
{
"measure": "Concentration of Plasma Glucose"
},
{
"measure": "Concentration of Plasma Palmitate"
},
{
"measure": "Concentration of Plasma Free Fatty Acids"
},
{
"measure": "Level of HbA1c"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gamification in Disaster Nursing Education"
}
]
},
"conditionsModule": {
"conditions": [
"Gamification",
"Nursing Students",
"Multiple Intelligence Theory",
"Disaster Nursing"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": [
{
"email": "[email protected]",
"name": "Sema Yilmaz Dean, MD",
"phone": "+903322230763",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Selcuk University Faculty of Nursing",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": "Selcuklu",
"status": null,
"zip": "42000"
}
]
},
"descriptionModule": {
"briefSummary": "This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis \"H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group.\""
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Gamification in Disaster Nursing Education",
"nctId": "NCT06380374",
"orgStudyIdInfo": {
"id": "2024\\01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Level of knowledge related to disaster nursing services"
},
{
"measure": "Volunteer intention to become a disaster nurse"
},
{
"measure": "Perception of self-efficacy related to disaster nursing"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Selcuk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BioSpy System"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "No masking",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"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": "INSPECT",
"briefTitle": "InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology",
"nctId": "NCT06380361",
"orgStudyIdInfo": {
"id": "SEN-ONCO-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy."
}
],
"secondaryOutcomes": [
{
"measure": "The ability of BioSpy Sysem to differentiate the lesion from healthy tissue"
},
{
"measure": "The ability of BioSpy Sysem to differentiate various lesion types"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sensome"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "JMT101 Injection"
},
{
"name": "Osimertinib tablet"
},
{
"name": "Cisplatin injection"
},
{
"name": "Pemetrexed injection"
}
]
},
"conditionsModule": {
"conditions": [
"Local Advanced or Metastatic NSCLC"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 398,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations",
"nctId": "NCT06380348",
"orgStudyIdInfo": {
"id": "JMT101-012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Overall Response Rate (ORR) by IRC per RECIST 1.1"
},
{
"measure": "Duration of Response (DoR) by IRC per RECIST 1.1"
},
{
"measure": "PFS by investigator per RECIST 1.1"
},
{
"measure": "ORR by investigator per RECIST 1.1"
},
{
"measure": "DoR by investigator per RECIST 1.1"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Shanghai JMT-Bio Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Liver Cirrhosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bristol",
"contacts": null,
"country": "United Kingdom",
"facility": "Bristol Royal Infirmary",
"geoPoint": {
"lat": 51.45523,
"lon": -2.59665
},
"state": null,
"status": "RECRUITING",
"zip": "BS2 8HW"
},
{
"city": "Edinburgh",
"contacts": null,
"country": "United Kingdom",
"facility": "Royal Infirmary Edinburgh",
"geoPoint": {
"lat": 55.95206,
"lon": -3.19648
},
"state": null,
"status": "RECRUITING",
"zip": "EH16 4SA"
},
{
"city": "Liverpool",
"contacts": null,
"country": "United Kingdom",
"facility": "Royal Liverpool Hospital",
"geoPoint": {
"lat": 53.41058,
"lon": -2.97794
},
"state": null,
"status": "RECRUITING",
"zip": "L7 8XP"
},
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "Royal Free Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "NW3 2QG"
},
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "King's College Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "SE5 9RS"
},
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "St George's Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "SW17 0QT"
},
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "St Mary's Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "W2 1NY"
},
{
"city": "Nottingham",
"contacts": null,
"country": "United Kingdom",
"facility": "Nottingham University Hospital",
"geoPoint": {
"lat": 52.9536,
"lon": -1.15047
},
"state": null,
"status": "RECRUITING",
"zip": "NG5 1PB"
},
{
"city": "Sunderland",
"contacts": null,
"country": "United Kingdom",
"facility": "Sunderland Royal Hospital",
"geoPoint": {
"lat": 54.90465,
"lon": -1.38222
},
"state": null,
"status": "RECRUITING",
"zip": "SR4 7TP"
}
]
},
"descriptionModule": {
"briefSummary": "OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OPAL",
"briefTitle": "Study in Patients With Decompensated Liver Cirrhosis",
"nctId": "NCT06380335",
"orgStudyIdInfo": {
"id": "RTX001-01S",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Explore clinical and laboratory parameters."
},
{
"measure": "Evaluate the effect of disease progression on biomarkers of inflammatory activity"
}
],
"primaryOutcomes": [
{
"measure": "Examine the characteristics of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Examine the characteristics of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Examine the characteristics of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Examine the characteristics of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Examine the characteristics of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Examine the characteristics of patients admitted to hospital with hepatic decompensation."
}
],
"secondaryOutcomes": [
{
"measure": "Follow the natural history of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Follow the natural history of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Follow the natural history of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Follow the natural history of patients admitted to hospital with hepatic decompensation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
},
{
"measure": "Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Resolution Therapeutics Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Hypertension",
"Type 2 Diabetes",
"Dyslipidemias",
"Cardiovascular Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baton Rouge",
"contacts": [
{
"email": "[email protected]",
"name": "Claire E Berryman, PhD, RD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Pennington Biomedical Research Center",
"geoPoint": {
"lat": 30.45075,
"lon": -91.15455
},
"state": "Louisiana",
"status": null,
"zip": "70808"
}
]
},
"descriptionModule": {
"briefSummary": "The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MHANES",
"briefTitle": "Military Health and Nutrition Examination Study",
"nctId": "NCT06380322",
"orgStudyIdInfo": {
"id": "PBRC 2023-034",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dietary intake"
},
{
"measure": "Dietary quality"
}
],
"secondaryOutcomes": [
{
"measure": "Depression"
},
{
"measure": "Anxiety"
},
{
"measure": "Resilience"
},
{
"measure": "Posttraumatic stress disorder"
},
{
"measure": "Self-efficacy"
},
{
"measure": "Mood"
},
{
"measure": "Physical activity"
},
{
"measure": "Physical activity"
},
{
"measure": "Physical performance"
},
{
"measure": "Physical injuries"
},
{
"measure": "Sleep duration and quality"
},
{
"measure": "Sleep duration and quality"
},
{
"measure": "Eating behavior (Satiety)"
},
{
"measure": "Eating behavior (Fast Eating Rate)"
},
{
"measure": "Eating behavior (Slow Eating Rate)"
},
{
"measure": "Blood pressure"
},
{
"measure": "Anthropometric and body composition measures"
},
{
"measure": "Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation"
},
{
"measure": "Albumin, iodine, and other biomarkers of health"
},
{
"measure": "Gut microbiome composition"
},
{
"measure": "Prescription and over-the-counter medication and supplement use"
},
{
"measure": "Resting metabolic rate (RMR)"
},
{
"measure": "Heart rate variability (HRV)"
},
{
"measure": "Genomics"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "U.S. Army Medical Research and Development Command"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Pennington Biomedical Research Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IDOV-SAFE"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Malignant Solid Tumor of Digestive System"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Lin Shen",
"phone": "+86 10 8819 6561",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Cancer Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy.In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE",
"nctId": "NCT06380309",
"orgStudyIdInfo": {
"id": "LY001-I001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Occurrence of dose-limiting toxicity (DLT)"
},
{
"measure": "Incidence of adverse events (AE)"
}
],
"secondaryOutcomes": [
{
"measure": "The level of (non-essential) viral DNA in tumor tissue"
},
{
"measure": "Tumor markers"
},
{
"measure": "Anti-vaccinia virus neutralizing antibody test(VV-Nab)"
},
{
"measure": "Levels of viral DNA in blood"
},
{
"measure": "Levels of viral DNA in saliva"
},
{
"measure": "T cell subsets"
},
{
"measure": "Cytokines"
},
{
"measure": "ORR"
},
{
"measure": "DCR"
},
{
"measure": "DOR"
},
{
"measure": "PFS"
},
{
"measure": "OS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Primary molars pulpotomies with NeoMTA"
},
{
"name": "Primary molar pulpotomies with NeoPUTTY"
}
]
},
"conditionsModule": {
"conditions": [
"Pulp Disease, Dental"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications."
},
"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": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars",
"nctId": "NCT06380296",
"orgStudyIdInfo": {
"id": "2024-10240",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Success rate of a primary molar pulpotomy"
},
{
"measure": "Radiographic success of a primary molar pulpotomy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "McGill University Health Centre/Research Institute of the McGill University Health Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual reality headset"
}
]
},
"conditionsModule": {
"conditions": [
"Children, Only",
"Dental Anxiety",
"Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montreal",
"contacts": [
{
"email": "[email protected]",
"name": "Beatriz Ferraz dos Santos, DDS, MSc",
"phone": "+1 (514) 412-4400",
"phoneExt": "23357",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 128,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety",
"nctId": "NCT06380283",
"orgStudyIdInfo": {
"id": "2024-10221",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Children's pain perception during dental treatment"
},
{
"measure": "Children's fear during dental treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Children's acceptability of virtual reality intervention during dental care"
},
{
"measure": "Oral health care provider's acceptability of virtual reality during dental care"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "McGill University Health Centre/Research Institute of the McGill University Health Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral probiotic Streptococcus salivarius K12 sachet"
}
]
},
"conditionsModule": {
"conditions": [
"Strep Throat"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jāmshoro",
"contacts": [
{
"email": "[email protected]",
"name": "Dr. Amjad Khan, DPhil",
"phone": "03000506955",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Liaquat University of Medical and Health Sciences",
"geoPoint": {
"lat": 25.43773,
"lon": 68.28522
},
"state": null,
"status": null,
"zip": "76090"
}
]
},
"descriptionModule": {
"briefSummary": "Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12",
"nctId": "NCT06380270",
"orgStudyIdInfo": {
"id": "LUMHS/B12/Temp/14.04.2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effect on oral health physical condition"
},
{
"measure": "Effect on other physical features"
},
{
"measure": "Effect on vital signs"
},
{
"measure": "Effect on vital signs"
},
{
"measure": "Effect on vital signs"
},
{
"measure": "Effect on vital signs"
},
{
"measure": "Effect on blood biochemistry"
},
{
"measure": "Effect on blood biochemistry"
},
{
"measure": "Effect on blood biochemistry"
},
{
"measure": "Effect on blood biochemistry"
},
{
"measure": "Effect on blood electrolytes balance"
},
{
"measure": "Effect on hematology"
},
{
"measure": "Incidence of inflammation"
},
{
"measure": "Incidence of gastrointestinal side effects"
},
{
"measure": "Incidence of Adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Liaquat University of Medical & Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Observational study methods"
}
]
},
"conditionsModule": {
"conditions": [
"Anorexia Nervosa"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "19 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Anorexia Nervosa and Brain in Adolescence",
"nctId": "NCT06380257",
"orgStudyIdInfo": {
"id": "ANBA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Psychiatric evaluation"
},
{
"measure": "Body composition measurement"
},
{
"measure": "Laboratory tests"
}
],
"primaryOutcomes": [
{
"measure": "Neuroimaging"
}
],
"secondaryOutcomes": [
{
"measure": "Neuroimaging"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kuopio University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "anesthesia without opioids"
}
]
},
"conditionsModule": {
"conditions": [
"Analgesics, Opioid",
"Anesthesia, Endotracheal",
"Anesthesia, General"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kraków",
"contacts": [
{
"email": "[email protected]",
"name": "Tomasz Skladzien, phd md",
"phone": "506602250",
"phoneExt": "48",
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Jagiellonian University",
"geoPoint": {
"lat": 50.06143,
"lon": 19.93658
},
"state": "Malopolskie",
"status": "RECRUITING",
"zip": "31501"
}
]
},
"descriptionModule": {
"briefSummary": "Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life.The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery",
"nctId": "NCT06380244",
"orgStudyIdInfo": {
"id": "1072.6120.136.2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain level"
}
],
"secondaryOutcomes": [
{
"measure": "Total long acting opioid consumption in oxycodone equivalents"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jagiellonian University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "kangaroo mother care (KMC)"
}
]
},
"conditionsModule": {
"conditions": [
"Kangaroo-mother Care"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "TC Istanbul Rumeli University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Haliç",
"status": null,
"zip": "34445"
}
]
},
"descriptionModule": {
"briefSummary": "Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "37 Weeks",
"minimumAge": "24 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Skin-to-skin Contact Between Premature Infant and Mother",
"nctId": "NCT06380231",
"orgStudyIdInfo": {
"id": "IRU-YAZILE-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "power analysis"
}
],
"secondaryOutcomes": [
{
"measure": "The effect of kangaroo mother care"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Rumeli University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nutrional and physical activity program"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lille",
"contacts": [
{
"email": "[email protected]",
"name": "Coralie Berthier, PhD",
"phone": "0320877333",
"phoneExt": "0033",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Bérengère Legendre",
"phone": "0320877346",
"phoneExt": "0033",
"role": "CONTACT"
},
{
"email": null,
"name": "Jean-Michel Lecerf, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "NutrInvest - Institut Pasteur de Lille",
"geoPoint": {
"lat": 50.63297,
"lon": 3.05858
},
"state": "Nord",
"status": "RECRUITING",
"zip": "59019"
}
]
},
"descriptionModule": {
"briefSummary": "The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of \"Primevère margarine\" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SAFE",
"briefTitle": "Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)",
"nctId": "NCT06380218",
"orgStudyIdInfo": {
"id": "2023-A00249-36",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program"
},
{
"measure": "Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of \"Primevère margarine\""
},
{
"measure": "Satisfaction of Primevere products"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut Pasteur de Lille"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Povorcitinib"
},
{
"name": "Levonorgestrel/Ethinyl estradiol"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Participants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tempe",
"contacts": null,
"country": "United States",
"facility": "Celerion Clinical Research Unit",
"geoPoint": {
"lat": 33.41477,
"lon": -111.90931
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85283"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females."
},
"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": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females",
"nctId": "NCT06380205",
"orgStudyIdInfo": {
"id": "INCB54707-111",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Levonorgestrel (LNG) concentration in plasma"
},
{
"measure": "Ethinyl estradiol (EE) concentration in plasma"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with Treatment-emergent Adverse Events (TEAEs)"
},
{
"measure": "Additional LNG/EE PK parameters in plasma"
},
{
"measure": "Povorcitinib concentration in plasma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Incyte Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Developmental and Epileptic Encephalopathy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "DEE-RETRO",
"briefTitle": "Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data",
"nctId": "NCT06380192",
"orgStudyIdInfo": {
"id": "HJ22-DEE-RETRO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies"
},
{
"measure": "Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies"
}
],
"secondaryOutcomes": [
{
"measure": "Identification of patient subgroups presenting the identified biomarkers"
},
{
"measure": "Assessment of patients' quality of life"
},
{
"measure": "Assessment of age-related adaptive behavior"
},
{
"measure": "Assessment of behavioral disorders"
},
{
"measure": "Assessment of autism spectrum disorders"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Imagine Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "THOR3 training + Photobiomodulation Therapy (PBMT)"
},
{
"name": "THOR3 training + sham PBMT"
}
]
},
"conditionsModule": {
"conditions": [
"Photobiomodulation Therapy",
"Photomedicine",
"Low-Level Laser Therapy",
"Performance Enhancement",
"Quadriceps",
"Special Operations Readiness"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.The specific aims of this study are to:1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 116,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
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"sex": "MALE",
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"ADULT"
]
},
"identificationModule": {
"acronym": "SOF",
"briefTitle": "Photomedicine Project 14: PBMT for Performance Enhancement in SOF",
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"id": "USUHS.2023-126",
"link": null,
"type": null
},
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},
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{
"measure": "Body Measurements: Height (cm)"
},
{
"measure": "Body Measurements: Weight (kg/lbs)"
},
{
"measure": "Body Measurements: Body composition (% body fat)"
},
{
"measure": "Body Measurements: C1 - proximal thigh circumference (cm)"
},
{
"measure": "Body Measurements: C2 - distal thigh circumference (cm)"
},
{
"measure": "Body Measurements: L1 - length of thigh (cm)"
}
],
"primaryOutcomes": [
{
"measure": "Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse"
},
{
"measure": "Countermovement Jump (CMJ) initial baseline: peak force production"
},
{
"measure": "Countermovement Jump (CMJ) initial baseline: rate of force production"
},
{
"measure": "Countermovement Jump (CMJ) initial baseline: unilateral performance comparison"
},
{
"measure": "Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse"
},
{
"measure": "Countermovement Jump (CMJ) week 1 follow-up: peak force production"
},
{
"measure": "Countermovement Jump (CMJ) week 1 follow-up: rate of force production"
},
{
"measure": "Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison"
},
{
"measure": "Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse"
},
{
"measure": "Countermovement Jump (CMJ) week 2 follow-up: peak force production"
},
{
"measure": "Countermovement Jump (CMJ) week 2 follow-up: rate of force production"
},
{
"measure": "Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison"
},
{
"measure": "Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse"
},
{
"measure": "Countermovement Jump (CMJ) week 3 follow-up: peak force production"
},
{
"measure": "Countermovement Jump (CMJ) week 3 follow-up: rate of force production"
},
{
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},
{
"measure": "Isometric Quadriceps Strength Testing initial baseline"
},
{
"measure": "Isometric Hamstrings Strength Testing initial baseline"
},
{
"measure": "Isokinetic Quadriceps Strength Testing initial baseline"
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{
"measure": "Isokinetic Hamstrings Strength Testing initial baseline"
},
{
"measure": "Isometric Quadriceps Strength Testing 3-week follow-up"
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{
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},
{
"measure": "Isokinetic Quadriceps Strength Testing 3-week follow-up"
},
{
"measure": "Isokinetic Hamstrings Strength Testing 3-week follow-up"
},
{
"measure": "Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline"
},
{
"measure": "Defense and Veteran's Pain Rating Scale (DVPRS) daily reports"
},
{
"measure": "Visual Analog Scale (VAS) initial baseline"
},
{
"measure": "Visual Analog Scale (VAS) week 1 follow-up"
},
{
"measure": "Visual Analog Scale (VAS) week 2 follow-up"
},
{
"measure": "Visual Analog Scale (VAS) week 3 follow-up"
},
{
"measure": "Borg Modified Rating of Perceived Exertion (RPE) initial baseline"
},
{
"measure": "Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up"
},
{
"measure": "Elloumi fatigue scale initial baseline"
},
{
"measure": "Elloumi fatigue scale 3-week follow-up"
},
{
"measure": "Quick Physical Activity Rating scale (QPAR)"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - sleep duration"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - time in bed"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - light sleep length"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - deep sleep length"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - sleep latency"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - sleep efficiency score"
},
{
"measure": "Oura Ring Sleep Data: sleep metrics - sleep quality score"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - body temperature changes"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - heart rate changes"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV)"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - respiration rate"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - blood oxygen saturation"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - sleep regularity"
},
{
"measure": "Oura Ring Sleep Data: Readiness trends - readiness score"
}
],
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{
"name": "Uniformed Services University (USU) of the Health Sciences"
},
{
"name": "1st Special Forces Group (Airborne), United States Army"
},
{
"name": "United States Army Special Operations Command"
},
{
"name": "The Geneva Foundation"
}
],
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"name": "Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)"
}
},
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"date": "2026-01"
},
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},
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"primaryCompletionDateStruct": {
"date": "2025-08"
},
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"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
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"size": 435470,
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} |
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{
"name": "Hepatitis C core antigen"
}
]
},
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"conditions": [
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]
},
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},
"descriptionModule": {
"briefSummary": "Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories."
},
"designModule": {
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"sex": "ALL",
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"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "Hepatitis C Lab Testing Comparison Study",
"nctId": "NCT06380166",
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"link": null,
"type": null
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"primaryOutcomes": [
{
"measure": "Serum on the clot stability"
},
{
"measure": "Serum off the clot stability"
},
{
"measure": "Plasma on the gel stability"
},
{
"measure": "Plasma off the gel stability"
}
],
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},
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"collaborators": null,
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"class": "OTHER",
"name": "HealthPartners Institute"
}
},
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"date": "2024-09"
},
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"date": "2024-07"
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"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
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"interventions": [
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"name": "Hemay005"
}
]
},
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"conditions": [
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]
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},
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"briefSummary": "The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment."
},
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},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment",
"nctId": "NCT06380153",
"orgStudyIdInfo": {
"id": "HM005PS1S07",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）"
},
{
"measure": "Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）"
},
{
"measure": "Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)"
},
{
"measure": "Relevant pharmacokinetic parameters，half-life (T1/2)"
},
{
"measure": "Relevant pharmacokinetic parameters，clearance (CL/F)"
},
{
"measure": "Relevant pharmacokinetic parameters，volume of distribution (Vz/F)"
},
{
"measure": "Relevant pharmacokinetic parameters ，Renal clearance rate（CLr）"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "INDUSTRY",
"name": "Ganzhou Hemay Pharmaceutical Co., Ltd"
}
},
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"date": "2024-12"
},
"lastUpdatePostDateStruct": {
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"date": "2024-12"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Open Tension-free Inguinal Hernia Repair"
}
]
},
"conditionsModule": {
"conditions": [
"Post Operative Pain",
"Inguinal Hernia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Augusto Lauro",
"phone": "+39 388 8663 879",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Augusto Lauro",
"geoPoint": {
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"lon": 12.51133
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"status": "RECRUITING",
"zip": "000186"
}
]
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"descriptionModule": {
"briefSummary": "Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:* predict the severity of pain;* select most suitable pain relief therapy for the patient."
},
"designModule": {
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study",
"nctId": "NCT06380140",
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"id": "cami3zgmxf3vqyc30ndmdqh6gfjid1",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair"
},
{
"measure": "Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair"
},
{
"measure": "Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair"
},
{
"measure": "Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair"
},
{
"measure": "Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Roma La Sapienza"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-03"
},
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"startDateStruct": {
"date": "2023-05-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
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"label": "Study Protocol and Statistical Analysis Plan",
"size": 274127,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-04-18T14:17"
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise training"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
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"locations": [
{
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"descriptionModule": {
"briefSummary": "The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care.Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover.",
"maskingInfo": {
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},
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"type": "ACTUAL"
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],
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"sex": "ALL",
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]
},
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"briefTitle": "Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes",
"nctId": "NCT06380127",
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"id": "CEFADE012021",
"link": null,
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"primaryOutcomes": [
{
"measure": "Change from Baseline on Short Physical Performance Battery (SPBB)"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline on Handgrip test"
},
{
"measure": "Change from baseline on isokinetic knee strength"
},
{
"measure": "Change from Baseline on circulating levels of myostatin"
},
{
"measure": "Change from Baseline on circulating levels of Decorin"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Universidade do Porto"
}
},
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"date": "2023-12-15"
},
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"date": "2024-04-24"
},
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"primaryCompletionDateStruct": {
"date": "2023-09-30"
},
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"startDateStruct": {
"date": "2021-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
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"interventions": [
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"name": "Communication"
},
{
"name": "Standing Orders"
}
]
},
"conditionsModule": {
"conditions": [
"Hpv"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds."
},
"designModule": {
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"allocation": "RANDOMIZED",
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"maskingInfo": {
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},
"observationalModel": null,
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "11 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination",
"nctId": "NCT06380114",
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"id": "STUDY00009296",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "HPV vaccination"
}
],
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},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Rochester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NEAAR Medical Food"
}
]
},
"conditionsModule": {
"conditions": [
"Rectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Burgess, MS",
"phone": "434-806-6445",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Veronique Perry, MSHA",
"phone": "2549873658",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Richard Tuli, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of South Florida",
"geoPoint": {
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"lon": -82.45843
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33606"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NEAAR-LARC",
"briefTitle": "Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)",
"nctId": "NCT06380101",
"orgStudyIdInfo": {
"id": "NEAAR-LARC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema"
},
{
"measure": "Absolute and relative change from baseline of circulating non-essential amino acids"
},
{
"measure": "Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food"
},
{
"measure": "molecular ctDNA response."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of South Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Isometric Task"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Genova",
"contacts": null,
"country": "Italy",
"facility": "Università degli Studi di Genova",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": null,
"status": null,
"zip": "16122"
}
]
},
"descriptionModule": {
"briefSummary": "This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "27 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Improving Motor Skills: The Role of Music and Encouragement",
"nctId": "NCT06380088",
"orgStudyIdInfo": {
"id": "VEM-DINOGMI-24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Duration of the task"
},
{
"measure": "Biceps Brachii muscle fatigue"
},
{
"measure": "Triceps Brachii muscle fatigue"
},
{
"measure": "Biceps Brachii activity"
},
{
"measure": "Triceps Brachii activity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universita degli Studi di Genova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-08-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spectralis FAF imaging"
},
{
"name": "Optos imaging"
},
{
"name": "Clarus imaging"
}
]
},
"conditionsModule": {
"conditions": [
"Retinal Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madison",
"contacts": [
{
"email": "[email protected]",
"name": "Amy Remm",
"phone": "608-262-3377",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kimberly Stepien, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Department of Ophthalmology and Visual Sciences",
"geoPoint": {
"lat": 43.07305,
"lon": -89.40123
},
"state": "Wisconsin",
"status": null,
"zip": "53705"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).Participants will:* undergo pupillary dilation* have photographs taken of the inside of the eyes using three different cameras"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"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": "COCO-IRD",
"briefTitle": "COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease",
"nctId": "NCT06380075",
"orgStudyIdInfo": {
"id": "2024-0480",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "UW Madison",
"id": "A536000",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "SMPH/OPHTHAL&VIS SCI/GEN",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "Protocol Version 3/22/24",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging"
},
{
"measure": "Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging"
},
{
"measure": "Compare FAF retinal patterns by Clarus and Optos FAF imaging"
},
{
"measure": "Compare Spectralis FAF imaging to Spectralis OCT imaging"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images"
},
{
"measure": "Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Wisconsin, Madison"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Plasma concentration of choline"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Prostate Urothelial Cancer",
"Benign Prostatic Hyperplasia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Homburg",
"contacts": null,
"country": "Germany",
"facility": "University of Saarland",
"geoPoint": {
"lat": 49.32637,
"lon": 7.33867
},
"state": "Saarland",
"status": null,
"zip": "66424"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 350,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia",
"nctId": "NCT06380062",
"orgStudyIdInfo": {
"id": "Choline Prostate Cancer",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plasma choline concentrations"
},
{
"measure": "Whole blood choline concentrations"
}
],
"secondaryOutcomes": [
{
"measure": "Plasma and whole blood folate forms"
},
{
"measure": "Plasma phospholipids"
},
{
"measure": "Plasma S-adenosylmethionine concentrations"
},
{
"measure": "Plasma betaine concentrations"
},
{
"measure": "Plasma methylmalonic acid concentrations"
},
{
"measure": "Plasma homocysteine concentrations"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universität des Saarlandes"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2015-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2015-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2012-01-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EMG Analysis Software"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Fall"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data",
"nctId": "NCT06380049",
"orgStudyIdInfo": {
"id": "0720242110",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Ministry of Food and Drug Safety",
"id": "20240012366",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Area Under the Receiver Operating Characteristic Curve"
},
{
"measure": "Matthews Correlation Coefficient"
}
],
"primaryOutcomes": [
{
"measure": "Sensitivity of the Machine Learning Model"
}
],
"secondaryOutcomes": [
{
"measure": "Specificity of the Machine Learning Model"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministry of Trade, Industry & Energy, Republic of Korea"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "video assisted fistula tract surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Fistula in Ano"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rahim yar khan",
"contacts": null,
"country": "Pakistan",
"facility": "Sheikh Zayed Medical College",
"geoPoint": {
"lat": 28.41987,
"lon": 70.30345
},
"state": "Punjab",
"status": null,
"zip": "64200"
}
]
},
"descriptionModule": {
"briefSummary": "A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery",
"nctId": "NCT06380036",
"orgStudyIdInfo": {
"id": "003AEstb/EC/01/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "recurrence"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Sairah Sadaf"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Enclosure barrier"
}
]
},
"conditionsModule": {
"conditions": [
"Airway Aspiration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": null,
"country": "Hong Kong",
"facility": "North District Hospital",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": "000000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \\& practical enclosure device in general ward. Suction will be performed in manikin in supine lying.Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \\& enclosure tent will be adopted as the enclosure barrier device in this study.Research Question1. To assess the extent of the environmental contamination during coughing and simulated airway suction2. To measure the air particle count during coughing and simulated open airway suction.3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 13,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices",
"nctId": "NCT06380023",
"orgStudyIdInfo": {
"id": "2022.354",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Air particle count"
}
],
"secondaryOutcomes": [
{
"measure": "A fluorescent Dye"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Hong Kong Polytechnic University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "North District Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mediterranean diet group"
}
]
},
"conditionsModule": {
"conditions": [
"Polycystic Ovary Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Athens",
"contacts": null,
"country": "Greece",
"facility": "IASO Hospital",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null,
"status": null,
"zip": "15123"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Recruitment involved adolescents with polycystic ovary syndrome. Participants, who expressed their willingness to take part, attended personal meetings with the appointed dieticians who provided comprehensive explanations on the objectives, methods, and the potential benefits/risks of the study. A leaflet with related information was provided to all patients. Every eligible volunteer, and their guardian, signed a written informed consent and then kept a hard copy of the signed document. All eligible females were recruited in 12/2019 and were randomly allocated in groups of one to either the Control group (CG) or the Intervention group (IG). The IG received a personalized Mediterranean dietary plan, delivered through a clinical decision support system, while the CG received general dietary advice. Every participant had two individual sessions with the assigned dietician, at the beginning and at the trial endpoint, which involved anthropometry, dietary assessment, and blood withdrawal.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "15 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome",
"nctId": "NCT06380010",
"orgStudyIdInfo": {
"id": "IASO HOSPITAL (ATHENS-GREECE)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adherance to the Mediterranean diet"
}
],
"secondaryOutcomes": [
{
"measure": "Improvement of psychological well-being"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Harokopio University"
},
{
"name": "University of Peloponnese"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Iaso Maternity Hospital, Athens, Greece"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Collagen, Hyaluronic Acid, Vitamin C, and Manganese"
},
{
"name": "Intra-articular infiltration"
}
]
},
"conditionsModule": {
"conditions": [
"Tendinitis of Shoulder",
"Hyaluronic Acid",
"Dietary Supplements",
"Shoulder Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections.The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2).The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality.Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used:Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement.Shoulder Disability Questionnaire (SDQ) for functionality.Assessments will be conducted at the following time points:T0) Before the administration of corticosteroid intra-articular injection (baseline).T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0).T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1).T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "The enrolling physiatrist, in agreement with the patient and adhering to Good Clinical Practice standards related to safety and clinical-anthropomorphic characteristics, will decide whether to continue the treatment with oral supplements (Group 1 - G1) or with intra-articular hyaluronic acid (Group 2 - G2)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Both study groups will undergo assessment using pain and functional scales by a clinician who is blinded to the treatment group",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies",
"nctId": "NCT06379997",
"orgStudyIdInfo": {
"id": "SANTA LUCIA IRCCS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric rating scale (NRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Shoulder Disability Questionnaire (SDQ) for shoulder functionality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "I.R.C.C.S. Fondazione Santa Lucia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Buprenorphine"
}
]
},
"conditionsModule": {
"conditions": [
"Opioid Use Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test.Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI).For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \\[COWS\\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8-12 mg twice daily. This is the current standard of care.For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8-12 mg twice daily.The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ROLDI",
"briefTitle": "Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use",
"nctId": "NCT06379984",
"orgStudyIdInfo": {
"id": "855013",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Successful initiation of buprenorphine maintenance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Placebo"
},
{
"name": "Choline"
}
]
},
"conditionsModule": {
"conditions": [
"Child Development",
"Cannabis Use"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "Sharon Hunter, PhD",
"phone": "303-724-6246",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UC Health",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": null,
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phosphatidylcholine or placebo",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development",
"nctId": "NCT06379971",
"orgStudyIdInfo": {
"id": "23-2327",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index"
},
{
"measure": "Auditory Sensory Gating (P50)"
},
{
"measure": "Child Behavior Checklist (CBCL) 1 1/2-5"
}
],
"secondaryOutcomes": [
{
"measure": "Maternal Plasma Choline Levels"
},
{
"measure": "Bayley Scales of Infant and Toddler Development"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Denver"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "leramistat 40mg"
},
{
"name": "Itraconazole 200 mg"
},
{
"name": "Phenytoin 100 Mg Oral Capsule"
},
{
"name": "Simvastatin 40mg"
}
]
},
"conditionsModule": {
"conditions": [
"Pharmacokinetics"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Belfast",
"contacts": [
{
"email": null,
"name": "Phase 1 Unit",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nadine Abdullah",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Celerion",
"geoPoint": {
"lat": 54.59682,
"lon": -5.92541
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects",
"nctId": "NCT06379958",
"orgStudyIdInfo": {
"id": "IST-05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "leramistat: Area under the curve - AUC0 t"
},
{
"measure": "leramistat: Area under the curve - AUC0 24"
},
{
"measure": "leramistat: Area under the curve - AUC0 inf"
},
{
"measure": "leramistat: Maximum observed concentration - Cmax"
},
{
"measure": "leramistat: Time of the maximum observed concentration - Tmax"
},
{
"measure": "leramistat:Elimination rate constant -Kel"
},
{
"measure": "leramistat: Half life - t½"
},
{
"measure": "leramistat: Plasma Clearance -CL/F"
},
{
"measure": "leramistat: Volume of distribution - Vz/F"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of adverse event."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Modern Biosciences Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Myelodysplastic Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Badalona",
"contacts": [
{
"email": "[email protected]",
"name": "Francesc Solé, PhD",
"phone": "935 57 28 06",
"phoneExt": "4040",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Fundación Instituto de Investigación Germans Trias i Puyol",
"geoPoint": {
"lat": 41.45004,
"lon": 2.24741
},
"state": "Barcelona",
"status": "RECRUITING",
"zip": "08916"
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "David Valcárcel Ferreiras, PhD",
"phone": "934 89 30 00",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Universitario Vall d´Hebron",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08035"
},
{
"city": "Pamplona",
"contacts": [
{
"email": "[email protected]",
"name": "Felipe López Cardoso, PhD",
"phone": "848 42 87 00",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Clínica Universitaria de Navarra",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": null,
"status": "RECRUITING",
"zip": "31008"
},
{
"city": "Salamanca",
"contacts": [
{
"email": "[email protected]",
"name": "María Díez Campelo, PhD",
"phone": "+34 923 29 11 00",
"phoneExt": "55418",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sandra Muntión Olave, PhD",
"phone": "+34 923 29 11 00",
"phoneExt": "55015",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Complejo Asistencial Universitario de Salamanca",
"geoPoint": {
"lat": 40.96882,
"lon": -5.66388
},
"state": null,
"status": "RECRUITING",
"zip": "37007"
}
]
},
"descriptionModule": {
"briefSummary": "Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease.More concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and/or plasma from all prospective MDS patients.On the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "UMBRELLA-SUMMA",
"briefTitle": "Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA)",
"nctId": "NCT06379945",
"orgStudyIdInfo": {
"id": "PI23/01103",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Ethics Committee for Drug Research of the Salamanca Health Area",
"id": "PI2024 01 1484",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Structural variants and complex rearrangements in MDS"
},
{
"measure": "Mutations in MDS"
},
{
"measure": "Overall survival and leukemia-free survival in patients with MDS"
},
{
"measure": "ISCIII collections of viable samples"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Carlos III Health Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Instituto de Investigación Biomédica de Salamanca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surveys completion"
}
]
},
"conditionsModule": {
"conditions": [
"Neuromuscular Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future."
},
"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": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BIODOMU",
"briefTitle": "Pain and Muscle Biopsy",
"nctId": "NCT06379932",
"orgStudyIdInfo": {
"id": "APHP240433",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale."
}
],
"secondaryOutcomes": [
{
"measure": "To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service"
},
{
"measure": "Gather patient feedback on procedures, facilities and reception to improve our service to patients."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
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}
} | false | null |
{
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{
"name": "Irrisept Irrigation"
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{
"name": "Saline Irrigation Solution Delivery"
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]
},
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"conditions": [
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},
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"city": "Orange",
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{
"email": "[email protected]",
"name": "Edward Quilligan, BS",
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"role": "CONTACT"
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{
"email": "[email protected]",
"name": "Kalyn Smith, BS",
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"measure": "C Acnes Presence"
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"measure": "American Shoulder and Elbow Surgeons Patient Reported Outcome Measure"
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{
"measure": "Shoulder Range of Motion (ROM)"
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]
},
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"name": "Irrimax Corporation"
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}
}
} | false | null |
{
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},
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"zip": null
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"measure": "Upper Extremity Muscle Strength Measurements"
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{
"measure": "Trunk Control Measurement Scale"
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{
"measure": "Functional Reach Test"
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{
"measure": "Timed Up & Go Test"
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{
"measure": "Pediatric Evaluation of Disability Inventory"
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]
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{
"name": "Biruni University"
},
{
"name": "Istanbul University"
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"date": "2024-04-23"
}
}
} | false | null |
{
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{
"name": "Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only)"
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{
"name": "Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only)"
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]
},
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},
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"measure": "Change from Baseline in the Average Minutes of MVPA at Week 2"
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{
"measure": "Change from Baseline in the Average Minutes of MVPA at Week 3"
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{
"measure": "Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21"
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{
"measure": "Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21"
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{
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{
"measure": "Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21"
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{
"measure": "Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21"
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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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"email": null,
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{
"email": null,
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{
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{
"email": null,
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],
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{
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{
"email": null,
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{
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{
"email": null,
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{
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{
"email": null,
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{
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{
"email": null,
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{
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{
"email": null,
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{
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"email": null,
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{
"email": null,
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"facility": "Institut de cancérologie Strasbourg Europe",
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{
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"email": null,
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{
"email": null,
"name": "Bertrand MENNECIER, MD",
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"type": null
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],
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{
"measure": "Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months)"
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{
"measure": "Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months)"
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{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group"
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{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group"
},
{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group"
},
{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group"
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{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group"
},
{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group"
},
{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group"
},
{
"measure": "Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group"
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{
"measure": "Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion"
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{
"measure": "Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion"
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{
"measure": "Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion"
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{
"measure": "Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion"
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{
"measure": "Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning"
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{
"measure": "Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning"
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]
},
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{
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{
"name": "WeShare"
}
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"date": "2024-11-25"
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},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
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"name": "HSK3486"
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{
"name": "Placebo"
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{
"name": "Moxifloxacin"
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},
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"conditions": [
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},
"contactsLocationsModule": {
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"zip": null
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},
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"measure": "Change in body weight 1"
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{
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{
"measure": "Change in body weight 3"
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{
"measure": "Change in body weight 4"
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"measure": "Length in cm"
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{
"measure": "Weight in kilograms"
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{
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{
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{
"measure": "Cardiovascular disease risk factor change - Waist-to-hip ratio 2"
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{
"measure": "Cardiovascular disease risk factor change - Waist-to-hip-ratio 3"
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{
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"measure": "Change in exposure pattern to the food environment"
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{
"measure": "Change in exposure pattern to the built environment"
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"measure": "Process evaluation measure 6A - Perceived facilitators"
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{
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{
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"briefSummary": "Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the \"study drug\". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy.The main aim of this study is to find a safe and well-tolerated dose of the study drug by checking the side effects that may happen from taking it.The study is looking at several other research questions including:* How much study drug is in the blood at different times* Whether the body makes antibodies against parts of the study drug, which could make the drug less effective or could lead to side effects. Antibodies are proteins produced by the body's immune system in response to a foreign substance* Whether the body makes antibodies against the clotting factor replacement therapy* How quality of life is affected by hemophilia B and if it changes after taking study drug* How joint health is affected by hemophilia B and if it changes after taking study drug* How often visits are required for the emergency room, urgent care center, physician's office, hospital, telephone or online are required as a result of bleeding events, and if the frequency changes after taking study drug* How often factor replacement therapy is needed, both on a regular basis for prevention of bleeding, and as needed to treat bleeding events (and it if changes after taking study drug)* Whether there is a difference in 2 different methods for measuring Factor 9 activity in the blood"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 130,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BEYOND-9",
"briefTitle": "A Trial to Learn if REGV131-LNP1265 is Safe and Works to Help the Body Make Clotting Factor in Pediatric, Adolescent and Adult Patients With Hemophilia B",
"nctId": "NCT06379789",
"orgStudyIdInfo": {
"id": "R131L1265-HEMB-2318",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CTR Number",
"id": "2023-507260-40-00",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of treatment-emergent adverse events (TEAEs)"
},
{
"measure": "Severity of TEAEs"
},
{
"measure": "Coagulation Factor IX (FIX) functional activity measured using the chromogenic substrate assay"
},
{
"measure": "Change in FIX functional activity in plasma, measured using the chromogenic substrate assay"
},
{
"measure": "Annualized bleeding rate (ABR) following sustained FIX functional activity among participants receiving the RDE"
}
],
"secondaryOutcomes": [
{
"measure": "Change in FIX functional activity in plasma measured using the chromogenic substrate assay"
},
{
"measure": "ABR following sustained FIX functional activity among participants receiving the RDE"
},
{
"measure": "FIX functional activity in plasma over time during the study period using the chromogenic substrate assay"
},
{
"measure": "Annualized treated bleeding rate (tABR) following sustained FIX functional activity, among participants receiving the RDE"
},
{
"measure": "Annualized utilization (IU/kg/year) of FIX replacement therapy following sustained FIX functional activity among participants receiving the RDE"
},
{
"measure": "Remaining free of FIX replacement therapy among those receiving the RDE following sustained FIX expression"
},
{
"measure": "Remaining zero spontaneous bleeding events among those receiving the RDE over sustained FIX functional activity period"
},
{
"measure": "Concentrations of REGV131 components"
},
{
"measure": "Concentrations of LNP1265 components"
},
{
"measure": "Detection of antibodies to the F9 transgene product FIX protein"
},
{
"measure": "Detection of total binding antibodies (TAbs) to the adeno-associated virus 8 (AAV8) capsid proteins"
},
{
"measure": "Detection of neutralizing antibodies/transduction inhibitors (NAb/TI) to the adeno-associated virus 8 (AAV8) capsid proteins"
},
{
"measure": "Detection of antibodies to LNP1265"
},
{
"measure": "Detection of antibodies to CRISPR-associated protein 9 (Cas9) protein"
},
{
"measure": "Detection of vector DNA in blood"
},
{
"measure": "Detection of vector DNA in saliva"
},
{
"measure": "Detection of vector DNA in nasal secretions"
},
{
"measure": "Detection of vector DNA in semen"
},
{
"measure": "Detection of vector DNA in urine"
},
{
"measure": "Detection of vector DNA in feces"
},
{
"measure": "Incidence of TEAEs"
},
{
"measure": "Severity of TEAEs"
},
{
"measure": "Detection of vector DNA in relevant matrices based on data analysis of Part 1 Dose Confirmation Cohort"
},
{
"measure": "Detection of vector DNA in relevant matrices over time based on data analysis from adult cohorts over time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Intellia Therapeutics"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Regeneron Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-07-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2032-07-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Education through a 3D model"
},
{
"name": "Education through a traditional pedagogical support"
}
]
},
"conditionsModule": {
"conditions": [
"Lumbar Spine Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification (AO Spine) among orthopedic residents.The main questions this study aims to answer are:Does the use of a 3D interactive model improve residents' knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods? To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy, injury mechanisms, pathophysiology, and fracture diagnosis among surgical residents?Participants will be randomly assigned to either:Group A: Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification. They can explore fractures, access textual information, and anatomical annotations.Group B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification.Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model.Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge, experience with 3D educational tools, confidence levels in managing spine fractures, and satisfaction with the teaching method.The study aims to ascertain if the use of the 3D model significantly enhances residents' comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "3D Model - Classification of Thoracic and Lumbar Spinal Fractures.",
"nctId": "NCT06379776",
"orgStudyIdInfo": {
"id": "LabForSIMS-LC1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Specific Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Structured Assessment of Technical Skills (OSATS)"
},
{
"measure": "Subjective questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Université Paris-Sud"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "diaphragmatic breathing exercise"
},
{
"name": "conventional physiotherapy exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Non-specific Chronic Neck Pain",
"Diaphragmatic Breathing Exercise"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amman",
"contacts": [
{
"email": "[email protected]",
"name": "ISLAM ALNAQEEB, master",
"phone": "00962797246713",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Musab Abu beidar, master",
"phone": "00962790319243",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Jordan",
"facility": "The university of Jordan",
"geoPoint": {
"lat": 31.95522,
"lon": 35.94503
},
"state": null,
"status": "RECRUITING",
"zip": "11942"
}
]
},
"descriptionModule": {
"briefSummary": "This research focuses on adding diaphragmatic breathing to conventional physiotherapy sessions, particularly for patients suffering from chronic neck pain aged between 20-40 years in Jordan. Chronic neck pain is recognized as one of the most prevalent musculoskeletal pain disorders, significantly impacting physical, social, and psychological aspects of life. This issue leads to a decline in functional performance and work productivity, negatively affecting both individual and societal levels. Several factors, such as poor posture and prolonged use of smartphones, contribute to the exacerbation of non-specific chronic neck pain. These problems also affect respiratory muscles, particularly the diaphragm responsible for primary respiration, resulting in a shift from abdominal to chest breathing. This alteration increases the use of neck muscles, subsequently intensifying neck pain and negatively impacting sleep quality in these individuals. The primary objective of this therapeutic study is to investigate the role of adding diaphragmatic breathing to physiotherapy sessions in alleviating pain and improving sleep quality.RCT study will investigate the effect of adding the diaphragmatic breathing to conventional physiotherapy treatment on pain and sleep quality over one month."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized clinical trial (RCT) Participants will be randomly allocated into two groups using the block randomization method. The following groups will be formed: experimental group A (diaphragmatic breathing plus conservative physiotherapy intervention, cervical neck ROM, neck stretching exercises), and group B,",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "the participants will not know which of exercises that will be giving for them more better in experimental or control group",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Diaphragmatic Breathing Exercise on Pain and Sleep Quality in Individuals With Non-specific Chronic Neck Pain",
"nctId": "NCT06379763",
"orgStudyIdInfo": {
"id": "170/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "neck pain"
},
{
"measure": "neck pain"
}
],
"secondaryOutcomes": [
{
"measure": "sleep quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Jordan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nurse-delivered care using WelTel check-ins and BCC SMS"
},
{
"name": "Community-based peer-support model"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension",
"Diabetes"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. We will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. We will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, we will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which we evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which we use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. We will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1320,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania",
"nctId": "NCT06379750",
"orgStudyIdInfo": {
"id": "STOPNCD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Systolic blood pressure"
}
],
"secondaryOutcomes": [
{
"measure": "Blood pressure control"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kilimanjaro Clinical Research Institute"
},
{
"name": "Muhimbili University of Health and Allied Sciences"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Queen's University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Multi-systemic Rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Long COVID"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Padova",
"contacts": null,
"country": "Italy",
"facility": "Universityof Padua",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": null,
"zip": "35128"
}
]
},
"descriptionModule": {
"briefSummary": "Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MULTI-COVID",
"briefTitle": "Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial",
"nctId": "NCT06379737",
"orgStudyIdInfo": {
"id": "359n/AO/23",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Fondazione Cariparo",
"id": "MASI_CARIVARI21_01",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numerical Rating Scale (NRS)"
},
{
"measure": "Hand grip strength"
},
{
"measure": "Barthel Dyspnea Scale"
},
{
"measure": "Fatigue Assessment Scale"
},
{
"measure": "Beck's Depression Inventory (BDI"
},
{
"measure": "Beck Anxiety Inventory (BAI)"
},
{
"measure": "12-Item Short Form Health Survey (SF-12)"
}
],
"secondaryOutcomes": [
{
"measure": "Patients satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Padua University General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tranexamic acid"
},
{
"name": "Thrombin JMI"
},
{
"name": "skin graft"
}
]
},
"conditionsModule": {
"conditions": [
"Burns",
"Skin Graft Complications"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, randomized, blinded, non-inferiority study",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Subjects will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future. The research coordinator will have the code to the blind. The surgical team will not be blinded as the overall consistency of the topical agents will differ and may be apparent.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 62,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft",
"nctId": "NCT06379724",
"orgStudyIdInfo": {
"id": "150349",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The number of participants with hematoma occurrence"
},
{
"measure": "The rate of percentage of graft take adherence amongst participants"
},
{
"measure": "Comparison of number of participants that require re-operation"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in cost between two hemostatic agents"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Kansas Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous Spinal Cord Stimulation (tSCS)"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injuries",
"Cardiovascular Diseases",
"Cardiopulmonary Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vancouver",
"contacts": null,
"country": "Canada",
"facility": "Blusson Spinal Cord Centre",
"geoPoint": {
"lat": 49.24966,
"lon": -123.11934
},
"state": "British Columbia",
"status": null,
"zip": "V5Z 1M9"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Pre-Post Study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
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},
"enrollmentInfo": {
"count": 22,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury",
"nctId": "NCT06379711",
"orgStudyIdInfo": {
"id": "H22-03727",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Circulating endothelial biomarkers in EMV/µL (Park et al., 2023)"
}
],
"secondaryOutcomes": [
{
"measure": "Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008)"
},
{
"measure": "Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC"
},
{
"measure": "Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of British Columbia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "personalized 3D model pré-opérative education"
},
{
"name": "generic 3D model pré-opérative education"
}
]
},
"conditionsModule": {
"conditions": [
"Tumoral Kidney"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bordeaux",
"contacts": [
{
"email": null,
"name": "Gaëlle MARGUE, Docteur",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Bordeaux",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "R3DP-P",
"briefTitle": "Rein 3D PRINT PERSONALIZE",
"nctId": "NCT06379698",
"orgStudyIdInfo": {
"id": "CHUBX 2023/78",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Qualitative assessment of patient experience 1"
},
{
"measure": "Qualitative assessment of patient experience 2"
},
{
"measure": "Qualitative assessment of patient experience 3"
}
],
"secondaryOutcomes": [
{
"measure": "Description of interactions between carers and patients"
},
{
"measure": "Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care."
},
{
"measure": "Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process"
},
{
"measure": "To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model)"
},
{
"measure": "Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire)"
},
{
"measure": "Description of the changes perceived by carers in patients management in both group"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Bordeaux"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PRO-190"
},
{
"name": "Systane Ultra®"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye",
"Dry Eyes Chronic",
"Dry Eye Syndromes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase I, controlled, comparative, controlled, comparative.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Single-blind",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.",
"nctId": "NCT06379685",
"orgStudyIdInfo": {
"id": "SOPH190-0923/I",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence Unexpected Related Adverse Reactions"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in the ocular comfort index (OCI) score in between interventions"
},
{
"measure": "Changes in Best Corrected Visual Acuity (BCVA)"
},
{
"measure": "Changes in tear film breakup time"
},
{
"measure": "Changes in intraocular pressure (IOP)"
},
{
"measure": "Changes in the integrity of the ocular surface (fluorescein staining)"
},
{
"measure": "Changes in lissamine green staining"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Laboratorios Sophia S.A de C.V."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-23"
}
}
} | false | null |
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