documentSection
dict | hasResults
bool 2
classes | protocolSection
dict |
|---|---|---|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Camrelizumab + chemotherapy+Thalidomide"
},
{
"name": "Camrelizumab + chemotherapy+placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer",
"Camrelizumab"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)",
"nctId": "NCT06276933",
"orgStudyIdInfo": {
"id": "MA-NSCLC-II-039",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)"
}
],
"secondaryOutcomes": [
{
"measure": "Median time to RCCEP"
},
{
"measure": "Median time to RCCEP of level 3 or above"
},
{
"measure": "Incidence rate of ≥G3 grade RCCEP"
},
{
"measure": "Overall Response Rate (ORR)"
},
{
"measure": "Progression-Free Survival (PFS)"
},
{
"measure": "Overall Survival(OS)"
},
{
"measure": "Treatment-related Adverse Events (TRAE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai Pulmonary Hospital, Shanghai, China"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tongji University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Proprioception"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Malatya",
"contacts": [
{
"email": "[email protected]",
"name": "DILAN DEMİRTAŞ KARAOBA",
"phone": "0554112779",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Inonu University",
"geoPoint": {
"lat": 38.35018,
"lon": 38.31667
},
"state": null,
"status": "RECRUITING",
"zip": "12000"
}
]
},
"descriptionModule": {
"briefSummary": "It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 4,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Joint Position Sense in Healthy Individuals",
"nctId": "NCT06276920",
"orgStudyIdInfo": {
"id": "2024/5554(1)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Joint position sense measurement with universal goniometer in close kinetic chain"
},
{
"measure": "Joint position sense measurement with universal goniometer in open kinetic chain"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Inonu University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Plasma Exchange"
},
{
"name": "Standard Medical Treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Acute on Chronic Liver Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Delhi",
"contacts": [
{
"email": "[email protected]",
"name": "Dr Rakhi Maiwall, DM",
"phone": "01146300000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "India",
"facility": "Institute of Liver & Biliary Sciences",
"geoPoint": {
"lat": 28.63576,
"lon": 77.22445
},
"state": "Delhi",
"status": null,
"zip": "110070"
}
]
},
"descriptionModule": {
"briefSummary": "Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 190,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response",
"nctId": "NCT06276907",
"orgStudyIdInfo": {
"id": "ILBS-ACLF-16",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The AARC grading is done by AARC score the values of which vary from 5-15 , pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival"
}
],
"secondaryOutcomes": [
{
"measure": "Transplant-free survival at 28-days"
},
{
"measure": "The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28"
},
{
"measure": "the development of infection at day 7 and 14 in patients who had no infection"
},
{
"measure": "Duration of ICU and hospital stay"
},
{
"measure": "The proportion of patients developing adverse events will be compared between the two groups"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institute of Liver and Biliary Sciences, India"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Motek C-Mill™ treadmill"
},
{
"name": "training session with and without VR wearing the fNIRS cap"
}
]
},
"conditionsModule": {
"conditions": [
"Traumatic Brain Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Englewood",
"contacts": null,
"country": "United States",
"facility": "Craig Hospital",
"geoPoint": {
"lat": 39.64777,
"lon": -104.98776
},
"state": "Colorado",
"status": null,
"zip": "80113"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "fNIRS",
"briefTitle": "Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention",
"nctId": "NCT06276894",
"orgStudyIdInfo": {
"id": "IRB #2064530-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability)"
},
{
"measure": "Acceptability of the intervention"
},
{
"measure": "fNIRS Data Quality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Craig Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
{
"largeDocumentModule": {
"largeDocs": [
{
"date": "2021-12-21",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 689133,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-08T12:20"
}
]
}
}
| true |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Visual Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hoboken",
"contacts": null,
"country": "United States",
"facility": "Dandelion Science",
"geoPoint": {
"lat": 40.74399,
"lon": -74.03236
},
"state": "New Jersey",
"status": null,
"zip": "07030"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Visual Stimulation for Pain Relief",
"nctId": "NCT06276881",
"orgStudyIdInfo": {
"id": "DSC1001",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1R43DA054845-01",
"link": "https://reporter.nih.gov/quickSearch/1R43DA054845-01",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale (VAS) Score"
},
{
"measure": "Event-related Potential (ERP)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
},
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Dandelion Science"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-28"
},
"resultsFirstPostDateStruct": {
"date": "2024-04-03"
},
"startDateStruct": {
"date": "2022-06-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dalcilib+letrozole+HP treatment group"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"HER2-positive Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Henan",
"contacts": null,
"country": "China",
"facility": "Henan cacer hospital",
"geoPoint": null,
"state": "Henan",
"status": null,
"zip": "450008"
}
]
},
"descriptionModule": {
"briefSummary": "This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, single arm clinical study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer",
"nctId": "NCT06276868",
"orgStudyIdInfo": {
"id": "HELEN-017",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pathologic complete response"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse event occurrence"
},
{
"measure": "objective response rate"
},
{
"measure": "Residual cancer burden"
},
{
"measure": "Event free survival"
},
{
"measure": "Disease free survival"
},
{
"measure": "Distant disease/recurrence free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Henan Cancer Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sleep hygiene education"
}
]
},
"conditionsModule": {
"conditions": [
"Fibromyalgia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sivas",
"contacts": null,
"country": "Turkey",
"facility": "Sivas Cumhuriyet University",
"geoPoint": {
"lat": 39.74833,
"lon": 37.01611
},
"state": "Center",
"status": null,
"zip": "58140"
}
]
},
"descriptionModule": {
"briefSummary": "Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.\n\nPatients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Experimental group Control group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression",
"nctId": "NCT06276855",
"orgStudyIdInfo": {
"id": "CUtülay",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Demographic Information Form (DIF)."
},
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)."
},
{
"measure": "Visual Analog Scale (VAS)."
},
{
"measure": "Beck Depression Inventory (BDI)."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cumhuriyet University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Inferior Alveolar Nerve Block"
},
{
"name": "Buccal Infiltration"
},
{
"name": "Inferior Alveolar Nerve Block and Buccal Infiltration"
}
]
},
"conditionsModule": {
"conditions": [
"Pulpitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Multan",
"contacts": null,
"country": "Pakistan",
"facility": "Dr Ayesha Ahmed",
"geoPoint": {
"lat": 30.19679,
"lon": 71.47824
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.\n\nSTUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.\n\nMATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ACTUAL"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration",
"nctId": "NCT06276842",
"orgStudyIdInfo": {
"id": "12345678",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "CIMS Dental College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LDH/albumin ratio"
}
]
},
"conditionsModule": {
"conditions": [
"Behcet's Disease",
"Albumin",
"Lactate Dehydrogenase",
"Disease Severity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": null,
"country": "Turkey",
"facility": "Erdal Pala",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": null,
"status": null,
"zip": "25240"
}
]
},
"descriptionModule": {
"briefSummary": "ABSTRACT Objective: To investigate whether the lactate dehydrogenase to albumin ratio can be used as a parameter to determine disease severity in Behçet's disease, an inflammatory disease, by comparing it to healthy controls.\n\nPatients and Methods: In this retrospective cohort study, patients with Behçet's disease aged 18-69 years who presented to the outpatient clinic between February 2020 and April 2023 and healthy individuals of similar age and gender were enrolled. LDH, albumin levels, and LDH/albumin ratio of both groups were compared. Clinical findings and characteristics of Behçet's patients and disease severity were recorded and analyzed in relation to LDH/albumin ratio."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 1,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "69 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Behçet and LDH/Albumin",
"nctId": "NCT06276829",
"orgStudyIdInfo": {
"id": "02.05.2023/291",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "LDH/albumin ratio"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Sinus Bradycardia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Yao Yan, MD PhD",
"phone": "+86-1390-1121-319",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 88,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia",
"nctId": "NCT06276816",
"orgStudyIdInfo": {
"id": "2022-LC14",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients with postoperative recurrence of bradycardia symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "The result of the atropine test"
},
{
"measure": "Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36)"
},
{
"measure": "Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS)"
},
{
"measure": "Changes in minmum heart rate"
},
{
"measure": "Changes in mean heart rate"
},
{
"measure": "Changes in deceleration capacity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "China National Center for Cardiovascular Diseases"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LINFU®"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cancer",
"Pancreatic Ductal Adenocarcinoma",
"Pancreatic Dysplasia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The LINFU® U.S. Registry for the in the General Population Without Risk Factors",
"nctId": "NCT06276803",
"orgStudyIdInfo": {
"id": "Adenocyte 104",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified with LINFU®"
}
],
"primaryOutcomes": [
{
"measure": "The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®"
},
{
"measure": "The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term"
}
],
"secondaryOutcomes": [
{
"measure": "Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Adenocyte, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ultrasound-guided/hysteroscopic curettage"
},
{
"name": "Procedure/Surgery: laparoscopic removal of the pregnancy lesion"
}
]
},
"conditionsModule": {
"conditions": [
"Caesarean Scar Pregnancy",
"Ultrasound Scoring System"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengde",
"contacts": null,
"country": "China",
"facility": "Chengde Central Hospital",
"geoPoint": {
"lat": 40.9519,
"lon": 117.95883
},
"state": null,
"status": null,
"zip": "067000"
}
]
},
"descriptionModule": {
"briefSummary": "This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 117,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Objective Analysis of Caesarean Scar Pregnancy",
"nctId": "NCT06276790",
"orgStudyIdInfo": {
"id": "ChengdeCentralHospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "intraoperative blood loss"
},
{
"measure": "length of hospital stay"
},
{
"measure": "serum β-HCG levels"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Chengde Central Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tooth varnish (PRG Barrier Coat from Shofu)"
},
{
"name": "Tooth varnish (Clinpro white varnish 3M)"
}
]
},
"conditionsModule": {
"conditions": [
"Dentin Hypersensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Eman Omar, bachelor",
"phone": "01156677558",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Dentistry Cairo University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": "11331"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants and both assessors will be blind to the type of material used.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "S-PRG",
"briefTitle": "The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial",
"nctId": "NCT06276777",
"orgStudyIdInfo": {
"id": "SPRG Dentin Hypersensitivity",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dentin hypersensitivity reduction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Eman Omar Elfarouk"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LINFU®"
},
{
"name": "Standard imaging tests"
}
]
},
"conditionsModule": {
"conditions": [
"IPMN, Pancreatic",
"Pancreas Cancer",
"Pancreatic Cyst"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes."
},
"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": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)",
"nctId": "NCT06276764",
"orgStudyIdInfo": {
"id": "Adenocyte 103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU®"
}
],
"primaryOutcomes": [
{
"measure": "The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods"
}
],
"secondaryOutcomes": [
{
"measure": "The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period"
},
{
"measure": "Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Adenocyte, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "End-tidal CO2 monitor"
}
]
},
"conditionsModule": {
"conditions": [
"Pneumothorax"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Bilkent Şehir Hastanesi",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Çankaya",
"status": null,
"zip": "06170"
}
]
},
"descriptionModule": {
"briefSummary": "Pneumothorax (PTX) is defined as the accumulation of air in the pleural space. PTX can cause a disruption in the perfusion of lung tissue in the affected area and increase intrathoracic pressure, potentially leading to obstruction of venous return and, consequently, posing a life-threatening condition. Therefore, PTX requiring urgent intervention is a significant concern in emergency departments.\n\nEnd-tidal carbon dioxide (ETCO2) provides insight into carbon dioxide levels resulting from lung perfusion and serves as a respiratory parameter informing the prognosis of various critical illnesses. One of the most important factors determining lung perfusion is the effective lung area. Among the crucial issues for emergency departments are PTX cases, which typically regress following urgent intervention, leading to the establishment of an effective lung area. Hypotheses have been proposed in the literature suggesting that ETCO2 may be affected in PTX cases due to the relationship between effective lung area and ETCO2.\n\nIn this study, investigetors aimed to investigate changes in ETCO2 levels following tube thoracostomy applied to PTX cases."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 43,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax",
"nctId": "NCT06276751",
"orgStudyIdInfo": {
"id": "E1-23-3870 ptx endtidalco2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ETCO2-0"
},
{
"measure": "ΔETCO2-1"
},
{
"measure": "ΔETCO2-2"
},
{
"measure": "ETCO2-1"
},
{
"measure": "ETCO2-2"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cancer",
"Jaundice",
"Abdominal Neoplasm"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease",
"nctId": "NCT06276738",
"orgStudyIdInfo": {
"id": "Adenocyte 102",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU®"
}
],
"primaryOutcomes": [
{
"measure": "The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods"
}
],
"secondaryOutcomes": [
{
"measure": "The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined"
},
{
"measure": "Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Adenocyte, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Writing Wrongs"
}
]
},
"conditionsModule": {
"conditions": [
"Posttraumatic Stress Disorder",
"Discriminatory Stress",
"Microaggression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Auburn",
"contacts": [
{
"email": "[email protected]",
"name": "Cassidy M Brydon, MS",
"phone": "954-591-5261",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Tracy K Witte, PhD",
"phone": "334-844-6465",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Auburn University",
"geoPoint": {
"lat": 32.60986,
"lon": -85.48078
},
"state": "Alabama",
"status": "RECRUITING",
"zip": "368849"
}
]
},
"descriptionModule": {
"briefSummary": "Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "After consenting to participate in the study, participants will be randomized in a 1:1 manner into either the Writing Wrongs Intervention or the Assessment Control condition. All participants will complete a total of five online study sessions including a pre-intervention assessment, three intervention or assessment only sessions, and a one-week follow-up assessment .",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "WW",
"briefTitle": "Writing Wrongs: Expressive Writing for Microaggressions",
"nctId": "NCT06276725",
"orgStudyIdInfo": {
"id": "23-606",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Negative Affect"
},
{
"measure": "Positive Affect"
},
{
"measure": "Acceptability of Writing Wrongs"
}
],
"primaryOutcomes": [
{
"measure": "Racial and Discriminatory Trauma"
},
{
"measure": "Daily Racial and Discrimination Trauma"
}
],
"secondaryOutcomes": [
{
"measure": "Depression"
},
{
"measure": "Anxiety"
},
{
"measure": "Stress"
},
{
"measure": "Posttraumatic Stress"
},
{
"measure": "Daily Depression"
},
{
"measure": "Daily Anxiety"
},
{
"measure": "Daily Posttraumatic Stress"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Medical University of South Carolina"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Auburn University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Implant placement with 3.5 mm diameter KS implants."
},
{
"name": "Implant placement with 3.5 mm diameter TS implants."
}
]
},
"conditionsModule": {
"conditions": [
"Dental Implant",
"Dental Implant-Abutment Design",
"Edentulous Jaw"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A multicenters, randomized controlled trial.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RCT Comparing KS Versus TS for Ovedenture",
"nctId": "NCT06276712",
"orgStudyIdInfo": {
"id": "UNISS_PHD_Osstem_5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of implant failure"
},
{
"measure": "Number of prosthesis failure"
},
{
"measure": "Number of complications"
},
{
"measure": "Rate of implant stability"
}
],
"secondaryOutcomes": [
{
"measure": "Peri-implant marginal bone level changes"
},
{
"measure": "Patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Dr. Dario Melodia"
},
{
"name": "Dr. Milena Pisano"
},
{
"name": "Dr. Aurea Lumbau"
},
{
"name": "Prof. Silvio Mario Meloni"
},
{
"name": "Prof. Edoardo Baldoni"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Università degli Studi di Sassari"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "1.Isometric exercise 2.combined conservative treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Radiculopathy"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "35 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy",
"nctId": "NCT06276699",
"orgStudyIdInfo": {
"id": "FAHS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline."
}
],
"secondaryOutcomes": [
{
"measure": "Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline."
},
{
"measure": "Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Peradeniya"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Supervised Vigorous intensity aerobic interval exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Locally Advanced Rectal Carcinoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer",
"nctId": "NCT06276686",
"orgStudyIdInfo": {
"id": "RS211 - 332296",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recruitment rate"
},
{
"measure": "Attendance rate"
},
{
"measure": "withdrawal rate"
}
],
"secondaryOutcomes": [
{
"measure": "Serum Carcinoembryonic antigen levels"
},
{
"measure": "Quality of life"
},
{
"measure": "Quality of life"
},
{
"measure": "Physical activity levels"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hull University Teaching Hospitals NHS Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Hull"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Delfi"
}
]
},
"conditionsModule": {
"conditions": [
"Blood Vessel Disease",
"Muscle Edema"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salisbury",
"contacts": null,
"country": "United States",
"facility": "Salisbury University",
"geoPoint": {
"lat": 38.36067,
"lon": -75.59937
},
"state": "Maryland",
"status": null,
"zip": "21801"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Unable to blind due to differences in cuff size and appearance.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs",
"nctId": "NCT06276673",
"orgStudyIdInfo": {
"id": "301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Arterial Stiffness"
},
{
"measure": "Muscle Morphology"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Salisbury University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BCTT"
},
{
"name": "Dynamic ExIT"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Traumatic Brain Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Cynthia Holland, MPH",
"phone": "412-904-1298",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UPMC/Univ of Pgh Sports Medicine Concussion Research Program",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "15203"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test",
"nctId": "NCT06276660",
"orgStudyIdInfo": {
"id": "STUDY23070079",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physiological response to dynamic or aerobic test (HEART RATE)"
}
],
"secondaryOutcomes": [
{
"measure": "Post Concussion Symptom Scale"
},
{
"measure": "Patient Health Questionnaire (PHQ-9)"
},
{
"measure": "Generalized Anxiety Disorder (GAD-7)"
},
{
"measure": "Vestibular Ocular Motor Screening (VOMS)"
},
{
"measure": "Clinical Profiles Screening (CP-Screen)"
},
{
"measure": "Blood Pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pittsburgh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HOME"
}
]
},
"conditionsModule": {
"conditions": [
"Maternal Behavior",
"Postpartum Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Elizabeth Howell, MD MPP",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Micki Burdick, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elizabeth Howell, MD MPP",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Hospital of the University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question\\[s\\] it aims to answer are:\n\n* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?\n* How can the investigators increase the ability of participants to \"obtain needed services\" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?\n\nParticipants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 214,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "HOME",
"briefTitle": "Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk",
"nctId": "NCT06276647",
"orgStudyIdInfo": {
"id": "850584",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01MD016029",
"link": "https://reporter.nih.gov/quickSearch/R01MD016029",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Emergency Department (ED) Visits and Readmissions"
}
],
"secondaryOutcomes": [
{
"measure": "Ability to Obtain Needed Services"
},
{
"measure": "Depressive Symptoms"
},
{
"measure": "Depressive Symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
},
{
"name": "Columbia University"
},
{
"name": "National Institute on Minority Health and Health Disparities (NIMHD)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acute Intermittent Hypoxia"
},
{
"name": "Sham-Acute Intermittent Hypoxia"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis",
"Multiple Sclerosis-Relapsing-Remitting",
"Multiple Sclerosis, Secondary Progressive"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Alexander Barry, MS, CCRC",
"phone": "312-238-1435",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Milap Sandhu, PT, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Molly Bright, D.Phil.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Shirley Ryan AbilityLab",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60611"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intermittent Hypoxia in Persons With Multiple Sclerosis",
"nctId": "NCT06276634",
"orgStudyIdInfo": {
"id": "STU00219535",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R21HD108587",
"link": "https://reporter.nih.gov/quickSearch/R21HD108587",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Timed 25 Feet Walk test"
},
{
"measure": "Six-Minute Walk test"
},
{
"measure": "Stride length"
},
{
"measure": "12-Item Multiple Sclerosis walk scale (MSWS-12)"
},
{
"measure": "Resting-State fMRI"
}
],
"primaryOutcomes": [
{
"measure": "Ankle Plantarflexion Strength"
}
],
"secondaryOutcomes": [
{
"measure": "Task fMRI"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"
},
{
"name": "Northwestern University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shirley Ryan AbilityLab"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Family Bridge Program"
},
{
"name": "Care as usual - resources only"
}
]
},
"conditionsModule": {
"conditions": [
"Healthcare Inequities",
"General Pediatric Medical Conditions",
"Healthcare System Navigation",
"Patient-provider Communication"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Pediatric healthcare inequities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP).\n\nThe FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children of color, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.\n\nIn pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children of color. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits for families of low-income children of color; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children of color, including those who prefer a language other than English for their medical care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 728,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Family Bridge Program",
"nctId": "NCT06276621",
"orgStudyIdInfo": {
"id": "STUDY00003564",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "System Navigation Ability"
},
{
"measure": "Pediatric Transition Experience Measure (P-TEM)"
}
],
"secondaryOutcomes": [
{
"measure": "Diagnosis Comprehension"
},
{
"measure": "Perceived Stress Scale"
},
{
"measure": "Observed Communication: utterances in which team offers information"
},
{
"measure": "Observed Communication: utterances in which team offers supportive talk"
},
{
"measure": "Observed Communication: utterances in which parent asks questions"
},
{
"measure": "Observed Communication: utterances in which parent responds assertively"
},
{
"measure": "Observed Communication: parent talk-time"
},
{
"measure": "Observed Communication: global partnership rating"
},
{
"measure": "30-day readmissions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Children's Hospital of Philadelphia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Seattle Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Iron status"
}
]
},
"conditionsModule": {
"conditions": [
"Iron Deficiencies",
"Iron Deficiency Anemia",
"Cardiac Surgical Procedures",
"Congenital Heart Disease in Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussels",
"contacts": [
{
"email": "[email protected]",
"name": "Denis Schmartz, MD",
"phone": "+3225553919",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "H.U.B - Hôpital Universitaire des Enfants Reine Fabiola",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "RECRUITING",
"zip": "1020"
}
]
},
"descriptionModule": {
"briefSummary": "The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Iron Deficiency in Pediatric Heart Surgery",
"nctId": "NCT06276608",
"orgStudyIdInfo": {
"id": "PED_Fe_def",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of preoperative iron deficiency (%)"
},
{
"measure": "Complications"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Queen Fabiola Children's University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)"
},
{
"name": "Control condition - 3 Monthly Group Activities in the Community"
}
]
},
"conditionsModule": {
"conditions": [
"Substance Use",
"Sexual Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Whiteriver",
"contacts": null,
"country": "United States",
"facility": "White Mountain Apache Center for Indigenous Health",
"geoPoint": {
"lat": 33.83699,
"lon": -109.96427
},
"state": "Arizona",
"status": null,
"zip": "85941"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. This project will evaluate the impact of \"Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 183,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "8 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TODOS",
"briefTitle": "Telling Our Daughters Our Story",
"nctId": "NCT06276595",
"orgStudyIdInfo": {
"id": "IRB00009466",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in child cultural knowledge score on knowledge assessment"
},
{
"measure": "Change in average score on risky behaviors assessment"
},
{
"measure": "Change in child reproductive health knowledge via a reproductive health knowledge questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "White Mountain Apache Tribe"
},
{
"name": "Native American Research Centers for Health"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins Bloomberg School of Public Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2022-03-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Screening for neonatal jaundice with a mobile health device"
}
]
},
"conditionsModule": {
"conditions": [
"Jaundice, Neonatal"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oaxaca",
"contacts": [
{
"email": "[email protected]",
"name": "Rey Manuel Silva Mendez",
"phone": "+529511283520",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Mexico",
"facility": "Hospital General de Zona 1",
"geoPoint": {
"lat": 17.06542,
"lon": -96.72365
},
"state": null,
"status": "RECRUITING",
"zip": "68040"
}
]
},
"descriptionModule": {
"briefSummary": "The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Days",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.",
"nctId": "NCT06276582",
"orgStudyIdInfo": {
"id": "519379-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Accuracy of Picterus JP to screen for neonatal jaundice"
}
],
"primaryOutcomes": [
{
"measure": "Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between bilirubin measurements with Picterus JP and total serum bilirubin"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Picterus AS"
},
{
"name": "Instituto Mexicano del Seguro Social"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Norwegian University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sivelestat"
},
{
"name": "placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Disease"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute respiratory distress syndrome (ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 384,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial.",
"nctId": "NCT06276569",
"orgStudyIdInfo": {
"id": "2023-LCYJ-MS-26",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Oxygenation index"
},
{
"measure": "Inflammatory index"
},
{
"measure": "Myocardial injury marker"
},
{
"measure": "Acute physiology and chronic health evaluation(APACHE II) socre"
},
{
"measure": "Murray socre"
},
{
"measure": "ICU time"
},
{
"measure": "In-hospital time"
},
{
"measure": "30-day all-cause mortality"
},
{
"measure": "90-day all-cause mortality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ABP-671"
},
{
"name": "Allopurinol"
}
]
},
"conditionsModule": {
"conditions": [
"Gout"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tempe",
"contacts": null,
"country": "United States",
"facility": "Alliance for Multispecialty Research",
"geoPoint": {
"lat": 33.41477,
"lon": -111.90931
},
"state": "Arizona",
"status": null,
"zip": "85281"
},
{
"city": "Tucson",
"contacts": null,
"country": "United States",
"facility": "Tucson Neuroscience Research, LLC",
"geoPoint": {
"lat": 32.22174,
"lon": -110.92648
},
"state": "Arizona",
"status": null,
"zip": "85710"
},
{
"city": "Anaheim",
"contacts": null,
"country": "United States",
"facility": "Anaheim Clinical Trials (Cenexel ACT)",
"geoPoint": {
"lat": 33.83529,
"lon": -117.9145
},
"state": "California",
"status": null,
"zip": "92801"
},
{
"city": "Sacramento",
"contacts": null,
"country": "United States",
"facility": "Center for Clinical Trials of Sacramento",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California",
"status": null,
"zip": "95823"
},
{
"city": "Brooksville",
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"name": "EOS imaging for musculoskeletal disorder"
},
{
"name": "Movement analysis by an optoelectronic camera."
},
{
"name": "Stabilometric measurement by strength platform"
}
]
},
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"Resectable Lung Non-Small Cell Carcinoma"
]
},
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"locations": [
{
"city": "Paris",
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{
"email": "[email protected]",
"name": "Harry ETIENNE, M.D., PhD",
"phone": "+33 6 67 96 82 89",
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}
],
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},
"state": null,
"status": null,
"zip": "75020"
}
]
},
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"briefSummary": "This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy."
},
"designModule": {
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},
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},
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"count": 50,
"type": "ESTIMATED"
},
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],
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},
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]
},
"identificationModule": {
"acronym": "VaPosVent",
"briefTitle": "Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling",
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"id": "APHP231036",
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"type": null
},
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},
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{
"measure": "Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS)"
}
],
"secondaryOutcomes": [
{
"measure": "Width of rib cage (EOS)"
},
{
"measure": "Rib cage volume (EOS)"
},
{
"measure": "\" Umbrella \"angle (EOS)"
},
{
"measure": "Center of Pressure displacement (Optoelectronic system)"
}
]
},
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"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
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"completionDateStruct": {
"date": "2025-03"
},
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"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-02"
},
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"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "questionnaire"
},
{
"name": "SS-QoL"
},
{
"name": "SF-36"
},
{
"name": "CIQ-R"
},
{
"name": "BREFF"
},
{
"name": "MoCA"
},
{
"name": "IADL"
},
{
"name": "mMRS"
},
{
"name": "PCL-5"
},
{
"name": "Brief-Cope"
}
]
},
"conditionsModule": {
"conditions": [
"Intracranial Hemorrhages"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
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},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HIDDEN",
"briefTitle": "Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom",
"nctId": "NCT06276517",
"orgStudyIdInfo": {
"id": "APHP220918",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IDRCB",
"id": "2022-A01739-34",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome."
}
],
"secondaryOutcomes": [
{
"measure": "- study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year"
},
{
"measure": "To study the prevalence of post-traumatic stress in this population"
},
{
"measure": "Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
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"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2028-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection"
}
]
},
"conditionsModule": {
"conditions": [
"Progressive Multifocal Leukoencephalopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Nicolas WEISS, Pr",
"phone": "+33 (0)1 42 16 27 70",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation",
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"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75013"
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Damien ROOS-WEIL, Dr",
"phone": "+33 (0)1 42 16 15 96",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Pitié-Salpêtrière - Service d'hématologie clinique",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75013"
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Valérie POURCHER, Pr",
"phone": "+33 (0)1 42 16 02 62",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Pitié-Salpêtrière - Service des Maladies infectieuses et tropicales",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75013"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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},
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},
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"count": 33,
"type": "ESTIMATED"
},
"phases": [
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"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PENALTY",
"briefTitle": "Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection",
"nctId": "NCT06276504",
"orgStudyIdInfo": {
"id": "APHP211001",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CT number",
"id": "2023-503520-31-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period"
}
],
"secondaryOutcomes": [
{
"measure": "Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event"
},
{
"measure": "Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF)"
},
{
"measure": "Repositivation of JCV PCR: at least a positive result following at least a negative result"
},
{
"measure": "Evolution of National Institutes of Health Stroke Scale (NIHSS) score"
},
{
"measure": "Evolution of 6-item Modified Rankin Scale score (includes death as most severe state)"
},
{
"measure": "Evolution of Glasgow Outcome Scale Extended (GOS-E) score"
},
{
"measure": "Relapse or progression"
},
{
"measure": "Death (and date of death)"
},
{
"measure": "Cause specific death: death related to PML"
},
{
"measure": "Any adverse event classified by using US NCI CTCAE"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
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"primaryCompletionDateStruct": {
"date": "2028-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "XmAb541"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer",
"Endometrial Cancer",
"Germ Cell Tumor",
"Testicular Germ Cell Tumor",
"Ovarian Germ Cell Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bronx",
"contacts": null,
"country": "United States",
"facility": "Montefiore Einstein Comprehensive Cancer Center",
"geoPoint": {
"lat": 40.84985,
"lon": -73.86641
},
"state": "New York",
"status": "RECRUITING",
"zip": "10461"
}
]
},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate effect of XmAb541 on tumor outcomes."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Dose escalation and expansion study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 212,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors",
"nctId": "NCT06276491",
"orgStudyIdInfo": {
"id": "XmAb541-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Adverse Events"
},
{
"measure": "Incidence of dose-limiting toxicities (DLTs)"
},
{
"measure": "Incidence of cytokine release syndrome (CRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Measurement of Cmax"
},
{
"measure": "Measurement of area under curve (AUC)"
},
{
"measure": "Measurement of Ctrough"
},
{
"measure": "Objective Response Rate"
},
{
"measure": "Duration of Response"
},
{
"measure": "Changes in Circulating Tumor DNA (ctDNA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Xencor, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AI-video"
},
{
"name": "Verbal instructions"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Anxiety",
"Dental Phobia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pavia",
"contacts": null,
"country": "Italy",
"facility": "Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": "Lombardy",
"status": null,
"zip": "27100"
}
]
},
"descriptionModule": {
"briefSummary": "Pediatric patients who will be attending dental treatment at both the Orthodontics and Pediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences at the University of Pavia, Pavia, Italy and a private dental practice in Genoa, Italy, will be recruited for the study.\n\nA cartoon version of a small molar will be drawn using the software Paint (version 22000.0, Microsoft Corporation, Redmond, Washington State, U.S.). The drawing will be animated using an AI-based software (Sketch MetaDemolab, Meta AI Research, Astor Place, New York city, New York, U.S.). A text will be created in collaboration with OpenAI (version 3.5, Open AI, San Francisco, California, U.S.) to be integrated into the video, utilizing terminology deemed most suitable for a patient with dental anxiety. The text will be transformed from written to spoken dialogue using an AI-based software (Flexclip, version 5.6.0, PearlMountain, Hong Kong, China), and then incorporated into the video.\n\nChildren will undergo the first dental visit at the baseline (T0), in which the following indexes will be assessed: Modified Dental Anxiety Scale (MDAS), Face-Leg-Activity-Cry-Consolability Scale (FLACC), Simplified Oral Hygiene Index (OHI-S), Bleeding on Probing (BOP) and the International Caries Detection and Assessment System (ICDAS). They will be randomly divided into two group:\n\n* in the Trial group, patients will watch the the video, and then the tell-show-do technique will be used to explain the dental procedures;\n* in the Control group, only the \"tell-show-do\" technique will be used. Variables considered will include age, gender, and the presence/absence of a parent or another companion.\n\nAt the second visit (T1), scheduled approximately after two weeks, the variables will be re-evaluated and professional debridement will be performed with a piezoelectric instrument (Satelect Acteon Newton p5 xs,Acteon Group, Mèrignac, France and Sonicflex Kavo, KaVo Dental, Biberach an der Riss, Germany) and manual scaler/curettes (Courette 9/10, 11/12 and 13/14 Gracey and Scaler lm 23, Hu Friedy, Europe). Values will be registered again, for the third time, after the professional debridement."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence",
"nctId": "NCT06276478",
"orgStudyIdInfo": {
"id": "2024-PEDOAI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997)"
},
{
"measure": "Change in Bleeding on Probing - BoP (Löe H. et al.,1967)"
},
{
"measure": "Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964)"
},
{
"measure": "International Caries Detection and Assessment System - ICDAS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pavia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Darolutamide 300 mg"
},
{
"name": "Stereotactic body radiation therapy"
},
{
"name": "Androgen deprivation therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Prostatic Cancer, Castration-Resistant"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.\n\nIn the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.\n\nAn early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.\n\nThe treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.\n\nThe principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Eligible patients will be randomly allocated in a 1:1 ratio to either the:\n\n* Control arm: ADT + darolutamide.\n* Experimental arm: ADT + darolutamide + SBRT.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 336,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PEACE8",
"briefTitle": "Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging",
"nctId": "NCT06276465",
"orgStudyIdInfo": {
"id": "UC-GTG-2306",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU-CT",
"id": "2023-507482-26-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Radiographic Progression-free survival (rPFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Time to treatment failure (TTF)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Prostate cancer-specific survival"
},
{
"measure": "Time to PSA progression"
},
{
"measure": "Biochemical response rate"
},
{
"measure": "Time to next symptomatic skeletal event (SSE)"
},
{
"measure": "Time to pain progression"
},
{
"measure": "Safety/tolerance"
},
{
"measure": "Functional Assessment of CAncer Therapy - Prostate (FACT-P)"
},
{
"measure": "Brief Pain Inventory - Short Form (BP-SFI) questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bayer"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "UNICANCER"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Psychoeducation"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Louisville",
"contacts": [
{
"email": "[email protected]",
"name": "Stephanie Grace Prost, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "New Legacy Reentry",
"geoPoint": {
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"lon": -85.75941
},
"state": "Kentucky",
"status": "RECRUITING",
"zip": "40203"
}
]
},
"descriptionModule": {
"briefSummary": "The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.\n\nAim 1 participants will:\n\n* complete a baseline survey\n* participate in a focus group\n\nAim 2 participants will:\n\n* complete a baseline survey\n* participate in an 8-week once weekly intervention\n* complete three follow up surveys"
},
"designModule": {
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
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"minimumAge": "45 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SRRS",
"briefTitle": "Supporting Resilience Among Re-entered Seniors",
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"id": "23.0434",
"link": null,
"type": null
},
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{
"domain": null,
"id": "U2CDA050097",
"link": "https://reporter.nih.gov/quickSearch/U2CDA050097",
"type": "NIH"
}
]
},
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"primaryOutcomes": [
{
"measure": "Chronic disease self managment"
}
],
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},
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"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
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"class": "OTHER",
"name": "University of Louisville"
}
},
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"date": "2024-11-30"
},
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"date": "2024-03-15"
},
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"date": "2024-11-30"
},
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"date": "2024-03-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surgical removal of breast cancer and lymph nodes"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Skopje",
"contacts": [
{
"email": "[email protected]",
"name": "Viktor Gruev, PhD",
"phone": "+1.267.847.4020",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Goran Kondov, MD, PHD",
"phone": "+389 70 252010",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "North Macedonia",
"facility": "University Clinic Hospital",
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"lon": 21.43141
},
"state": null,
"status": "RECRUITING",
"zip": "1000"
}
]
},
"descriptionModule": {
"briefSummary": "One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers."
},
"designModule": {
"designInfo": {
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"interventionModel": null,
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},
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},
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},
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"sex": "FEMALE",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
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"nctId": "NCT06276439",
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"id": "IRB23-0314",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Positive lymph node detection with custom sensors"
}
],
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},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "U.S. National Science Foundation"
},
{
"name": "Ss. Cyril and Methodius University of Skopje, Macedonia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Urbana-Champaign"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-19"
},
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"date": "2024-02-26"
},
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"date": "2025-03-30"
},
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"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Soy foods"
},
{
"name": "Non-Soy Plant-Based Foods"
}
]
},
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"conditions": [
"Healthy Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Urbana",
"contacts": [
{
"email": "[email protected]",
"name": "Naiman Khan, PhD, RD",
"phone": "217-300-2197",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Naiman Khan, PhD, RD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Illinois",
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"lat": 40.11059,
"lon": -88.20727
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "61801"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PODS",
"briefTitle": "Plants Optimizing Development Study (PODS)",
"nctId": "NCT06276426",
"orgStudyIdInfo": {
"id": "24468",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Sex steroid excretion"
}
],
"secondaryOutcomes": [
{
"measure": "Gut microbiota"
},
{
"measure": "Attentional Accuracy"
},
{
"measure": "Attentional Reaction Time"
},
{
"measure": "Hippocampal-dependent Relational memory"
},
{
"measure": "Body Composition"
},
{
"measure": "Metabolic Markers"
},
{
"measure": "Pubertal Staging"
},
{
"measure": "Cognitive Abilities and Academic Achievement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Soy Nutrition Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Urbana-Champaign"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
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"date": "2026-09-30"
},
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"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GORE TAG Thoracic Branch Endoprosthesis"
}
]
},
"conditionsModule": {
"conditions": [
"Aortic Aneurysm, Thoracic",
"Aortic Dissection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Padova",
"contacts": [
{
"email": "[email protected]",
"name": "Michele Piazza, Pr",
"phone": "3498644688",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Vascular and Endovascular Clinic - Padova University",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": null,
"zip": "35020"
}
]
},
"descriptionModule": {
"briefSummary": "Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "REBRA",
"briefTitle": "REgistRy BRAnch goRE EndopRosthEsis",
"nctId": "NCT06276413",
"orgStudyIdInfo": {
"id": "REBRA",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "REBRA",
"id": "REBRA",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "early mortality"
},
{
"measure": "device stability"
},
{
"measure": "technical success"
}
],
"secondaryOutcomes": [
{
"measure": "early major adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Padova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emotion valence"
},
{
"name": "Time"
},
{
"name": "TMS Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santa Barbara",
"contacts": null,
"country": "United States",
"facility": "University of California, Santa Barbara",
"geoPoint": {
"lat": 34.42083,
"lon": -119.69819
},
"state": "California",
"status": "RECRUITING",
"zip": "93106"
}
]
},
"descriptionModule": {
"briefSummary": "To support optimal behavior in daily life, goals and responses following emotional events should ideally incorporate not only the valence and intensity of prior emotional episodes but also their temporal features, such as the relative duration of positive vs. negative attributes. However, how specific brain regions contribute to the integration of temporal and emotional information and promote goal-directed response remains unknown.\n\nThe goal of this study is to examine how specific brain regions track both emotional and temporal information of dynamic emotional events to inform other related brain regions to guide goal-oriented and context-appropriate actions. The investigators will scan healthy human participants using functional MRI (fMRI) while they view emotional image sequences and track the associated emotional and temporal (duration) information, and act accordingly. The investigators will employ multivariate patterns analysis and pattern similarity analysis to identify brain regions that represent (can decode) emotion, time, and their combined signals, as well as brain regions that represent the associated action goal. In addition, to infer the causal contributions of these brain regions in forming task-relevant representations (emotion, time, and action goal), the same participants will be recruited to receive transcranial magnetic stimulation (TMS) in these regions."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns).",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "LPFC Organization in Emotion-Duration Difference Estimation",
"nctId": "NCT06276400",
"orgStudyIdInfo": {
"id": "4-24-0023:1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Multivariate BOLD metrics"
},
{
"measure": "Behavioral response"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Santa Barbara"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindfulness Program"
}
]
},
"conditionsModule": {
"conditions": [
"Arthritis, Rheumatoid"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": null,
"country": "United States",
"facility": "Osher Center for Integrative Health",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": "RECRUITING",
"zip": "94115"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:\n\n* Assess patient satisfaction with a mindfulness course\n* Identify barriers to participation in, or completion of, a mindfulness course\n* Gather initial information to understand how a mindfulness course impacts RA symptoms\n\nParticipants will:\n\n* Complete online questionnaires\n* Attend two in-person study visits, involving a brief joint exam and blood draw\n* Roughly half the participants will have the chance to participate in an 8-week online mindfulness course\n* Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course\n\nResearchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomly assigned to participate in a mindfulness-based stress reduction (MBSR) course or treatment as usual (TAU). Randomization will be done using a program-tracking system.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DREAMER",
"briefTitle": "Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis",
"nctId": "NCT06276387",
"orgStudyIdInfo": {
"id": "K23AT011768-01",
"link": "https://reporter.nih.gov/quickSearch/K23AT011768-01",
"type": "NIH"
},
"secondaryIdInfos": [
{
"domain": null,
"id": "K23AT011768",
"link": "https://reporter.nih.gov/quickSearch/K23AT011768",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Clinical Disease Activity Index (CDAI)"
},
{
"measure": "Disease Activity Score in 28 Joints (DAS-28)"
},
{
"measure": "Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5)"
},
{
"measure": "Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale"
},
{
"measure": "Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale"
},
{
"measure": "Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale"
},
{
"measure": "Perceived Stress Scale, 10-item"
},
{
"measure": "Brief Resilience Scale"
}
],
"primaryOutcomes": [
{
"measure": "Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study"
}
],
"secondaryOutcomes": [
{
"measure": "MBSR Course Attendance (Intervention Adherence)"
},
{
"measure": "Percent of Study Completers (Study Retention)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Center for Complementary and Integrative Health (NCCIH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Francisco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patients who are scheduled to undergo carotid artery stenting"
}
]
},
"conditionsModule": {
"conditions": [
"Carotid Artery Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1556,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients",
"nctId": "NCT06276374",
"orgStudyIdInfo": {
"id": "SMC 2023-12-107",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinically significant bleeding"
}
],
"secondaryOutcomes": [
{
"measure": "Combined cardiovascular and cerebrovascular accidents"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Woo-Keun Seo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral risperidone; QUAR F1/2, Dose 1 - Gluteal"
},
{
"name": "Oral risperidone; QUAR F1/2, Dose 2 - Gluteal"
},
{
"name": "Oral risperidone; QUAR F1/2, Dose 3 - Gluteal"
},
{
"name": "Oral risperidone; QUAR F1/2, Dose 3 - Deltoids"
}
]
},
"conditionsModule": {
"conditions": [
"Schizophrenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amman",
"contacts": null,
"country": "Jordan",
"facility": "Investigational Site",
"geoPoint": {
"lat": 31.95522,
"lon": 35.94503
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "QUARTZ",
"briefTitle": "Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia",
"nctId": "NCT06276361",
"orgStudyIdInfo": {
"id": "ROV-QUAR-2023-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "λz"
},
{
"measure": "t1/2"
},
{
"measure": "Tmax"
},
{
"measure": "Cmax"
},
{
"measure": "Cmin"
},
{
"measure": "Clast"
},
{
"measure": "AUC0-t"
},
{
"measure": "AUCinf"
},
{
"measure": "AUCextrap"
},
{
"measure": "Vd/F"
},
{
"measure": "Cl/F"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Rovi Pharmaceuticals Laboratories"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Whole genome sequencing"
},
{
"name": "BeginNGS test"
},
{
"name": "WES"
}
]
},
"conditionsModule": {
"conditions": [
"Genetic Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": null,
"country": "United States",
"facility": "Rady Children's Hospital San Diego",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": null,
"zip": "92123"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:\n\n* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?\n* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?\n* What are the potential issues related to implementing DWGS in this population?\n\nEnrolled newborns will have a blood sample taken and will receive three tests:\n\n* DWGS\n* BeginNGS\n* WES"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single group, multiple interventions. All enrollees receive all interventions.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Days",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Newborn Genomic Sequencing Pilot Study",
"nctId": "NCT06276348",
"orgStudyIdInfo": {
"id": "20226892",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of enrolled infants who are diagnosed with a genetic disease by DWGS."
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of enrolled infants who are identified with a genetic disease by BeginNGS."
},
{
"measure": "Proportion of enrolled infants who are identified with a genetic disease by WES."
},
{
"measure": "Proportion of enrolled infants who have a positive standard NBS test."
},
{
"measure": "Proportion of parents approached who agree to participate in the study."
},
{
"measure": "Parental reasons for refusal."
},
{
"measure": "Time from sample arriving in lab to return of DWGS results."
},
{
"measure": "Time from birth to return of DWGS results."
},
{
"measure": "Results of confirmatory testing if BeginNGS or WES identifies a diagnostic finding not reported by DWGS."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rady Pediatric Genomics & Systems Medicine Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-04"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-26"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Immediate implant placement and guided bone regeneration (Test)"
},
{
"name": "Late implant placement and guided bone regeneration (Control)"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Implant",
"Healing Wound",
"Biomarkers",
"Saliva"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Nikolaos Donos, DDS MS PhD",
"phone": "+44(0)2078823063",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Vandana Luthra, Dr",
"phone": "+44(0)2078826348",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nikolaos Donos, DDS MS PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Centre for Oral Clinical Research",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "E1 2AD"
}
]
},
"descriptionModule": {
"briefSummary": "Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP).\n\nThe primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Influence of Timing of Implant Placement on Early Healing Molecular Events",
"nctId": "NCT06276335",
"orgStudyIdInfo": {
"id": "IRAS:322440",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva"
}
],
"secondaryOutcomes": [
{
"measure": "Blood flow changes"
},
{
"measure": "Soft tissue volume changes"
},
{
"measure": "Peri-implant bone level"
},
{
"measure": "Full mouth plaque score (FMPS)"
},
{
"measure": "Full mouth bleeding score (FMBS)"
},
{
"measure": "Probing pocket depth (PPD)"
},
{
"measure": "Gingival recession (REC)"
},
{
"measure": "Clinical attachment level (CAL)"
},
{
"measure": "Suppuration"
},
{
"measure": "Patient satisfaction at 6 months after loading"
},
{
"measure": "Changes in the pink esthetic score (PES)"
},
{
"measure": "Changes in the white esthetic score (WES)"
},
{
"measure": "Changes in the papilla fill index (PFI)"
},
{
"measure": "Implant survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Zurich"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low back pain group"
},
{
"name": "Healthy group"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Sümeyye Zehra Güler, MSc",
"phone": "5079320390",
"phoneExt": "+90",
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Hacettepe university",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Altındağ",
"status": "RECRUITING",
"zip": "06050"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Low back pain group and healthy group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of All Spine Segments ın Individuals With Low Back Pain",
"nctId": "NCT06276322",
"orgStudyIdInfo": {
"id": "HU-FTR-SZK-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the kinematics of the all spine during walking"
},
{
"measure": "Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects"
},
{
"measure": "Evaluation of the kinematics of the all spine during Standing from Sitting"
},
{
"measure": "Evaluation of the kinematics of the all spine during Climbing Step"
}
],
"secondaryOutcomes": [
{
"measure": "Spine Normal Joint Movement evaluation"
},
{
"measure": "Pain intensity: Visual Analog Scale"
},
{
"measure": "Oswestry Disability Index"
},
{
"measure": "Fear of movement: Tampa Kinesiophobia Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Neuroendocrine Neoplasm",
"China",
"Women",
"Cervical Cancer",
"Cervical Lesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Binhua Dong",
"phone": "+8687558732",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fujian Maternity and Child Health Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": "RECRUITING",
"zip": "350001"
},
{
"city": "Fuzhou",
"contacts": [
{
"email": null,
"name": "Dongjie Chen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fujian Provincial Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": "RECRUITING",
"zip": null
},
{
"city": "Ningde",
"contacts": [
{
"email": null,
"name": "Fang Xie",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ningde Mindong Hospital",
"geoPoint": {
"lat": 26.66167,
"lon": 119.52278
},
"state": "Fujian",
"status": "RECRUITING",
"zip": null
},
{
"city": "Putian",
"contacts": [
{
"email": null,
"name": "Yi Chen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Putian City first Hospital",
"geoPoint": {
"lat": 25.43944,
"lon": 119.01028
},
"state": "Fujian",
"status": "RECRUITING",
"zip": null
},
{
"city": "Quanzhou",
"contacts": [
{
"email": null,
"name": "Luhong Li",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Fujian Medical University",
"geoPoint": {
"lat": 24.91389,
"lon": 118.58583
},
"state": "Fujian",
"status": "RECRUITING",
"zip": null
},
{
"city": "Zhangzhou",
"contacts": [
{
"email": null,
"name": "Feifeng Shi, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhangzhou affiliated Hospital of Fujian Medical University",
"geoPoint": {
"lat": 24.51333,
"lon": 117.65556
},
"state": "Fujian",
"status": "RECRUITING",
"zip": "363000"
},
{
"city": "Wuhan",
"contacts": [
{
"email": null,
"name": "Hongning Cai, M.D",
"phone": "+8615926224867",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Maternal and Child Health Hospital of Hubei Province",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": "RECRUITING",
"zip": null
},
{
"city": "Changsha",
"contacts": [
{
"email": null,
"name": "Yu Zhang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xiangya Hospital, Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": "RECRUITING",
"zip": null
},
{
"city": "Nanchang",
"contacts": [
{
"email": null,
"name": "Ling Li",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jiangxi maternal and Child Health Hospital",
"geoPoint": {
"lat": 28.68396,
"lon": 115.85306
},
"state": "Jiangxi",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors",
"nctId": "NCT06276309",
"orgStudyIdInfo": {
"id": "NECC2401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "mortality rate"
},
{
"measure": "Disease-free survival"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fujian Maternity and Child Health Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Holter EKG - 1 day before ablation"
},
{
"name": "Radiofrequency ablation"
},
{
"name": "Pulsed field ablation"
},
{
"name": "Holter EKG - 1 month after ablation"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Prague",
"contacts": [
{
"email": "[email protected]",
"name": "Jana Vesela, Ing.,Ph.D.",
"phone": "+420267162714",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Pavel Osmancik, MD,Ph.D.",
"phone": "+420267162714",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": null,
"status": "RECRUITING",
"zip": "10034"
}
]
},
"descriptionModule": {
"briefSummary": "Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Heart Rate Variability After Ablation",
"nctId": "NCT06276296",
"orgStudyIdInfo": {
"id": "0001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean RR interval (ms)"
},
{
"measure": "SDNN (ms)"
},
{
"measure": "RMSSD (ms)"
},
{
"measure": "pNN50 (%)"
},
{
"measure": "peak frequency (Hz)"
},
{
"measure": "power (ms2)"
},
{
"measure": "LF/HF ratio"
},
{
"measure": "SD1 (ms)"
},
{
"measure": "SD2 (ms)"
},
{
"measure": "SD2/SD1"
},
{
"measure": "ApEn"
},
{
"measure": "Correlation dimension"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vascular surgery, University hospital Královské Vinohrady, Prague"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Charles University, Czech Republic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DZD9008 plus Bevacizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": null,
"name": "Lu, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai Chest Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200030"
}
]
},
"descriptionModule": {
"briefSummary": "This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)",
"nctId": "NCT06276283",
"orgStudyIdInfo": {
"id": "DZ2022E0006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs."
}
],
"secondaryOutcomes": [
{
"measure": "Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Dizal Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mucopad HA"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Mucositis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brno",
"contacts": [
{
"email": "[email protected]",
"name": "Tomáš Novotný",
"phone": "+420543131103",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Masarykův onkologický ústav, Klinika radiační onkologie",
"geoPoint": {
"lat": 49.19522,
"lon": 16.60796
},
"state": "Česká Republika",
"status": "RECRUITING",
"zip": "56401"
},
{
"city": "Hradec Králové",
"contacts": [
{
"email": "[email protected]",
"name": "Milan Vošmik",
"phone": "+420495832316",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "FN Hradec Králové Klinika onkologie a radioterapie",
"geoPoint": {
"lat": 50.20923,
"lon": 15.83277
},
"state": "Česká Republika",
"status": "RECRUITING",
"zip": "56401"
},
{
"city": "Ostrava",
"contacts": [
{
"email": "[email protected]",
"name": "Jana Jackaninová",
"phone": "+420597371111",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Fakultní nemocnice Ostrava, Klinika onkologická",
"geoPoint": {
"lat": 49.83465,
"lon": 18.28204
},
"state": "Česká Republika",
"status": "RECRUITING",
"zip": "56401"
},
{
"city": "Praha",
"contacts": [
{
"email": "[email protected]",
"name": "Petra Holečková",
"phone": "+420266084516",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Etická komise FN Bulovka",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": "Česká Republika",
"status": "RECRUITING",
"zip": "56401"
},
{
"city": "Praha",
"contacts": [
{
"email": "[email protected]",
"name": "Radka Lohynská",
"phone": "+420261083890",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": "Česká Republika",
"status": "RECRUITING",
"zip": "56401"
}
]
},
"descriptionModule": {
"briefSummary": "The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Multi-centre, Open-label, First-in-man Study With Mucopad HA",
"nctId": "NCT06276270",
"orgStudyIdInfo": {
"id": "PT-MUC-1_05-21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Resolution of mucositis symptoms since completion of radiotherapy"
}
],
"secondaryOutcomes": [
{
"measure": "- Pain management (VAS scale)"
},
{
"measure": "Development of xerostomy"
},
{
"measure": "Subjective evaluation on scale 1-5 of the treatment by investigator/ patient"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Contipro Pharma a.s."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Paravertebral block"
},
{
"name": "Usual analgesia"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Pain"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.\n\nThe main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Paravertebral Block for Mastectomy With Immediate Reconstruction",
"nctId": "NCT06276257",
"orgStudyIdInfo": {
"id": "2024-7301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of postoperative pain using the BPI"
}
],
"secondaryOutcomes": [
{
"measure": "Total use of opioids received intraoperatively."
},
{
"measure": "Use of non-opioid analgesia intraoperatively"
},
{
"measure": "Total dose of opioids received in the PACU"
},
{
"measure": "Time before first opioid"
},
{
"measure": "Total opioids consumed in the 48 hours following surgery"
},
{
"measure": "Chronic pain"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "CHU de Quebec-Universite Laval"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"CDM",
"ChDM"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "Fondazione Serena Onlus - Centro Clinico NeMO Milano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20162"
}
]
},
"descriptionModule": {
"briefSummary": "Children with congenital myotonic dystrophy (CDM) present at birth with respiratory insufficiency, talipes equinovarus, feeding difficulties and hypotonia. There is a 30% mortality rate in the first year of life. Children with childhood onset myotonic dystrophy present with symptoms later on but soon develop behavioural difficulties and learning difficulties and are at risk for autistic features and gastrointestinal symptoms. The ability to conduct a therapeutic trial in children with CDM or ChDM is directly limited by the lack of available data regarding appropriate clinical endpoints and biomarkers. Whereas there is an active Italian collaboration recruiting adults with DM1 to study muscle and multisystem aspects in this population, there is no active network in Italy involved in the pediatric population with DM1. Though the underlying mechanism is the same in adult DM1, in CDM and ChDM there are specific challenges to the pediatric population. The aim of this project is to coordinate the Italian Child Neurologist actively involved with CDM and ChDM in a common effort of standardizing protocols and procedures to be applied in the care of these patients. Specific aims are to collect functional measures and clinical information over time to define clinically meaningful endpoints and outcome measures in preparation for international therapeutic clinical trials. This project will contribute to the ongoing international study in CDM by recruiting additional patients from all over Italy and will extend the investigations to the childhood onset forms as an additional add-on pilot study in view of potential treatment options. The investigators expect that the Italian network, with Telethon support, will provide the necessary backbone for trial readiness in the pediatric population both at the national and international levels."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "GUP19002",
"briefTitle": "Trial Readiness and Endpoint Assessment in Congenital and Childhood Myotonic Dystrophy",
"nctId": "NCT06276244",
"orgStudyIdInfo": {
"id": "NM040-GUP19002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physical function"
},
{
"measure": "Physical function"
},
{
"measure": "Cognitive-behavioral and Quality of Life"
},
{
"measure": "Cognitive-behavioral and Quality of Life"
},
{
"measure": "Biomarkers"
},
{
"measure": "Biomarkers"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bambino Gesù Hospital and Research Institute"
},
{
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
},
{
"name": "IRCCS Istituto delle Scienze Neurologiche di Bologna"
},
{
"name": "IRCCS Fondazione Stella Maris"
},
{
"name": "IRCCS Istituto Neurologico Mondino, Pavia, Italy"
},
{
"name": "Azienda Ospedaliera Città della Salute e della Scienza di Torino"
},
{
"name": "Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta"
},
{
"name": "Istituto Giannina Gaslini"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Serena Onlus - Centro Clinico NeMO Milano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-07-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Salbutamol"
},
{
"name": "0.9% Normal Saline"
},
{
"name": "Diclofenac Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Renal Colic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic.\n\nResearch Summary:\n\nINTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department.\n\nMETHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge.\n\nAIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic.\n\nPRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS).\n\nSECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge.\n\nPATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colic\n\nINTERVENTION: Single dose of Nebulized Salbutamol 10mg.\n\nCLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.\n\nOUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 214,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nebulized Salbutamol in Acute Renal Colic",
"nctId": "NCT06276231",
"orgStudyIdInfo": {
"id": "SalbuEase",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain reduction at 60 minutes"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse Event/Side Effects"
},
{
"measure": "Need of Rescue medications"
},
{
"measure": "Pain reduction rate."
},
{
"measure": "ED revisits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Oman Medical Speciality Board"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Clavicular brace"
}
]
},
"conditionsModule": {
"conditions": [
"Clavicle Fracture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Songkla",
"contacts": [
{
"email": "[email protected]",
"name": "Thanachai Klongsangsorn",
"phone": "+66991964733",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Thailand",
"facility": "Prince of Songkla University",
"geoPoint": {
"lat": 7.19882,
"lon": 100.5951
},
"state": "Hatyai",
"status": "RECRUITING",
"zip": "90110"
}
]
},
"descriptionModule": {
"briefSummary": "A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study",
"nctId": "NCT06276218",
"orgStudyIdInfo": {
"id": "PSU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "DASH"
}
],
"secondaryOutcomes": [
{
"measure": "Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prince of Songkla University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin D"
},
{
"name": "Levothyroxin"
}
]
},
"conditionsModule": {
"conditions": [
"Hypothyroidism Primary",
"Lipid Disorder",
"Dyslipidemias"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "AP Endocrinology",
"phone": "+923004683473",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "King Edward Medical University",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.\n\nThe main question it aims to answer is:\n\n• whether adding Vitamin D to standard therapy has any additional benefits\n\nParticipants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.\n\nResearchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ViDaLLiT",
"briefTitle": "Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism",
"nctId": "NCT06276205",
"orgStudyIdInfo": {
"id": "1037/RC/KEMU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Decline in Total Cholesterol"
},
{
"measure": "Decline in LDL"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "King Edward Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital Physiotherapy (diSAID)"
},
{
"name": "Traditional Physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Subacromial Pain Syndrome",
"Shoulder Pain",
"Rotator Cuff Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Linköping",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Petersson, PhD student",
"phone": "+46101031053",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Teresa Holmgren, PhD",
"phone": "+46101034158",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hanna Björnsson Hallgren, Associate Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Jenny Samuelsson, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Anna Petersson",
"geoPoint": {
"lat": 58.41086,
"lon": 15.62157
},
"state": null,
"status": null,
"zip": "SE 58191"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.\n\nThe main question this clinical trial aims to answer are:\n\n- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Non-Inferiority Randomised Controlled Trial",
"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": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "diSAID",
"briefTitle": "Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care",
"nctId": "NCT06276192",
"orgStudyIdInfo": {
"id": "2023-01882-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Patients treatment expectancies"
},
{
"measure": "Patients self-reported rating of pain sensitivity"
},
{
"measure": "Costs and cost-effectiveness direct and indirect"
},
{
"measure": "Impact on the environment"
}
],
"primaryOutcomes": [
{
"measure": "Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI)"
}
],
"secondaryOutcomes": [
{
"measure": "Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS)"
},
{
"measure": "Mean change in pain Self-Efficacy"
},
{
"measure": "Mean change of self-reported rating of improvement"
},
{
"measure": "Mean change of health-related quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Linkoeping University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Region Östergötland"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oxycodone"
},
{
"name": "Bupivacaine"
}
]
},
"conditionsModule": {
"conditions": [
"Epidural",
"Oxycodone",
"Pain",
"Lower Limb Amputation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kafr Ash Shaykh",
"contacts": [
{
"email": "[email protected]",
"name": "Gamal H Shams, MD",
"phone": "00201095927971",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ahmed A Ghareeb, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mohamed H Osman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Heba F Dawood, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mohamed M Kotb, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Kafrelsheikh University",
"geoPoint": {
"lat": 31.11174,
"lon": 30.93991
},
"state": "Kafrelsheikh",
"status": "RECRUITING",
"zip": "33516"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Epidural Oxycodone for Pain Management for Lower Limb Amputation",
"nctId": "NCT06276179",
"orgStudyIdInfo": {
"id": "KFSIRB200-97",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acute postoperative pain scores"
}
],
"secondaryOutcomes": [
{
"measure": "Time to the first request for the rescue analgesia"
},
{
"measure": "Postoperative morphine consumption"
},
{
"measure": "Incidence of phantom limb pain"
},
{
"measure": "Adverse effects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kafrelsheikh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-24"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Frailty",
"Cognitive Dysfunction",
"Community-dwelling Older Adults"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To explore the heterogeneity of the development trend of frailty and cognitive function of older adults."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 934,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Trajectory of Frailty and Cognitive Dysfunction in Older Adults",
"nctId": "NCT06276166",
"orgStudyIdInfo": {
"id": "72374215",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Health status and life style"
},
{
"measure": "Activities of daily life (ADLs)"
},
{
"measure": "Anxiety"
},
{
"measure": "Apathy"
},
{
"measure": "Perceived social support"
},
{
"measure": "Social network"
}
],
"primaryOutcomes": [
{
"measure": "Frailty"
},
{
"measure": "Cognitive function"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zheng Li"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "no interventions"
}
]
},
"conditionsModule": {
"conditions": [
"Biliary Tract Diseases",
"Gallbladder Cancer",
"Gallbladder Neoplasms"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 5000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "74 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CRGGCext",
"briefTitle": "Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer",
"nctId": "NCT06276153",
"orgStudyIdInfo": {
"id": "CRGGCext",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "progression-free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "RenJi Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Laboratory analyses for the detection of iron deficiency anaemia"
}
]
},
"conditionsModule": {
"conditions": [
"Iron Deficiencies",
"Iron Deficiency Anaemia",
"Postoperative Complications",
"Colorectal Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are:\n\n* whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery\n* whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients.\n\nBlood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin.\n\nData about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected.\n\nThe researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ID-COLO",
"briefTitle": "Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery",
"nctId": "NCT06276140",
"orgStudyIdInfo": {
"id": "4/23/2-4661/2-9",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall morbidity"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population"
},
{
"measure": "Red blood cell transfusion rate"
},
{
"measure": "All-cause infection rate"
},
{
"measure": "Days of antibiotic use"
},
{
"measure": "Number of different antibiotics administered"
},
{
"measure": "Length of Intensive care unit-stay"
},
{
"measure": "Length of hospital-stay"
},
{
"measure": "Intraoperative complications"
},
{
"measure": "Quality of postoperative recovery"
},
{
"measure": "Reoperation"
},
{
"measure": "Estimated total iron-deficit"
},
{
"measure": "Serum ferritin level"
},
{
"measure": "Values of different erythrocyte indices"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Bern"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Oncology Institute of Vojvodina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral Bisoprolol"
},
{
"name": "Intravenous Diltiazem"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation With Rapid Ventricular Response",
"Atrial Flutter With Rapid Ventricular Response"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Muscat",
"contacts": [
{
"email": "[email protected]",
"name": "Fatin k Al omairi, MD",
"phone": "71308058",
"phoneExt": "+968",
"role": "CONTACT"
},
{
"email": null,
"name": "Awatif Al-Alalawi, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Usama Alkhalasi, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Mohamed Al Rawahi, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Adil Al Riyami, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Said Al Hadhrami, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Hatim Al Lawati, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Oman",
"facility": "Sultan Qaboos University Hospital",
"geoPoint": {
"lat": 23.58413,
"lon": 58.40778
},
"state": "Al-khod",
"status": null,
"zip": "38"
}
]
},
"descriptionModule": {
"briefSummary": "INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.\n\nMETHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.\n\nAIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.\n\nPRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \\< 60 bpm and SBP \\< 95 mm Hg.\n\nSECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)\n\nPATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.\n\nINTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).\n\nCLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.\n\nOUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes."
},
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"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "* Study Design: Double-blind, randomized controlled trial.\n* Participants: Patients with atrial fibrillation/flutter and rapid ventricular rate.\n* Treatment Arms: Oral Bisoprolol vs. Intravenous Diltiazem.\n* Randomization: Subjects randomly assigned to either treatment group.\n* Primary Endpoint: Reduction of heart rate to a target level within a specific timeframe.\n* Secondary Outcomes: Adverse effects, hospital admission rates, additional rate control needs.\n* Objective: Compare effectiveness and safety of oral Bisoprolol to intravenous Diltiazem.\n* Monitoring: Continuous observation of vital signs and electrocardiograms for safety.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "While the treating physician, nurse, and the patient will not be blinded to the treatment, the investigator collecting data and the statistician analysing it will remain blinded to treatment allocations. This ensures unbiased data collection and analysis.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
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"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BisoAF",
"briefTitle": "Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate.",
"nctId": "NCT06276127",
"orgStudyIdInfo": {
"id": "MERC301123",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction"
},
{
"measure": "Safety Outcome Evaluated by the Presence of serious adverse event"
}
],
"secondaryOutcomes": [
{
"measure": "The use of Rescue medication"
},
{
"measure": "Proportion of patients who required hospitalization"
},
{
"measure": "ED revisit"
},
{
"measure": "Number of Participants Experiencing Treatment-Related Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Oman Medical Speciality Board"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
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"date": "2024-03-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stent Underexpansion"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Calcification",
"Intravascular Lithotripsy",
"Excimer Laser-coronary Atherectomy",
"Stent Restenosis",
"Stent Occlusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Florence",
"contacts": null,
"country": "Italy",
"facility": "Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital",
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},
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},
{
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},
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},
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},
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},
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},
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},
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},
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},
{
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},
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},
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"facility": "Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland",
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},
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},
{
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"facility": "1st Military Hospital in Lublin, Lublin, Poland",
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},
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},
{
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},
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},
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},
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},
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},
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},
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},
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},
{
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},
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},
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},
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},
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},
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},
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"facility": "Third Department of Cardiology, Medical University of Katowice",
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},
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}
]
},
"descriptionModule": {
"briefSummary": "The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.\n\nThe primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 121,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DRAGON",
"briefTitle": "IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)",
"nctId": "NCT06276114",
"orgStudyIdInfo": {
"id": "07",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The primary efficacy endpoint was device success"
}
],
"secondaryOutcomes": [
{
"measure": "Device-oriented composite endpoint (DOCE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Silesia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NWRD08 administered by electroporation"
}
]
},
"conditionsModule": {
"conditions": [
"High-grade Squamous Intraepithelial Lesion (HSIL)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Fang Jiang, M.D.",
"phone": "86-010-69155635",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 9,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL",
"nctId": "NCT06276101",
"orgStudyIdInfo": {
"id": "NEWISH-HPV-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety"
},
{
"measure": "Dose-limiting toxicity (DLT)"
}
],
"secondaryOutcomes": [
{
"measure": "Immunogenicity"
},
{
"measure": "Histopathology outcome and HPV Viral clearance"
},
{
"measure": "The recommended phase II dose (RP2D)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Newish Technology (Beijing) Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Immunotherapy",
"Hyperprogression",
"Biomarker"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Jian Guan, M.D.",
"phone": "86+13632102247",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jian Guan, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Nanfang hospital, Southern medical university",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510515"
},
{
"city": "Fuzhou",
"contacts": [
{
"email": null,
"name": "Yongmei Dai",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fujian Provinical Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Huizhou",
"contacts": [
{
"email": null,
"name": "Yunming Tian",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Huizhou Central People's Hospital",
"geoPoint": {
"lat": 23.11147,
"lon": 114.41523
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Jieyang",
"contacts": [
{
"email": null,
"name": "Peibao Lai",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jieyang people's hospital",
"geoPoint": {
"lat": 23.5418,
"lon": 116.36581
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Meizhou",
"contacts": [
{
"email": null,
"name": "Jianda Sun",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou",
"geoPoint": {
"lat": 24.2886,
"lon": 116.11767
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 374,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy",
"nctId": "NCT06276088",
"orgStudyIdInfo": {
"id": "NFEC-2024-067",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of hyperprogression"
}
],
"secondaryOutcomes": [
{
"measure": "Event-free survival"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanfang Hospital, Southern Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Conventional rehabilitation, the Erigo®Pro table, motor imagery"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": null,
"country": "Poland",
"facility": "Military Institute of Medicine",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "Masovian District",
"status": null,
"zip": "04-141"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "38 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients.",
"nctId": "NCT06276075",
"orgStudyIdInfo": {
"id": "10/KRN/2020",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Trunk Control Test"
},
{
"measure": "Berg Balance Scale"
},
{
"measure": "RiabloTM device"
},
{
"measure": "RiabloTM device"
},
{
"measure": "Luna EMG"
},
{
"measure": "Luna EMG"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Anna Olczak"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-10"
},
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"date": "2024-02-23"
},
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"date": "2023-05-10"
},
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"date": "2022-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Distal radius fracture fixation in pediatrics."
}
]
},
"conditionsModule": {
"conditions": [
"Trauma Injury of Upper Extremity Forearm Multiple",
"Fracture of Distal End of Radius"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sohag",
"contacts": null,
"country": "Egypt",
"facility": "Sohag university",
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"lat": 26.55695,
"lon": 31.69478
},
"state": null,
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"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures."
},
"designModule": {
"designInfo": {
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},
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},
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"count": 15,
"type": "ESTIMATED"
},
"phases": [
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],
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},
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"maximumAge": "16 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
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"id": "Titanium nail usage",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
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{
"measure": "Comparison between usage of titanium nail and old methods"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "OTHER",
"name": "Sohag University"
}
},
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"completionDateStruct": {
"date": "2024-10"
},
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"date": "2024-02-28"
},
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"date": "2024-09"
},
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"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "custom GPT supported self-directed learning"
}
]
},
"conditionsModule": {
"conditions": [
"Self-Directed Learning",
"Artificial Intelligence",
"Medical Education"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Changsha",
"contacts": null,
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"facility": "Department of Geriatirc Surgery",
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},
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}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the effect of LearnGuide, a custom GPT developed with ChatGPT for supporting self-directed learning (SDL) in medical students. The main questions it aims to answer are:\n\nHow does LearnGuide influence SDL skills among medical students? Can LearnGuide improve critical thinking and learning flow as measured by Cornell Critical Thinking Test (CCTT) Level Z score and Global Flow Score (GFS)?\n\nParticipants will:\n\nUndergo a two-hour introduction to LearnGuide. Engage in 12 weeks of SDL task-based training with LearnGuide\\&#39;s support.\n\nIf there is a comparison group: Researchers will compare the group utilizing LearnGuide for SDL and the group without this tool to see if there is a significant difference in SDL skills, critical thinking, and learning flow experiences."
},
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},
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},
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},
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],
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},
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CHAT-MS",
"briefTitle": "ChatGPT Helping Advance Training for Medical Students: A Study on Self-Directed Learning Enhancement",
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"id": "DGETRRP2023-54",
"link": null,
"type": null
},
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},
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{
"measure": "Self-Directed Learning Scale"
}
],
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{
"measure": "Cornell Critical Thinking Test (CCTT) Level Z"
},
{
"measure": "Flow Short Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Central South University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Wang Shalong"
}
},
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"date": "2024-03-02"
},
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"date": "2024-02-23"
},
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"date": "2024-01-06"
},
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"startDateStruct": {
"date": "2023-11-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Identification of specific markers"
}
]
},
"conditionsModule": {
"conditions": [
"Cytopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": null,
"country": "United States",
"facility": "University of South Florida",
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"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": null,
"zip": "33620"
},
{
"city": "Ghent",
"contacts": null,
"country": "Belgium",
"facility": "Ghent University Hospital",
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"lat": 51.05,
"lon": 3.71667
},
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},
{
"city": "Catania",
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"country": "Italy",
"facility": "Clinica Pediatrica - Università di Catania",
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"lat": 37.49223,
"lon": 15.07041
},
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},
{
"city": "Florence",
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"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
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"lat": 43.77925,
"lon": 11.24626
},
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},
{
"city": "Genova",
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"facility": "IRCCS Istituto Giannina Gaslini",
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},
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},
{
"city": "Pisa",
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"facility": "Azienda Ospedaliero Universitaria Pisana",
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"lat": 43.70853,
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},
"state": null,
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}
]
},
"descriptionModule": {
"briefSummary": "Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies"
},
"designModule": {
"designInfo": {
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},
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},
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"type": "ACTUAL"
},
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],
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},
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"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
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"acronym": null,
"briefTitle": "Autoimmune Cytopenias as a Sign of Primary Immunodeficiency.",
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"id": "CAPID",
"link": null,
"type": null
},
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},
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{
"measure": "Identification of specific markers"
}
],
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},
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"name": "Meyer Children's Hospital IRCCS"
}
},
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"date": "2025-06-01"
},
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},
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"date": "2024-12-01"
},
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"date": "2019-07-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindful and Self-Compassionate Care Program (MASC)"
},
{
"name": "Health Education Program (HEP)"
}
]
},
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"Caregiver Stress"
]
},
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{
"city": "Boston",
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{
"email": "[email protected]",
"name": "Michelle StPaul, MS",
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}
],
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},
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}
]
},
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},
"designModule": {
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"maskingInfo": {
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]
},
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},
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},
"phases": [
"NA"
],
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},
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SOCIAL",
"briefTitle": "Supporting Our Caregivers In ADRD Learning (SOCIAL)",
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"id": "2023P003638",
"link": null,
"type": null
},
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{
"domain": null,
"id": "1R01AG078204-01",
"link": "https://reporter.nih.gov/quickSearch/1R01AG078204-01",
"type": "NIH"
}
]
},
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{
"measure": "Symptoms of Depression"
},
{
"measure": "Mindfulness"
},
{
"measure": "Perceived Stress Scale"
},
{
"measure": "Symptoms of Anxiety"
},
{
"measure": "The Self-Compassion Scale"
},
{
"measure": "Compassion"
},
{
"measure": "Caregiver self-efficacy"
},
{
"measure": "Loneliness"
},
{
"measure": "Social Support"
},
{
"measure": "Well-being"
},
{
"measure": "Distress Due to Patient Challenges Behaviors"
},
{
"measure": "Dyadic Relationship Scale"
}
],
"primaryOutcomes": [
{
"measure": "Feasibility of Recruitment"
},
{
"measure": "Feasibility of Randomization"
},
{
"measure": "Feasibility of Assessment Measures"
},
{
"measure": "Feasibility of Quantitative Measures"
},
{
"measure": "Adherence to treatment"
},
{
"measure": "Patient's Global Impression of Change (PGIC)"
},
{
"measure": "Perceptions of Questionnaire Battery"
},
{
"measure": "Adherence to Home Practice"
},
{
"measure": "Perceptions of Email and Text Reminders"
},
{
"measure": "Credibility and Expectancy"
},
{
"measure": "Modified Perception of Global Improvement"
},
{
"measure": "Satisfaction with the Intervention"
},
{
"measure": "Therapist Fidelity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Aging (NIA)"
},
{
"name": "University of California, San Francisco"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Massachusetts General Hospital"
}
},
"statusModule": {
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"date": "2025-04-01"
},
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"date": "2024-03-25"
},
"overallStatus": "RECRUITING",
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"date": "2025-03-15"
},
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"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "nafamostat mesilate"
},
{
"name": "unfractionated heparin group"
}
]
},
"conditionsModule": {
"conditions": [
"Extracorporeal Membrane Oxygenation Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Beijing Anzhen Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100029"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery."
},
"designModule": {
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"allocation": "RANDOMIZED",
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO",
"nctId": "NCT06276010",
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"id": "2023-102",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Incidence of thrombotic complications"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of severe bleeding complications"
},
{
"measure": "Infusion volume of blood products"
},
{
"measure": "ACT qualified rate"
},
{
"measure": "Hospitalization mortality"
},
{
"measure": "The incidence of oxygenator dysfunction"
},
{
"measure": "Heparin-induced thrombocytopenia"
},
{
"measure": "Time to reach the target anticoagulant level for the first time"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Xiaotong Hou"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-03-01"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Integration of Artificial Intelligence (AI) assistance to screening gastroscopy"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.\n\nThe nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4)."
},
"designModule": {
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"whoMasked": null
},
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},
"enrollmentInfo": {
"count": 6600,
"type": "ESTIMATED"
},
"phases": [
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],
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},
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"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GAIN",
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"nctId": "NCT06275997",
"orgStudyIdInfo": {
"id": "GAIN",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Miss rate reduction"
}
],
"secondaryOutcomes": [
{
"measure": "Change number of Detections"
},
{
"measure": "patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
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"class": "OTHER",
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}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
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"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "online CPR-AED training"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiorespiratory Arrest",
"Cardiopulmonary Arrest With Successful Resuscitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Ester Granado_Font, PhD",
"phone": "977778715",
"phoneExt": "405",
"role": "CONTACT"
},
{
"email": null,
"name": "Ester Granado-Font, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "IDIAP Jordi Gol",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": "08007"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventions\n\nHypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrests\n\nObjectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.\n\nMethodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodology\n\nVariables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.\n\nIn phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into account\n\nExpected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.\n\nApplicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"whoMasked": null
},
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"primaryPurpose": "PREVENTION",
"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": "EFORCP",
"briefTitle": "Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers.",
"nctId": "NCT06275984",
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"id": "PI23/00288",
"link": null,
"type": null
},
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{
"domain": "IDIAP Jordi Gol",
"id": "4R23/440",
"link": null,
"type": "OTHER"
}
]
},
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"primaryOutcomes": [
{
"measure": "Difference between pre and post training scores in ad hoc designed scale"
},
{
"measure": "Percentage of participants that reach or exceed 10 out of 12 on the checklist"
}
],
"secondaryOutcomes": [
{
"measure": "Odds ratios (with 95% CI) for adjustment variables"
},
{
"measure": "Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities"
}
]
},
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{
"name": "Hospital Universitari Joan XXIII de Tarragona."
}
],
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"class": "OTHER",
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}
},
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"date": "2026-12"
},
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},
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"date": "2024-06"
},
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"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexcom G6"
},
{
"name": "SMBG or venous/arterial blood glucose"
}
]
},
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"conditions": [
"Cardiac Disease",
"PreDiabetes",
"Diabetes Mellitus"
]
},
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{
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{
"email": null,
"name": "Sun Joon Moon, MD",
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"role": "CONTACT"
}
],
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},
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},
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},
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"type": null
},
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},
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{
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],
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{
"measure": "Time within the target range of 100-140 mg/dL"
},
{
"measure": "Time within the target range of 70-180 mg/dL"
},
{
"measure": "Time to reach <70 mg/dL"
},
{
"measure": "Time to reach <54 mg/dL"
},
{
"measure": "Time to reach >180 mg/dL"
},
{
"measure": "Time to reach >250 mg/dL"
},
{
"measure": "Standard Deviation (SD)"
},
{
"measure": "Coefficient of variation (CV)"
},
{
"measure": "Mean glucose"
},
{
"measure": "Glucose management indicator (GMI)"
},
{
"measure": "Number of days of ICU hospitalization"
},
{
"measure": "Number of days hospitalized after surgery"
},
{
"measure": "Number of participants with pneumonia occurrence after surgery"
},
{
"measure": "Number of participants with wound infection occurrence after surgery"
},
{
"measure": "Number of participants who underwent CRRT implementation after surgery"
},
{
"measure": "Number of participants with Atrial fibrillation occurrence after surgery"
},
{
"measure": "Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery"
},
{
"measure": "Changes in concentration of serum CRP level after surgery"
},
{
"measure": "Mortality within 30 days of surgery"
}
]
},
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{
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],
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},
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}
}
}
|
null | false |
{
"armsInterventionsModule": {
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{
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{
"name": "Doublet Chemotherapy, Dose-reduced (75%)"
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{
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}
]
},
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},
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{
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},
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},
{
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},
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},
{
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},
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},
{
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},
{
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},
{
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},
{
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},
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},
{
"city": "Terneuzen",
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},
{
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},
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},
{
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},
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},
{
"city": "Utrecht",
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},
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},
{
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},
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},
{
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},
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},
{
"city": "Zaandam",
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"country": "Netherlands",
"facility": "Zaans Medisch Centrum",
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}
]
},
"descriptionModule": {
"briefSummary": "The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.\n\nPrimary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A phase III, open-label, non-inferiority, randomized controlled clinical trial comparing dose-reduced chemotherapy versus standard dose chemotherapy in older adults with metastasized colorectal cancer",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 587,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "70 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DOSAGE",
"briefTitle": "DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer",
"nctId": "NCT06275958",
"orgStudyIdInfo": {
"id": "2023-506115-17",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-506115-17",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-Free Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of Life Questionnaire"
},
{
"measure": "Quality of Life Questionnaire"
},
{
"measure": "Physical functioning Questionnaire"
},
{
"measure": "Physical functioning Questionnaire"
},
{
"measure": "Grade 3-5 chemotherapy-related toxicity"
},
{
"measure": "Overall Survival"
},
{
"measure": "Number of completed treatment cycles"
},
{
"measure": "Dose reductions during treatment"
},
{
"measure": "Dose delay during treatment"
},
{
"measure": "Unplanned hospitalizations"
},
{
"measure": "Cumulative received dosage"
},
{
"measure": "Cost-effectiveness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Dutch Colorectal Cancer Group"
},
{
"name": "Stichting Darmkanker"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Leiden University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Voro Urologic Scaffold"
}
]
},
"conditionsModule": {
"conditions": [
"Stress Urinary Incontinence",
"Radical Prostatectomy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Panama City",
"contacts": [
{
"email": "[email protected]",
"name": "Natalia Vega",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Margelis Munoz",
"phone": "507-6499-9304",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gustavo Espino, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Panama",
"facility": "National Hospital",
"geoPoint": {
"lat": 8.9936,
"lon": -79.51973
},
"state": "Punta Pacifica",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.\n\nThe study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, non-randomized first-in-man study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "45 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ARID",
"briefTitle": "Feasibility Study of A VoRo UrologIc ScaffolD (ARID)",
"nctId": "NCT06275945",
"orgStudyIdInfo": {
"id": "1010073",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups."
}
],
"secondaryOutcomes": [
{
"measure": "The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups."
},
{
"measure": "The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "RQMplus"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Levee Medical, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interventional group"
},
{
"name": "Standard of care group"
}
]
},
"conditionsModule": {
"conditions": [
"Newborn, Infant",
"Body Temperature",
"Delivery Room"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Gabriele Sorrentino, pedRN",
"phone": "+393496060149",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gabriele Sorrentino, pedRN",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20122"
}
]
},
"descriptionModule": {
"briefSummary": "At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.\n\nHypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).\n\nOne of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.\n\nTo date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.\n\nSome studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.\n\nThe aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 776,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Management of Healthy Newborn's Body Temperature at Birth",
"nctId": "NCT06275932",
"orgStudyIdInfo": {
"id": "TermoNeo/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Newborn's body temperature at the end of skin-to-skin contact"
}
],
"secondaryOutcomes": [
{
"measure": "Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery"
},
{
"measure": "Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery"
},
{
"measure": "Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery"
},
{
"measure": "Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery"
},
{
"measure": "Newborns' average temperature one hour after arriving at the nursery"
},
{
"measure": "Duration of nursery stay"
},
{
"measure": "Duration of skin-to-skin contact"
},
{
"measure": "Newborns' proportion exclusively breastfed at discharge"
},
{
"measure": "Type of breastfeeding at discharge"
},
{
"measure": "Newborns' proportion with hypoglycemia during hospitalization"
},
{
"measure": "Newborns' proportion affected by respiratory distress syndrome"
},
{
"measure": "Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU)"
},
{
"measure": "Newborns' weight loss at discharge"
},
{
"measure": "Mortality before discharge from hospital"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Regorafenib 40 MG Oral Tablet"
},
{
"name": "Local Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
"Meningioma, Malignant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Meldola",
"contacts": [
{
"email": "[email protected]",
"name": "Lorena Gurrieri, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lorena Gurrieri, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRST Istituto Romagnolo per lo Studio dei Tumori \"Dino Amadori\"",
"geoPoint": {
"lat": 44.12775,
"lon": 12.0626
},
"state": "Forlì-Cesena",
"status": null,
"zip": null
},
{
"city": "Rozzano",
"contacts": [
{
"email": "[email protected]",
"name": "Matteo Simonelli, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matteo Simonelli, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Humanitas Cancer Center",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": "Milano",
"status": null,
"zip": null
},
{
"city": "Bari",
"contacts": [
{
"email": "[email protected]",
"name": "Valeria Internò, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Valeria Internò, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale San Paolo",
"geoPoint": {
"lat": 41.11148,
"lon": 16.8554
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Enrico Franceschi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Enrico Franceschi, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale Bellaria - AUSL Bologna",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Firenze",
"contacts": [
{
"email": "[email protected]",
"name": "Isacco Desideri, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Isacco Desideri, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Careggi",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Genova",
"contacts": [
{
"email": "[email protected]",
"name": "Elisa Bennicelli, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elisa Bennicelli, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Policlinico San Martino",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Livorno",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Luisa Di Stefano, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anna Luisa Di Stefano, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Spedali Riuniti",
"geoPoint": {
"lat": 43.54427,
"lon": 10.32615
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Messina",
"contacts": [
{
"email": "[email protected]",
"name": "Nicola Silvestris, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nicola Silvestris, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria G. Martino",
"geoPoint": {
"lat": 38.19394,
"lon": 15.55256
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Paola Gaviani, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Paola Gaviani, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Istituto Neurologico Carlo Besta",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Giulia Berzero, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Giulia Berzero, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Napoli",
"contacts": [
{
"email": "[email protected]",
"name": "Bruno Daniele, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bruno Daniele, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale del Mare",
"geoPoint": {
"lat": 40.85216,
"lon": 14.26811
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Silvia Chiesa, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Silvia Chiesa, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Veronica Villani, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Veronica Villani, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Tumori Regina Elena",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Giuseppe Minniti, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Giuseppe Minniti, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Policlinico Umberto I - Università Sapienza Roma",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Torino",
"contacts": [
{
"email": "[email protected]",
"name": "Roberta Rudà, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Roberta Rudà, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "A.O.U. Città della Salute e della Scienza di Torino",
"geoPoint": {
"lat": 45.07049,
"lon": 7.68682
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III meningiomas.\n\nSmall trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome.\n\nRegorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas.\n\nNoteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\\<0.05) for Regorafenib treated mice.\n\nMoreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MIRAGE",
"briefTitle": "Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)",
"nctId": "NCT06275919",
"orgStudyIdInfo": {
"id": "IOV-BT-1-2023 MIRAGE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression free survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Patient Reported Outcomes (PROs)"
},
{
"measure": "Patient Reported Outcomes (PROs)"
},
{
"measure": "Toxicity during treatment"
},
{
"measure": "Disease control rate (DCR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bayer"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Oncologico Veneto IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mediterranean diet and moderate intensity physical exercise (outdoor walking)."
}
]
},
"conditionsModule": {
"conditions": [
"NAFLD",
"Obesity",
"IBS"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Castellana Grotte",
"contacts": null,
"country": "Italy",
"facility": "Irccs Saverio de Bellis",
"geoPoint": {
"lat": 40.88643,
"lon": 17.16549
},
"state": "Bari",
"status": null,
"zip": "70013"
}
]
},
"descriptionModule": {
"briefSummary": "The study in question is an interventional study with nutritional intervention.\n\nThe aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:\n\n* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;\n* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;\n* intestinal barrier;\n* body composition;\n* intestinal microbiota;\n* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk.\n\nThe Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "NAFLD-POS5",
"briefTitle": "Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.",
"nctId": "NCT06275906",
"orgStudyIdInfo": {
"id": "NAFLD-POS5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The effect of intervention on CAP value"
},
{
"measure": "The effect of intervention on FLI value"
},
{
"measure": "The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk"
},
{
"measure": "The effect of the intervention on the integrity of the intestinal barrier"
}
],
"secondaryOutcomes": [
{
"measure": "The effect of the intervention on the Gastrointestinal Symptoms"
},
{
"measure": "The effect of the intervention on the Body Composition"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Russo Francesco"
},
{
"name": "Cozzolongo Raffaele"
},
{
"name": "Shahini Endrit"
},
{
"name": "Zappimbulso Marianna"
},
{
"name": "Giannuzzi Vito"
},
{
"name": "De Nucci Sara"
},
{
"name": "Rinaldi Roberta"
},
{
"name": "Sila Annamaria"
},
{
"name": "Tatoli Rossella"
},
{
"name": "Cerabino Nicole"
},
{
"name": "Donghia Rossella"
},
{
"name": "Franco Isabella"
},
{
"name": "Bianco Antonella"
},
{
"name": "Curci Ritanna"
},
{
"name": "Bagnato Claudia Beatrice"
},
{
"name": "Sciarra Sabrina"
},
{
"name": "Prospero Laura"
},
{
"name": "Serino Grazia"
},
{
"name": "Scalavino Viviana"
},
{
"name": "Piccinno Emanuele"
},
{
"name": "Pesole Pasqua Letizia"
},
{
"name": "Coletta Sergio"
},
{
"name": "Stabile Dolores"
},
{
"name": "Riezzo Giuseppe"
},
{
"name": "Ancona Anna"
},
{
"name": "D'Attoma Benedetta"
},
{
"name": "Ignazzi Antonia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IC14"
}
]
},
"conditionsModule": {
"conditions": [
"Arrhythmogenic Right Ventricular Dysplasia",
"Arrhythmogenic Left Ventricular Cardiomyopathy",
"Arrhythmogenic Right Ventricular Cardiomyopathy 1",
"Arrhythmogenic Cardiomyopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint Louis",
"contacts": [
{
"email": null,
"name": "Philip S. Cuculich, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Washington University School of Medicine",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "63110"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.\n\nParticipants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 5,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy",
"nctId": "NCT06275893",
"orgStudyIdInfo": {
"id": "ACM01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety: Treatment-emergent adverse events and serious adverse events"
},
{
"measure": "Safety: Incidence of anti-drug antibodies"
}
],
"secondaryOutcomes": [
{
"measure": "Inflammatory biomarker C-reactive protein"
},
{
"measure": "CCR2+ Myocardial Imaging (optional)"
},
{
"measure": "Ventricular tachycardia"
},
{
"measure": "Ventricular premature contractions"
},
{
"measure": "Sustained and non-sustained ventricular tachycardia"
},
{
"measure": "Treated ventricular tachycardia"
},
{
"measure": "Atrial premature contractions"
},
{
"measure": "New York Heart Association (NYHA) Functional Class"
},
{
"measure": "Implantable cardioverter/defibrillator (ICD) discharges"
},
{
"measure": "Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire"
},
{
"measure": "Disease biomarker Troponin I"
},
{
"measure": "Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP)"
},
{
"measure": "Inflammatory biomarker interleukin (IL)1-beta"
},
{
"measure": "Pharmacokinetics: Serum IC14 concentration versus time curve"
},
{
"measure": "Pharmacokinetics: Peak serum IC14 concentration"
},
{
"measure": "Pharmacokinetics: Half life"
},
{
"measure": "Pharmacodynamics: Receptor Occupancy"
},
{
"measure": "Pharmacodynamics: Effective Concentration 95%"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Implicit Bioscience"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intra-articular infiltration of PVP Collagen"
},
{
"name": "Rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Gonarthrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mérida",
"contacts": null,
"country": "Mexico",
"facility": "Hospital General Regional No. 1 Lic. Ignacio García Téllez",
"geoPoint": {
"lat": 20.97537,
"lon": -89.61696
},
"state": "Yucatán",
"status": null,
"zip": "97155"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:\n\n1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.\n2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.\n3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.\n\nPatients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 130,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intraarticular Collagen in Patients With Gonarthrosis",
"nctId": "NCT06275880",
"orgStudyIdInfo": {
"id": "F-2023-3201-066",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Western Ontario and McMaster Universities Osteoarthritis Index - Pain"
},
{
"measure": "Western Ontario and McMaster Universities Osteoarthritis Index - stiffness"
},
{
"measure": "Western Ontario and McMaster Universities Osteoarthritis Index - functionality"
},
{
"measure": "Number Analog Scale for pain"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Instituto Mexicano del Seguro Social"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Free high-quality care"
},
{
"name": "Close distance"
},
{
"name": "Far distance"
}
]
},
"conditionsModule": {
"conditions": [
"Health Care Utilization",
"Health Knowledge, Attitudes, Practice",
"Health, Subjective"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Soweto",
"contacts": [
{
"email": "[email protected]",
"name": "Nomalanga Boyce",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "HDSS Soweto clusters",
"geoPoint": {
"lat": -26.26781,
"lon": 27.85849
},
"state": "Gauteng",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Years",
"minimumAge": "2 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Improved Access to Quality Care and Healthcare Use",
"nctId": "NCT06275867",
"orgStudyIdInfo": {
"id": "SOPRIMA//T023635",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Underuse"
},
{
"measure": "Overuse"
}
],
"secondaryOutcomes": [
{
"measure": "Illness duration"
},
{
"measure": "Out-of-pocket expenditures"
},
{
"measure": "Health knowledge"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Witwatersrand, South Africa"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "London School of Economics and Political Science"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cancer",
"Leukemia",
"Sarcoma",
"Germ Cell Cancer",
"Lymphoma",
"Colorectal Cancer",
"Melanoma",
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question\\[s\\] it aims to understand are:\n\n* What are the levels of depression, anxiety, social support, and financial distress\n* Determine effectiveness of YASU programming by measuring changes over time\n\nWith this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.\n\nParticipants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 5000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "YASU Research Registry: For Young Adults With Cancer",
"nctId": "NCT06275854",
"orgStudyIdInfo": {
"id": "22265",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anxiety"
},
{
"measure": "Depressive symptoms"
},
{
"measure": "Social Support"
},
{
"measure": "Financial Toxicity"
},
{
"measure": "Needs Assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Name, address, email, phone number"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Staunton Farm Foundation"
},
{
"name": "Elsie H. Hillman Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Young Adult Survivors United"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "vepdegestrant"
},
{
"name": "esomeprazole"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Haven",
"contacts": null,
"country": "United States",
"facility": "Pfizer Clinical Research Unit - New Haven",
"geoPoint": {
"lat": 41.30815,
"lon": -72.92816
},
"state": "Connecticut",
"status": "RECRUITING",
"zip": "06511"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants.\n\nAll participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to determine if the PPI affects how vepdegestrant is processed differently in healthy adults."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant",
"nctId": "NCT06275841",
"orgStudyIdInfo": {
"id": "C4891035",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone"
},
{
"measure": "Maxium observed plasma concentration of vepdegestrant when vepdegestrant is administered with esomeprazole"
},
{
"measure": "Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone"
},
{
"measure": "Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole"
}
],
"secondaryOutcomes": [
{
"measure": "number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs)"
},
{
"measure": "Number of participants with clinical laboratory abnormalities"
},
{
"measure": "Number of participants with electrocardiogram (ECG) abnormalities"
},
{
"measure": "Number of participans with clinically significant change from baseline in vital signs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Arvinas Estrogen Receptor, Inc."
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pfizer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "slow beat mesic listening by headphone"
}
]
},
"conditionsModule": {
"conditions": [
"Anterior Cruciate Ligament Tear"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": null,
"country": "Thailand",
"facility": "Police General Hospital",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": "Pathuwam",
"status": null,
"zip": "10330"
}
]
},
"descriptionModule": {
"briefSummary": "study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction",
"nctId": "NCT06275828",
"orgStudyIdInfo": {
"id": "PoliceGeneralHospiral",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "visual analog scale"
}
],
"secondaryOutcomes": [
{
"measure": "analgesic drug use"
},
{
"measure": "Amsterdam Preoperative Anxiety and Information Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Police General Hospital, Thailand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sit Together and Read (STAR)"
},
{
"name": "Monetary Reward"
},
{
"name": "Text Encouragement"
}
]
},
"conditionsModule": {
"conditions": [
"Developmental Language Disorder",
"Reading; Difficult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Columbus",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer M Bostic, MA",
"phone": "614-292-5715",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Laura M Justice, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Rebecca Dore, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Hui Jiang, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43201"
},
{
"city": "Columbus",
"contacts": [
{
"email": "[email protected]",
"name": "Jamie B Boster, PhD",
"phone": "614-722-8756",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jamie B Boster, PhD, CCC-SLP",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Nationwide Children's Hospital",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43205"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:\n\n* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.\n* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.\n\nCaregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.\n\nResearchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 320,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "66 Months",
"minimumAge": "48 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Promoting Caregiver Implementation of an Effective Early Learning Intervention",
"nctId": "NCT06275815",
"orgStudyIdInfo": {
"id": "R01DC020958",
"link": "https://reporter.nih.gov/quickSearch/R01DC020958",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Preschool Word and Print Awareness (PWPA)"
},
{
"measure": "Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing"
},
{
"measure": "The Reading House (THR)"
},
{
"measure": "Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification"
},
{
"measure": "Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Nationwide Children's Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ohio State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nutrition Education"
},
{
"name": "nutritional status, eating habits"
}
]
},
"conditionsModule": {
"conditions": [
"Nutrition, Healthy",
"Nutrition Disorders in Adolescence",
"Eating Habit",
"Eating Behavior",
"Body Image"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İzmir",
"contacts": [
{
"email": null,
"name": "Sibel ÖZER",
"phone": "(0232) 832 26 29",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Menemen District Directorate of National Education",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Nutrition Education Interventions for Adolescents",
"nctId": "NCT06275802",
"orgStudyIdInfo": {
"id": "22-5.1T/2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "nutrition literacy"
},
{
"measure": "Mediterranean Diet Quality Index (KID-MED)"
},
{
"measure": "Eating Attitudes Test 26 (EAT-26)"
},
{
"measure": "weight and height measurement"
},
{
"measure": "waist circumference measurement"
},
{
"measure": "Food Consumption Record"
},
{
"measure": "International Physical Activity Questionnaire (IPAQ- Short Form)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ege University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Alveolar ridge preservation"
}
]
},
"conditionsModule": {
"conditions": [
"Alveolar Ridge Preservation",
"Dental Extraction",
"Bone Graft"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fort Lauderdale",
"contacts": [
{
"email": "[email protected]",
"name": "Saynur Vardar-Sengul, DDS, PhD",
"phone": "954-262-1815",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Nova Southeastern University",
"geoPoint": {
"lat": 26.12231,
"lon": -80.14338
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33328"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?",
"nctId": "NCT06275789",
"orgStudyIdInfo": {
"id": "2023-268",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "thickness of the buccal plate in mm and its influence on the ridge dimension"
},
{
"measure": "the thickness of the lingual plate in mm and its influence on the ridge dimension"
},
{
"measure": "the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension"
},
{
"measure": "the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension"
},
{
"measure": "# of cigarettes and its influence on the ridge dimension"
},
{
"measure": "oral hygiene using the plaque index and its influence on the ridge dimension"
}
],
"primaryOutcomes": [
{
"measure": "changes in horizontal dimensions of the alveolar ridge"
},
{
"measure": "changes in vertical dimensions of the alveolar ridge"
}
],
"secondaryOutcomes": [
{
"measure": "vital bone percentage"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Geistlich Pharma AG"
},
{
"name": "ZimVie"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nova Southeastern University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ethicon Monocryl Smooth Suture"
},
{
"name": "Ethicon Vicryl Rapide Braided Suture"
},
{
"name": "Flexifuze Indermil Topical Skin Adhesive"
},
{
"name": "Dermabond Prineo Skin Closure System"
},
{
"name": "Stryker Zip Skin Closure System"
}
]
},
"conditionsModule": {
"conditions": [
"Wound Healing Disturbance of"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zoetermeer",
"contacts": [
{
"email": "[email protected]",
"name": "Brechtje Hesseling, Msc",
"phone": "003179-2065595",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nina MC Mathijssen, Dr.",
"phone": "003179-2065595",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Reinier Haga Orthopedisch Centrum",
"geoPoint": {
"lat": 52.0575,
"lon": 4.49306
},
"state": "Zuid Holland",
"status": null,
"zip": "2725NA"
}
]
},
"descriptionModule": {
"briefSummary": "This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.\n\nThis will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.\n\nThe photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.\n\nHypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Test subjects are randomised into one of four study arms. Each study arm corresponds with one of the suturing techniques that are going to be used to close the superficial skin after Total Hip Arthroplasty.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "No one in this study can reasonably be blinded for the suturing technique during the duration of the study, since the suturing techniques differ substantially in shape, appearance and size. The only blinding in this study is the blinding of the outcome assessor to data of the test subjects. The assessor will only see the photographs of the wound/plaster, and the moment on which the photograph was taken. Additional information on the test subject, such as age, comorbidities, et cetera, will be withheld from the assessor.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 236,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "HIP-STITCH (Wound Recovery After THA)",
"nctId": "NCT06275776",
"orgStudyIdInfo": {
"id": "OC-2022-005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants with Aberrant Wound Recovery"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants with Superficial or Deep Wound Infection"
},
{
"measure": "Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)"
},
{
"measure": "Costs"
},
{
"measure": "Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)"
},
{
"measure": "Patient reported outcome measure: Number of Participants with Other postoperative symptoms"
},
{
"measure": "Number and Type of Complications"
},
{
"measure": "Number of Visits to a Healthcare Professional"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Reinier Haga Orthopedisch Centrum"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Phase C: Eplerenone"
},
{
"name": "Phase C: Spironolactone"
},
{
"name": "Phase C: Torasemide"
},
{
"name": "Phase B: Triplixam / Elestar HCT"
},
{
"name": "Phase A: Confirmation of uncontrolled hypertension"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": [
{
"email": "[email protected]",
"name": "Agata Skutnik",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "National Institute of Cardiology",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "Mazowieckie",
"status": "RECRUITING",
"zip": "04628"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \\<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2500,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OPTIMAL-HT",
"briefTitle": "Optimal Medical Treatment of Difficult-to-treat Hypertension",
"nctId": "NCT06275763",
"orgStudyIdInfo": {
"id": "2020/ABM/01/00037",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patients with uncontrolled BP on ABPM"
},
{
"measure": "Patients with controlled BP after 12 weeks on triple SPC"
},
{
"measure": "Systolic BP reduction on 4th antihypertensive drug"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of patients with BP controlled confirmed by HBPM"
},
{
"measure": "Consistency of the rate of uncontrolled BP"
},
{
"measure": "Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM"
},
{
"measure": "Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM"
},
{
"measure": "Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM"
},
{
"measure": "Percentage of patients requiring an increase in the dose"
},
{
"measure": "Consistency of the rate of uncontrolled BP"
},
{
"measure": "The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks"
},
{
"measure": "The magnitude of changes in HBPM and ABPM derived indices after 12 weeks"
},
{
"measure": "Phase C"
},
{
"measure": "Changes of SBP on ABPM (24h mean) after 12 weeks of treatment"
},
{
"measure": "Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM"
},
{
"measure": "Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM"
},
{
"measure": "Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM"
},
{
"measure": "Phase C continuation"
},
{
"measure": "Phase C continuation"
},
{
"measure": "Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups"
},
{
"measure": "Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone"
},
{
"measure": "Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline"
},
{
"measure": "Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups"
},
{
"measure": "Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups"
},
{
"measure": "Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups"
},
{
"measure": "Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks"
},
{
"measure": "Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups"
},
{
"measure": "Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups"
},
{
"measure": "Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Institute of Cardiology, Warsaw, Poland"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.)"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain",
"Sciatica",
"Lumbar Disc Herniation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guadalajara",
"contacts": null,
"country": "Mexico",
"facility": "Hospital Civil de Guadalajara Fray Antonio Alcalde",
"geoPoint": {
"lat": 20.66682,
"lon": -103.39182
},
"state": "Jalisco",
"status": null,
"zip": "44280"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.\n\nThe main questions it aims to answer were:\n\n* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?\n* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?\n\nParticipants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"status": "RECRUITING",
"zip": "815-0082"
},
{
"city": "Gifu",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 35.42291,
"lon": 136.76039
},
"state": null,
"status": "RECRUITING",
"zip": "500-8384"
},
{
"city": "Kagoshima",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 31.56667,
"lon": 130.55
},
"state": null,
"status": "RECRUITING",
"zip": "892-0853"
},
{
"city": "Nagasaki",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 32.75,
"lon": 129.88333
},
"state": null,
"status": "RECRUITING",
"zip": "852-8055"
},
{
"city": "Oita",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 33.23333,
"lon": 131.6
},
"state": null,
"status": "RECRUITING",
"zip": "870-1133"
},
{
"city": "Oita",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 33.23333,
"lon": 131.6
},
"state": null,
"status": "RECRUITING",
"zip": "879-7761"
},
{
"city": "Osaka",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
},
"state": null,
"status": "RECRUITING",
"zip": "545-8586"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 560,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Specified Drug-use Survey of Leqvio for s.c. Injection.",
"nctId": "NCT06275724",
"orgStudyIdInfo": {
"id": "CKJX839A11401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients with adverse events"
},
{
"measure": "Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions"
}
],
"secondaryOutcomes": [
{
"measure": "Number of patients with adverse events leading to discontinuation of treatment with the product"
},
{
"measure": "Percent change from baseline in LDL-C levels"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novartis Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Therapeutic communication methods"
}
]
},
"conditionsModule": {
"conditions": [
"Psychological"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Adıyaman",
"contacts": null,
"country": "Turkey",
"facility": "K-1 Container City",
"geoPoint": {
"lat": 37.76441,
"lon": 38.27629
},
"state": "Altınsehir",
"status": null,
"zip": "02040"
}
]
},
"descriptionModule": {
"briefSummary": "Earthquake is a disaster that causes physical, psychological, social, economic and cultural losses for individuals and affects/interrupts all age groups and normal life. Children are a group that is more affected by the earthquake than other members of the society and are exposed to its long-term effects. Children who have experienced earthquakes and continue to stay in the earthquake zone experience physical, economic, and social problems. In addition, the emotional and psychological development of these children is negatively affected.\n\nDue to the earthquake that occurred on 6 February 2023 affecting 11 provinces in our country, the needs in the field vary. After the acute period (first 1 month), children need psychological support. Problems that cannot be solved in the early period may cause health and behavioural problems in children in later ages and adulthood. In this context, approaching children with appropriate therapeutic communication methods positively affects their psychological well-being and directly affected physical resilience by enabling them to express their emotions.\n\nThe aim of the study was to evaluate the effect of therapeutic communication programme on state and trait anxiety levels, psychological resilience, mental health and well-being of children aged 8-12 years affected by the earthquake.\n\nHypotheses H1. After the therapeutic communication programme, children's State Anxiety Scale scores decrease.\n\nH2. After the therapeutic communication programme, children's Continuance Anxiety Scale scores decrease.\n\nH3. After the therapeutic communication programme, children's Me and My Emotions Scale scores decrease.\n\nH4. After the therapeutic communication programme, children's scores on the Child and Adolescent Psychological Resilience Scale increase."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Pre-test post-test quasi-experimental study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 65,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Therapeutic Communication Methods on the Psychological State of Children",
"nctId": "NCT06275711",
"orgStudyIdInfo": {
"id": "223K003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "State Anxiety Scale on Children"
},
{
"measure": "Trait Anxiety Scale on Children"
},
{
"measure": "Me and My Feelings Scale on Children"
},
{
"measure": "Child and Youth Resilience Measure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Scientific and Technological Research Council of Turkey"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Gazi University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manuka honey MGO 1000"
},
{
"name": "Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring"
}
]
},
"conditionsModule": {
"conditions": [
"Post Surgical Pain",
"Analgesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stevenage",
"contacts": [
{
"email": "[email protected]",
"name": "Toral Odedra",
"phone": "07918 360 060",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Lister Hospital",
"geoPoint": {
"lat": 51.90224,
"lon": -0.20256
},
"state": null,
"status": "RECRUITING",
"zip": "SG1 4AB"
}
]
},
"descriptionModule": {
"briefSummary": "Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.\n\nMain aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Intervention arm - Manuka honey, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.\n\nPlacebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Intervention (Manuka honey) and placebo will be supplied in identical opaque jars with identical labels apart from individual unique ID numbers to facilitate un-blinding in the case of adverse events.\n\nNeither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"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": "HONEY-POT",
"briefTitle": "HONEY for the Treatment of POst-Tonsillectomy Pain",
"nctId": "NCT06275698",
"orgStudyIdInfo": {
"id": "RD2023-14 HONEY-POT",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRAS",
"id": "323188",
"link": null,
"type": "OTHER"
},
{
"domain": "CPMS",
"id": "56974",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS pain scores"
}
],
"secondaryOutcomes": [
{
"measure": "Number and frequency of concurrent analgesia usage"
},
{
"measure": "Rate of readmission to hospital"
},
{
"measure": "Rate of secondary haemorrhage"
},
{
"measure": "Rate of infection requiring antibiotics treatment"
},
{
"measure": "Speed of return to work"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Manuka Doctor UK Ltd"
},
{
"name": "National Institute for Health Research, United Kingdom"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "East and North Hertfordshire NHS Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SeizureWise algorithm"
},
{
"name": "Multi-day Visualizations"
}
]
},
"conditionsModule": {
"conditions": [
"Epilepsy; Seizure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.\n\nThe main questions it aims to answer are:\n\n* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.\n* does this tool improve the lives of people with epilepsy?\n\nResearchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 3000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Foresight",
"briefTitle": "Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking",
"nctId": "NCT06275685",
"orgStudyIdInfo": {
"id": "CIP-0001510",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sensitivity of SeizureWise"
}
],
"secondaryOutcomes": [
{
"measure": "Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)"
},
{
"measure": "Qualitative assessment of multi-day visualizations"
},
{
"measure": "Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)"
},
{
"measure": "Modifiable behavior change"
},
{
"measure": "Accuracy of SeizureWise low-likelihood forecast"
},
{
"measure": "Accuracy of SeizureWise high-likelihood forecast"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Empatica, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adapted version of the mhGAP-IG"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Issue",
"Stigma, Social",
"Child Development",
"Child Abuse"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oslo",
"contacts": [
{
"email": "[email protected]",
"name": "Ane-Marthe Skar, PhD",
"phone": "97661591",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "Nowegian Center for Violence and Traumatic Stress Studies",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null,
"status": "RECRUITING",
"zip": "0655"
}
]
},
"descriptionModule": {
"briefSummary": "This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (WHO) \"Mental Health Gap Action Programme Intervention Guide\" (mhGAP). Both teachers and health workers will receive training in mhGAP, and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated. The project is conducted in close collaboration with key stakeholders from the Ministry, the health and education sector, the police, and religious leaders. The aim is to increase mental health literacy among school staff, facilitate a healthy school environment, and increase detection of mental health needs among primary school aged children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "TREAT",
"briefTitle": "Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda",
"nctId": "NCT06275672",
"orgStudyIdInfo": {
"id": "TREAT INTERACT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reach questionnaire, developed by the project group"
},
{
"measure": "The Program Sustainability tool (Finch et al., 2013)"
},
{
"measure": "Service measure on access to mental health care, developed by the project group"
},
{
"measure": "Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire"
},
{
"measure": "The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007)"
},
{
"measure": "Treatment at home, developed by the project group, by inspiration from our siste project \"TREAT C-AUD\")"
}
],
"secondaryOutcomes": [
{
"measure": "The Implementation Quality Questionnaire (Bogen, 2020)"
},
{
"measure": "Fidelity Scale, developed by the project group"
},
{
"measure": "General Health Questionnaire (GHQ; Goldberg, 1970)"
},
{
"measure": "Attitudes on Gender Norms (Waszak et al., 2000) questionnaire"
},
{
"measure": "Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022"
},
{
"measure": "Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998)"
},
{
"measure": "Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008)"
},
{
"measure": "Teacher violence scale (Piskin et al, 2014)"
},
{
"measure": "The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007)"
},
{
"measure": "The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014)"
},
{
"measure": "Organizational Readiness for Implementing Change (Shea et al., 2014)"
},
{
"measure": "Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022"
},
{
"measure": "Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021)"
},
{
"measure": "Mental health knowledge (Evans-Lacko et al.,"
},
{
"measure": "AUDIT scale (WHO)"
},
{
"measure": "Child alcohol use, developed by the project group"
},
{
"measure": "Child mental health - Pediatric symptoms (Jelinek et al.)"
},
{
"measure": "Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008)"
},
{
"measure": "Sexual violence, developed by the project group"
},
{
"measure": "Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Makerere University"
},
{
"name": "University of Bergen"
},
{
"name": "Norwegian Institute of Public Health"
},
{
"name": "Norwegian University of Science and Technology"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Norwegian Center for Violence and Traumatic Stress Studies"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CT-100-004-A"
},
{
"name": "CT-100-004-B"
}
]
},
"conditionsModule": {
"conditions": [
"Psoriasis",
"Atopic Dermatitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": null,
"country": "United States",
"facility": "Click Therapeutics",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10013"
}
]
},
"descriptionModule": {
"briefSummary": "CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.\n\nDiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis",
"nctId": "NCT06275659",
"orgStudyIdInfo": {
"id": "CT-100-D-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Peak Pruritus Numerical Rating Scale"
},
{
"measure": "Change in Dermatology Life Quality Index"
},
{
"measure": "Change in Quality of Life symptoms"
},
{
"measure": "Time in App"
},
{
"measure": "Experience with Study App"
},
{
"measure": "Improved global rating of change"
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of Adverse Events"
},
{
"measure": "Severity of Adverse Events"
},
{
"measure": "Frequency of Serious Adverse Events"
},
{
"measure": "Severity of Serious Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Click Therapeutics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PRP layer"
},
{
"name": "dartos flap"
}
]
},
"conditionsModule": {
"conditions": [
"Hypospadias"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "The Children Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "42000"
}
]
},
"descriptionModule": {
"briefSummary": "To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized control trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 220,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Months",
"sex": "MALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison Of Outcome Of Different Layers in Hypospadias Surgery",
"nctId": "NCT06275646",
"orgStudyIdInfo": {
"id": "Adeel2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "wound infectiom"
},
{
"measure": "frequency of glans dehiscence"
},
{
"measure": "frequency of meatal stenosis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children Hospital and Institute of Child Health, Lahore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
}
|
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