protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Osteosynthesis"
}
]
},
"conditionsModule": {
"conditions": [
"Spine Fracture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kairouan",
"contacts": null,
"country": "Tunisia",
"facility": "IBN jazzar hospital",
"geoPoint": {
"lat": 35.6781,
"lon": 10.09633
},
"state": null,
"status": null,
"zip": "3190"
}
]
},
"descriptionModule": {
"briefSummary": "Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Surgical Treatment of Fractures of the Dorso-lombar Spine",
"nctId": "NCT06374472",
"orgStudyIdInfo": {
"id": "IRB00001194",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Age (in years)"
},
{
"measure": "Sex"
},
{
"measure": "Neurological status ( Frenkel classification)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ibn Jazzar Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Zumsemetinib"
},
{
"name": "Capecitabine"
},
{
"name": "Zoledronic acid"
},
{
"name": "Denosumab"
}
]
},
"conditionsModule": {
"conditions": [
"Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Westwood",
"contacts": [
{
"email": null,
"name": "Qamar Khan, M.D.",
"phone": "913-588-1227",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Qamar Khan, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The University of Kansas Cancer Center",
"geoPoint": {
"lat": 39.04056,
"lon": -94.6169
},
"state": "Kansas",
"status": null,
"zip": "66205"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Matthew Goetz, M.D.",
"phone": "507-284-2511",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew Goetz, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
},
{
"city": "Saint Louis",
"contacts": [
{
"email": "[email protected]",
"name": "Cynthia X Ma, M.D., Ph.D.",
"phone": "314-362-8903",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Cynthia X Ma, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Sheila Stewart, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Roberto Civitelli, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jingqin (Rosy) Luo, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Foluso Ademuyiwa, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Nusayba Bagegni, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ron Bose, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Andrew Davis, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ashley Frith, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Faisal Fa'ak, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lindsay Peterson, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Rama Suresh, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Washington University School of Medicine",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": null,
"zip": "63110"
}
]
},
"descriptionModule": {
"briefSummary": "This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "The Phase I portion of the study is sequential and patients will not be randomized and the Phase II portion is parallel and patients will be randomized.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 138,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis",
"nctId": "NCT06374459",
"orgStudyIdInfo": {
"id": "24-x109",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Department of Defense",
"id": "BC200714",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with adverse events (Phase Ib only)"
},
{
"measure": "Recommended phase II dose of zunsemetinib (Phase Ib only)"
},
{
"measure": "Percent change in serum CTX (Phase II only)"
},
{
"measure": "Progression-free survival (PFS) (Phase II only)"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only)"
},
{
"measure": "Treatment-induced changes in sCTX by clinical assay (Phase II only)"
},
{
"measure": "Objective response rate (ORR) (Phase II only)"
},
{
"measure": "Clinical benefit rate (Phase II only)"
},
{
"measure": "Overall survival (OS) (Phase II only)"
},
{
"measure": "Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only)"
},
{
"measure": "Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only)"
},
{
"measure": "Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only)"
},
{
"measure": "Number of participants with adverse events (Phase II only)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "United States Department of Defense"
},
{
"name": "Aclaris Therapeutics, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Washington University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Classical Treatment"
},
{
"name": "Virtual Reality Combined with Classical Treatment"
},
{
"name": "Virtual Reality"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"COVID-19"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "SARS-CoV-2 was first detected in Wuhan, Hubei Province, China, in late 2019. It is a highly contagious virus that has been reported to occur in humans and is said to cause pneumonia.Covid-19 infection is transmitted through droplets during coughing and sneezing and through contact with the mouth, nose or eyes after contaminated hands. The most obvious symptoms of Covid-19 symptoms include cough, dyspnea and fever. Covid-19, which can also be seen asymptomatic, is in intensive care it may be severe enough to require hospitalization, cause multiple organ failure and even death it could be. Musculoskeletal symptoms such as fatigue, myalgia, and arthralgia are common with Covid-19 are the symptoms. The first case in Turkey was reported on March 11, 2020.Long-term Covid or Chronic Post Covid Syndrome are multi-system syndromes that last more than 12 weeks and physical, cognitive, psychological, social and occupational domains. The most commonly reported long covid symptoms are; fatigue, shortness of breath, cough, joint pain, chest pain.Virtual reality application provides its users with content created using computer technology. In a virtual environment with a high perception of reality, the aim is to enable mirror neuron activation, enabling the individual to interact with virtual objects and events with three-dimensional movements and to create the perception of doing all these in the real world.Virtual reality for training, treatment, rehabilitation, analysis and testing purposes in healthcare can be used. It is possible to use virtual reality for different purposes, for treatment and rehabilitation. With virtual reality applications in treatment and rehabilitation processes It was stated that patient motivation will increase and patient fear and anxiety will decrease.No study was found in the literature investigating the effect of virtual reality application on fatigue, functional capacity and respiratory function in long-term Covid-19 patients. The purpose of this study; To investigate the effect of virtual reality application on fatigue, functional level and respiratory function in long-term Covid-19 patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Virtual Reality in Patients With Long Covid-19",
"nctId": "NCT06374446",
"orgStudyIdInfo": {
"id": "22-172",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fatigue"
},
{
"measure": "Kinesiophobia"
},
{
"measure": "Evaluation of Respiratory Function"
},
{
"measure": "Shuttle Walking Test"
},
{
"measure": "Endurance Shuttle Walking Test"
},
{
"measure": "Sit and Reach Test"
},
{
"measure": "Peripheral Muscle Strength"
},
{
"measure": "The Nottingham Health Profile"
},
{
"measure": "Dyspnea"
},
{
"measure": "Energy Consumption"
},
{
"measure": "Posture Analysis"
},
{
"measure": "Covid-19 Yorkshire Performance"
},
{
"measure": "FACIT Fatigue Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istinye University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Occipital tACS at IAF-2Hz"
},
{
"name": "Occipital tACS at IAF+2Hz"
},
{
"name": "Frontal tACS at 4-7 Hz"
},
{
"name": "Occipital tRNS"
},
{
"name": "Frontal tRNS"
},
{
"name": "Sham/placebo tACS"
},
{
"name": "Sham/placebo tRNS"
}
]
},
"conditionsModule": {
"conditions": [
"Human Brain and Cognition"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 210,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PREDICOM",
"briefTitle": "Investigating the Plasticity of Human Predictive Coding Through Neuromodulation",
"nctId": "NCT06374433",
"orgStudyIdInfo": {
"id": "PREDICOM-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Behavioral measures"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Alessia Santoni"
},
{
"name": "Sara Stottmeier"
},
{
"name": "Klara Hemmerich"
},
{
"name": "Giuseppe Di Dona"
},
{
"name": "Luigi Ferini-Strambi"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Università Vita-Salute San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"COVID-19"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": null,
"country": "Egypt",
"facility": "Mansoura University",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": "Dakhlia",
"status": null,
"zip": "050"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome",
"nctId": "NCT06374420",
"orgStudyIdInfo": {
"id": "MD.21.11.564",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "investigating pulmonary sequelae of covid-19."
},
{
"measure": "investigating pulmonary sequelae of covid-19."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dietary intervention based on the MIND diet"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Depressive Symptoms",
"Anxiety",
"Stress",
"Eating Habit",
"Dysbiosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Skövde",
"contacts": [
{
"email": null,
"name": "Gianluca Tognon, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "University of Skövde",
"geoPoint": {
"lat": 58.39118,
"lon": 13.84506
},
"state": null,
"status": null,
"zip": "54128"
}
]
},
"descriptionModule": {
"briefSummary": "This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "We plan to randomly assign participants to either the intervention or control group.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Participants will be blinded to their group assignment and will use a smartphone app for meal planning. However, those in the intervention group may have some awareness of their assignment due to specific food choices. Meanwhile, the control group will have access to a variety of foods and recipes, maintaining blinding between the groups regarding their assigned diets, addressing a common challenge in diet intervention studies.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 126,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MINDGUT",
"briefTitle": "The MIND-GUT Digital Pilot Intervention Study",
"nctId": "NCT06374407",
"orgStudyIdInfo": {
"id": "GT-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Program retention"
},
{
"measure": "Adherence"
},
{
"measure": "Acceptability"
},
{
"measure": "Study effectiveness: change in eating attitudes at follow-up"
},
{
"measure": "Study effectiveness: change in stress levels at follow-up"
},
{
"measure": "Study effectiveness: change in depression symptoms at follow-up"
},
{
"measure": "Study effectiveness: change in anxiety symtoms at follow-up"
},
{
"measure": "Study effectiveness: change in body weight at follow-up"
},
{
"measure": "Study effectiveness: change in % total fat mass at follow-up"
},
{
"measure": "Study effectiveness: change in % visceral fat mass at follow-up"
},
{
"measure": "Study effectiveness: change in waist circumference at follow-up"
},
{
"measure": "Study effectiveness: change in hip circumference at follow-up"
},
{
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{
"measure": "RSV-A neutralization titers expressed as Seroresponse Rate (SRR)"
},
{
"measure": "Percentage of participants having RSV-A neutralizing titers >= assay cut-off value"
},
{
"measure": "RSV-B neutralization titers expressed as GMT"
},
{
"measure": "RSV-B neutralization titers expressed as MGI"
},
{
"measure": "RSV-B neutralization titers expressed as SRR"
},
{
"measure": "Percentage of participants having RSV-B neutralizing titers >= assay cut-off value"
},
{
"measure": "SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT"
},
{
"measure": "SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI"
},
{
"measure": "Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value"
},
{
"measure": "Percentage of participants reporting each solicited administration site event"
},
{
"measure": "Percentage of participants reporting each solicited systemic event"
},
{
"measure": "Percentage of participants reporting unsolicited adverse events (AEs)"
},
{
"measure": "Percentage of participants reporting serious adverse events (SAEs)"
},
{
"measure": "Percentage of participants reporting potential immune-mediated diseases (pIMDs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "GlaxoSmithKline"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PEACE Online Resources"
},
{
"name": "PEACE Weekly Group Facilitation"
},
{
"name": "PEACE Weekly Individual Facilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": null,
"country": "United States",
"facility": "Center for Mental Health",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Outcome assessors will be masked to randomization condition.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "12 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PEACE for ImPACT Study",
"nctId": "NCT06374381",
"orgStudyIdInfo": {
"id": "854990",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool"
}
],
"secondaryOutcomes": [
{
"measure": "Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)"
},
{
"measure": "Autism Impact Measure (AIM)"
},
{
"measure": "Social Communication Checklist (SCC)"
},
{
"measure": "Confusion, Hubbub, and Order Scale (CHAOS)"
},
{
"measure": "Acceptability, Appropriateness, and Adoption measure"
},
{
"measure": "Qualitative Interview"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Institute of Education Sciences"
},
{
"name": "Michigan State University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2027-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-11-30",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 508769,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-04-12T13:20"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "jejuno-ileal diversion"
},
{
"name": "jejuno-colic diversion"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Type2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ostrava",
"contacts": null,
"country": "Czechia",
"facility": "University of Ostrava, Faculty of Medicine",
"geoPoint": {
"lat": 49.83465,
"lon": 18.28204
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Crea-tion of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without seri-ous adverse events. This non-surgical approach resulted in Significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and Significant improvement in A1C in T2DM (16).In summary, metabolic disease is a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Small Bowel Diversion",
"nctId": "NCT06374368",
"orgStudyIdInfo": {
"id": "JID-SURG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total body weight loss"
},
{
"measure": "Glycated hemoglobin loss"
},
{
"measure": "Diabetes medication loss"
},
{
"measure": "Total cholesterol loss"
},
{
"measure": "Low density lipoprotein loss"
},
{
"measure": "High density lipoprotein loss"
},
{
"measure": "Leptin metabolism evaluation"
},
{
"measure": "Adiponectin metabolism evaluation"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline quality of life-Lite"
},
{
"measure": "Change from baseline quality of life - Sort Form Survey"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Institute for Clinical and Experimental Medicine"
},
{
"name": "Vitkovice Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Ostrava"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Semibranch CMD branched aortic stentgraft"
}
]
},
"conditionsModule": {
"conditions": [
"Aortic Aneurysm",
"Endovascular Aortic Repair",
"Stent-Graft Endoleak"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Münster",
"contacts": null,
"country": "Germany",
"facility": "Muenster University Hospital",
"geoPoint": {
"lat": 51.96236,
"lon": 7.62571
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Semibranch Registry - Retrospective",
"nctId": "NCT06374355",
"orgStudyIdInfo": {
"id": "Semibranch_Retro",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Freedom from target vessel instability"
},
{
"measure": "Mortality"
},
{
"measure": "Technical success"
}
],
"secondaryOutcomes": [
{
"measure": "Morbidity"
},
{
"measure": "Freedom of Endoleak type I and III"
},
{
"measure": "Long term mortality"
},
{
"measure": "Branch patency"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Muenster"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bone defect"
},
{
"name": "Spine fusion"
},
{
"name": "Cage filling"
}
]
},
"conditionsModule": {
"conditions": [
"Bone Resorption"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mainvilliers",
"contacts": [
{
"email": "[email protected]",
"name": "Jean MEYBLUM, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jean MEYBLUM, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pôle Rachis Hôpital Privé d'Eure et Loir",
"geoPoint": {
"lat": 48.45003,
"lon": 1.45607
},
"state": "Eure Et Loir",
"status": "RECRUITING",
"zip": "28300"
},
{
"city": "Toulouse",
"contacts": [
{
"email": "[email protected]",
"name": "Gérard GIORDANO, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gérard GIORDANO, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hôpital Joseph Ducuing",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": "Haute Garonne",
"status": "RECRUITING",
"zip": "31000"
},
{
"city": "Toulouse",
"contacts": [
{
"email": "[email protected]",
"name": "Dominique VARDON, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dominique VARDON, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Clinique Médipole Garonne",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": "Haute Garonne",
"status": "RECRUITING",
"zip": "31100"
},
{
"city": "Nancy",
"contacts": [
{
"email": "[email protected]",
"name": "Didier MAINARD, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Didier MAINARD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHRU Brabois",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": "Meurthe Et Moselle",
"status": "RECRUITING",
"zip": "54000"
},
{
"city": "Le Mans",
"contacts": [
{
"email": "[email protected]",
"name": "Jean-Patrick RAKOVER, MD",
"phone": "02 43 77 54 21",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jean-Patrick RAKOVER, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Clinique du Pré",
"geoPoint": {
"lat": 48,
"lon": 0.2
},
"state": "Sarthe",
"status": "RECRUITING",
"zip": "72000"
},
{
"city": "München",
"contacts": [
{
"email": "[email protected]",
"name": "Markus SCHROEDEL, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Markus SCHROEDEL, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "OCM Klinik GmbH",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": "Bavière",
"status": "RECRUITING",
"zip": "D-81369"
}
]
},
"descriptionModule": {
"briefSummary": "A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a \"real-life\" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 425,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "BONE SUBSTITUTES OUTCOMES",
"nctId": "NCT06374342",
"orgStudyIdInfo": {
"id": "SO01-TK-SUBSTITUTES",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Successful bone repair"
}
],
"secondaryOutcomes": [
{
"measure": "Alleviation of Pain"
},
{
"measure": "Bone reconstruction"
},
{
"measure": "Well-being"
},
{
"measure": "Patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Teknimed"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-09-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interceptive Slow Maxillary Expansion with removable plates"
}
]
},
"conditionsModule": {
"conditions": [
"Tooth Impaction",
"Canine Teeth"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern.This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "RCTcanines2",
"briefTitle": "Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines",
"nctId": "NCT06374329",
"orgStudyIdInfo": {
"id": "S68717",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Position of the impacted maxillary canine towards the dental midline (3^ML)."
}
],
"secondaryOutcomes": [
{
"measure": "Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Karolinska Institutet"
},
{
"name": "University of Copenhagen"
},
{
"name": "Palacky University"
},
{
"name": "The University of Hong Kong"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ceiling-Mounted Air Purifiers"
},
{
"name": "Portable Air Purifiers"
},
{
"name": "Portable or Ceiling Mounted Air Purifiers"
}
]
},
"conditionsModule": {
"conditions": [
"Feasibility",
"Acceptability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oslo",
"contacts": null,
"country": "Norway",
"facility": "Norwegian Institute of Public Health",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the acceptability and feasibility of deploying air purifiers equipped with HEPA (high-efficiency particulate air) filters in classrooms, to study air purifiers as an infection control measure. It will also evaluate the direct effect of air purifiers on air quality, comparing ceiling-mounted purifiers, portable purifiers and no purifier."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "We will select schools for participation in arm 1 and 2, respectively, based on the feasibility of installing ceiling-mounted and placing portable air purifiers in each relevant classroom. In arm 3, all three classrooms will be equipped with both ceiling-mounted and portable air purifiers, as well as indoor air quality sensors.For this arm, we will randomize the three classrooms to each of three weekly programs for the air purifiers;Program 1) Week 1, 4, and 7: Ceiling-mounted ON, Week 2, 5, and 8: No purifier on, Week 3, 6, and 9: Portable ON. Program 2) Week 1, 4, and 7: Portable ON, Week 2, 5, and 8: Ceiling-mounted ON, Week 3, 6, and 9: No purifier on. Program 3) Week 1, 4, and 7: No purifier on Week 2, 5, and 8: Portable ON, Week 3, 6, and 9: Ceiling-mounted ON.Each classroom will be assigned a computer-generated random number and will based on the ascending order of the random numbers be allocated to the three predetermined sequences of programs.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Air Purifiers in Classrooms for Infection Control - a Pilot Study",
"nctId": "NCT06374316",
"orgStudyIdInfo": {
"id": "2302888",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms."
},
{
"measure": "Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms."
},
{
"measure": "Acceptability of having Air Purifiers in Classrooms"
},
{
"measure": "Untoward events when installing air purifiers in classrooms"
},
{
"measure": "Untoward events when running air purifiers in classrooms"
},
{
"measure": "How student absence data can be collected from existing school registration systems."
}
],
"secondaryOutcomes": [
{
"measure": "Response rate of class teachers to the study surveys."
},
{
"measure": "Response rate of students/their guardians to study surveys."
},
{
"measure": "Proportion of absence due to respiratory disease."
},
{
"measure": "Absence frequency among students"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "SINTEF Health Research"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Norwegian Institute of Public Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NE + Meal Delivery (NE+MD) intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Food Security"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Burlington",
"contacts": null,
"country": "United States",
"facility": "University of Vermont",
"geoPoint": {
"lat": 44.47588,
"lon": -73.21207
},
"state": "Vermont",
"status": null,
"zip": "05401"
}
]
},
"descriptionModule": {
"briefSummary": "The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death.In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD.Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions: Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home.The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis.The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's\\<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100).Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's\\<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's\\<.05), with no changes among NE participants.This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, parallel-groups pilot study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial",
"nctId": "NCT06374303",
"orgStudyIdInfo": {
"id": "CHRBSS 00001940",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Household food insecurity Survey"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Vermont"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Naltrexone (Vivitrol)"
},
{
"name": "Bupropion"
}
]
},
"conditionsModule": {
"conditions": [
"Smoking Cessation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Jin H Yoon, PhD",
"phone": "713-486-2800",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jessica Vincent",
"phone": "(713) 486-2645",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Texas health Science Center at Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia",
"nctId": "NCT06374290",
"orgStudyIdInfo": {
"id": "HSC-MS-24-0024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility as assessed by the percentage of participants that enroll in the study"
},
{
"measure": "Percentage of participants that complete 3 weeks of treatment"
},
{
"measure": "Safety as assessed by the percentage of participants that show no serious adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Change in number of cigarettes smoked per day (CPD)"
},
{
"measure": "Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)"
},
{
"measure": "Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT)"
},
{
"measure": "Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas Health Science Center, Houston"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Med AAAction intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes",
"Hypertension",
"High Cholesterol/Hyperlipidemia",
"Coronary Artery Disease",
"Congestive Heart Failure",
"Chronic Lung Disease",
"Chronic Kidney Diseases",
"Arrythmia",
"Stroke",
"Depression",
"Anxiety",
"Pulmonary Embolism",
"Heart Attack"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Knoxville",
"contacts": [
{
"email": "[email protected]",
"name": "Shauntá M Chamberlin",
"phone": "865-305-5061",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Tennessee Medical Center",
"geoPoint": {
"lat": 35.96064,
"lon": -83.92074
},
"state": "Tennessee",
"status": "NOT_YET_RECRUITING",
"zip": "37920"
},
{
"city": "Memphis",
"contacts": [
{
"email": "[email protected]",
"name": "Kay Ryan, PharmD",
"phone": "901-545-7840",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Tennessee Health Science Center/Regional One Health",
"geoPoint": {
"lat": 35.14953,
"lon": -90.04898
},
"state": "Tennessee",
"status": "RECRUITING",
"zip": "38103"
}
]
},
"descriptionModule": {
"briefSummary": "Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Eligible patients who sign consent forms and complete baseline surveys will be randomized to the Med AAAction intervention group or the usual care in a 1:1 ratio, stratified by health system. The participants will be enrolled before hospital discharge. The Med AAAction intervention will include the following components: 1) medications with zero copay, 2) bedside delivery and subsequent home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up after hospital discharge. The intervention will be provided for one-year.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 388,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MedAAAction",
"briefTitle": "Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence",
"nctId": "NCT06374277",
"orgStudyIdInfo": {
"id": "23-09339-IAA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adherence to chronic disease medications"
}
],
"secondaryOutcomes": [
{
"measure": "Health care utilization"
},
{
"measure": "Cost"
},
{
"measure": "Qualitative Evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Sponsor GmbH"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Tennessee"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MR-C-014"
}
]
},
"conditionsModule": {
"conditions": [
"Neuromyelitis Optica Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Eric Klawiter, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Massachusetts General Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02114"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "aNiMatO",
"briefTitle": "Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder",
"nctId": "NCT06374264",
"orgStudyIdInfo": {
"id": "NM100",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors"
},
{
"measure": "Spatiotemporal variability of gait as measured by the MR-C-014 sensors"
},
{
"measure": "Stride length as measured by the MR-C-014 sensors"
},
{
"measure": "Falls Efficacy Scale-International (FES-I)"
},
{
"measure": "Number of falls as recorded in Falls Diary"
},
{
"measure": "Multiple Sclerosis Walking Scale (MSWS-12)"
},
{
"measure": "Visual Analogue Scale (VAS)"
},
{
"measure": "Generalized Anxiety Disorder-7 (GAD-7)"
},
{
"measure": "9 Hole Peg Test (9-HPT)"
},
{
"measure": "Symbol Digit Modalities Test (SDMT)"
},
{
"measure": "Fatigue Scale for Motor and Cognitive Functions (FSMC)"
},
{
"measure": "Expanded Disability Status Scale (EDSS) Ambulation Score"
},
{
"measure": "Activities-Specific Balance Confidence Scale (ABC)"
},
{
"measure": "Patient Experience and Satisfaction Survey"
}
],
"primaryOutcomes": [
{
"measure": "Participant acceptability of MR-C-014"
},
{
"measure": "Number of device-related adverse events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "6-Minute Walk Test (6MWT)"
},
{
"measure": "Number of walks per week"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Alexion Pharmaceuticals, Inc."
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "MedRhythms, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Discussion"
},
{
"name": "Interview"
},
{
"name": "Survey Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Malignant Digestive System Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Eve L. Makoff",
"phone": "323-865-3000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eve L. Makoff",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "USC / Norris Comprehensive Cancer Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90033"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers",
"nctId": "NCT06374251",
"orgStudyIdInfo": {
"id": "0S-23-2",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2023-08890",
"link": null,
"type": "REGISTRY"
},
{
"domain": "USC / Norris Comprehensive Cancer Center",
"id": "0S-23-2",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "P30CA014089",
"link": "https://reporter.nih.gov/quickSearch/P30CA014089",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants who complete the narrative medicine sessions"
},
{
"measure": "Change in well-being scores"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern California"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-27"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CBT+ Health coach"
},
{
"name": "CBT w/o Health Coach ( self-guided)"
},
{
"name": "Usual Care"
}
]
},
"conditionsModule": {
"conditions": [
"Pain",
"Sickle Cell Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Three-arm, phase III randomized controlled effectiveness trial. Participants will be randomized 3:3:2 into (1) CBT + peer, (2) self-guided CBT, or (3) UC, stratified by site",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 470,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PRESENCE",
"briefTitle": "Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain",
"nctId": "NCT06374238",
"orgStudyIdInfo": {
"id": "UG3HL165839",
"link": "https://reporter.nih.gov/quickSearch/UG3HL165839",
"type": "NIH"
},
"secondaryIdInfos": [
{
"domain": null,
"id": "UG3HL165839",
"link": "https://reporter.nih.gov/quickSearch/UG3HL165839",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain"
},
{
"measure": "Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain"
}
],
"secondaryOutcomes": [
{
"measure": "Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain"
},
{
"measure": "Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain"
},
{
"measure": "Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain"
},
{
"measure": "Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain"
},
{
"measure": "Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain"
},
{
"measure": "Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pittsburgh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Automated Titration (O2matic)"
}
]
},
"conditionsModule": {
"conditions": [
"Critical Illness",
"Wounds and Injury",
"Disease Attributes",
"Pathologic Processes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": null,
"country": "United States",
"facility": "University of Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": null,
"zip": "80045"
},
{
"city": "Portland",
"contacts": null,
"country": "United States",
"facility": "Oregon Health and Sciences University",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon",
"status": null,
"zip": "97239"
},
{
"city": "Nashville",
"contacts": null,
"country": "United States",
"facility": "Vanderbilt University Medical Center",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee",
"status": null,
"zip": "37232"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SAVE-O2 AI",
"briefTitle": "Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention",
"nctId": "NCT06374225",
"orgStudyIdInfo": {
"id": "23-0866",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of time spent within the targeted normoxemia range"
}
],
"secondaryOutcomes": [
{
"measure": "Amount of supplemental oxygen administered"
},
{
"measure": "Proportion of time spent in hypoxemia (SpO2<88%)"
},
{
"measure": "Proportion of time spent in hyperoxemia (SpO2 >96%)"
},
{
"measure": "Time to Room Air"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "United States Department of Defense"
},
{
"name": "O2matic ApS"
},
{
"name": "IDTS Medical, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Denver"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anifrolumab"
}
]
},
"conditionsModule": {
"conditions": [
"Hidradenitis Suppurativa",
"Acne Inversa",
"Hidradenitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Erika Hanami",
"phone": "984-974-3682",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher Sayed, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UNC Dermatology and Skin Cancer Center",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27516"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS.The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase.During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to:* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received.* Receive related medical evaluation* Receive the study drug intravenously* Stay 20 minutes after the infusion for monitoring"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "All study participants, if eligible, will receive the study drug (anifrolumab).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Anifrolumab for Hidradenitis Suppurativa",
"nctId": "NCT06374212",
"orgStudyIdInfo": {
"id": "24-0191",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants achieving a HiSCR 50 at 24 weeks"
},
{
"measure": "Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks"
},
{
"measure": "Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AstraZeneca"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Med-South Lifestyle Intervention for Pregnancy--Arm 1"
},
{
"name": "Med-South Lifestyle Intervention for Pregnancy--Arm 2"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": null,
"country": "United States",
"facility": "Center for Health Promotion and Disease Prevention/UNC-Chapel Hill",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27599"
}
]
},
"descriptionModule": {
"briefSummary": "Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program.The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called \"Med-South.\" All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Standard 2 group parallel randomized trial study design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Med-South Lifestyle Program for Pregnancy",
"nctId": "NCT06374199",
"orgStudyIdInfo": {
"id": "24-0181",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "skin carotenoids"
}
],
"primaryOutcomes": [
{
"measure": "Percent that would recommend this program to others who are pregnancy"
},
{
"measure": "Percent of participants who take part in the 10 study counseling sessions"
}
],
"secondaryOutcomes": [
{
"measure": "Maternal diet quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Behavioral Intervention with financial rewards and coaching"
},
{
"name": "Control"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "Carrie R Kriz",
"phone": "816-512-7473",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jared M Bruce, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Missouri - Kansas City School of Medicine",
"geoPoint": {
"lat": 39.09973,
"lon": -94.57857
},
"state": "Missouri",
"status": null,
"zip": "64108"
}
]
},
"descriptionModule": {
"briefSummary": "This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition.",
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COMMITTED2-KC",
"briefTitle": "Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City",
"nctId": "NCT06374186",
"orgStudyIdInfo": {
"id": "2095072",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "UMKC IRB",
"id": "2095072",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time in target blood glucose range per CGM"
},
{
"measure": "Hemoglobin A1C"
}
],
"secondaryOutcomes": [
{
"measure": "Diabetes Quality of Life Brief Inventory"
},
{
"measure": "Diabetes Distress Scale"
},
{
"measure": "PROMIS Medication Adherence Scale"
},
{
"measure": "Perceived Dietary Adherence Questionnaire"
},
{
"measure": "Motivation and Confidence Ruler"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Missouri, Kansas City"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TGI-6 Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced or Metastatic Solid Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Hang Zhou",
"phone": null,
"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": "A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 123,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors",
"nctId": "NCT06374173",
"orgStudyIdInfo": {
"id": "TGI6-T1-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose-limiting Toxicity (DLT)"
},
{
"measure": "Dose-Finding"
},
{
"measure": "Frequency and Severity of Adverse Events (AE)"
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacokinetics of TGI-6"
},
{
"measure": "Pharmacokinetics of TGI-6"
},
{
"measure": "Number of subjects with Anti-TGI-6 antibody positive"
},
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Duration of Response (DoR)"
},
{
"measure": "Disease Control Rate (DCR)"
},
{
"measure": "Progression Free Survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hefei TG ImmunoPharma Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Lung Carcinoma",
"First Line Treatment",
"Second Line Treatment",
"NSCLC Stage IV",
"NSCLC Stage IIIB",
"Palliative Treatment",
"NSCLC Stage IIIC"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Essen",
"contacts": [
{
"email": "[email protected]",
"name": "Mitra Tewes, PD. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nico De Lazzari, M. Sc.",
"phone": "+49 201 723-82035",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mitra Tewes, PD. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Marcel Wiesweg, PD. Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Miriam Götte, PD. Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eva-Maria Hüßler, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Andreas Stang, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Matthias Totzeck, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen",
"geoPoint": {
"lat": 51.45657,
"lon": 7.01228
},
"state": "North Rhine-Westphalia",
"status": null,
"zip": "45147"
}
]
},
"descriptionModule": {
"briefSummary": "Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BREATH",
"briefTitle": "Exercise in Patients With Advanced Non-small Cell Lung Cancer",
"nctId": "NCT06374160",
"orgStudyIdInfo": {
"id": "70115371",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum oxygen uptake (VO2 peak [ml/min/kg])"
}
],
"secondaryOutcomes": [
{
"measure": "Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)"
},
{
"measure": "European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)"
},
{
"measure": "European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)"
},
{
"measure": "Arterial blood pressure"
},
{
"measure": "Change in ECG"
},
{
"measure": "Adherence to exercise intervention"
},
{
"measure": "Drop-out rate"
},
{
"measure": "Recruitment rate"
},
{
"measure": "Serious Adverse Event/Adverse Events"
},
{
"measure": "Therapy response"
},
{
"measure": "Treatment Toxicity"
},
{
"measure": "Treatment scheme"
},
{
"measure": "NT-pro-BNP"
},
{
"measure": "High sensitive troponin I"
},
{
"measure": "Erythrocytes"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Leukocytes"
},
{
"measure": "Lymphocytes"
},
{
"measure": "Neutrophils"
},
{
"measure": "CRP"
},
{
"measure": "CYRFRA 21-1"
},
{
"measure": "Physical function (Hypothetical One-repetition maximum)"
},
{
"measure": "Blood gas analysis pH value"
},
{
"measure": "Blood gas analysis (PAO2)"
},
{
"measure": "Blood gas analysis (SaO2)"
},
{
"measure": "Blood gas analysis (PCO2)"
},
{
"measure": "Blood gas analysis (BE)"
},
{
"measure": "Blood gas analysis (HCO3)"
},
{
"measure": "Blood gas analysis (SBCe)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "German Cancer Aid"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Essen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SVS mattress"
}
]
},
"conditionsModule": {
"conditions": [
"Apnea of Prematurity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "3 Months",
"minimumAge": "0 Days",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "Prapela AOP",
"briefTitle": "\"Prapela® SVS Incubator Pad for Apnea of Prematurity",
"nctId": "NCT06374147",
"orgStudyIdInfo": {
"id": "STUDY00004467",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reduce apnea events by 30% or more in the three days after study entry"
}
],
"secondaryOutcomes": [
{
"measure": "Reduce the number of days caffeine citrate is used after study entry by 3 days or more"
},
{
"measure": "Reduce the number of days of respiratory support by 3 days or more"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Alabama at Birmingham"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tufts Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Community Engagement Practice"
},
{
"name": "Patient-Centric Protocol Element"
}
]
},
"conditionsModule": {
"conditions": [
"Vaccine Hesitancy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to demonstrate an empirical relationship between community- engagement practices, and between patient-centric clinical trial design, execution and communication practices, and vaccine adoption experience.Our hypothesis is that patient-centric clinical trial activity, and community engagement in late-stage clinical trials and early-stage commercialization, reduces vaccine hesitancy and increases vaccine confidence among health care providers overall and within diverse patient communities and ultimately drives faster vaccine adoption."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "ECOLOGIC_OR_COMMUNITY",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States",
"nctId": "NCT06374134",
"orgStudyIdInfo": {
"id": "STUDY00004835",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Units of Vaccine Dispensed"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Merck Sharp & Dohme LLC"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tufts University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PerSorb cartridge (CytoSorbents Europe GmbH, Germany)"
},
{
"name": "PerLife PerKidney"
}
]
},
"conditionsModule": {
"conditions": [
"Kidney Replacement"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bergamo",
"contacts": null,
"country": "Italy",
"facility": "ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò",
"geoPoint": {
"lat": 45.69601,
"lon": 9.66721
},
"state": "BG",
"status": null,
"zip": "24027"
}
]
},
"descriptionModule": {
"briefSummary": "In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and \"PerSorb ECOS-300CY ™\" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor \\>70-years-old or aged 60 to 69 years but with hypertension, diabetes and/or clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "To compare the biochemical profiles of the perfusate obtained from 5 kidneys treated with perfusion and concomitant adsorption, with that of the perfusate obtained from 5 kidneys treated with perfusion without adsorption.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "POWER",
"briefTitle": "Kidney Perfusion With or Without Absorption",
"nctId": "NCT06374121",
"orgStudyIdInfo": {
"id": "POWER",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Oxidative stress markers"
},
{
"measure": "Acute kidney injury markers"
},
{
"measure": "Inflammatory cytokine markers"
},
{
"measure": "Complement activation markers"
},
{
"measure": "Vascular resistances"
},
{
"measure": "Perfusate sample collection"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mario Negri Institute for Pharmacological Research"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Progressive resistance training"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NEXIMS",
"briefTitle": "Resistance Training and Corticospinal Excitability in Multiple Sclerosis",
"nctId": "NCT06374108",
"orgStudyIdInfo": {
"id": "Neuro_Exercise",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MEP/Mmax ratio"
}
],
"secondaryOutcomes": [
{
"measure": "Muscle strength"
},
{
"measure": "Voluntary activation I"
},
{
"measure": "Voluntary activation II"
},
{
"measure": "Force Steadiness"
},
{
"measure": "Rate of Force Developement"
},
{
"measure": "Ultrasound"
},
{
"measure": "Resting Motor Threshold (rMT)"
},
{
"measure": "Active Motor Threshold (aMT)"
},
{
"measure": "MEP latency (resting)"
},
{
"measure": "MEP latency (active)"
},
{
"measure": "MEP amplitude (resting)"
},
{
"measure": "MEP amplitude (active)"
},
{
"measure": "Short-interval intracortical Inhibition (SICI)"
},
{
"measure": "Intracortical facilitation (ICF)"
},
{
"measure": "Cortical Silent Period (CSP)"
},
{
"measure": "Central Motor Conduction Time (CMCT)"
},
{
"measure": "EEG-EMG coherence (0-1)"
},
{
"measure": "Timed 25 feet walk test (T25FWT)"
},
{
"measure": "6-minute walk test (6MWT)"
},
{
"measure": "Six spot step test (SSST)"
},
{
"measure": "5 sit-to-stand (5STS)"
},
{
"measure": "9-step stair ascend (9SSA)"
},
{
"measure": "Patient determined disease steps (PDDS)"
},
{
"measure": "Multiple Sclerosis Walking Scale (MSWS)"
},
{
"measure": "Modified fatigue impact scale (MFIS)"
},
{
"measure": "MS impact scale (MSIS)"
},
{
"measure": "Falls-efficacy scale - international (FES-1)"
},
{
"measure": "The Physical Activity Enjoyment Scale (PACES)"
},
{
"measure": "Brief pain inventory (BPI)"
},
{
"measure": "Baecke physical activity"
},
{
"measure": "Accelerometry"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Aarhus University Hospital"
},
{
"name": "University of Copenhagen"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Aarhus"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RATG"
},
{
"name": "Basiliximab"
}
]
},
"conditionsModule": {
"conditions": [
"Kidney Replacement"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bergamo",
"contacts": null,
"country": "Italy",
"facility": "ASST HPG23 - Unità di Nefrologia",
"geoPoint": {
"lat": 45.69601,
"lon": 9.66721
},
"state": "BG",
"status": null,
"zip": "24127"
}
]
},
"descriptionModule": {
"briefSummary": "This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ONSET",
"briefTitle": "1 vs 7 RATG Infusions in Renal Transplantation",
"nctId": "NCT06374095",
"orgStudyIdInfo": {
"id": "ONSET",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of thrombocytopenia and/or leukopenia"
}
],
"secondaryOutcomes": [
{
"measure": "Occurrence of anemia"
},
{
"measure": "Occurrence of viral infections"
},
{
"measure": "Occurrence of pneumonia"
},
{
"measure": "Occurrence of opportunistic infections"
},
{
"measure": "Occurrence of delayed graft function"
},
{
"measure": "Occurrence of allograft rejection"
},
{
"measure": "Occurrence of biopsy proven rejection"
},
{
"measure": "Survival"
},
{
"measure": "Platelet and WBC counts"
},
{
"measure": "Creatinine levels"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mario Negri Institute for Pharmacological Research"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "WhatsApp message"
}
]
},
"conditionsModule": {
"conditions": [
"Smoking Cessation Counseling Ability",
"Smoking Cessation Counseling Practice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Derek Yee Tak Cheung, PhD",
"phone": "+852 3917 6652",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Derek Yee Tak Cheung, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Xiaoyun Xie, PhDcandidate",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Guowen Zhang, DN student",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Tzu Tsun Luk, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Man Ping Wang, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Siu Chee Chan, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Hong Kong",
"facility": "Hong KongLKS Faculty of Medicine",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": "00"
}
]
},
"descriptionModule": {
"briefSummary": "This research aims to assess the impact of instant messaging reinforcement on the learning outcomes of smoking cessation counseling (SCC) training among master of nursing (MN) students at the University of Hong Kong. The hypotheses suggest that this reinforcement can enhance students' SCC knowledge and techniques, improve their perception of SCC, and increase their application of SCC in clinical work.The study is a pragmatic randomized controlled trial (RCT) with a 1:1 allocation ratio, using WhatsApp Messenger (WhatsApp) messages for intervention and control groups. The intervention group receives messages related to SCC, while the control group receives generic mental health information. The subjects are MN students enrolled in the \"Tobacco Dependency Nursing Intervention and Management\" course.The study uses various tools for measurement, including Ecological momentary assessment (EMA) and Providers Smoking Cessation Training Evaluation (ProSCiTE). The main outcome measures include SCC practice frequency, SCC knowledge score, SCC attitude score, and SCC practice score.Data analysis will be performed in Statistical Package for the Social Sciences (SPSS), using descriptive statistics, intention-to-treat analysis, Chi-square and t-tests, Cohen's d for effect size, and linear mixed models. The expected results suggest that instant messaging reinforcement will enhance SCC knowledge, attitude, and practice among MN students."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Double-blinding technique will be used to conceal the allocation. Participants will not know which group they are in as placebo messages will be introduced. Using a central allocation web-based-controlled randomization, outcome assessors and data analysts will be blind to group allocation, only the principal investigator will be aware of who belongs to the control and intervention groups.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Instant Messaging Reinforcement for Smoking Cessation Counseling Training",
"nctId": "NCT06374082",
"orgStudyIdInfo": {
"id": "HKWC-2024-179",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SCC practice measurement"
}
],
"secondaryOutcomes": [
{
"measure": "SCC knowledge score"
},
{
"measure": "SCC attitude score"
},
{
"measure": "SCC practice score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Longevity",
"Familial Longevity",
"Extreme Longevity",
"Aging"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leiden",
"contacts": null,
"country": "Netherlands",
"facility": "Leiden University Medical Center",
"geoPoint": {
"lat": 52.15833,
"lon": 4.49306
},
"state": "South Holland",
"status": "RECRUITING",
"zip": "2333ZA"
}
]
},
"descriptionModule": {
"briefSummary": "The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind. Families surviving into exceptionally high ages (longevity) in good physical and mental health illustrate that this is physiologically possible. Such families harbor cross generational socio-genetic mechanisms that mediate healthy aging and protection from (multi)morbidity.The purpose of our research is: to identify gene variants associated with healthy aging and protection from (multi)morbidity; to study the social-, environment- and behavioral factors of familial longevity, their role in (multi-)morbidity and its interaction with the genetic component."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "FAMILY_BASED",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "75 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LOF-NL",
"briefTitle": "Longevity Families of the Netherlands",
"nctId": "NCT06374069",
"orgStudyIdInfo": {
"id": "NL81887.058.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identifying the genetic variants of Familial Longevity"
}
],
"secondaryOutcomes": [
{
"measure": "Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jacobijn Gussekloo, Prof. dr."
},
{
"name": "Simon P. Mooijaart, Prof. dr."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Leiden University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kintsugi Voice Device"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Depression Moderate",
"Depression Severe",
"Depression Mild"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berkeley",
"contacts": [
{
"email": "[email protected]",
"name": "Alexa A Mazur, BA",
"phone": "610-724-1431",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Victoria Graham, MS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Albert Ihochi, MBA",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Prentice Tom, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Kintsugi Mindful Wellness Inc.",
"geoPoint": {
"lat": 37.87159,
"lon": -122.27275
},
"state": "California",
"status": "RECRUITING",
"zip": "94707"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Kintsugi Voice Device Pilot Study",
"nctId": "NCT06374056",
"orgStudyIdInfo": {
"id": "0458",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5"
}
],
"secondaryOutcomes": [
{
"measure": "PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5"
},
{
"measure": "Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT"
},
{
"measure": "Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Sonar Strategies"
},
{
"name": "Vituity Psychiatry"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Kintsugi Mindful Wellness, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dapagliflozin 10mg Tab"
},
{
"name": "Placebo"
},
{
"name": "Withings BPM Connect"
},
{
"name": "Withings Body+"
},
{
"name": "Hem-Col Capillary Blood Collection Device"
},
{
"name": "MEMS (Medication Electronic Monitoring System) Cap"
},
{
"name": "Questionnaire: participants' perspectives toward remote data collection"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2",
"Diabetes Mellitus Type 2 With Proteinuria",
"Diabetes Mellitus",
"Diabetes",
"Diabetes Complications",
"Albuminuria",
"Chronic Kidney Diseases",
"Chronic Kidney Disease Due to Type 2 Diabetes Mellitus",
"CKD",
"Proteinuria"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Almelo",
"contacts": null,
"country": "Netherlands",
"facility": "Ziekenhuisgroep Twente",
"geoPoint": {
"lat": 52.35667,
"lon": 6.6625
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Groningen",
"contacts": null,
"country": "Netherlands",
"facility": "University Medical Center Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \\>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare.The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose.Participants will collect all study data in the comfort of their own environments:* First-morning void urine samples* Capillary blood samples* Blood pressure* Body weightParticipants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized placebo-controlled double-blind cross-over trial with repeated administration (i.e., a series of N=1 trials).",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "@HOME",
"briefTitle": "Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.",
"nctId": "NCT06374043",
"orgStudyIdInfo": {
"id": "2020/1002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "UACR response"
}
],
"secondaryOutcomes": [
{
"measure": "Systolic blood pressure response"
},
{
"measure": "Body weight response"
},
{
"measure": "eGFR response"
},
{
"measure": "Fasting plasma glucose response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AstraZeneca"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Center Groningen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-09-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-09-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Endotracheal intubation"
}
]
},
"conditionsModule": {
"conditions": [
"Endotracheal Intubation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leeuwarden",
"contacts": null,
"country": "Netherlands",
"facility": "Leeuwarden Medical Centre",
"geoPoint": {
"lat": 53.20139,
"lon": 5.80859
},
"state": null,
"status": null,
"zip": "8934AD"
}
]
},
"descriptionModule": {
"briefSummary": "Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Retrospective Study of Airway Management in Dutch ED's",
"nctId": "NCT06374030",
"orgStudyIdInfo": {
"id": "EDSAM2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Intubator characteristics"
},
{
"measure": "Indication for intubation"
},
{
"measure": "Sedation agent used"
},
{
"measure": "Paralytic agent used"
},
{
"measure": "Sedative agent after intubation"
},
{
"measure": "Method of intubation"
},
{
"measure": "Patient characteristics"
}
],
"primaryOutcomes": [
{
"measure": "Different complications of endotracheal intubation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "VieCuri Medical Centre"
},
{
"name": "Catharina Ziekenhuis Eindhoven"
},
{
"name": "Rijnstate Hospital"
},
{
"name": "Zuyderland Medical Centre"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical Centre Leeuwarden"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-15",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 247439,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-20T05:01"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Normal saline, Lidocaine, dexmetomidine"
}
]
},
"conditionsModule": {
"conditions": [
"To Measure Systolic Blood Pressure Postintubation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Dina M Mohamed, MD",
"phone": "01005249134",
"phoneExt": "MD",
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Cairo University hospitals",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": "11559"
}
]
},
"descriptionModule": {
"briefSummary": "Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response",
"nctId": "NCT06374017",
"orgStudyIdInfo": {
"id": "N-258-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To measure systolic blood pressure immediately after intubation."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kasr El Aini Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise Group"
},
{
"name": "Thoracic Mobilization Group"
}
]
},
"conditionsModule": {
"conditions": [
"Subacromial Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Hacettepe University, Faculty of Physical Therapy and Rehabilitation",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants will be randomly divided into two groups and participants will not know which group participants are in.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome",
"nctId": "NCT06374004",
"orgStudyIdInfo": {
"id": "HU-FTR-MC-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Electromyography (EMG)"
},
{
"measure": "Acromiohumeral Distance (AHD)"
}
],
"secondaryOutcomes": [
{
"measure": "Muscle Tone"
},
{
"measure": "Functional Activity Level"
},
{
"measure": "Pain Intensity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ATHENA CAR-T"
},
{
"name": "Fludarabine"
},
{
"name": "Cyclophosphamide"
}
]
},
"conditionsModule": {
"conditions": [
"Lupus Erythematosus, Systemic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Luoyang",
"contacts": [
{
"email": null,
"name": "Muchen Liu",
"phone": "(86)-13663884080",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Henan University of Science and Technology",
"geoPoint": {
"lat": 34.68361,
"lon": 112.45361
},
"state": "Henan",
"status": "RECRUITING",
"zip": "471003"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:• To evaluate the safety and tolerability of ATHENA CAR-T.After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus",
"nctId": "NCT06373991",
"orgStudyIdInfo": {
"id": "EDI-901-SLE01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "PK characteristics"
},
{
"measure": "PK characteristics (cont)"
},
{
"measure": "PK characteristics (cont)"
},
{
"measure": "PD characteristics"
},
{
"measure": "PD characteristics (cont)"
}
],
"primaryOutcomes": [
{
"measure": "Dose Limiting Toxicity"
},
{
"measure": "Frequency of AEs, SAEs, lab abnormalities, AESIs"
}
],
"secondaryOutcomes": [
{
"measure": "Efficacy: Percent of patients achieved SRI-4"
},
{
"measure": "Efficacy: Patients SLEDAI-2000 change compared with baseline"
},
{
"measure": "Efficacy: Patients BILAG-2004 change compared with baseline"
},
{
"measure": "Efficacy: Percent of patients' PGA not worsen"
},
{
"measure": "Percent of patients responded by BILAG-2004"
},
{
"measure": "Efficacy: Immunologic parameters"
},
{
"measure": "Efficacy: Immunologic parameters (cont)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The First Affiliated Hospital of Henan University of Science and Technology"
},
{
"name": "Changping Laboratory"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "EdiGene Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diclofenac"
},
{
"name": "Tramadol"
}
]
},
"conditionsModule": {
"conditions": [
"Elbow Pain",
"Chronic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Coral Springs",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Baldwin",
"phone": "216-390-5833",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Alison Klika",
"phone": "216 444-4954",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Dakkak, DO",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Cleveland Clinic Florida",
"geoPoint": {
"lat": 26.27119,
"lon": -80.2706
},
"state": "Florida",
"status": null,
"zip": "33067"
},
{
"city": "Avon",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Baldwin",
"phone": "216-390-5833",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jason Genin, DO",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Vikas Patel, DO",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Cleveland Clinic Ohio",
"geoPoint": {
"lat": 41.45171,
"lon": -82.03542
},
"state": "Ohio",
"status": null,
"zip": "44011"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients\\' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow.The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark.The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study will be a double-blind, randomized trial comparing a control group receiving the standard care narcotic Tramadol (50mg) to an experimental group receiving Diclofenac (50mg).",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 92,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow",
"nctId": "NCT06373978",
"orgStudyIdInfo": {
"id": "24-307",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of pills taken"
}
],
"secondaryOutcomes": [
{
"measure": "Non narcotic use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Cleveland Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Online to offline counseling"
}
]
},
"conditionsModule": {
"conditions": [
"HIV Prevention Program"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuala Lumpur",
"contacts": null,
"country": "Malaysia",
"facility": "Centre of Excellence For Research in AIDS (CERiA)",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for transgender women (TGW) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like TGW, and allows immediate engagement in the post-test linkage process to prevention or treatment services."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"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": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI)",
"nctId": "NCT06373965",
"orgStudyIdInfo": {
"id": "B2024-000",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "HIVST uptake"
},
{
"measure": "Linkage to PrEP"
},
{
"measure": "Linkage to HIV treatment services"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Malaya"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Connecticut"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Online to offline counseling"
}
]
},
"conditionsModule": {
"conditions": [
"HIV Prevention Program"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuala Lumpur",
"contacts": null,
"country": "Malaysia",
"facility": "Centre of Excellence For Research in AIDS (CERiA)",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CINTAI",
"briefTitle": "Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men",
"nctId": "NCT06373952",
"orgStudyIdInfo": {
"id": "23-08-658-910",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "HIVST uptake"
},
{
"measure": "Linkage to PrEP"
},
{
"measure": "Linkage to HIV treatment services"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Malaya"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Connecticut"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital lung auscultation"
},
{
"name": "Pulse oximetry measurement"
},
{
"name": "Non invasive body temperature measurement"
}
]
},
"conditionsModule": {
"conditions": [
"Respiratory Diseases",
"Pneumonia",
"Asthma",
"Cyanotic Heart Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Geneva",
"contacts": [
{
"email": "[email protected]",
"name": "Alain Gervaix, Prof",
"phone": "(0)22 372 45 55",
"phoneExt": "+41",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Johan Siebert, MD",
"phone": "(0)79 553 40 72",
"phoneExt": "+41",
"role": "CONTACT"
},
{
"email": null,
"name": "Johan N Siebert, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Laurence Lacroix-Duccardonnoy, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Isabelle Ruchonnet-Métrailler, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Geneva University Hospitals",
"geoPoint": {
"lat": 46.20222,
"lon": 6.14569
},
"state": null,
"status": null,
"zip": "1205"
}
]
},
"descriptionModule": {
"briefSummary": "Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three particularly useful tools to identify these conditions when assessing the patient's status: the stethoscope, the pulse oximeter, and the thermometer. The Pneumoscope is an all-in-one device including a digital stethoscope, a pulse oximeter, and a thermometer. This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood oxygen saturation levels and heart rate in children and adults."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This single center, open, non-controlled investigation will be conducted at one site; the University Hospitals of Geneva, Switzerland. This will be a non-inferiority study between Pneumoscope and CE marked comparable medical devices in children and adults.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 225,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Performance and Safety of the Pneumoscope Device in Adults and Children",
"nctId": "NCT06373939",
"orgStudyIdInfo": {
"id": "Pneumoscope study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of Pneumoscope's built-in sensors"
}
],
"secondaryOutcomes": [
{
"measure": "Collect audio records of lung sounds for AI models training and sensor calibration"
},
{
"measure": "Pulse oximetry"
},
{
"measure": "Body temperature"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Hospital, Geneva"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Pediatric Clinical Research Platform"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "blood withdrawal"
}
]
},
"conditionsModule": {
"conditions": [
"Antiphospholipid Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amiens",
"contacts": [
{
"email": "[email protected]",
"name": "Valéry SALLE, MD",
"phone": "+33 3 22 66 82 30",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Amiens",
"geoPoint": {
"lat": 49.9,
"lon": 2.3
},
"state": null,
"status": "RECRUITING",
"zip": "80054"
}
]
},
"descriptionModule": {
"briefSummary": "Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C/protein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte/macrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"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": "MONOCYTAN",
"briefTitle": "Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome",
"nctId": "NCT06373926",
"orgStudyIdInfo": {
"id": "PI2019_843_0010",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cell membrane expression rate of ANXA2 on circulating monocytes in APS"
}
],
"secondaryOutcomes": [
{
"measure": "Cellular expression of ANXA2 and S100A10 in APS patients"
},
{
"measure": "cell membrane expression of ANXA2 and S100A10 in APS patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire, Amiens"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Hyperlipidemias",
"Nephrotic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kolding",
"contacts": [
{
"email": null,
"name": "Rikke Z Langkilde, md, phd",
"phone": "004576362554",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anne D Thuesen, md, phd",
"phone": "004576360555",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Kolding Sygehus, Lillebælt Hospital",
"geoPoint": {
"lat": 55.4904,
"lon": 9.47216
},
"state": null,
"status": "RECRUITING",
"zip": "6000"
}
]
},
"descriptionModule": {
"briefSummary": "Nephrotic syndrome (NS) is characterized by gross proteinuria (\\>3.5 g/day), hypoalbuminaemia, edema and often hyperlipidemia. Hyperlipidemia is correlated with increased morbidity and mortality.The study aim is to investigate the role of the protein convertase subtilisin/kexin type 9 (PCSK9) in hyperlipidemia of NS, which has been suggested to play an important role. This is done by testing the following hypotheses:1. PCSK9 is increased in patients with NS and hyperlipidemia compared to kidney-healthy controls2. The level of PCSK9 in plasma correlates to the degree of proteinuria.3. PCSK9 i increased in the kidney tissue of patients with NSThe study will compare plasma levels of PCSK9 in correlation with degree of protein in the urine between test persons with NS and kidney healthy controls. Furthermore the investigators will study the the degree of PCSK9 in the kidney in biopsies obtained from test persons with nephrotic syndrome and test persons without proteinuria."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PCSK9",
"briefTitle": "The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom",
"nctId": "NCT06373913",
"orgStudyIdInfo": {
"id": "MASP2NSRZL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plasma PCSK9 correlated to the degree of protein in the urine"
},
{
"measure": "Degree of PCSK9 in kidney tissue"
}
],
"secondaryOutcomes": [
{
"measure": "Localization of PCSK9 in kidney tissue"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Odense University Hospital"
},
{
"name": "Vejle Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kolding Sygehus"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "wound closure"
}
]
},
"conditionsModule": {
"conditions": [
"Wound Heal",
"Wound Dehiscence",
"Wound Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karachi",
"contacts": null,
"country": "Pakistan",
"facility": "Indus Hospital and Health Network",
"geoPoint": {
"lat": 24.8608,
"lon": 67.0104
},
"state": "Sindh",
"status": null,
"zip": "74900"
}
]
},
"descriptionModule": {
"briefSummary": "Comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to SNOS protocol into group A and B for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "SNOS protocol",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture.",
"nctId": "NCT06373900",
"orgStudyIdInfo": {
"id": "IndusH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Wound characteristics and complications"
},
{
"measure": "Wound Infection Grade"
},
{
"measure": "Hollander Cosmetic Wound Evaluation Score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indus Hospital and Health Network"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-02-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2022-02-04",
"filename": "Prot_SAP_ICF_000.pdf",
"hasIcf": true,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol, Statistical Analysis Plan, and Informed Consent Form",
"size": 130365,
"typeAbbrev": "Prot_SAP_ICF",
"uploadDate": "2024-04-03T02:55"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "plant-based Low carbohydrate diet"
},
{
"name": "plant-based Low low fat diet"
}
]
},
"conditionsModule": {
"conditions": [
"Weight Loss"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": [
{
"email": "[email protected]",
"name": "Chun-Ying Wu",
"phone": "+886-28712121",
"phoneExt": "4190",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "HSIAO-PING CHEN",
"phone": "+886-28712121",
"phoneExt": "4190",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Taipei Veterans General Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": "Beitou District",
"status": "RECRUITING",
"zip": "11217"
}
]
},
"descriptionModule": {
"briefSummary": "In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes.Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue ."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Single-blinded",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs)",
"nctId": "NCT06373887",
"orgStudyIdInfo": {
"id": "2023-09-005A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Body weight loss/fat mass loss"
}
],
"secondaryOutcomes": [
{
"measure": "microbiota change"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Taipei Veterans General Hospital, Taiwan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Heel blood collection in a newborn simulation model"
}
]
},
"conditionsModule": {
"conditions": [
"Students",
"Educational Problems",
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Manisa",
"contacts": null,
"country": "Turkey",
"facility": "Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery",
"geoPoint": {
"lat": 38.61202,
"lon": 27.42647
},
"state": null,
"status": null,
"zip": "45140"
},
{
"city": "Manisa",
"contacts": null,
"country": "Turkey",
"facility": "Yonca çiçek okuyan",
"geoPoint": {
"lat": 38.61202,
"lon": 27.42647
},
"state": null,
"status": null,
"zip": "45140"
}
]
},
"descriptionModule": {
"briefSummary": "The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment experimental study with experimental and control group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 92,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "32 Years",
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection",
"nctId": "NCT06373874",
"orgStudyIdInfo": {
"id": "MCBU-SBF-YC-04",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Skill checklist"
},
{
"measure": "State and Trait Anxiety Scales"
},
{
"measure": "Self-Efficacy Scale"
},
{
"measure": "Student Satisfaction and Self-Confidence in Learning Questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Celal Bayar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "no intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Sex Chromosome Aneuploidy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "Shanlee M Davis, MD, PhD",
"phone": "720-777-6073",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Children's Hospital Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "GALAXY is a registry research study that plans to learn more about individuals with X\\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\\&Y variations and the care they receive."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 5000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "0 Days",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GALAXY",
"briefTitle": "Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY)",
"nctId": "NCT06373861",
"orgStudyIdInfo": {
"id": "20-0482",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Health Conditions"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of mental health diagnoses"
},
{
"measure": "Cardiometabolic diagnoses - prevalence of obesity"
},
{
"measure": "Cardiometabolic diagnoses - prevalence of dyslipidemia"
},
{
"measure": "Cardiometabolic diagnoses-prevalence of hypertension"
},
{
"measure": "Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism"
},
{
"measure": "Autoimmune diagnoses - prevalence of diabetes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Children's Hospital Colorado"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Denver"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2037-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2037-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Receive 30 mg of Coq10"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontal Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tehran",
"contacts": null,
"country": "Iran, Islamic Republic of",
"facility": "Amirhossein Farahmand",
"geoPoint": {
"lat": 35.69439,
"lon": 51.42151
},
"state": null,
"status": null,
"zip": "1947833113"
}
]
},
"descriptionModule": {
"briefSummary": "Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment, Randomized, Double-blind, Controlled design.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The study was carried out utilizing a double-blind approach. In order to guarantee objectivity, all three groups - the Vitamin E group, the Coq10 group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A, B, and C (empty) based on their content, and then distributed them among the patients.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 85,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "28 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation",
"nctId": "NCT06373848",
"orgStudyIdInfo": {
"id": "346",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total Antioxidant capacity (TAC) of saliva"
}
],
"secondaryOutcomes": [
{
"measure": "Bleeding on probing"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Islamic Azad University, Tehran"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-08-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emodepside"
}
]
},
"conditionsModule": {
"conditions": [
"Strongyloides Stercoralis Infection",
"Strongyloidiasis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis",
"nctId": "NCT06373835",
"orgStudyIdInfo": {
"id": "EMODEPSIDE_LAOS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cure rate (CR) of emodepside against Strongyloides stercoralis"
}
],
"secondaryOutcomes": [
{
"measure": "Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin."
},
{
"measure": "Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis."
},
{
"measure": "Exposure response of emodepside in adults"
},
{
"measure": "Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Public Health, Vientiane, Laos"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Swiss Tropical & Public Health Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Circulating-mirna"
}
]
},
"conditionsModule": {
"conditions": [
"Adenomyosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussel",
"contacts": [
{
"email": "[email protected]",
"name": "Emilie Wacheul, MD",
"phone": "027645246",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "CUSL",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": "Woluwe-Saint-Lambert",
"status": "RECRUITING",
"zip": "1200"
}
]
},
"descriptionModule": {
"briefSummary": "Objectives:To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methodsHypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the diseaseStudy Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ADENO-MIRNA",
"briefTitle": "New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs",
"nctId": "NCT06373822",
"orgStudyIdInfo": {
"id": "2024/18JAN/028",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Circulating-miRNA as diagnostic biomarkers"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Université Catholique de Louvain"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transplantation of Placenta Derived Stem Cells"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetic Foot",
"Diabetic Neuropathies",
"Diabetic Foot Ulcer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "León",
"contacts": null,
"country": "Nicaragua",
"facility": "Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA)",
"geoPoint": {
"lat": 12.43787,
"lon": -86.87804
},
"state": "Leon",
"status": null,
"zip": "21000"
},
{
"city": "Matagalpa",
"contacts": null,
"country": "Nicaragua",
"facility": "Hospital Escuela Cesar Amador Molina",
"geoPoint": {
"lat": 12.92559,
"lon": -85.91747
},
"state": null,
"status": null,
"zip": "61000"
}
]
},
"descriptionModule": {
"briefSummary": "This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective an open label",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PDSC",
"briefTitle": "Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy",
"nctId": "NCT06373809",
"orgStudyIdInfo": {
"id": "PDSC1970222",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Foot Ulcer Healing"
}
],
"secondaryOutcomes": [
{
"measure": "Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes."
},
{
"measure": "Vibration: Documenting diabetes-associated lower extremity pathophysiology changes."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministerio de Salud de Nicaragua"
},
{
"name": "Wake Forest Institute for Regenerative Medicine"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Michael H Carstens"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Echographic scan"
}
]
},
"conditionsModule": {
"conditions": [
"Steatosis of Liver"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FAT-PLUS",
"briefTitle": "Ultrasound Index Fat Fraction",
"nctId": "NCT06373796",
"orgStudyIdInfo": {
"id": "2024-A00523-44",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "FAT PLUS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "SuperSonic Imagine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "subepithelial connective tissue graft"
},
{
"name": "de- epithelize gingival graft"
},
{
"name": "ultrasonography"
}
]
},
"conditionsModule": {
"conditions": [
"Gingival Recession, Localized"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Denizli",
"contacts": null,
"country": "Turkey",
"facility": "Pamukkale University of the Dentistry",
"geoPoint": {
"lat": 37.77417,
"lon": 29.0875
},
"state": null,
"status": null,
"zip": "20160"
}
]
},
"descriptionModule": {
"briefSummary": "Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage",
"nctId": "NCT06373783",
"orgStudyIdInfo": {
"id": "2023/05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "tissue thickness"
}
],
"secondaryOutcomes": [
{
"measure": "pulsatility index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pamukkale University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ayres sensory integration therapy"
},
{
"name": "Behaviour Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Faisalabad",
"contacts": null,
"country": "Pakistan",
"facility": "RICCER Institute",
"geoPoint": {
"lat": 31.41554,
"lon": 73.08969
},
"state": "Punjab",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum",
"nctId": "NCT06373770",
"orgStudyIdInfo": {
"id": "MSRSW/Batch-Fall22/700",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "sensory profile by winnie dunn"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Superior University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nano-HAP/Chitosan hydrogel"
}
]
},
"conditionsModule": {
"conditions": [
"Chitosan",
"Nano-hydroxyapatite Hydrogel",
"Intrabony Defect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": null,
"country": "Egypt",
"facility": "October 6 University",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": null,
"zip": "12511"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect",
"nctId": "NCT06373757",
"orgStudyIdInfo": {
"id": "RECO6U/5-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gingival index"
}
],
"secondaryOutcomes": [
{
"measure": "Plaque index"
},
{
"measure": "Clinical attachment level"
},
{
"measure": "Periodontal probing depth"
},
{
"measure": "Acrylic stent for pocket assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "October 6 University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "cyclophosphamide , methotrexate , vinorelbine ,capecitabine"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": null,
"country": "China",
"facility": "Shusen Wang",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Gangdong",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 597,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients",
"nctId": "NCT06373744",
"orgStudyIdInfo": {
"id": "SYSU-022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival"
},
{
"measure": "Objective Response Rate"
},
{
"measure": "Disease Control Rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Elamipretide"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Age-Related Macular Degeneration"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Subjects will be randomized (2:1) to once daily 40 mg SC of elamipretide or placebo for 96 weeks of treatment by a central randomization",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Trial personnel and subjects will be masked to treatment until the database is locked at the end of the trial, unless noted below. The Investigator will contact the Sponsor Medical Monitor prior to unmasking any subject's treatment sequence unless in the instance of a medical emergency. In case of an immediate medical emergency, or if directed by the Sponsor, and only if the information is required by the Investigator to manage a subject's AE, a subject's treatment assignment may be unmasked prematurely using the computerized system. The Sponsor must be notified as soon as possible regarding the reason for unmasking.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 360,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ReNEW",
"briefTitle": "ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)",
"nctId": "NCT06373731",
"orgStudyIdInfo": {
"id": "SPIAM-301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Week 48 Rate of change in the macular area of photoreceptor loss"
}
],
"secondaryOutcomes": [
{
"measure": "Week 72 Rate of change in the Macular area of photoreceptor loss"
},
{
"measure": "Week 96 Rate of change in the Macular area of photoreceptor loss"
},
{
"measure": "Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA)"
},
{
"measure": "Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Stealth BioTherapeutics Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cognitive Behavioral Therapy for Insomnia"
}
]
},
"conditionsModule": {
"conditions": [
"Insomnia",
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palo Alto",
"contacts": [
{
"email": "[email protected]",
"name": "Pandora Lam",
"phone": "650-497-5130",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andrea Goldstein-Piekarski, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Stanford University",
"geoPoint": {
"lat": 37.44188,
"lon": -122.14302
},
"state": "California",
"status": null,
"zip": "94304"
}
]
},
"descriptionModule": {
"briefSummary": "This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Enrolled participants will be randomized into either the Immediate Treatment group, or the Monitored Control group. Both study groups will receive CBT-I.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase)",
"nctId": "NCT06373718",
"orgStudyIdInfo": {
"id": "IRB-74553",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging"
},
{
"measure": "Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging"
},
{
"measure": "Change in Beck Depression Inventory"
},
{
"measure": "Change in PSG Sleep Efficiency"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Columbia Suicide Severity Rating Scale"
},
{
"measure": "Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity"
},
{
"measure": "Change in Actigraph Number of Arousals as a Measure of Sleep Continuity"
},
{
"measure": "Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity"
},
{
"measure": "Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity"
},
{
"measure": "Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity"
},
{
"measure": "Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture"
},
{
"measure": "Change in PSG Number of Arousals as a Measure of Sleep Architecture"
},
{
"measure": "Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture"
},
{
"measure": "Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture"
},
{
"measure": "Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture"
},
{
"measure": "Change in Sleep Physiology measured by PSG"
},
{
"measure": "Change in Insomnia Severity Index (ISI) Scale Score"
},
{
"measure": "Change in 36-Item Short Form Survey (SF-36) Score"
},
{
"measure": "Change in Beck Anxiety Inventory"
},
{
"measure": "Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Mental Health (NIMH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cardiac simulator"
}
]
},
"conditionsModule": {
"conditions": [
"Congenital Heart Disease in Children"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.To aid surgeons in envisioning different surgical approaches for each individual patient.To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.Participants will:Consent to being randomized with a 50% chance of receiving standard of care \"on the fly\" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "1:1 randomization to either receive standard of care \"on the fly\" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups.Patient and surgeon will both be notified which group they have been assigned to.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 275,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cardiac Simulator for Surgical Planning",
"nctId": "NCT06373705",
"orgStudyIdInfo": {
"id": "74566",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NIH",
"id": "1R01HL173845 - 01",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Number of repair revisions needed"
},
{
"measure": "Time on cardiopulmonary bypass"
},
{
"measure": "Ventricular function"
},
{
"measure": "Ventricular function"
},
{
"measure": "Ventricular function"
},
{
"measure": "Valvular function"
},
{
"measure": "Valvular function"
},
{
"measure": "Valvular function"
},
{
"measure": "Number of days in hospital post-operation"
},
{
"measure": "Type of post-operative inotrope"
}
],
"primaryOutcomes": [
{
"measure": "Mortality"
}
],
"secondaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Number of cardioplegic arrest"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2026-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Bronchial Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zhengzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Hai-bin Yu, Ph.D",
"phone": "+86 13526671773",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Henan University of Traditional Chinese Medicine",
"geoPoint": {
"lat": 34.75778,
"lon": 113.64861
},
"state": "Henan",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1508,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)",
"nctId": "NCT06373692",
"orgStudyIdInfo": {
"id": "TCM for Asthma Cohort",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Asthma control rate"
}
],
"secondaryOutcomes": [
{
"measure": "Number of exacerbations"
},
{
"measure": "Asthma exacerbation severity"
},
{
"measure": "Change in severity of chronic persistent disease"
},
{
"measure": "The dose used by glucocorticoids"
},
{
"measure": "Rapid-acting beta2 agonists use drugs and doses"
},
{
"measure": "Asthma Control Test (ACT) score"
},
{
"measure": "Asthma Control Questionnaire (ACQ)"
},
{
"measure": "Asthma Quality of Life Score (AQLQ)"
},
{
"measure": "Anxiety Self-Assessment Form (SAS)"
},
{
"measure": "Depression Self-Rating Scale (SDS)"
},
{
"measure": "Pulmonary function"
},
{
"measure": "Exhaled nitric oxide (FeNO)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The First Affiliated Hospital of Henan University of Traditional Chinese Medicine"
},
{
"name": "Tianjin University of Traditional Chinese Medicine"
},
{
"name": "The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine"
},
{
"name": "Hebei Provincial Hospital of Traditional Chinese Medicine"
},
{
"name": "Peking University People's Hospital"
},
{
"name": "The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine"
},
{
"name": "The First Affiliated Hospital of Zhengzhou University"
},
{
"name": "First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine"
},
{
"name": "The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Henan University of Traditional Chinese Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Switching to E-Cigarette"
},
{
"name": "Switching using Medication"
}
]
},
"conditionsModule": {
"conditions": [
"Cigarette Smoking",
"Smoking Behaviors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Charleston",
"contacts": null,
"country": "United States",
"facility": "Medical Univeristy of South Carolina",
"geoPoint": {
"lat": 32.77657,
"lon": -79.93092
},
"state": "South Carolina",
"status": null,
"zip": "29425"
}
]
},
"descriptionModule": {
"briefSummary": "This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 225,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Switch or Quit R01",
"nctId": "NCT06373679",
"orgStudyIdInfo": {
"id": "Pro00125514",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1R01DA056445-01A1",
"link": "https://reporter.nih.gov/quickSearch/1R01DA056445-01A1",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback"
}
],
"secondaryOutcomes": [
{
"measure": "Greater than 50% reduction in cigarette smoking"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of South Carolina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spatz4 Adjustable Balloon System"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).",
"nctId": "NCT06373666",
"orgStudyIdInfo": {
"id": "SPZ4-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Spatz FGIA, Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manzanilla Sophia®"
},
{
"name": "Meticel Ofteno®"
}
]
},
"conditionsModule": {
"conditions": [
"Eye Strain",
"Eye Strain of Both Eyes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Open-label,",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.",
"nctId": "NCT06373653",
"orgStudyIdInfo": {
"id": "SOPHMAN-0922/IV",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Analog visual eyestrain test score"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of unexpected adverse events related to the interventions"
},
{
"measure": "Incidence of conjunctival hyperemia"
},
{
"measure": "Incidence of sensation of ocular dryness."
},
{
"measure": "Incidence of ocular irritation"
},
{
"measure": "Incidence of sensation of (sleep-crust)"
},
{
"measure": "Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Laboratorios Sophia S.A de C.V."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Insertion of drains"
},
{
"name": "Vancomycin"
}
]
},
"conditionsModule": {
"conditions": [
"Subarachnoid Hemorrhage"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HAPTO",
"briefTitle": "Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage",
"nctId": "NCT06373640",
"orgStudyIdInfo": {
"id": "RHM NEU0458",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "CSF-haemoglobin concentration"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Southampton NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hypnosis"
},
{
"name": "Conventional medications used for sedation-analgesia"
},
{
"name": "Medications used in addition to hypnosis"
}
]
},
"conditionsModule": {
"conditions": [
"Procedural Pain",
"Congenital Heart Disease",
"Heart Surgery",
"Hypnosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PEACE-HYPNO",
"briefTitle": "Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease",
"nctId": "NCT06373627",
"orgStudyIdInfo": {
"id": "2024-A00534-43",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Outcome : Pain evaluation by VAS self-assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal"
},
{
"measure": "Maximum heart rate"
},
{
"measure": "Cumulative doses of intravenous analgesics"
},
{
"measure": "Respiratory depression"
},
{
"measure": "Parental satisfaction using Visual Analogic Scale (VAS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondation Hôpital Saint-Joseph"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "foot massage"
},
{
"name": "bed bath"
}
]
},
"conditionsModule": {
"conditions": [
"Patients"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Ayşe Kabuk, Dr",
"phone": "05469596616",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ayşe Kabuk, PhD",
"phone": "+905469596616",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ayşe Kabuk, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "University of Health Sciences",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Uskudar",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "foot massage (intervention group) bed bath (intervention group) control (control group)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"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 Foot Massage and Bed Bath on Individuals With Cancer",
"nctId": "NCT06373614",
"orgStudyIdInfo": {
"id": "2023/18",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "sleep quality"
},
{
"measure": "fatigue"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Saglik Bilimleri Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "sirolimus-eluting balloon (Selution)"
},
{
"name": "paclitaxel-eluting balloon (SeQuent Please Neo)"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease",
"Stenosis Coronary",
"Coronary Artery Lesion",
"Percutaneous Coronary Intervention"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) at 12 months follow-up."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A subject is randomized at a 1:1 ratio either to drug-coated balloon (DCB) angioplasty with a sirolimus-eluting Selution balloon (n=60 subjects) or DCB angioplasty with a paclitaxel-eluting Sequent Please Neo balloon (n=60 subjects).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SPAGO",
"briefTitle": "SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective",
"nctId": "NCT06373601",
"orgStudyIdInfo": {
"id": "SPAGO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure"
}
],
"secondaryOutcomes": [
{
"measure": "Device success (lesion based)"
},
{
"measure": "Procedure success"
},
{
"measure": "Angiographic outcomes 1"
},
{
"measure": "Angiographic outcomes 2"
},
{
"measure": "Angiographic outcomes 3"
},
{
"measure": "Angiographic outcomes 4"
},
{
"measure": "Device oriented Composite Endpoint (DoCE/ TLF)"
},
{
"measure": "Acute/subacute/early/late vessel thrombosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patient Navigator"
}
]
},
"conditionsModule": {
"conditions": [
"Patient Navigation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Ahrrabie Thirunavukkarasu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shazeen Suleman, MD MPH FRCPC",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Unity Health Toronto, Compass Clinic",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5B 1W8"
},
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Xinyang Ye",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Meb Rashid",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Women's College Hospital, Crossroads Clinic",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5S 1B2"
},
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Patricia LI",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Patricia Li",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Juan Carlos Chirgwin",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "CLSC de Parc-Extension",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H3N 1Y9"
},
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Melissa Tachdjian",
"phone": "514-233-1873",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Patricia Li",
"phone": "438-402-0510",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Patricia Li",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Montreal Children's Hospital",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H4A 3J1"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).The main questions are, for migrant families with a child or youth with special healthcare needs:Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?Participants will:* Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months* Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Multi-centre, pragmatic, assessor-blinded, parallel randomized controlled trial with an embedded qualitative study. In the control arm, participants will receive a standard information package and care usually provided within their clinics. In the intervention arm, participants will receive support from a trained patient navigator. The patient navigator will contact participants: 1) Within 7 days of randomization; 2) At least once every 3 months up to 12 months; 3) As needed to follow-up on tasks identified in previous visits; and 4) As initiated by the participant. The navigator will tailor the topics addressed during these interactions according to the needs of the participant and compile a care plan with input from the patient, family, and clinicians.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 324,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions",
"nctId": "NCT06373588",
"orgStudyIdInfo": {
"id": "MP-37-2023-9418",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Barriers to Care (BCQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Effective care coordination"
},
{
"measure": "Parental empowerment scale"
},
{
"measure": "Healthcare utilization"
},
{
"measure": "PROMIS - Pediatric Global Health 7"
},
{
"measure": "Short-form survey 12"
},
{
"measure": "Patient Health Questionnaire (PHQ-2)"
},
{
"measure": "Distress Thermometer"
},
{
"measure": "Perceived stress scale"
},
{
"measure": "Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canadian Institutes of Health Research (CIHR)"
},
{
"name": "Montreal Children's Hospital of the MUHC"
},
{
"name": "Unity Health Toronto"
},
{
"name": "The Hospital for Sick Children"
},
{
"name": "Women's College Hospital"
},
{
"name": "National Newcomer Navigation Network"
},
{
"name": "Centre for Refugee Children, Toronto"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "McGill University Health Centre/Research Institute of the McGill University Health Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lung and inferior vena cava ultrasound guidance"
},
{
"name": "Conventional protocol guidance"
}
]
},
"conditionsModule": {
"conditions": [
"End-stage Renal Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "Jiangsu Province Hospital",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": "210029"
}
]
},
"descriptionModule": {
"briefSummary": "The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure",
"nctId": "NCT06373575",
"orgStudyIdInfo": {
"id": "2023-SR-891",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improvement in pulmonary congestion score"
},
{
"measure": "Improvement in heart failure symptoms score"
}
],
"secondaryOutcomes": [
{
"measure": "Total ultrafiltration volume"
},
{
"measure": "Mean ultrafiltration rate during prolonged hemodialysis"
},
{
"measure": "Fluid balance (total outflow - total inflow)"
},
{
"measure": "Lung B-line reduction"
},
{
"measure": "The change of width of inferior vena cava"
},
{
"measure": "Incidence of hypotension during prolonged hemodialysis"
},
{
"measure": "Blood pressure variability during the prolonged hemodialysis"
},
{
"measure": "In-hospital mortality"
},
{
"measure": "Length of hospital stay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hypoxia"
}
]
},
"conditionsModule": {
"conditions": [
"Hypoxia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Twelve male wrestlers of the National Polish Team were observed in the study during the camp. The hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. The hypoxic group lived and slept in hypoxic rooms. During the camp, all wrestlers followed the same training schedule and diet. In the blood were determined levels of creatine kinase (CK), C-reactive protein (hsCRP) concentration, nitric oxide (NO), morphology, reticulocytes, lipid profile, and ferritin. Also vascular endothelial growth factor (VEGF, VEGFR2, and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Wrestlers in H group were living in hypoxic rooms for 8-14h/d and between that they were participating in sports training. C group was participating in the same training protocol.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Hypoxic Exposure on Blood Variables in Elite Wrestlers",
"nctId": "NCT06373562",
"orgStudyIdInfo": {
"id": "Wrestlers",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "blood count"
},
{
"measure": "lipid profile"
},
{
"measure": "ferritin"
},
{
"measure": null
}
],
"primaryOutcomes": [
{
"measure": "CK"
},
{
"measure": "hsCRP"
},
{
"measure": "HIF-1"
},
{
"measure": "EPO"
},
{
"measure": "VEGF, VEGF 2, VEGF 3."
},
{
"measure": "Ang 1, Ang 2"
},
{
"measure": "VCAM-1"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Poznan University of Physical Education"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2013-12-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2013-12-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-12-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions"
},
{
"name": "Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Myocardial Reperfusion Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Kadıköy",
"status": null,
"zip": "34668"
}
]
},
"descriptionModule": {
"briefSummary": "Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 2,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery",
"nctId": "NCT06373549",
"orgStudyIdInfo": {
"id": "2022/183-3896",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Istanbul University - Cerrahpasa (IUC)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tamer cebe"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thermoacoustic imaging, MRI and Ultrasound imaging"
}
]
},
"conditionsModule": {
"conditions": [
"Steatosis of Liver"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "München",
"contacts": [
{
"email": "[email protected]",
"name": "Monika Dienst, M.Sc.",
"phone": "+49 89 4400 76642",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dirk-Andre Clevert, Prof. Dr. med.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": null,
"status": null,
"zip": "81377"
}
]
},
"descriptionModule": {
"briefSummary": "Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\\'s most common liver disease and affects around 33% of the adult population.Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH.In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults",
"nctId": "NCT06373536",
"orgStudyIdInfo": {
"id": "LMU-RAD-01167",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Thermoacoustic Fat Measurements"
},
{
"measure": "Estimate Accuracy of Thermoacoustic Fat Fraction"
}
],
"secondaryOutcomes": [
{
"measure": "Usability Metric"
},
{
"measure": "Estimate Operator Variability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Endra Lifesciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dapagliflozin 10mg Tab"
},
{
"name": "Placebo"
},
{
"name": "Levothyroxine Replacement daily"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatic Steato-Fibrosis",
"Non-Alcoholic Fatty Liver Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chandigarh",
"contacts": [
{
"email": "[email protected]",
"name": "ASHU RASTOGI, MD,DM",
"phone": "9781001046",
"phoneExt": "91",
"role": "CONTACT"
}
],
"country": "India",
"facility": "PGIMER",
"geoPoint": {
"lat": 30.73629,
"lon": 76.7884
},
"state": "Punjab",
"status": null,
"zip": "160012"
}
]
},
"descriptionModule": {
"briefSummary": "Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of \"drug repositioning\" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group)",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The placebo pills will be manufactured in identical appearance to the study drug (Dapagliflozin)",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SHIELD",
"briefTitle": "MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin",
"nctId": "NCT06373523",
"orgStudyIdInfo": {
"id": "SHIELD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in liver fat content"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography"
},
{
"measure": "Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months"
},
{
"measure": "Changes in Lipid Profile at 3 and 6 months"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Post Graduate Institute of Medical Education and Research, Chandigarh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood collection"
}
]
},
"conditionsModule": {
"conditions": [
"Vaccination Reaction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ELCAV",
"briefTitle": "Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study",
"nctId": "NCT06373510",
"orgStudyIdInfo": {
"id": "ELCAV",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "CerbaXpert"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "18-F-NaF Cardiac PET/MRI and"
},
{
"name": "CT Angiogram"
}
]
},
"conditionsModule": {
"conditions": [
"Oligometastatic Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trial Recruitment Navigator",
"phone": "310-423-2133",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Katelyn Atkins, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Alan Kwan, MD, MS",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Louise Thomson, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Andriana Nikolova, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Anja Karlstaedt, MD, Phd",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eric Vail, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Celeste Eno, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Stephen Shiao, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Elizabeth McKenzie, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Cedars Sinai Medical Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90048"
}
]
},
"descriptionModule": {
"briefSummary": "The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography",
"nctId": "NCT06373497",
"orgStudyIdInfo": {
"id": "IIT2023-08-ATKINS-ATHERO-RT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of using F-NaF PET/MRI imaging"
}
],
"secondaryOutcomes": [
{
"measure": "To measure changes in standard uptake value (SUV)"
},
{
"measure": "To measure changes in coronary microcalcification activity (CMA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Katelyn Atkins"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Behavioral Parent Training"
}
]
},
"conditionsModule": {
"conditions": [
"Disruptive Behavior Disorder",
"Emotional Disorder",
"Behavioural Disorder",
"Attention Deficit Hyperactivity Disorder",
"Conduct Disorder",
"Oppositional Defiant Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Brendan F. Andrade, PhD",
"phone": "416-535-8501",
"phoneExt": "33642",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Centre for Addiction and Mental Health",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "M6J 1H4"
}
]
},
"descriptionModule": {
"briefSummary": "This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "MATCH-DB",
"briefTitle": "Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents",
"nctId": "NCT06373484",
"orgStudyIdInfo": {
"id": "018-2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year)"
},
{
"measure": "Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year)"
},
{
"measure": "Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre for Addiction and Mental Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Comprehensive geriatric assessment (CGA) and treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Hematologic Malignancy",
"Treatment Adherence",
"Treatment Complication",
"Frailty",
"Quality of Life"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense C",
"contacts": [
{
"email": "[email protected]",
"name": "Nina Andersen, M.D.",
"phone": "+4540437488",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Odense University Hospital",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": null,
"status": "RECRUITING",
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 152,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "70 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMPROVE",
"briefTitle": "Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment",
"nctId": "NCT06373471",
"orgStudyIdInfo": {
"id": "S-20230101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Elderly functional Index"
}
],
"secondaryOutcomes": [
{
"measure": "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)."
},
{
"measure": "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14)."
},
{
"measure": "Handgrip strength"
},
{
"measure": "30-second chair stand test"
},
{
"measure": "Treatment toxicity"
},
{
"measure": "Adherence to hematological cancer treatment"
},
{
"measure": "Polypharmacy yes/no"
},
{
"measure": "Unplanned hospital admissions"
},
{
"measure": "Overall and cancer specific survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Velux Fonden"
},
{
"name": "Danish Cancer Research Foundation"
},
{
"name": "The Dagmar Marshall Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Odense University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ritlecitinib"
}
]
},
"conditionsModule": {
"conditions": [
"Keloid"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Giselle Singer",
"phone": "212-241-3288",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sharlene Martin",
"phone": "212-241-3288",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Emma Guttman",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Icahn School of Medicine at Mount Sinai",
"geoPoint": {
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"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10029"
}
]
},
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"briefSummary": "Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy",
"nctId": "NCT06373458",
"orgStudyIdInfo": {
"id": "STUDY-23-01508",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recurrence Rate"
},
{
"measure": "Change in Detroid Keloid Scale Score"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Peak keloid tension"
},
{
"measure": "Change in Detroid Keloid Scale Score (DKS)"
},
{
"measure": "Change in Pain Numerical Rating Scale (Pain-NRS)"
},
{
"measure": "Change in Itch-NRS"
},
{
"measure": "Change in PGIC (Patient Global Impression of Change)"
},
{
"measure": "Change in DLQI (Dermatology Life Quality Index)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Pfizer"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Icahn School of Medicine at Mount Sinai"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "repetitive transcranial magnetic stimulation active stimulation"
},
{
"name": "repetitive transcranial magnetic stimulation sham stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Neuromodulation and Sleep Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tanta",
"contacts": [
{
"email": "[email protected]",
"name": "Marwa Y Badr",
"phone": "01003639125",
"phoneExt": "Tanta",
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of medicine",
"geoPoint": {
"lat": 30.78847,
"lon": 31.00192
},
"state": "ElGharbia",
"status": "RECRUITING",
"zip": "6620010"
}
]
},
"descriptionModule": {
"briefSummary": "This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "participants randomly allocated to either no, one, some or all interventions simultaneously",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Interventional Neuromodulation in Fibromyalgia",
"nctId": "NCT06373445",
"orgStudyIdInfo": {
"id": "36264PR596",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "The Medical Outcomes Study Sleep Scale (MOS )"
},
{
"measure": "polysomnography"
}
],
"secondaryOutcomes": [
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "The Medical Outcomes Study Sleep Scale (MOS)"
},
{
"measure": "polysomnography"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tanta University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fingerstick"
}
]
},
"conditionsModule": {
"conditions": [
"Neonatal Hypoglycemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": null,
"country": "United States",
"facility": "Mount Sinai West Hospital",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10019"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in \"frequent\" vs \"infrequent\" glucose monitoring intrapartum and assessing neonatal glucose levels at birth."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Frequency of Glucose Monitoring in Labor",
"nctId": "NCT06373432",
"orgStudyIdInfo": {
"id": "STUDY-22-01607",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal Hypoglycemia"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Icahn School of Medicine at Mount Sinai"
}
},
"statusModule": {
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"date": "2024-11-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TFL"
},
{
"name": "MOSES holmium laser"
}
]
},
"conditionsModule": {
"conditions": [
"Urolithiasis of Bladder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Thunder Bay",
"contacts": [
{
"email": "[email protected]",
"name": "Rabail Siddiqui",
"phone": "(807) 684-6000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hazem Elmansy",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Thunder Bay Regional Health Sciences Centre",
"geoPoint": {
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"lon": -89.25018
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "P7B 6V4"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.The main question it aims to answer is:Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?Participants will randomized to either TFL of MOSES arm for their bladder resection procedure."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"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": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors",
"nctId": "NCT06373419",
"orgStudyIdInfo": {
"id": "RP-1007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Presence of muscularis propria"
},
{
"measure": "Incidence of inconclusive pathology"
}
],
"secondaryOutcomes": [
{
"measure": "Tumor-free rate (TFR)"
},
{
"measure": "Total operative time"
},
{
"measure": "Total procedural time"
},
{
"measure": "Number of recurrences"
},
{
"measure": "Total blood loss"
},
{
"measure": "Rate of complications"
},
{
"measure": "Number of inconclusive pathology"
},
{
"measure": "Lasing time"
},
{
"measure": "Total energy used"
},
{
"measure": "Frequency and severity of peri-operative complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Thunder Bay Regional Health Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MHB036C"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Shun Lu, MD",
"phone": "13601813062",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai Chest Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": "RECRUITING",
"zip": "200030"
}
]
},
"descriptionModule": {
"briefSummary": "Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C in advanced malignant tumors."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of MHB036C for Advanced Solid Tumor",
"nctId": "NCT06373406",
"orgStudyIdInfo": {
"id": "MHB036C-CP001CN",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of participants with adverse events (AE)"
},
{
"measure": "Number of participants with dose-limiting toxicity (DLT)"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum Plasma Concentration (Cmax)"
},
{
"measure": "The area under the plasma concentration-time curve (AUC)"
},
{
"measure": "To detectable anti-drug antibodies with treated subjects"
},
{
"measure": "Objective response rate (ORR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Minghui Pharmaceutical (Hangzhou) Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "STABILISE"
}
]
},
"conditionsModule": {
"conditions": [
"Aortic Dissection",
"Spinal Cord Ischemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lisbon",
"contacts": null,
"country": "Portugal",
"facility": "Unidade Local de Saúde Santa Maria",
"geoPoint": {
"lat": 38.71667,
"lon": -9.13333
},
"state": null,
"status": null,
"zip": "1500"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI).Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA.Secondary end-point: spinal cord ischaemia"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SPIRIT",
"briefTitle": "SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique",
"nctId": "NCT06373393",
"orgStudyIdInfo": {
"id": "1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "number of patent intercostal and lumbar arteries"
}
],
"secondaryOutcomes": [
{
"measure": "number of patients with spinal cord ischemia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Cardiovascular Center of the University of Lisbon"
},
{
"name": "Unidade Local de Saúde Santa Maria"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HB-200"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"HPV16+ Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Basking Ridge",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)",
"geoPoint": {
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"lon": -74.54932
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07920"
},
{
"city": "Middletown",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Monmouth (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.39652,
"lon": -74.09211
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07748"
},
{
"city": "Montvale",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Bergen (Limited Protocol Activities)",
"geoPoint": {
"lat": 41.04676,
"lon": -74.02292
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07645"
},
{
"city": "Commack",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.84288,
"lon": -73.29289
},
"state": "New York",
"status": "RECRUITING",
"zip": "11725"
},
{
"city": "Harrison",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Westchester (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.96899,
"lon": -73.71263
},
"state": "New York",
"status": "RECRUITING",
"zip": "10604"
},
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Cancer Center (All Protocol Activites)",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10065"
},
{
"city": "Uniondale",
"contacts": [
{
"email": null,
"name": "Winston Wong, MD",
"phone": "646-608-4245",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Nassau (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.70038,
"lon": -73.59291
},
"state": "New York",
"status": "RECRUITING",
"zip": "11553"
}
]
},
"descriptionModule": {
"briefSummary": "The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This will be a randomized multi-centered, double-blind, placebo-controlled trial",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "The study will be conducted using a double-blind design.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 51,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)",
"nctId": "NCT06373380",
"orgStudyIdInfo": {
"id": "23-293",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease free survival (DFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with adverse events (type, frequency, severity)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hookipa Biotech GmbH"
},
{
"name": "Naveris"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Memorial Sloan Kettering Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Illustration based application"
},
{
"name": "Text based application"
}
]
},
"conditionsModule": {
"conditions": [
"Preeclampsia",
"Preeclampsia Severe",
"Preeclampsia Mild",
"Preeclampsia Postpartum"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions."
},
"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": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PrEPS",
"briefTitle": "Preeclampsia Educational Program Study (PrEPS)",
"nctId": "NCT06373367",
"orgStudyIdInfo": {
"id": "461-24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Preeclampsia knowledge score - short"
}
],
"secondaryOutcomes": [
{
"measure": "Preeclampsia knowledge score - long"
},
{
"measure": "GAD-7 score"
},
{
"measure": "72 hour BP check"
},
{
"measure": "Postpartum visit"
},
{
"measure": "Daily BP recordings"
},
{
"measure": "Accessed material"
},
{
"measure": "Unplanned readmission"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "MemorialCare Health System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital Breast Tomosynthesis (DBT)"
}
]
},
"conditionsModule": {
"conditions": [
"Architectural Distortions",
"Breast Tomosynthesis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Tanya Moseley, MD",
"phone": "713-792-5755",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tanya Moseley, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems",
"nctId": "NCT06373354",
"orgStudyIdInfo": {
"id": "2023-0924",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03341",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Siemens Medical Solutions"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VR training for arm and hand rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Post-Intensive Care Syndrome",
"ICU Acquired Weakness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leeuwarden",
"contacts": [
{
"email": "[email protected]",
"name": "Lise Beumeler, PhD",
"phone": "(058) 286 6738",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lise Beumeler, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Carina Bethlehem, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Dept of intensive care, Medical Centre Leeuwarden",
"geoPoint": {
"lat": 53.20139,
"lon": 5.80859
},
"state": "Friesland",
"status": "RECRUITING",
"zip": "8901 BR"
}
]
},
"descriptionModule": {
"briefSummary": "Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 108,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HANDQUEST",
"briefTitle": "Hand and Arm Rehabilitation Using VR",
"nctId": "NCT06373341",
"orgStudyIdInfo": {
"id": "NL85317.099.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Handgrip strength"
}
],
"secondaryOutcomes": [
{
"measure": "Handgrip strength"
},
{
"measure": "Arm and hand functionality"
},
{
"measure": "Arm and hand functionality"
},
{
"measure": "Arm and hand range of motion"
},
{
"measure": "Balance and mobility"
},
{
"measure": "Support need and experience with VR training"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical Centre Leeuwarden"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Pneumococcal Carriage"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 900,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "7 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post Pandemic Pneumococcal Carriage Among Children and Adults",
"nctId": "NCT06373328",
"orgStudyIdInfo": {
"id": "STUDY00006081",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR."
}
],
"secondaryOutcomes": [
{
"measure": "Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries."
},
{
"measure": "Putative transmission networks between children and adult populations from online questionnaires."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Merck Sharp & Dohme Corporation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Central Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Upper Extremity Problem",
"Smartphone Addiction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Niğde",
"contacts": [
{
"email": "[email protected]",
"name": "Feyza Altindal Karabulut, Assoc. Prof.",
"phone": "+905056263833",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Nigde Omer Halisdemir University, Bor Faculty of Health Sciences",
"geoPoint": {
"lat": 37.96583,
"lon": 34.67935
},
"state": "Nigde",
"status": null,
"zip": "51700"
}
]
},
"descriptionModule": {
"briefSummary": "Mobile phones have different uses in different disciplines, and this encourages long-term use. For optimum comfort use, it is important to ensure users' awareness when purchasing mobile phones that match their hand sizes. The number of studies in the literature on this subject is limited. In this context, the aim of our study is to investigate the relationship between smartphone and hand anthropometry measurements and upper extremity pain and functions."
},
"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": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Smartphone and Hand Anthropometry on Pain and Upper Extremity Functions",
"nctId": "NCT06373315",
"orgStudyIdInfo": {
"id": "2023/11-18",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hand anthropometric measurements: Hand length"
},
{
"measure": "Hand anthropometric measurements: Palm length"
},
{
"measure": "Hand anthropometric measurements: Width of the hand (Metacarpal)"
},
{
"measure": "Hand anthropometric measurements: Maximum hand spread measurement"
},
{
"measure": "Gross grip strength measurement"
},
{
"measure": "Pinch grip strength"
},
{
"measure": "Measurement of phone dimensions"
},
{
"measure": "Upper extremity functional status assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Pain assessment"
},
{
"measure": "Smartphone addiction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nigde Omer Halisdemir University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Peripheral Arterial Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PADBIRD",
"briefTitle": "Peripheral Arterial Disease Biomarkers",
"nctId": "NCT06373302",
"orgStudyIdInfo": {
"id": "IRAS 323948",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correlation between PAD biomarker levels and walking distance."
},
{
"measure": "Change in PAD biomarker levels following exercise therapy."
},
{
"measure": "Change in PAD biomarker levels following endovascular intervention"
}
],
"secondaryOutcomes": [
{
"measure": "To determine whether biomarker levels normalise with improved walking distance."
},
{
"measure": "To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention."
},
{
"measure": "Levels of biomarkers and (Major Adverse Cardiovascular Events)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Norfolk and Norwich University Hospitals NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "higher oxygen saturation target using Nellcor pulse oximetry sensors"
},
{
"name": "lower oxygen saturation target using Nellcor pulse oximetry sensors"
}
]
},
"conditionsModule": {
"conditions": [
"Bronchopulmonary Dysplasia",
"Pulmonary Hypertension"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 2 weeks of exposure A, infants will cross over to exposure B for 2 weeks with a 1-week washout period.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 39,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Months",
"minimumAge": "2 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "TORPH",
"briefTitle": "Target Oxygen Ranges in Infants With Pulmonary Hypertension",
"nctId": "NCT06373289",
"orgStudyIdInfo": {
"id": "000539476",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NICHD (pending)",
"id": "1K23HD113837-01A1",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Intermittent hypoxemia event duration"
}
],
"secondaryOutcomes": [
{
"measure": "Echocardiographic shunting"
},
{
"measure": "Echocardiographic interventricular septal flattening"
},
{
"measure": "Echocardiographic tricuspid regurgitation"
},
{
"measure": "Intermittent hypoxemia frequency"
},
{
"measure": "Cumulative hypoxemia"
},
{
"measure": "Brain natriuretic peptide"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Alabama at Birmingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "multiplanar balance training exercise with education"
},
{
"name": "education only"
}
]
},
"conditionsModule": {
"conditions": [
"Fall Risk"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "dilshaad vad, DPT",
"phone": "917-478-2444",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lior Cohen, DPT",
"phone": "9175549511",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Metro PT",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10021"
}
]
},
"descriptionModule": {
"briefSummary": "The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category.Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention.Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention.Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance.Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants in the multiplanar balance training home-based exercise and educational group (group A) will have a video, as well as written instructions, of the intervention and dosage, along with the five educational brochures loaded on their phone via the SAFE beta app. In the SAFE beta app, the participants will be prompted daily to click on the beta app to watch the demonstration of the interventional exercise. They are then prompted to begin their daily prescriptive intervention, which is a 7-day-a-week program for 12 weeks. Participants can view a video of the exercise intervention in real-time in order to \"mirror\" the exercises as they are completing the exercises.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The primary investigator, who delivers the treatment, is blinded to to the performance outcome measures.",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category",
"nctId": "NCT06373276",
"orgStudyIdInfo": {
"id": "1511",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Timed up and Go Test measured in Seconds"
},
{
"measure": "3 stage balance test measured in seconds"
},
{
"measure": "30-second chair stand measured in repeitions"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dilshaad Basrai Vad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Plain-language summary"
},
{
"name": "Dissemination Tool (Infographic)"
}
]
},
"conditionsModule": {
"conditions": [
"Scleroderma",
"Systemic Sclerosis"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 488,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SPIN-KT",
"briefTitle": "Evaluating Tools to Communicate Scleroderma Research Results to Patients",
"nctId": "NCT06373263",
"orgStudyIdInfo": {
"id": "2024-4165",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Completeness"
},
{
"measure": "Understandability"
},
{
"measure": "Ease of use"
}
],
"secondaryOutcomes": [
{
"measure": "Please to have received results"
},
{
"measure": "Intention to participate in future studies"
},
{
"measure": "Open-ended items"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Lady Davis Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Membrane stripping group"
},
{
"name": "Control group"
}
]
},
"conditionsModule": {
"conditions": [
"Maternal Care for Other Abnormalities of Cervix"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kocaeli",
"contacts": [
{
"email": "[email protected]",
"name": "Burcu Ozturk, M.Sc.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Kocaeli University",
"geoPoint": {
"lat": 39.62497,
"lon": 27.51145
},
"state": null,
"status": "RECRUITING",
"zip": "41380"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\\*Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\\*Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Maternal Consequences of Membrane Stripping",
"nctId": "NCT06373250",
"orgStudyIdInfo": {
"id": "sdilek7",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual analogue scale evaluation of vaginal examination pain"
},
{
"measure": "Visual analogue scale evaluation of vaginal examination pain"
},
{
"measure": "Evaluation of the cervix with Bishop score"
},
{
"measure": "Evaluation of the amount of bleeding"
},
{
"measure": "Birth Satisfaction Scale Short Form"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kocaeli University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Infertility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "Inception Fertility LLC",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77081"
}
]
},
"descriptionModule": {
"briefSummary": "This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A",
"nctId": "NCT06373237",
"orgStudyIdInfo": {
"id": "INC-IG-2024-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Frequency of embryo re-biopsy"
},
{
"measure": "Re-biopsy results"
},
{
"measure": "Embryo disposition"
},
{
"measure": "Embryo transfer outcome"
},
{
"measure": "Pregnancy outcome"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Igenomix"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Inception Fertility, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Flush"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cincinnati",
"contacts": [
{
"email": "[email protected]",
"name": "Rachel Baker, PhD, RN",
"phone": "513-569-6191",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Bethesda North Hospital",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "45242"
}
]
},
"descriptionModule": {
"briefSummary": "Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cold Saline Irrigation Before Endobronchial Biopsy",
"nctId": "NCT06373224",
"orgStudyIdInfo": {
"id": "23-037",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of unreadable biopsy slides"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TriHealth Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Immunoglobulins IV (CLAYRIG)"
},
{
"name": "Cyclophosphamide IV"
},
{
"name": "Methylprednisolone IV"
}
]
},
"conditionsModule": {
"conditions": [
"Paraneoplastic Sensory Neuronopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Dimitri Psimaras, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Alice LEPRINCE-LAURENGE, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Pitié-Salpêtrière",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75013"
}
]
},
"descriptionModule": {
"briefSummary": "Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NESPA",
"briefTitle": "Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy",
"nctId": "NCT06373211",
"orgStudyIdInfo": {
"id": "APHP230701",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTIS",
"id": "2023-506942-22-01",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months"
},
{
"measure": "Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months"
},
{
"measure": "Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months"
},
{
"measure": "Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months"
},
{
"measure": "Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months"
},
{
"measure": "Percentage of patients alive and without tumor progression at 6 months"
},
{
"measure": "Tolerance to treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "standard of care"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatitis C Chronic",
"Hepatitis C"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era.From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others.Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV."
},
"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": null,
"briefTitle": "Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina.",
"nctId": "NCT06373198",
"orgStudyIdInfo": {
"id": "0040/2023-versión 1.0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "rate of relinked HCV patients"
},
{
"measure": "proportion of relinked patients who received antiviral treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation and characteristics of the treatment established"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Gilead Sciences"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hospital El Cruce"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound-guided sacral erector spinae plane block"
},
{
"name": "Ultrasound-guided caudal block"
}
]
},
"conditionsModule": {
"conditions": [
"Urogenital Diseases",
"Nerve Block",
"Pain, Postoperative"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gi̇resun",
"contacts": [
{
"email": "[email protected]",
"name": "Bilge Olgun Keleş",
"phone": "05317338805",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Dilek Yeniay",
"phone": "05375521553",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Giresun Research and Training Hospital",
"geoPoint": {
"lat": 40.91698,
"lon": 38.38741
},
"state": "Central",
"status": "RECRUITING",
"zip": "28100"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled double blind study",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "7 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "SESPB",
"briefTitle": "Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children",
"nctId": "NCT06373185",
"orgStudyIdInfo": {
"id": "2023/21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Face, Leg, Activity, Cry, Consolability (FLACC) score"
}
],
"secondaryOutcomes": [
{
"measure": "Analgesic requirement"
},
{
"measure": "Satisfaction of the patient's parents"
},
{
"measure": "Satisfaction of the surgeons"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Giresun University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-18"
}
}
} | false | null |
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