protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GARP/TGF-β1 monoclonal antibody"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"IPF"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product."
},
"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": 66,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects",
"nctId": "NCT06310746",
"orgStudyIdInfo": {
"id": "HLX6018-FIH101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs)"
}
],
"secondaryOutcomes": [
{
"measure": "AUC0-inf"
},
{
"measure": "Cmax"
},
{
"measure": "Tmax"
},
{
"measure": "T1/2"
},
{
"measure": "CL"
},
{
"measure": "λz"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Shanghai Henlius Biotech"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LGG"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Functional Abdominal Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Songkhla",
"contacts": [
{
"email": "[email protected]",
"name": "Atchariya Chanpong, M.D, Ph.D.",
"phone": "+6674451250",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Thailand",
"facility": "Atchariya Chanpong",
"geoPoint": {
"lat": 7.19882,
"lon": 100.5951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless be severe enough to impair the patient's quality of life, growth, and development. To help rule out organic disorders and diagnose this condition, some individuals underwent multiple invasive and costly studies.Generally, the diagnosis of FAPDs is based on clinical symptoms and criteria, it can be divided into irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP) and functional dyspepsia (FD). Approximately 14% of children globally, between the ages of 4 and 18, experience functional abdominal pain issues8. In Thailand, the prevalence of FAPDs among adolescents (mean age of 16 years) was 5.3%, functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes.The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis, which may happen early in life or throughout. Hence, several studies, specifically in western countries, reported the role of probiotics, specifically Lactobacillus rhamnosus GG (LGG), in modulating abdominal symptoms in children with FAPDs.It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity, mode of delivery, dietary and environmental factors. However, the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries. Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs, the investigators aim to evaluate the effects of probiotics, LGG, in the treatment of children who suffered from FAPDs.The secondary objectives are to measure daily pain score in children with and without FAPDs, to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs, and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders",
"nctId": "NCT06310733",
"orgStudyIdInfo": {
"id": "REC 66-517-1-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs"
},
{
"measure": "The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs"
},
{
"measure": "The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs"
}
],
"secondaryOutcomes": [
{
"measure": "To measure daily pain score in children with and without FAPDs"
},
{
"measure": "To measure daily pain score in children with and without FAPDs"
},
{
"measure": "To measure daily pain score in children with and without FAPDs"
},
{
"measure": "To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prince of Songkla University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Video Education"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Hemorrhage",
"Postpartum Depression",
"Postpartum Sepsis",
"Postpartum Preeclampsia",
"Patient Empowerment",
"Patient Education",
"Postpartum Care"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Heather Lipkind, MD, MSce",
"phone": "212-746-3045",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Heather Lipkind, MD, MSce",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Alexandra Cohen Hospital for Women and Newborns",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10065"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postpartum Video Education in High Risk Populations",
"nctId": "NCT06310720",
"orgStudyIdInfo": {
"id": "23-10026618",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in baseline and post-education questionnaire score"
}
],
"secondaryOutcomes": [
{
"measure": "Change in post-education and post-discharge questionnaire score"
},
{
"measure": "Number of participants who attended 6 week postpartum visit"
},
{
"measure": "Healthcare utilization: Number of clinic visits"
},
{
"measure": "Healthcare utilization: Number of phone calls"
},
{
"measure": "Healthcare utilization: Number of urgent care/emergency room visits"
},
{
"measure": "Mean difference in patient satisfaction rating"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Weill Medical College of Cornell University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ePatch ® Extended Wear Holter (EWH)"
}
]
},
"conditionsModule": {
"conditions": [
"Arrythmia",
"Syncope"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bron",
"contacts": [
{
"email": "[email protected]",
"name": "Philippe Chevalier, MD PhD",
"phone": "+33.472.357.027",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Philippe Chevalier, MD PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel",
"geoPoint": {
"lat": 45.73333,
"lon": 4.91667
},
"state": null,
"status": "RECRUITING",
"zip": "69677 Cedex"
},
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Tharusan Thevathasan, MD",
"phone": "+49 1577 4407864",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tharusan Thevathasan, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "D-12203"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Multi-center, prospective, randomized, unblinded, two-arm study, to include approximately 128 subjects treated with the ePatch Extended Wear Holter (worn for 7 days) and approximately 128 subjects treated with a Standard Wear Holter (worn for 24 hours). Randomization will be balanced for gender.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 128,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter",
"nctId": "NCT06310707",
"orgStudyIdInfo": {
"id": "EU RCT: ePatch vs 24h Holter",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM, French competent authority",
"id": "2022-A02338-35",
"link": null,
"type": "OTHER"
},
{
"domain": "German Ethics Committee_Charité Universitätsmedizin Berlin",
"id": "EA4/071/23",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic yield (frequency) of clinically actionable arrythmia"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Atrial Fibrillation (AF) diagnoses > 30 seconds"
},
{
"measure": "Occurrence of symptomatic events"
},
{
"measure": "Number of Clinically actionable arrhythmia"
},
{
"measure": "Patient Quality of Life as measured by EQ-5D-5L"
},
{
"measure": "Patient Quality of Life as measured by Patient Experience Survey"
},
{
"measure": "Cost related to cardiac monitoring"
},
{
"measure": "Time Holter is worn/ removed"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Philips Clinical & Medical Affairs Global"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "intervention group (Elastane circular dressing on sterile transparent dressing)"
}
]
},
"conditionsModule": {
"conditions": [
"Nurse's Role"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Turgutlu",
"contacts": null,
"country": "Turkey",
"facility": "Şeyma Turan",
"geoPoint": {
"lat": 38.49533,
"lon": 27.6997
},
"state": "Manisa",
"status": null,
"zip": "45400"
}
]
},
"descriptionModule": {
"briefSummary": "The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 91,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Additional Circular Dressing Material",
"nctId": "NCT06310694",
"orgStudyIdInfo": {
"id": "EGE-HEM-SL-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Skin Penetration Difficulty Rating Scale"
},
{
"measure": "Visual Infusion Phlebitis Diagnostic Scale"
},
{
"measure": "Infiltration Rating Scale"
},
{
"measure": "Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ege University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "\"Encompass\" group programme"
}
]
},
"conditionsModule": {
"conditions": [
"Complex Neurodevelopmental Disorder",
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": null,
"name": "Frances Badenhorst",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Barts Health NHS Trust, Children's Occupational Therapy, Mile End Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "E1 4EH"
},
{
"city": "London",
"contacts": [
{
"email": null,
"name": "Melissa Homer",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "East London NHS Foundation Trust, Specialist Children's and Young People's Services",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "E15 4PT"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot feasibility study is to test a co-adapted community-based group programme (\"Encompass\") with parents/carers of children with complex neurodisability under 5 years of age in East London in the UK.The main questions it aims to answer are:* Is it feasible and acceptable to carry out this newly co-adapted programme with two groups of parents/carers of children with complex neurodisability under the age of 5?* Is it feasible to carry out an evaluation of the above programme, which could then inform a protocol for larger scale evaluation?The main activities for the parent/carer participants will include:* Attending ten \"Encompass\" parent/carer groups* Filling in questionnaires at the start and end of the groups* Attending an interview with the researcher to discuss their experiencesThe groups will be facilitated by a healthcare professional and a parent with lived experience. They will also be interviewed about their experiences after the groups have been completed."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ENCOMPASS",
"briefTitle": "Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodisability",
"nctId": "NCT06310681",
"orgStudyIdInfo": {
"id": "ETH2223-2528",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Group Attendance"
},
{
"measure": "Recruitment - percentage of eligible participants who consent to take part"
},
{
"measure": "Follow-up response rate-self-complete outcomes questionnaire(s)"
},
{
"measure": "Fidelity - delivery on items described in the Fidelity Checklist"
}
],
"secondaryOutcomes": [
{
"measure": "Family Empowerment Scale (FES)"
},
{
"measure": "Power Ladder Question (PLQ)"
},
{
"measure": "Parent Patient Activation Measure (P-PAM)"
},
{
"measure": "Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)"
},
{
"measure": "Parent/carer Quality of Life - EuroQoL-5D-5-level (EQ-5D-5L)"
},
{
"measure": "Parent/carer Needs and Goals"
},
{
"measure": "Childhood Cost Calculator (C3)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "City, University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
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"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "group cognitive behavioral therapy sessions"
}
]
},
"conditionsModule": {
"conditions": [
"Substance Use Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Aim of the study: In this study, the change in emotional intelligence will be assessed before and after group CBT sessions in male patients with substance use disorder in the inpatient department of the addiction unit at Mansoura University Hospital."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized clinical trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Has CBT an Effect on Emotional Intelligence in Patients With Substance Use Disorder?",
"nctId": "NCT06310668",
"orgStudyIdInfo": {
"id": "CBT IN substance use disorder",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "emotional intelligence"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Egyptian Medical Syndicate"
}
},
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"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Proton SBRT"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint Louis",
"contacts": [
{
"email": "[email protected]",
"name": "Allen Mo, M.D., Ph.D.",
"phone": "314-717-2320",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Allen Mo, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Hyun Kim, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Stephanie Perkins, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Joshua Schiff, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Weiren Liu, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Hailei Zhang, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Yi Huang, M.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Robbie Beckert",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eric Laugeman, M.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Farideh Pak, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Mike Watts, M.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Xiandong Zhao, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Tianyu Zhao, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Washington University School of Medicine",
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"lon": -90.19789
},
"state": "Missouri",
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"zip": "63110"
}
]
},
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"briefSummary": "This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy.Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "All patients will receive 5 fractions of proton radiotherapy for their cancer. At the time of each fraction, the initial pre-plan will be compared to the newly generated adapted plan, and the optimal treatment will be administered.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PARTy",
"briefTitle": "Online Proton Adaptive Radiotherapy",
"nctId": "NCT06310655",
"orgStudyIdInfo": {
"id": "202403078",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of online proton adaptive radiotherapy"
}
],
"secondaryOutcomes": [
{
"measure": "Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Washington University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Immediate descent from altitude."
},
{
"name": "Diphenhydramine"
},
{
"name": "Prochlorperazine 10 mg"
}
]
},
"conditionsModule": {
"conditions": [
"AMS",
"Acute Mountain Sickness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Corpus Christi",
"contacts": null,
"country": "United States",
"facility": "CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency",
"geoPoint": {
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"lon": -97.39638
},
"state": "Texas",
"status": null,
"zip": "78405"
}
]
},
"descriptionModule": {
"briefSummary": "A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Enrolled a cohort of consenting, healthy subjects aged \\>17 years. Thirty subjects enrolled in the study. 15 subjects received prochlorperazine. 15 subjects received placebo.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Patients were blinded in this study.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PAMS",
"briefTitle": "Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness",
"nctId": "NCT06310642",
"orgStudyIdInfo": {
"id": "2020-217",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups"
}
],
"secondaryOutcomes": [
{
"measure": "Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "CHRISTUS Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-03-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "COMPLETED",
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"date": "2023-03-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High Flow Nasal Cannula"
},
{
"name": "\"Intrinseque Health\" Non-Rebreathing Mask (\"IHNRM\")"
}
]
},
"conditionsModule": {
"conditions": [
"Respiratory Disease",
"Respiratory Distress Syndrome",
"Respiratory Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taichung",
"contacts": [
{
"email": "[email protected]",
"name": "Chih-Chihng Yen, MD, PhD",
"phone": "886-4-22052121",
"phoneExt": "3483",
"role": "CONTACT"
},
{
"email": null,
"name": "Chih-Ching Yen, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Taiwan",
"facility": "Department of Internal Medicine, China Medical Univdersity Hospital",
"geoPoint": {
"lat": 24.1469,
"lon": 120.6839
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Based on early bench-testing data and subsequent clinical case studies in the U.S., \"Intrinseque Health\" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula.Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward.This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward.The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between \"IHNRM\" and HFNC."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oxygenation Efficacy of \"Intrinseque Health\" Non-Rebreathing Mask (\"IHNRM\")",
"nctId": "NCT06310629",
"orgStudyIdInfo": {
"id": "CMUH112-REC3-163",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to reach SpO2 Criteria in Run-in"
},
{
"measure": "The percentage of subjects to reach SpO2 Criteria in maintenance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "China Medical University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
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"date": "2025-02-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VH4524184"
},
{
"name": "Loestrin"
}
]
},
"conditionsModule": {
"conditions": [
"HIV Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Antonio",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chinonye Chika Ogbonnaya-Odor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78209"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants",
"nctId": "NCT06310616",
"orgStudyIdInfo": {
"id": "219888",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184"
},
{
"measure": "AUC0-Tau, ss of EE and NEA with coadministration with VH4524184"
},
{
"measure": "Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184"
},
{
"measure": "Cmax for EE and NEA with coadministration with VH4524184"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with adverse events (AEs) and severity of AEs"
},
{
"measure": "Number of participants with AEs leading to discontinuation of study intervention"
},
{
"measure": "Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter)"
},
{
"measure": "Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L])"
},
{
"measure": "Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio)"
},
{
"measure": "Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR"
},
{
"measure": "Maximum plasma concentration at steady state (Cmax,ss) for VH4524184"
},
{
"measure": "Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184"
},
{
"measure": "Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184"
},
{
"measure": "Trough concentration prior to the next dose (Ctrough) for VH4524184"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "ViiV Healthcare"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low-Processed Food Diet"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Nutrition"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stillwater",
"contacts": [
{
"email": "[email protected]",
"name": "Sam Emerson, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Tyler Godsey, B.S.",
"phone": "405-744-7708",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sam Emerson, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Laboratory for Applied Nutrition and Exercise Science (LANES)",
"geoPoint": {
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"lon": -97.05837
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "74075"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\\[s\\] it aims to answer are:• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Determinants and Outcomes of High vs. Low Ultra-processed Feeding",
"nctId": "NCT06310603",
"orgStudyIdInfo": {
"id": "IRB-23-42",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Energy Intake"
},
{
"measure": "Energy Expenditure"
},
{
"measure": "Gut Microbiome Collection"
}
],
"primaryOutcomes": [
{
"measure": "Body Weight"
},
{
"measure": "Body Composition"
},
{
"measure": "Fat Mass Percentage"
},
{
"measure": "Fat-Free Mass Percentage"
}
],
"secondaryOutcomes": [
{
"measure": "Triglyceride Levels"
},
{
"measure": "Glucose Levels"
},
{
"measure": "Cholesterol Levels"
},
{
"measure": "HDL"
},
{
"measure": "LDL"
},
{
"measure": "Alanine transaminase (ALT)"
},
{
"measure": "Aspartate transaminase (AST)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Oklahoma State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-09"
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{
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{
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{
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},
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"measure": "Progression-free survival (PFS)."
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],
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{
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},
{
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},
{
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},
{
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},
{
"measure": "Number of acute side-effects"
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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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"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Patrick Yao",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 38.95362,
"lon": -94.73357
},
"state": "Kansas",
"status": null,
"zip": "66219"
},
{
"city": "San Antonio",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chinonye Chika Ogbonnaya-Odor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas",
"status": null,
"zip": "78209"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "First Time in Human Study of Long Acting VH4524184 Formulations",
"nctId": "NCT06310551",
"orgStudyIdInfo": {
"id": "218804",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of participants reporting AEs and related AEs"
},
{
"measure": "Percentage of participants with AEs by severity"
},
{
"measure": "Percentage of participants discontinuing the treatment due to AEs"
},
{
"measure": "Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184"
},
{
"measure": "Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184"
},
{
"measure": "Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184"
},
{
"measure": "Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase)"
},
{
"measure": "Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin)"
},
{
"measure": "Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio)"
},
{
"measure": "Percentage of participants reporting injection site reaction (ISR) AEs"
},
{
"measure": "Duration of injection site reaction AEs"
},
{
"measure": "Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of Long-Acting Injectable (LAI) VH4524184 following single dose administration"
},
{
"measure": "Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration"
},
{
"measure": "Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration"
},
{
"measure": "Cmax of LAI VH4524184 following multiple dose administration"
},
{
"measure": "Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration"
},
{
"measure": "Tmax of LAI VH4524184 following multiple dose administration"
},
{
"measure": "Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration"
},
{
"measure": "t1/2 of LAI VH4524184 following multiple dose administration"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GlaxoSmithKline"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "ViiV Healthcare"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "kou sha"
},
{
"name": "Hongjin Xiaojie Capsules"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Hyperplasia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World",
"nctId": "NCT06310538",
"orgStudyIdInfo": {
"id": "2024BZYLL0110",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Breast pain score"
},
{
"measure": "Short Form McGill Pain Inquiry Scale (SF-MPQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Breast color ultrasound score"
},
{
"measure": "Palpation lump score"
},
{
"measure": "Depression symptoms"
},
{
"measure": "Anxiety symptoms"
},
{
"measure": "The quality of life rating scale (QOL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hongguo Rong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Drowning incident"
}
]
},
"conditionsModule": {
"conditions": [
"Drowning",
"Drowning and Submersion While in Bath-Tub",
"Drowning and Submersion While in Natural Water",
"Drowning and Submersion While in Swimming-Pool",
"Drowning and Submersion Due to Fall Off Ship",
"Drowning and Nonfatal Submersion",
"Drowning, Near",
"Drowning; Asphyxia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Næstved",
"contacts": null,
"country": "Denmark",
"facility": "Prehospital Center",
"geoPoint": {
"lat": 55.22992,
"lon": 11.76092
},
"state": "Region Zealand",
"status": null,
"zip": "4700"
}
]
},
"descriptionModule": {
"briefSummary": "The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DROWN_DDF2",
"briefTitle": "Using Machine Learning to Optimise the Danish Drowning Formula",
"nctId": "NCT06310525",
"orgStudyIdInfo": {
"id": "DROWN_DDF2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sensitivity of the machine learning algorithm as a drowning identification tool"
},
{
"measure": "Specificity of the machine learning algorithm as a drowning identification tool"
},
{
"measure": "PPV of the machine learning algorithm"
},
{
"measure": "NPV of the machine learning algorithm"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prehospital Center, Region Zealand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Structured drug therapy management"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension",
"Medication Therapy Management"
]
},
"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 goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:To explore the effect of pharmacists' implementation of \"the medication therapy management pathway in hypertensive patients\"on the patients with hypertension.Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention."
},
"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": 420,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PharmMTMH",
"briefTitle": "Efficacy of Pharmacist Interventions Through the \"Medication Therapy Management Pathway in Hypertensive Patients\"",
"nctId": "NCT06310512",
"orgStudyIdInfo": {
"id": "ANZHEN HOSPITOL-LY-04",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "systolic blood pressure"
}
],
"secondaryOutcomes": [
{
"measure": "diastolic blood pressure"
},
{
"measure": "Change from baseline in mean sitting systolic blood pressure at 3 months"
},
{
"measure": "Change from baseline in number of medication-related problems (MRP) at 6 months"
},
{
"measure": "Average number of medication-related problems (MRP) resolved after 6 months"
},
{
"measure": "The compliance rate of blood pressure after 6 months"
},
{
"measure": "Effective rate of blood pressure lowering after 6 months"
},
{
"measure": "Time to BP Attainment in Intervention and Non-Intervention Groups"
},
{
"measure": "Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used."
},
{
"measure": "Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beijing Anzhen Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Drowning"
}
]
},
"conditionsModule": {
"conditions": [
"Drowning",
"Drowning; Anoxia",
"Drowning, Near",
"Drowning in Swimming Pool",
"Drowning; Asphyxia",
"Drowning/Diving/SCUBA Accident",
"Drowning or Immersion of Unknown Intent",
"Drowning and Submersion, Undetermined Intent",
"Drowning and Submersion While in Bath-Tub",
"Drowning and Submersion While in Natural Water",
"Drowning and Submersion Due to Sailboat Sinking",
"Drowning and Submersion Due to Fall Off Ship",
"Drowning and Submersion While in Swimming-Pool"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Næstved",
"contacts": null,
"country": "Denmark",
"facility": "Prehospital Center",
"geoPoint": {
"lat": 55.22992,
"lon": 11.76092
},
"state": "Region Zealand",
"status": null,
"zip": "4700"
}
]
},
"descriptionModule": {
"briefSummary": "According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 700,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DROWN_COD",
"briefTitle": "Primary or Secondary Drowning",
"nctId": "NCT06310499",
"orgStudyIdInfo": {
"id": "DROWN_COD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Autopsy rate"
},
{
"measure": "Primary fatal drowning rate"
},
{
"measure": "Secondary fatal drowning rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prehospital Center, Region Zealand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Drowning-related OHCA"
},
{
"name": "Drowning-related non-OHCA"
}
]
},
"conditionsModule": {
"conditions": [
"Drowning",
"Drowning; Anoxia",
"Drowning, Near",
"Drowning; Asphyxia",
"Drowning and Nonfatal Submersion",
"Drowning or Immersion of Unknown Intent",
"Drowning and Submersion, Undetermined Intent",
"Drowning and Submersion While in Bath-Tub",
"Drowning and Submersion While in Natural Water",
"Drowning and Submersion Due to Sailboat Sinking",
"Drowning and Submersion Due to Fall Off Ship",
"Drowning and Submersion While in Swimming-Pool"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Næstved",
"contacts": null,
"country": "Denmark",
"facility": "Prehospital Center",
"geoPoint": {
"lat": 55.22992,
"lon": 11.76092
},
"state": "Region Zealand",
"status": null,
"zip": "4700"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DROWN_CALL",
"briefTitle": "The Emergency Call on Drowning",
"nctId": "NCT06310486",
"orgStudyIdInfo": {
"id": "DROWN_CALL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient-related characteristics influencing the 30-day survival"
},
{
"measure": "Setting-related characteristics influencing the 30-day survival"
},
{
"measure": "Caller-related characteristics influencing the 30-day survival"
},
{
"measure": "Dispatcher-related characteristics influencing the 30-day survival"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prehospital Center, Region Zealand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cadonilimab"
},
{
"name": "Oxaliplatin"
},
{
"name": "Capecitabine"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer",
"Esophagogastric Junction Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Guoxin Li, M.D., Ph.D.",
"phone": "+86-138-0277-1450",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Guoxin Li, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Liying Zhao, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "Nanfang Hospital, Southern Medical University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510-515"
}
]
},
"descriptionModule": {
"briefSummary": "For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial",
"nctId": "NCT06310473",
"orgStudyIdInfo": {
"id": "NFEC-2023-582",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pathologic complete remission rate (pCR)"
}
],
"secondaryOutcomes": [
{
"measure": "Major pathologic response，MPR"
},
{
"measure": "R0 resection rate"
},
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Disease Control Rate (DCR)"
},
{
"measure": "3-year disease-free survival rate of 3year (DFS)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanfang Hospital, Southern Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Papillectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Cholangiopancreatography, Endoscopic Retrograde"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
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"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of \"PreCut-Papillectomy\" in Difficult Biliary Cannulation",
"nctId": "NCT06310460",
"orgStudyIdInfo": {
"id": "PCP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of treatment success"
},
{
"measure": "Adverse event rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kliniken Ludwigsburg-Bietigheim gGmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Ecological and Environmental Concepts"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Bilgi University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34440"
}
]
},
"descriptionModule": {
"briefSummary": "The natural environment, which is the living environment of all living things; Technological advances and industrialization activities are being affected more and more negatively every day. Increasing energy demand and resource consumption due to population growth lead to negative consequences on ecological balance, such as environmental pollution, climate change and loss of natural environments. Health services have also increased resource use with the advancement of technology and caused negative effects on the environment. Health services have been slow to understand their impact on the environment. The aim of the study is to determine the environmental awareness and environmental attitude levels of physiotherapy and rehabilitation department students, to popularize the field of \"Environmental Physiotherapy\" and to enable the training of physiotherapist candidates with high environmental awareness."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 151,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Determination of Ecological Awareness and Attitudes Levels of Undergraduate Physiotherapy Students in Istanbul",
"nctId": "NCT06310447",
"orgStudyIdInfo": {
"id": "IstanbulBUFC2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ecological Footprint Awareness Scale"
},
{
"measure": "Environmental Awareness Scale"
},
{
"measure": "Environmental Attitude Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Participant Information Form"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Bilgi University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "questionnaire"
},
{
"name": "Discussion group"
},
{
"name": "Reflective diary"
}
]
},
"conditionsModule": {
"conditions": [
"Compassion",
"Death Anxiety",
"Adolescent Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Murcia",
"contacts": [
{
"email": "[email protected]",
"name": "Eva Abad-Corpa, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Miriam Espinosa-Sánchez, MhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Instituto Murciano de Investigación Biosanitaria",
"geoPoint": {
"lat": 37.98704,
"lon": -1.13004
},
"state": "MU",
"status": null,
"zip": "30120"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators want to work on compassion, understood as the recognition of the suffering of others that motivates us to try to alleviate it. The goal of this Multicenter project, with a mixed sequential transformative methodology, is to analyze the impact of a participatory process of awareness and reflection on compassion, in the face of end-of-life processes, in adolescents aged 12-23 years in 6 Spanish provinces, and to understand how the participatory process can transform and improve their compassion.As the adolescents must be the protagonists of change, the study will be conducted with students enrolled in one public secondary school and in one degree in a public University, that belongs to the same \"health area\" in each province. The investigators also include families' and teachers' knowledge of the context because it can support the interventions of change proposals.Compassion will be assessed using the Compassion for the Lives of Others Scale (COOLS), comprising 26 items. Similarly, adolescents' attitudes toward death are another important concept and will be explored through the Death Anxiety Scale (DAS), which has 15 questions. Both scales will be distributed to the adolescents, requesting their permission anonymously.After the survey, a second phase will start with a Participatory Action Research (PAR) with different activities. The objective is to generate awareness of the need to improve it, allowing the participants to design the interventions, based on evidence-based proposals (cinema forum, colloquiums with testimonies of volunteers accompanying palliative patients, organization of Death Cafe, artistic and literary activities, generation of grief groups, etc.).At the end of the project, the investigators will evaluate the adolescent compassion level and create discussion groups again to understand the impact of the interventions.With this project, the investigators will empower new generations of people to encourage, facilitate, support, and celebrate mutual care and family and community development in end-of-life processes. The translation and implications of the results for clinical practice will contribute to reducing inequalities in health research in a vulnerable group of special interest, especially when treatments can do nothing for their survival but with interventions such as those in this study, the investigators can ensure quality and dignity of life as long as there is life."
},
"designModule": {
"designInfo": {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1852,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "23 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "COMPAS",
"briefTitle": "Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes.",
"nctId": "NCT06310434",
"orgStudyIdInfo": {
"id": "PI23/00409",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Describe and improve the level of compassion of high school and university students."
},
{
"measure": "Describe and improve the attitude towards death of high school and university students."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Instituto de Salud Carlos III"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Screening SMA test"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Muscular Atrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Monfalcone",
"contacts": [
{
"email": "[email protected]",
"name": "Danica Dragovic, MD",
"phone": "+39 0481 487252",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "SC Pediatria Gorizia - Monfalcone",
"geoPoint": {
"lat": 45.80463,
"lon": 13.53292
},
"state": "Gorizia",
"status": "RECRUITING",
"zip": null
},
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Sheila Ulivi, MSc",
"phone": "+36.040 3785 226",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Luca Ronfani, PhD MD",
"phone": "+39.040.3785.297",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "Spinal muscular atrophy (SMA) is a group of disorders caused by the degeneration of the motor neuron cells of the anterior horn of the spinal cord and, in some subtypes, of the bulbar motor neurons. Almost all cases are genetically determined. Most SMAs are autosomal recessive diseases, caused by homozygous deletions of the survival motor neuron (SMN) gene located on the long arm of chromosome 5. The estimated incidence of recessive childhood and juvenile SMA linked to deletion of the SMN gene is 1 in 6000 to 10000 live births, with a carrier frequency of 1 in 35 in the general population, making it a major genetic cause of infant mortality. Up to 95-97% of all childhood cases are due to homozygous deletions of the survival motor neuron 1 (SMN1) gene, or telomeric SMN, located on chromosome 5q11.2-13.3. The remaining 3-5% of cases are due to small mutations in SMN1 (rather than complete deletions).Until a few years ago, the prognosis of type 1 SMA was poor. In the absence of therapies, the only measures were supportive (ventilation, nutrition) and the prospect, especially in the early forms, was to accompany them towards an early end of life. There are currently three treatment options available: nusinersen, risdiplam, and gene therapy with onasemnogene abeparvovec. The three options were found to be equally effective in reducing the symptoms of the disease, making it possible to reach or safeguard fundamental stages in a child's neuromotor development, starting from the ability to remain seated. At this moment, gene therapy is probably the preferred choice. To date, in Italy, there are approximately 100 patients undergoing gene therapy.To ensure maximum benefit for affected patients, it is essential that the therapy is administered as soon as possible. Literature shows how the administration of gene therapy in pre-symptomatic subjects made it possible to achieve a better neurological outcome compared to symptomatic patients. From this perspective, the inclusion of spinal muscular atrophy in neonatal screening is of fundamental relevance."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "ECOLOGIC_OR_COMMUNITY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 11500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "72 Hours",
"minimumAge": "48 Hours",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Spinal Muscular Atrophy Neonatal Screening Program",
"nctId": "NCT06310421",
"orgStudyIdInfo": {
"id": "Screening_SMA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of newborn screened"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "nasal mask"
},
{
"name": "nasal prong"
}
]
},
"conditionsModule": {
"conditions": [
"Nasal Mask",
"Nasal Prong"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "to determine the comparison of nasal masks and nasal prongs on the pain response of neonate"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "1 group give nasal mask1 group give nasal prong",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "44 Weeks",
"minimumAge": "26 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate",
"nctId": "NCT06310408",
"orgStudyIdInfo": {
"id": "0214022024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pain response"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Acute Mesenteric Ischemia"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, and the aim of this study is to analyse the results of the patients admited with an AMI in Hospital de Mar."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AMI_HMAR",
"briefTitle": "Analysis of the Acute Mesenteric Ischemia in a Single Institution Over 10 Years",
"nctId": "NCT06310395",
"orgStudyIdInfo": {
"id": "AMI_H.MAR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospital del Mar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GH55"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumors With MAPK Signal Pathway Mutant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "JIN LI, DOCTORATE",
"phone": "021-38804518",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai East Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200120"
}
]
},
"descriptionModule": {
"briefSummary": "This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase I/II Clinical Study to Evaluate The Safety, PK, PD of GH55 in Patients With MAPK Mutant Advanced Solid Tumors",
"nctId": "NCT06310382",
"orgStudyIdInfo": {
"id": "GH55-CRS001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with dose limiting toxicities"
},
{
"measure": "Number of participants with adverse events"
},
{
"measure": "Objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Number of participants with adverse events"
},
{
"measure": "Plasma concentration (Cmax)"
},
{
"measure": "Time to achieve Cmax (Tmax)"
},
{
"measure": "Area under the plasma concentration-time curve (AUC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai East Hospital"
},
{
"name": "Shandong Tumor Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Suzhou Genhouse Bio Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "radiation therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
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"briefSummary": "We aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored."
},
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},
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},
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},
"phases": [
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],
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},
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"maximumAge": "100 Years",
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"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer",
"nctId": "NCT06310369",
"orgStudyIdInfo": {
"id": "EORTC 2335-GUCG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Proportion of patients with a CR at 6 months post-radiotherapy"
}
],
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{
"measure": "Progression-free survival"
},
{
"measure": "overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "European Organisation for Research and Treatment of Cancer - EORTC"
}
},
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"completionDateStruct": {
"date": "2030-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-10-01"
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"date": "2025-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Freestyle Libre 3"
},
{
"name": "Glucometer"
}
]
},
"conditionsModule": {
"conditions": [
"Gestational Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aalst",
"contacts": [
{
"email": null,
"name": "Inge Van Pottelbergh, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "OLV Aalst-Asse",
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"lat": 50.93604,
"lon": 4.0355
},
"state": "Oost-Vlaanderen",
"status": null,
"zip": "9300"
},
{
"city": "Antwerp",
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{
"email": null,
"name": "Niels Bochanen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UZA",
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"lon": 4.40346
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},
{
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"email": null,
"name": "Astrid Morrens, MD",
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"role": "CONTACT"
}
],
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"facility": "ZNA Antwerpen",
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},
{
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"email": null,
"name": "Da Hae Lee, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Imelda Bonheiden",
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"lat": 51.02261,
"lon": 4.54714
},
"state": null,
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},
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"city": "Brugge",
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{
"email": null,
"name": "Sara Vandewalle",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "AZ St Jan Brugge",
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"lat": 51.20892,
"lon": 3.22424
},
"state": null,
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},
{
"city": "Brussel",
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{
"email": null,
"name": "Tiphaine Carton",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Erasme",
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"lat": 50.85045,
"lon": 4.34878
},
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},
{
"city": "Brussel",
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{
"email": null,
"name": "Fabian Lurquin",
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"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UCL",
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"lat": 50.85045,
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},
{
"city": "Gent",
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"email": null,
"name": "Joke Marlier, MD",
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"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UZ Gent",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
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},
{
"city": "Gent",
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{
"email": null,
"name": "Inge Van Boxelaer",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "AZ St Lucas Gent",
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"lat": 51.05,
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},
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"email": null,
"name": "Ellen Heyns, MD",
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"role": "CONTACT"
}
],
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"facility": "AZ Groeninge Kortrijk",
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"lat": 50.82803,
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},
{
"city": "Leuven",
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{
"email": "[email protected]",
"name": "Katrien Benhalima, MD PhD",
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"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "UZ Leuven",
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"lat": 50.87959,
"lon": 4.70093
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},
{
"city": "Liège",
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{
"email": null,
"name": "JC Philips",
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"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "CHU de Liège",
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"lat": 50.63373,
"lon": 5.56749
},
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},
{
"city": "Mechelen",
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{
"email": null,
"name": "Kathleen Bollaerts",
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"role": "CONTACT"
}
],
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},
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{
"email": null,
"name": "Philippe Oriot",
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"role": "CONTACT"
}
],
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"facility": "Centre Hospitalier Mouscron",
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"lat": 50.74497,
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},
{
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{
"email": null,
"name": "Xavier-Philippe Aers",
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"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "AZ Delta Roeselare",
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"lat": 50.94653,
"lon": 3.12269
},
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},
{
"city": "Sint-Niklaas",
"contacts": [
{
"email": null,
"name": "Peter Coremans",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Vitaz",
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"lat": 51.16509,
"lon": 4.1437
},
"state": null,
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},
{
"city": "Turnhout",
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{
"email": null,
"name": "Joke Cuypers, MD",
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"role": "CONTACT"
}
],
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}
]
},
"descriptionModule": {
"briefSummary": "There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 17 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance."
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 386,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CORDELIA",
"briefTitle": "Continuous Glucose Monitoring for Women With Gestational Diabetes",
"nctId": "NCT06310356",
"orgStudyIdInfo": {
"id": "CORDELIA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "a composite of pregnancy outcomes"
}
],
"secondaryOutcomes": [
{
"measure": "time in glucose range overnight between 70-95mg/dl"
},
{
"measure": "time in glucose range during the day between 70-95mg/dl"
},
{
"measure": "time in glucose range overnight between 63-140mg/dl"
},
{
"measure": "time in glucoserange during the day between 63-140mg/dl"
},
{
"measure": "time in glucose range during the day between 54-95mg/dl"
},
{
"measure": "time in glucose range overnight between 54-95mg/dl"
},
{
"measure": "time in glucose range overnight between 63-120mg/dl"
},
{
"measure": "time in glucose range during the day between 63-120mg/dl"
},
{
"measure": "hypoglycemia <54mg/dl"
},
{
"measure": "hypoglycemia <50mg/dl"
},
{
"measure": "hypoglycemia <63mg/dl"
},
{
"measure": "hypoglycemia <70mg/dl"
},
{
"measure": "standard deviation"
},
{
"measure": "Coefficient of Variance"
},
{
"measure": "mean amplitude of glycemic excursions"
},
{
"measure": "glucose time overnight >100mg/dl"
},
{
"measure": "glucose postprandial time >120mg/dl"
},
{
"measure": "glucose postprandial time >140mg/dl"
},
{
"measure": "glucose time >180mg/dl"
},
{
"measure": "mean HbA1c"
},
{
"measure": "Glucose management indicator"
},
{
"measure": "timing of start insulin treatment"
},
{
"measure": "mean insulin dose"
},
{
"measure": "mean gestational weight gain"
},
{
"measure": "rate of postpartum hemorrhage"
},
{
"measure": "rate of macrosomia"
},
{
"measure": "rate of baby >4.5Kg"
},
{
"measure": "rate of Small-for-gestational age infant"
},
{
"measure": "rate of cesarean section"
},
{
"measure": "rate of instrumental delivery"
},
{
"measure": "rate of perineal inury"
},
{
"measure": "rate of labor inductions"
},
{
"measure": "rate of preeclamspia"
},
{
"measure": "rate of gestational hypertension"
},
{
"measure": "rate of fetal malformation"
},
{
"measure": "rate of miscarriage"
},
{
"measure": "rate of polycythemia"
},
{
"measure": "rate of neonatal hypoglycemia"
},
{
"measure": "Treatment satisfaction"
},
{
"measure": "Quality of life based on Short Form (SF-36) score"
},
{
"measure": "dietary intake"
},
{
"measure": "Physical activity"
},
{
"measure": "fear for hypoglycaemia"
},
{
"measure": "fear for hyperglycaemia"
},
{
"measure": "symptoms of depression"
},
{
"measure": "symptoms of anxiety"
},
{
"measure": "user-friendliness of CGM"
},
{
"measure": "user-friendliness of CGM compared to oral glucose tolerance test (OGTT)"
},
{
"measure": "duration of breastfeeding"
},
{
"measure": "rate of hypercholesterolemia"
},
{
"measure": "night glucose time in range between 70-180mg/dl"
},
{
"measure": "day glucose time in range between 70-180mg/dl"
},
{
"measure": "day glucose time in range <70mg/dl"
},
{
"measure": "night glucose time in range <70mg/dl"
},
{
"measure": "night glucose time in range >180mg/dl"
},
{
"measure": "day glucose time in range >180mg/dl"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Hospital, Antwerp"
},
{
"name": "General Hospital Groeninge"
},
{
"name": "Onze Lieve Vrouw Hospital"
},
{
"name": "AZ Delta"
},
{
"name": "Ziekenhuis Netwerk Antwerpen (ZNA)"
},
{
"name": "Vitaz"
},
{
"name": "Centre Hospitalier Universitaire de Liege"
},
{
"name": "Erasme University Hospital"
},
{
"name": "Université Catholique de Louvain"
},
{
"name": "Centre Hospitalier Mouscron"
},
{
"name": "University Hospital, Ghent"
},
{
"name": "AZ Turnhout"
},
{
"name": "AZ Sint-Lucas Gent"
},
{
"name": "AZ St- Jan Brugge"
},
{
"name": "AZ St Maarten Mechelen"
},
{
"name": "Imelda Hospital, Bonheiden"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Alemtuzumab"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "Barts Health NHS Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": "Second Floor Neurophys Dept",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 15,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ADAs to Alemtuzumab",
"nctId": "NCT06310343",
"orgStudyIdInfo": {
"id": "304993",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To quantify the longitudinal changes in alemtuzumab ADAs"
}
],
"secondaryOutcomes": [
{
"measure": "1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2."
},
{
"measure": "2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions."
},
{
"measure": "3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity."
},
{
"measure": "4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels"
},
{
"measure": "5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Comprehensive echocardiographic follow-up"
},
{
"name": "Simplified echocardiographic follow-up"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Neoplasm Malignant Primary"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trondheim",
"contacts": [
{
"email": "[email protected]",
"name": "Rune Wiseth, MD, PhD",
"phone": "92247845",
"phoneExt": "47",
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "St. Olavs hospital",
"geoPoint": {
"lat": 63.43049,
"lon": 10.39506
},
"state": null,
"status": "RECRUITING",
"zip": "7491"
}
]
},
"descriptionModule": {
"briefSummary": "TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomization 1:1 to two different modes of follow-up",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "No masking",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TRUST-ACE",
"briefTitle": "TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography",
"nctId": "NCT06310330",
"orgStudyIdInfo": {
"id": "2019/1059",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)"
},
{
"measure": "Risk classification"
},
{
"measure": "Risk classification"
},
{
"measure": "Test-retest variability, systolic left ventricular size and function"
},
{
"measure": "Test-retest variability, systolic left ventricular size and function"
},
{
"measure": "Test-retest variability, diastolic left ventricular size and function"
},
{
"measure": "Test-retest variability, diastolic left ventricular size and function"
},
{
"measure": "Test-retest variability, right ventricular size and function"
},
{
"measure": "Test-retest variability, right ventricular size and function"
},
{
"measure": "Time consumption"
},
{
"measure": "Time consumption"
}
],
"primaryOutcomes": [
{
"measure": "Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "St. Olavs Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Norwegian University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Applied Behavior Analysis protocol"
},
{
"name": "Traditional intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Autism",
"Autism Spectrum Disorder"
]
},
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{
"city": "Messina",
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{
"email": "[email protected]",
"name": "Flavia Marino",
"phone": "+393395798263",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maria Valeria Maiorana",
"phone": "+393285856656",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Flavia Marino",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Giovanni Pioggia",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Paola Chilà",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Roberta Minutoli",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Noemi Vetrano",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Chiara Failla",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Germana Doria",
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"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ileana Scarcella",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Cinzia Grasso",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Mariaelena Franchina",
"phone": null,
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"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)",
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"status": "RECRUITING",
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}
]
},
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"briefSummary": "Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors."
},
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},
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},
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},
"phases": [
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],
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},
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"maximumAge": "12 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
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]
},
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"briefTitle": "Applied Behavior Analysis With Technologies",
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"id": "CNR-IRIB-PRO-2024-003",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "OTHER",
"name": "Istituto per la Ricerca e l'Innovazione Biomedica"
}
},
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"date": "2025-01-31"
},
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"date": "2024-03-15"
},
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"date": "2025-01-31"
},
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"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ruxolitinib IR"
},
{
"name": "Ruxolitinib XR"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
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{
"city": "Lincoln",
"contacts": null,
"country": "United States",
"facility": "Celerion, Inc",
"geoPoint": {
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"lon": -96.66696
},
"state": "Nebraska",
"status": null,
"zip": "68502"
}
]
},
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"briefSummary": "This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants."
},
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},
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},
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"type": "ACTUAL"
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"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
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"briefTitle": "A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants.",
"nctId": "NCT06310304",
"orgStudyIdInfo": {
"id": "INCB18424-153",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "INCB018424 pharmacokinetic (PK) in Plasma"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with Treatment Emergent Adverse Events (TEAEs)"
},
{
"measure": "Additional INCB018424 pharmacokinetic (PK) in Plasma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Incyte Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-04-16"
},
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"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VTP-1000"
},
{
"name": "Matched Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Celiac Disease"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "The Single Ascending Dose part of the trial contains a placebo controlled randomized 4+2 design, where four participants will receive active IMP and two placebo. The Multiple Ascending Dose is a standard sequential design",
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},
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},
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"type": "ESTIMATED"
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"phases": [
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],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "VTP-1000 in Adults With Celiac Disease",
"nctId": "NCT06310291",
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"id": "GLU001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot)"
},
{
"measure": "Gluten Antigen-specific T Cell Responses - Intracellular cytokine staining (ICS)"
},
{
"measure": "T cell receptor (TCR) sequencing"
},
{
"measure": "Serum Cytokine Concentrations"
},
{
"measure": "Cytokine Whole Blood Stimulation"
}
],
"primaryOutcomes": [
{
"measure": "Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs)"
},
{
"measure": "Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters"
},
{
"measure": "Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters"
},
{
"measure": "Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters"
},
{
"measure": "Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters"
},
{
"measure": "Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters"
},
{
"measure": "Changes from baseline and clinically significant abnormalities in vital signs"
},
{
"measure": "Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies"
},
{
"measure": "Changes in physical examination findings"
}
],
"secondaryOutcomes": [
{
"measure": "PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component"
},
{
"measure": "PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component"
},
{
"measure": "AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component"
},
{
"measure": "AUC extrapolated to infinity (AUC0-∞)of rapamycin component"
},
{
"measure": "Half-life of rapamycin component"
},
{
"measure": "Clearance of rapamycin component"
},
{
"measure": "Volume of distribution of rapamycin component"
},
{
"measure": "Part B MAD:Maximum concentration in plasma (Cmax) rapamycin component"
},
{
"measure": "Part B MAD:Time corresponding to Cmax (Tmax) of rapamycin component"
},
{
"measure": "Part B MAD:AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component"
},
{
"measure": "Part B MAD:AUC extrapolated to infinity (AUC0-∞)of rapamycin component"
},
{
"measure": "Part B MAD: Half-life of rapamycin component"
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{
"measure": "Part B MAD: Clearance of rapamycin component"
}
]
},
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"name": "Barinthus Biotherapeutics"
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},
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},
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"date": "2024-03-15"
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"date": "2025-08"
},
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"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Ossicular mobility measurement"
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]
},
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"conditions": [
"Conductive Hearing Loss, Middle Ear"
]
},
"contactsLocationsModule": {
"locations": null
},
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"briefSummary": "The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss.The main questions the study aims to answer are:* What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus?* Are there any significant differences in these vibrational responses associated with sex or age?Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants."
},
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ossiview Normative Mobility Data Collection Protocol",
"nctId": "NCT06310278",
"orgStudyIdInfo": {
"id": "1030312",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Umbo mobility"
},
{
"measure": "Incus mobility"
}
],
"secondaryOutcomes": [
{
"measure": "Dependence on age and sex"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "INDUSTRY",
"name": "Audioptics Medical Incorporated"
}
},
"statusModule": {
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"date": "2024-10-31"
},
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},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Retrospective observational study"
}
]
},
"conditionsModule": {
"conditions": [
"Earthquake",
"Crush Injury",
"Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Sengul Ozmert",
"phone": "+905323861201",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara Bilkent City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": "06800"
},
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Çankaya",
"status": "RECRUITING",
"zip": "06800"
}
]
},
"descriptionModule": {
"briefSummary": "The study aimed to investigate anesthesia management of pediatric patients in the Ankara Bilkent City Hospital during the earthquake disaster of February 6."
},
"designModule": {
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"interventionModel": null,
"interventionModelDescription": null,
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},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "30 Days",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake",
"nctId": "NCT06310265",
"orgStudyIdInfo": {
"id": "TABED 1-24-21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The anesthesia management under pediatric earthquake victims"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
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"date": "2024-04-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
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"date": "2024-04-05"
},
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"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Opthalmic assessments"
}
]
},
"conditionsModule": {
"conditions": [
"Presbyopia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zlín",
"contacts": [
{
"email": "[email protected]",
"name": "Stodůlka",
"phone": "+420 577 202 202",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Czechia",
"facility": "Gemini - Oční klinika Zlín",
"geoPoint": {
"lat": 49.22645,
"lon": 17.67065
},
"state": null,
"status": "RECRUITING",
"zip": "760 01"
},
{
"city": "Dublin",
"contacts": null,
"country": "Ireland",
"facility": "Wellington Eye Clinic",
"geoPoint": {
"lat": 53.33306,
"lon": -6.24889
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "D18 T8P3"
},
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Tanriverdi",
"phone": "+904447044",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Medipol University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": "34214"
},
{
"city": "East Grinstead",
"contacts": null,
"country": "United Kingdom",
"facility": "Centre For Sight",
"geoPoint": {
"lat": 51.12382,
"lon": -0.0061
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "RH149 4RH"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia."
},
"designModule": {
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"interventionModel": null,
"interventionModelDescription": null,
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up",
"nctId": "NCT06310252",
"orgStudyIdInfo": {
"id": "PRO_010-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "An exploratory data collection project with no primary safety or effectiveness endpoints."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "INDUSTRY",
"name": "Allotex, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Collection of biologic samples and data"
}
]
},
"conditionsModule": {
"conditions": [
"Amputation With Osseointegration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "Angelica M Melendez-Munoz",
"phone": "202-549-3229",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Toby L Perkins",
"phone": "240-308-0548",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ean R Saberski, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Orhopaedic Surgery Service, Walter Reed National Military Medical Center,",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "20889"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and \"paint\" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the military community as a whole."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OLIMPAS",
"briefTitle": "Microbiome Population Adaptation Study",
"nctId": "NCT06310239",
"orgStudyIdInfo": {
"id": "WRNMMC-2023-0434",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "PRORP",
"id": "67407",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determine if OI surgery causes changes in the microbiome community using phylogenies"
},
{
"measure": "Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods"
},
{
"measure": "Quantify soft tissue health using a modified Holger Score (0 = healthy soft issue and 6 = unhealthy soft tissue) to phylogenetically correlate this with microbiome homeostasis."
}
],
"secondaryOutcomes": [
{
"measure": "Floral profiles"
},
{
"measure": "Floral colonization"
},
{
"measure": "Clinical guidelines"
},
{
"measure": "Surgical site questionnaire"
},
{
"measure": "Post-OI hygiene guidelines"
},
{
"measure": "Soft tissue stability guidelines"
},
{
"measure": "Holger score validation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "Walter Reed National Military Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Epidural electrical spinal cord stimulator"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": null,
"name": "Chau",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of California, Los Angeles",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90095"
}
]
},
"descriptionModule": {
"briefSummary": "Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain",
"nctId": "NCT06310226",
"orgStudyIdInfo": {
"id": "23-000347",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Neurological gait kinematics assessment"
},
{
"measure": "Neurophysiological functional assessment using somatosensory evoked potential (SSEP)"
},
{
"measure": "Neurophysiological functional assessment using pain-related evoked potential (PREP)"
}
],
"primaryOutcomes": [
{
"measure": "Detection of brain connectivity using functional MRI"
}
],
"secondaryOutcomes": [
{
"measure": "Detection of brain waves using electroencephalography (EEG)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Los Angeles"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Invasive Pressure Monitor"
}
]
},
"conditionsModule": {
"conditions": [
"Hydrocephalus in Infants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Indianapolis",
"contacts": [
{
"email": null,
"name": "Jignesh Talior, MD",
"phone": "317-944-6201",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Riley Hospital for Children",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana",
"status": null,
"zip": "46202"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without* Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "0 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus",
"nctId": "NCT06310213",
"orgStudyIdInfo": {
"id": "17368",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of modified smart soft contact lens evaluation of external intracranial pressure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indiana University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lidocaine Topical 4% Topical Solution"
},
{
"name": "Bitrex"
},
{
"name": "normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Cold Induced Headache",
"Brain Freeze",
"Cold Induced Cephalgia",
"Headache"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia (\"Brain Freeze\"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "All besides PI",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Sphenopalatine Ganglion Block and Cold Induced Headaches",
"nctId": "NCT06310200",
"orgStudyIdInfo": {
"id": "IRB-2023-398",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia"
}
],
"secondaryOutcomes": [
{
"measure": "Degree of pain"
},
{
"measure": "Duration of brain freeze"
},
{
"measure": "Time to onset of headache"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Wright State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High Oxidant Unflavored Little Cigar - Group A"
},
{
"name": "Low Oxidant Unflavored Little Cigar - Group B"
},
{
"name": "High Oxidant Flavored Little Cigar - Group C"
},
{
"name": "Low Oxidant Flavored Little Cigar - Group D"
},
{
"name": "Usual Cigarette - Group E"
},
{
"name": "Unlit Little Cigar - Group F"
}
]
},
"conditionsModule": {
"conditions": [
"Tobacco Use",
"Oxidative Stress"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Williams Design for Cross over-trials with a 6-period 6-treatment cross-over design in 36 healthy daily cigarette smokers.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Little Cigar Oxidants",
"nctId": "NCT06310187",
"orgStudyIdInfo": {
"id": "STUDY00023967",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "U54DA058271-01",
"link": "https://reporter.nih.gov/quickSearch/U54DA058271-01",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hydrogen Peroxide Concentration in Exhaled Breath Condensate"
},
{
"measure": "Hydrogen Peroxide Concentration in Exhaled Breath Condensate"
},
{
"measure": "Hydrogen Peroxide Concentration in Exhaled Breath Condensate"
},
{
"measure": "Hydrogen Peroxide Concentration in Exhaled Breath Condensate"
},
{
"measure": "8-isoprostanes Concentration in Exhaled Breath Condensate"
},
{
"measure": "8-isoprostanes Concentration in Exhaled Breath Condensate"
},
{
"measure": "8-isoprostanes Concentration in Exhaled Breath Condensate"
},
{
"measure": "8-isoprostanes Concentration in Exhaled Breath Condensate"
},
{
"measure": "C-reactive Protein Concentration in Exhaled Breath Condensate"
},
{
"measure": "C-reactive Protein Concentration in Exhaled Breath Condensate"
},
{
"measure": "C-reactive Protein Concentration in Exhaled Breath Condensate"
},
{
"measure": "C-reactive Protein Concentration in Exhaled Breath Condensate"
},
{
"measure": "Nicotine Concentration in Exhaled Breath Condensate"
},
{
"measure": "Nicotine Concentration in Exhaled Breath Condensate"
},
{
"measure": "Nicotine Concentration in Exhaled Breath Condensate"
},
{
"measure": "Nicotine Concentration in Exhaled Breath Condensate"
},
{
"measure": "4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate"
},
{
"measure": "4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate"
},
{
"measure": "4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate"
},
{
"measure": "4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate"
},
{
"measure": "N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate"
},
{
"measure": "N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate"
},
{
"measure": "N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate"
},
{
"measure": "N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Milton S. Hershey Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Central Venous Catheter Exit Site Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Lisa Fornaresio, PhD",
"phone": "443-927-3984",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Zyriah Robinson",
"phone": "443.927.3983",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "James Gammie, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Johns Hopkins Hospital",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21287"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 144,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SCAD",
"briefTitle": "Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications",
"nctId": "NCT06310174",
"orgStudyIdInfo": {
"id": "IRB00362883",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "User satisfaction with the new cannulation knife for CVC insertion."
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of skin incision revisions."
},
{
"measure": "Frequency of procedures being aborted and restarted."
},
{
"measure": "Frequency of reverting to use of the scalpel normally used to make the incision."
},
{
"measure": "Presence of a clean, dry dressing."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bright light"
},
{
"name": "Dim Light"
}
]
},
"conditionsModule": {
"conditions": [
"End Stage Renal Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Light Therapy in End Stage Kidney Disease",
"nctId": "NCT06310161",
"orgStudyIdInfo": {
"id": "855161",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fatigue Severity Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The Chronic Disease Co-Care (CDCC) Pilot Scheme"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2",
"Hypertension",
"Chronic Disease",
"Disease Management",
"Primary Healthcare"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Eric Yuk Fai Wan",
"phone": "852 28315057",
"phoneExt": "852 28147475",
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The Chronic Disease Co-Care (CDCC) Pilot Scheme is initiated for early screening and management of people with hypertension (HT), pre-diabetes mellitus (pre-DM) and diabetes mellitus (DM) in Hong Kong. This study will evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the Scheme.This is a 12-month cohort study among the District Health Centre (DHC) or DHC Express, healthcare providers, CDCC participants and a comparison group of 1,886 non-participants. All the person-in charge, 2 family doctors and 1 of each allied health provider from each DHC/DHC Express will be administered with the questionnaires on quality of care and costing. All CDCC participants will be included in subject characteristics, among which a convenience sample of 548 will complete a telephone survey on experience, enablement and satisfaction of the CDCC Pilot Scheme. The health outcomes of 1,886 CDCC participants and 1,886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness.Participant characteristics, enablement, compliance to the standards of care, and costing of CDCC Pilot Scheme will be summarized using descriptive statistics. Differences in the proportion of patients meeting treatment targeted for HT, pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions. The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization (WHO) threshold. This study will inform future healthcare planning and policy for manpower and resource allocation."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 3772,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Chronic Disease Co-Care Pilot Scheme",
"nctId": "NCT06310148",
"orgStudyIdInfo": {
"id": "UW 24-019",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Characteristics of the Chronic Disease Co-Care (CDCC) participants"
},
{
"measure": "Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire"
},
{
"measure": "Enablement of CDCC participants by the Chinese Patient Enablement Instrument"
},
{
"measure": "Effectiveness of the CDCC Pilot Scheme on disease control for pre-diabetes mellitus (pre-DM) and DM in percent of Glycated Hemoglobin (HbA1c) and hypertension (HT) in millimeter of mercury of systolic blood pressure (SBP)/diastolic blood pressure (DBP)"
},
{
"measure": "The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire"
},
{
"measure": "The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio"
}
],
"secondaryOutcomes": [
{
"measure": "Experience and satisfaction of CDCC participants by the experience and enablement questionnaire"
},
{
"measure": "Number of attendance to doctor consultation on times in comparison groups"
},
{
"measure": "Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups"
},
{
"measure": "Changes in mean HbA1c/FPG in percent between two groups"
},
{
"measure": "Changes in mean SBP and DBP in millimeter of mercury between two groups"
},
{
"measure": "Changes in mean of HbA1c in percent between two groups"
},
{
"measure": "Changes in BMI in kilogram per square metre between two groups"
},
{
"measure": "Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment"
},
{
"measure": "The predicted 10-year cardiovascular disease (CVD) risk between two groups"
},
{
"measure": "Amount of direct medical costs between two groups"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Health and Medical Research Fund"
},
{
"name": "Primary Healthcare Office, Hong Kong"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Filtered Eyewear"
},
{
"name": "Unfiltered Eyewear"
},
{
"name": "No Filters"
}
]
},
"conditionsModule": {
"conditions": [
"Sleep Quality"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Menands",
"contacts": [
{
"email": "[email protected]",
"name": "Barbara Plitnick, RN",
"phone": "518-242-4603",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mariana Figueiro",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Light and Health Research Center",
"geoPoint": {
"lat": 42.69202,
"lon": -73.72456
},
"state": "New York",
"status": null,
"zip": "12204"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"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": "Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1",
"nctId": "NCT06310135",
"orgStudyIdInfo": {
"id": "STUDY-23-00816",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Melatonin Levels"
}
],
"secondaryOutcomes": [
{
"measure": "Karolinska Sleepiness scale to measure Subjective Sleepiness"
},
{
"measure": "Numerical Verification Task (NVT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Icahn School of Medicine at Mount Sinai"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Extracorporeal shockwave therapy"
},
{
"name": "ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Plantar Fascitis",
"Extracorporeal Shockwave Therapy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is :* to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.* to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.* to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups : group (A) , group (B) One of them will receive traditional treatment ( ultra sound , exercises) Other one will recieve extracorporeal shockwave therapy and traditional treatment also",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 52,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Planter Fascitis",
"nctId": "NCT06310122",
"orgStudyIdInfo": {
"id": "ESWT on planter fascitis",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Foot function"
}
],
"primaryOutcomes": [
{
"measure": "Stride length mean distance measured by (meter)"
},
{
"measure": "stride time mean time measured by (second)"
},
{
"measure": "speed mean distance/ time measured by (meter/second)"
},
{
"measure": "cadence mean number of steps /times."
}
],
"secondaryOutcomes": [
{
"measure": "pain intensity level."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PICU diary"
}
]
},
"conditionsModule": {
"conditions": [
"Post Intensive Care Syndrome",
"Narrative Medicine",
"Post Traumatic Stress Disorder",
"Anxiety",
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": [
{
"email": null,
"name": "Orsola Gawronski, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Bambino Gesù Children's Hospital IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00165"
}
]
},
"descriptionModule": {
"briefSummary": "When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge.To help understand and improve these experiences, the investigators want to study the \"PICU diaries.\" These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge.The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too.The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference.The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "19 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PICS-p",
"briefTitle": "Effect of Pediatric Intensive Care Unit Diaries on PICS-p",
"nctId": "NCT06310109",
"orgStudyIdInfo": {
"id": "2358_OPBG 2020",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parent's Post Traumatic Stress Disease (PTSD)"
},
{
"measure": "Parent's Anxiety"
},
{
"measure": "Child's Strengths and difficulties"
},
{
"measure": "Child's Post Traumatic Stress Disease (PTSD)"
},
{
"measure": "Child's Anxiety"
},
{
"measure": "Child's Depression"
}
],
"secondaryOutcomes": [
{
"measure": "Satisfaction with PICU care"
},
{
"measure": "Patient's Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministry of Health, Italy"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Bambino Gesù Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TLF fascial stretching exercise"
},
{
"name": "conventional physiotherapy program."
}
]
},
"conditionsModule": {
"conditions": [
"Pain",
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Naime Uluğ, PhD.",
"phone": "+905365434409",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Atılım University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain",
"nctId": "NCT06310096",
"orgStudyIdInfo": {
"id": "E-59394181-604.01-79277",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain threshold"
},
{
"measure": "Temporal summation"
},
{
"measure": "NRS(Numerical rating scales)"
}
],
"secondaryOutcomes": [
{
"measure": "Pain Sensitivity Scale (PSS)"
},
{
"measure": "Brief Pain Inventory (BPI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kirsehir Ahi Evran Universitesi"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Atılım University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Turbinate; Hypertrophy Mucous Membrane"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assiut",
"contacts": null,
"country": "Egypt",
"facility": "Al-Azhar University Hospital of Assiut",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": null,
"zip": "17511"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group.Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty.Group B (control group): Who applied for partial inferior turbinectomy.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The surgeons performed the nasal surgery and evaluating postoperative measurable outcomes was blinded about cases who were subjected to Endoscopic submucosal resection Turbinoplasty",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy",
"nctId": "NCT06310083",
"orgStudyIdInfo": {
"id": "SMR for Turbinate Hypertrophy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Size Of Anterior part of Turbinate"
},
{
"measure": "Size Of Posterior part of Turbinate"
},
{
"measure": "Space of Anterior nasal Cavity"
},
{
"measure": "Space of posterior nasal Cavity"
}
],
"primaryOutcomes": [
{
"measure": "Nasal Obstruction"
},
{
"measure": "Nasal Discharge"
},
{
"measure": "Crustations"
}
],
"secondaryOutcomes": [
{
"measure": "intra operative blood loss"
},
{
"measure": "Duration of operation (Minutes )"
},
{
"measure": "Hyposmia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ahmed Nabil Selim"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "3D Printed Personalized Ostomy Appliance"
}
]
},
"conditionsModule": {
"conditions": [
"3D Printing",
"Ostomy",
"Leakage"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.Participants will* Spend 2 weeks with their standard of care ostomy appliance* Spend 2 weeks with their personalized ostomy appliance made from a 3D scan* Participate in daily surveys and weekly quality of life surveys conducted over the phone"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "3DPPOA",
"briefTitle": "3D Printed Personalized Ostomy Appliance",
"nctId": "NCT06310070",
"orgStudyIdInfo": {
"id": "IRB-23-1965",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Leaks"
}
],
"secondaryOutcomes": [
{
"measure": "Number of appliances"
},
{
"measure": "Overall patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Virginia Polytechnic Institute and State University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Carilion Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tofacitinib"
}
]
},
"conditionsModule": {
"conditions": [
"Axial Spondyloarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dhaka",
"contacts": null,
"country": "Bangladesh",
"facility": "Bangabandhu Sheikh Mujib Medical University",
"geoPoint": {
"lat": 23.7104,
"lon": 90.40744
},
"state": null,
"status": null,
"zip": "1000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria.The main question\\[s\\] it aims to answer are:* Efficacy and safety of tofacitinib in different doses* If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Dose escalation study, all the patients will recieve 10mg tofacitinib at the beginning. Then at 3rd month, one group will continue at 10mg, if they fulfill the ASDAS major improvement criteria and other group will escalate to 15mg.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 92,
"type": "ACTUAL"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study",
"nctId": "NCT06310057",
"orgStudyIdInfo": {
"id": "4139",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg"
}
],
"secondaryOutcomes": [
{
"measure": "Clinicodemographic characteristics of Ax-SpA, ASDAS CRP outcome rates, quality of life, adverse effects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Incepta Pharmaceuticals Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Root canal irrigant Commiphora Myrrh 50%"
}
]
},
"conditionsModule": {
"conditions": [
"Necrotic Pulp"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth",
"nctId": "NCT06310044",
"orgStudyIdInfo": {
"id": "Commiphora Myrrh",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Amount of intracanal Bacterial CFUs/ml"
},
{
"measure": "Number of analgesic Counting Tablets taken by the patient after endodontic treatment"
}
],
"primaryOutcomes": [
{
"measure": "Post-operative pain"
}
],
"secondaryOutcomes": [
{
"measure": "incidence of Post-operative swelling"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": null,
"contactsLocationsModule": null,
"descriptionModule": null,
"designModule": null,
"eligibilityModule": null,
"identificationModule": {
"acronym": null,
"briefTitle": "[Trial of device that is not approved or cleared by the U.S. FDA]",
"nctId": "NCT06310031",
"orgStudyIdInfo": {
"id": "CL-00545",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Embolism",
"Right Ventricular Dysfunction",
"Right Ventricular Failure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "multicenter, prospective, single-arm study",
"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": "SONIC-PE",
"briefTitle": "Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE",
"nctId": "NCT06310018",
"orgStudyIdInfo": {
"id": "2023A070902",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours"
},
{
"measure": "Frequency of ISTH major bleeding at 72 hours"
}
],
"secondaryOutcomes": [
{
"measure": "Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours"
},
{
"measure": "Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Boston Scientific Corporation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Brigham and Women's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BI 3006337"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tokyo, Shinjuku-ku",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "0120201230",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Japan",
"facility": "Clinical Research Hospital Tokyo",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": "160-0004"
}
]
},
"descriptionModule": {
"briefSummary": "The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Trial consists of a single-rising dose (SRD) and multiple dose (MD) part. In SRD part, the groups will be dosed consecutively in ascending order. The decision proceeding to MD part will be based upon safety and tolerability of all the preceding dose groups in SRD part. Within each dose group, patients will be randomized to either BI 3006337 or placebo.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The trial is designed single-blind. The treatments administered (BI 3006337 or placebo) will be blinded to subjects but will be known to the investigators (outcome assessors).",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated",
"nctId": "NCT06310005",
"orgStudyIdInfo": {
"id": "1466-0003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SRD + MD part: Percentage of patients with any treatment-emergent adverse event assessed as drug-related by the investigator"
}
],
"secondaryOutcomes": [
{
"measure": "SRD part: Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf)"
},
{
"measure": "SRD part: Maximum measured concentration of BI 3006337 in serum (Cmax)"
},
{
"measure": "MD part: Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6"
},
{
"measure": "MD part: Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Boehringer Ingelheim"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Survodutide"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Non-Alcoholic SteatoHepatitis (NASH)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Miami Lakes",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Panax Clinical Research",
"geoPoint": {
"lat": 25.90871,
"lon": -80.30866
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33014"
},
{
"city": "Miami",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Verus Clinical Research Corporation",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33135"
},
{
"city": "Shreveport",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Louisiana Research Center, LLC",
"geoPoint": {
"lat": 32.52515,
"lon": -93.75018
},
"state": "Louisiana",
"status": "RECRUITING",
"zip": "71105"
}
]
},
"descriptionModule": {
"briefSummary": "This study is open to adults who are at least 18 years old and have* presumed or confirmed NASH together with overweight or obesity and* a body mass index (BMI) of 30 kg/m² or more, or* a BMI of 27 kg/m² and at least one weight-related health problem.People with a history of other chronic liver diseases cannot take part in this study.The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight",
"nctId": "NCT06309992",
"orgStudyIdInfo": {
"id": "1404-0056",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTIS",
"id": "2023-505303-23-00",
"link": null,
"type": "REGISTRY"
},
{
"domain": "WHO registry",
"id": "U1111-1299-9925",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)"
},
{
"measure": "Relative change (%) in body weight from baseline to Week 48"
}
],
"secondaryOutcomes": [
{
"measure": "Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF"
},
{
"measure": "Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF"
},
{
"measure": "Reduction from baseline to Week 48 in Iron corrected T1 (cT1) levels of ≥80 ms (yes/no)"
},
{
"measure": "Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels"
},
{
"measure": "Relative change from baseline to Week 48 in alanine amino transferase (ALT) levels"
},
{
"measure": "Absolute change from baseline to Week 48 in waist circumference [cm]"
},
{
"measure": "Relative change from baseline to Week 48 in waist circumference [cm]"
},
{
"measure": "Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5)"
},
{
"measure": "Absolute change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE)"
},
{
"measure": "Relative change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE)"
},
{
"measure": "Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI"
},
{
"measure": "Relative change in liver volume [mL] from baseline to Week 48 measured using MRI"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Boehringer Ingelheim"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Idiopathic Short Stature"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Washington",
"contacts": null,
"country": "United States",
"facility": "Children's National Health System",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia",
"status": "RECRUITING",
"zip": "20010"
}
]
},
"descriptionModule": {
"briefSummary": "Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Assess Growth in Children With Idiopathic Short Stature",
"nctId": "NCT06309979",
"orgStudyIdInfo": {
"id": "111-903",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in annualized growth velocity (AGV)"
},
{
"measure": "Change in Height Z-score"
},
{
"measure": "Change in Standing Height"
},
{
"measure": "Change in BMI"
},
{
"measure": "Change in BMI Z-score"
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of event rates of medical events of interest"
},
{
"measure": "Frequency of Serious Medical Events"
},
{
"measure": "Association between specific variants and growth velocity"
},
{
"measure": "Association between other health outcomes directly related to short stature"
}
]
},
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{
"name": "BHV-7000"
},
{
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]
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},
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"name": "Deeba Ahmad",
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}
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"name": "Yalexis Lorenzo",
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"role": "CONTACT"
}
],
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}
],
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"email": "[email protected]",
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}
],
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"name": "Joseph Hilde",
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}
],
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"name": "Susan Ngo",
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}
],
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},
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{
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{
"email": "[email protected]",
"name": "Heather Scuderi",
"phone": "504-702-4624",
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}
],
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"email": "[email protected]",
"name": "Reggie Mister",
"phone": "504-336-2667",
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}
],
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},
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"email": "[email protected]",
"name": "Monica Coudurier",
"phone": "919-966-6727",
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}
],
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},
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},
{
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{
"email": "[email protected]",
"name": "Nikki Kamos",
"phone": "513-803-4552",
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"role": "CONTACT"
}
],
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{
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{
"email": "[email protected]",
"name": "Robin Bulgarino",
"phone": "843-792-1115",
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}
],
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},
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},
{
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{
"email": "[email protected]",
"name": "Jessica Benvenuto",
"phone": "423-698-4584",
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}
],
"country": "United States",
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},
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},
{
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"email": "[email protected]",
"name": "Shruti Konda",
"phone": "915-974-2200",
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}
],
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"email": "[email protected]",
"name": "Maria Poblete",
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}
],
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"zip": "77030"
}
]
},
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},
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},
"identificationModule": {
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"measure": "Change from Baseline in 28-day average seizure frequency during Weeks 8 to 16 of Treatment"
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],
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},
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}
}
} | false | null |
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]
},
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]
},
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"city": "Petaluma",
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},
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{
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},
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},
{
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},
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"zip": "55082"
},
{
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"lon": -94.57857
},
"state": "Missouri",
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"zip": "64154"
},
{
"city": "Brecksville",
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"geoPoint": {
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"lon": -81.62679
},
"state": "Ohio",
"status": "NOT_YET_RECRUITING",
"zip": "44141"
}
]
},
"descriptionModule": {
"briefSummary": "An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease"
},
"designModule": {
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"interventionModel": "SINGLE_GROUP",
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},
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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": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
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"nctId": "NCT06309953",
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"id": "937",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Mean change from baseline (CFB) in dry eye symptom severity at Visit 3"
}
],
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},
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"class": "INDUSTRY",
"name": "Bausch & Lomb Incorporated"
}
},
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"date": "2024-06-28"
},
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},
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"date": "2024-06-28"
},
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"date": "2024-02-28"
},
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}
}
} | false | null |
{
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"interventions": [
{
"name": "Prognostic factors of surgical evacuation of basal ganglionic haemorrhage"
}
]
},
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate"
},
"designModule": {
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},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage",
"nctId": "NCT06309940",
"orgStudyIdInfo": {
"id": "Basal ganglionic haemorrhage",
"link": null,
"type": null
},
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},
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"measure": "Prognostic factors of surgical evacuation of basal ganglionic haemorrhage"
}
],
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},
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"class": "OTHER",
"name": "Assiut University"
}
},
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"date": "2025-04"
},
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},
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"date": "2025-03"
},
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
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"interventions": [
{
"name": "Operative hysteroscopy (by tissue removal device)"
},
{
"name": "Suction curettage"
}
]
},
"conditionsModule": {
"conditions": [
"Early Pregnancy Loss",
"Intrauterine Adhesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Be'er Ya'aqov",
"contacts": [
{
"email": "[email protected]",
"name": "Noam Smorgick, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Shamir Medical Center",
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"lon": 34.83749
},
"state": null,
"status": null,
"zip": "70200"
}
]
},
"descriptionModule": {
"briefSummary": "Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).The surgical procedure will be determined randomly by computer generated allocation.All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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},
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"type": "ESTIMATED"
},
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],
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},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)",
"nctId": "NCT06309927",
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"id": "0025-24-ASF",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
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"measure": "Operative complications"
},
{
"measure": "Intrauterine adhesions"
},
{
"measure": "Subsequent fertility"
}
],
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"measure": "Conversion from operative hysteroscopy to suction curettage"
}
]
},
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"class": "OTHER_GOV",
"name": "Assaf-Harofeh Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
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"date": "2025-12"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Placebo"
},
{
"name": "Enovita Grape Seed Extract"
},
{
"name": "Mirtoselect Bilberry Extract"
},
{
"name": "Virtiva Plus Ginko Biloba Extract"
}
]
},
"conditionsModule": {
"conditions": [
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"Cognitive Change",
"Mood Change"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Jacob Wilson, PhD",
"phone": "813-673-8888",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Justine Davis, MS",
"phone": "813-673-8888",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Applied Science and Performance Institute",
"geoPoint": {
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"lon": -82.45843
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33607"
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 subjects. To account for potential dropouts, we aim to enroll up to 20% over the desired sample size. Therefore, this study will enroll up to 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States",
"nctId": "NCT06309914",
"orgStudyIdInfo": {
"id": "Pro00074459",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Visual Memory"
},
{
"measure": "Change in Verbal Memory"
},
{
"measure": "Change in Finger Tapping Test (FTT) Results"
},
{
"measure": "Change in Symbol Digit Coding (SDC) Test Results"
},
{
"measure": "Change in Stroop Test Results"
},
{
"measure": "Change in Shifting Attention Test Results"
},
{
"measure": "Change in Continuous Performance Test Results"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Abbreviated Profile of Mood States (POMS) Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Applied Science & Performance Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-15"
},
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"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
},
{
"name": "Fascial Distortion Model"
},
{
"name": "Instrument Assisted Soft Tissue Mobilisation"
}
]
},
"conditionsModule": {
"conditions": [
"Meniscus Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Yıldırım Beyazıt University Yenimahalle Training and Research Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06010"
}
]
},
"descriptionModule": {
"briefSummary": "To compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 33,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques",
"nctId": "NCT06309901",
"orgStudyIdInfo": {
"id": "ankaraYBU2019-199",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale"
},
{
"measure": "environmental measurement"
},
{
"measure": "Power Track Manuel Muscle Tester"
},
{
"measure": "sit and reach test"
},
{
"measure": "Goniometric measurement"
},
{
"measure": "The Western Ontario Meniscal Evaluation Tool (WOMET )"
},
{
"measure": "Lysholm Knee Score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara Yildirim Beyazıt University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nottwil",
"contacts": [
{
"email": "[email protected]",
"name": "Jothini Sritharan, MSc",
"phone": "+41419396557",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jothini Sritharan, MSc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Swiss Paraplegic Research",
"geoPoint": {
"lat": 47.13472,
"lon": 8.13772
},
"state": "Lucerne",
"status": "RECRUITING",
"zip": "6207"
}
]
},
"descriptionModule": {
"briefSummary": "In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury.Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
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},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "SCI_Cog",
"briefTitle": "Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury",
"nctId": "NCT06309888",
"orgStudyIdInfo": {
"id": "2023-18",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Brain activity"
}
],
"secondaryOutcomes": [
{
"measure": "Behavioral performance"
},
{
"measure": "Behavioral performance"
},
{
"measure": "Behavioral performance"
},
{
"measure": "Behavioral performance"
},
{
"measure": "Behavioral performance"
},
{
"measure": "Brain morphometry"
},
{
"measure": "Level of life satisfaction"
},
{
"measure": "Level of anxiety"
},
{
"measure": "Level of pain"
},
{
"measure": "Quality of sleep"
},
{
"measure": "Level of attention and awareness"
},
{
"measure": "Motor symptom severity"
},
{
"measure": "Demographics"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Swiss Paraplegic Research, Nottwil"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PLAN CUIDARTE"
},
{
"name": "Conventional care"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure",
"Caregiver Burden",
"Discharge Plan",
"Care Transitions",
"Nursing"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Manizales",
"contacts": [
{
"email": "[email protected]",
"name": "Claudia Marcela Vallejo, Mag",
"phone": "+573163614224",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Colombia",
"facility": "Universidad de Caldas",
"geoPoint": {
"lat": 5.06889,
"lon": -75.51738
},
"state": "Caldas",
"status": null,
"zip": "170004."
}
]
},
"descriptionModule": {
"briefSummary": "According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HFMethodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention \"PLAN CUIDARTE\" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test.The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later)",
"maskingInfo": {
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]
},
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},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PLANCUIDARTE",
"briefTitle": "Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure",
"nctId": "NCT06309875",
"orgStudyIdInfo": {
"id": "ENF- 25-2018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Care Competence"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universidad de Caldas"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universidad de la Sabana"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Cardio-Oncology",
"Cardiomyopathy Due to Drug"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"maskingInfo": null,
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"timePerspective": "PROSPECTIVE"
},
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"count": 15,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy",
"nctId": "NCT06309862",
"orgStudyIdInfo": {
"id": "5993",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Define changes in CMR tissue and blood biomarkers during ICI treatment."
},
{
"measure": "Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction."
},
{
"measure": "Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sunnybrook Health Sciences Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Radiculopathy"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "includes 30 participants.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, \"Randomized Clinical Trail\".",
"nctId": "NCT06309849",
"orgStudyIdInfo": {
"id": "Jerash University",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer."
}
],
"secondaryOutcomes": [
{
"measure": "3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "South Valley University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Basal Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "peris MD Peris",
"phone": "0630154211",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Irccs Fondazione Policlinico Gemelli",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "ITA",
"status": "RECRUITING",
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "REGISTRO-BCC",
"briefTitle": "Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma",
"nctId": "NCT06309836",
"orgStudyIdInfo": {
"id": "SID03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "clinical evolution, treatment and prognosis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MAS825"
}
]
},
"conditionsModule": {
"conditions": [
"X-linked Lymphoproliferative Syndrome Type 2 (XLP-2)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": null,
"country": "Canada",
"facility": "The Hospital for Sick Children",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5G1X8"
}
]
},
"descriptionModule": {
"briefSummary": "MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1,
"type": "ACTUAL"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "13 Years",
"sex": "MALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency",
"nctId": "NCT06309823",
"orgStudyIdInfo": {
"id": "1000080330",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Impact of MAS825 on Physician Global Assessment Score"
},
{
"measure": "Impact of MAS825 on Physician Severity Assessment of Disease Signs and Symptoms"
},
{
"measure": "Patient/Parent Global Assessment of Disease Activity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hospital for Sick Children"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Spasticity/Paresis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Negrar",
"contacts": [
{
"email": "[email protected]",
"name": "Luca Nicosia, Doctor",
"phone": "+39(0)456014800",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Sacro Cuore Don Calabria di Negrar",
"geoPoint": {
"lat": 45.52918,
"lon": 10.93899
},
"state": "Verona",
"status": "RECRUITING",
"zip": "37024"
}
]
},
"descriptionModule": {
"briefSummary": "This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia",
"nctId": "NCT06309810",
"orgStudyIdInfo": {
"id": "2022-35",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MAS"
}
],
"secondaryOutcomes": [
{
"measure": "Acute and late toxicity (CTCAE)"
},
{
"measure": "Quality of life (SF-12)"
},
{
"measure": "Quality of nursing (VAS)"
},
{
"measure": "Radiological characteristics and treatment-related changes of the spinal roots"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Sacro Cuore Don Calabria di Negrar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interdental brush+HA"
},
{
"name": "Interdental brush"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06010"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "single-center, single-blinded, randomized controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The investigator carrying out the measurements was not aware of which patients were assigned to the test group.",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis",
"nctId": "NCT06309797",
"orgStudyIdInfo": {
"id": "OSATAGUN2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gingival index (GI)"
},
{
"measure": "Plaque index (PI)"
},
{
"measure": "Papillary bleeding index (PBI)"
},
{
"measure": "Pocket depth (PD)"
},
{
"measure": "Clinical attachment loss (CAL)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Özlem SARAÇ ATAGÜN"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Drill Guidance System (DGS)"
}
]
},
"conditionsModule": {
"conditions": [
"Orthopaedic Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bath",
"contacts": [
{
"email": "[email protected]",
"name": "Jane Carter, BSc",
"phone": "01225821095",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Royal United hospitals NHS Foundation Trust",
"geoPoint": {
"lat": 51.3751,
"lon": -2.36172
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Swindon",
"contacts": [
{
"email": "[email protected]",
"name": "Adam Smith, FRCS",
"phone": "07533793889",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Great Western Hospital MHS foundation Trust",
"geoPoint": {
"lat": 51.55797,
"lon": -1.78116
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess:Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Participants undergoing orthopaedic Surgery",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"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": "Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling",
"nctId": "NCT06309784",
"orgStudyIdInfo": {
"id": "RD 2595",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NIHR",
"id": "NIHR II-LA-1116-20004",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Accuracy of placement of a screw or K wire in scaphoid bones"
},
{
"measure": "Accuracy of placement of a screw or K wire in other bones"
}
],
"secondaryOutcomes": [
{
"measure": "Length of material part of the procedure"
},
{
"measure": "Number of fluoroscopy (perioperative X-ray) images performed"
},
{
"measure": "Number of patients with treatment related adverse events as assessed by CTCAE v4.0"
},
{
"measure": "Immediate acceptability to surgeons and theatre staff"
},
{
"measure": "Initial acceptability to surgeons and theatre staff"
},
{
"measure": "Overall acceptability to surgeons and theatre staff"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Bath"
},
{
"name": "Great Western Hospitals NHS Foundation Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Royal United Hospitals Bath NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion."
}
]
},
"conditionsModule": {
"conditions": [
"Health Behavior",
"Health-Related Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lyon",
"contacts": null,
"country": "France",
"facility": "RESHAPE",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69008"
}
]
},
"descriptionModule": {
"briefSummary": "Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance.The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective.Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future.The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life and academic performance of 2nd cycle medical students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled clinical trial. Randomization into two groups: INTERVENTION group and CONTROL group. The INTERVENTION group will have the opportunity to follow a preventive remediation program based on 3 modules: stress management, sleep improvement and fatigue reduction, and sedentary behaviors reduction and physical activity promotion. The order of following the 3 modules will be randomized. The CONTROL group will not receive any intervention.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Assessors of pre and posttest measures will be blinded to the group allocation.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROMESS",
"briefTitle": "Preventive Remediation for Optimal MEdical StudentS (PROMESS)",
"nctId": "NCT06309771",
"orgStudyIdInfo": {
"id": "PROMESS - QOL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quality of life. Change from pre-intervention in a composite score obtained at the Brief Quality Of Life questionnaire at the post-interventional measure at Week 27."
}
],
"secondaryOutcomes": [
{
"measure": "Academic self-efficacy. Change from the pre-intervention in score obtained at the Academic self-efficacy questionnaire at the post-interventional measure at Week 27."
},
{
"measure": "Wu self efficacy questionnaire. Change from pre-intervention in score obtained at the adapted Wu self efficacy questionnaire at the post-interventional measure at Week 27."
},
{
"measure": "Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year."
},
{
"measure": "VAS - quality of life. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of Quality Of Life"
},
{
"measure": "VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence."
},
{
"measure": "VAS - self-efficacy. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-efficacy."
},
{
"measure": "VAS - resources. Evolution of the score obtained at the 100-mm Visual Analogue Scale assessing the perceived level of resources."
},
{
"measure": "VAS - work-life balances. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the work-life balances."
},
{
"measure": "VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors."
},
{
"measure": "VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level."
},
{
"measure": "VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations."
},
{
"measure": "VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress."
},
{
"measure": "VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality."
},
{
"measure": "VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep."
},
{
"measure": "VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue."
},
{
"measure": "VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness."
},
{
"measure": "VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity."
},
{
"measure": "VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors."
},
{
"measure": "Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 27."
},
{
"measure": "Coping strategies.Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 27."
},
{
"measure": "Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention."
},
{
"measure": "Big-5. Scores obtained at the Big-5 questionnaire."
},
{
"measure": "Perceived level of sleep troubles. Change from pre-intervention in score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI) at the post-interventional measure at Week 27."
},
{
"measure": "Epworth Sleepiness scale. Change from the pre-intervention in score obtained at the Epworth Sleepiness scale at the post-interventional measure at Week 27."
},
{
"measure": "Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 27."
},
{
"measure": "Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS)."
},
{
"measure": "Perceived level of physical activity. Change from the pre-intervention in score obtained at the Global Physical Activity Questionnaire (GPAQ) at the post-interventional measure at Week 27."
},
{
"measure": "Perceived level of sedentary. Change from the pre-intervention in score obtained at the Rapid Physical Activity Questionnaire (RPAQ) at the post-interventional measure at Week 27."
},
{
"measure": "Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 27."
},
{
"measure": "Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score in at the post-interventional measure at Week 27."
},
{
"measure": "Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 27."
},
{
"measure": "Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 27."
},
{
"measure": "Heart rate variability (HRV) markers.Change from pre-intervention in the Low frequency / High frequency ratio (LF/HF) ratio in at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Total activity at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Steps count at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in energy expenditure at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 27."
},
{
"measure": "Actimetry records. Change from pre-intervention in vector of the dynamic body acceleration (VeDBA) at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Strength. Change from pre-intervention in the force developed during a maximal isometric contraction of the quadriceps at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 27."
},
{
"measure": "Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 27."
},
{
"measure": "Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 27."
},
{
"measure": "Body composition markers. Change from the pre-intervention in fat mass at the post-interventional measure at Week 27."
},
{
"measure": "Body composition markers. Change from the pre-intervention in Skeletal muscle mass at the post-interventional measure at Week 27."
},
{
"measure": "Body composition markers.Change from the pre-intervention in total body hydration at the post-interventional measure at Week 27."
},
{
"measure": "Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module."
},
{
"measure": "Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sedentary behaviors and physical activity module."
},
{
"measure": "Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module."
},
{
"measure": "Question recommendation. Answer to the question \"Would you recommend a friend to participate at the PROMESS project?\" asked during the post-intervention."
},
{
"measure": "Question Habits change. Answer to the question \"Do you think that your participation at the PROMESS project has modified your health behaviors/actions?\" asked during the post-intervention."
},
{
"measure": "Question Habits change. Answer to the question \"\"For which behaviors do you think you have modified your habits/actions?\" asked during the post-intervention."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Research on Healthcare Performance Lab U1290"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Breinzorg"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Cognitive Impairment",
"Cognitive Decline"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.The main questions it aims to answer are:* Is the new website being used by the target population?* How does the target population experience the use of the website?* What is the effect of using the website?Participants will have access to the website and are free to use the website in any way they want."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "61 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD",
"nctId": "NCT06309758",
"orgStudyIdInfo": {
"id": "115022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability of the new online website following the theoretical framework of acceptability"
},
{
"measure": "Adoption / Uptake of the new online website. Website usage data."
},
{
"measure": "Demand of the new online website. Website usage data."
},
{
"measure": "Practicality of the new online website."
},
{
"measure": "Feeling of trust in yourself and your own abilities."
},
{
"measure": "Feeling of control about own life and future."
},
{
"measure": "Motivation to change lifestyle for reduction of dementia risk."
},
{
"measure": "Awareness about dementia risk reduction"
}
],
"secondaryOutcomes": [
{
"measure": "Change in alcohol consumption"
},
{
"measure": "Change in smoking behaviour"
},
{
"measure": "Change in physical exercise."
},
{
"measure": "Change in Diet."
},
{
"measure": "Change in Sleep behaviour"
},
{
"measure": "Change in cognitive activities."
},
{
"measure": "Change in Stress levels"
},
{
"measure": "Change in Mental health Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Radboud University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "retroperitoneal lymph node dissection"
},
{
"name": "Carboplatin AUC10"
}
]
},
"conditionsModule": {
"conditions": [
"Seminoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": null,
"name": "THERATEST Study coordinator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Barts and London Hospital NHS Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "THERATEST",
"briefTitle": "THERApy De-escalation for TESTicular Cancer",
"nctId": "NCT06309745",
"orgStudyIdInfo": {
"id": "THERATEST",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "FEASIBILITY of recruitment and retention"
}
],
"secondaryOutcomes": [
{
"measure": "QUALITY OF LIFE assessed by difference in HRQOL scores"
},
{
"measure": "QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction"
},
{
"measure": "Progression free SURVIVAL"
},
{
"measure": "OVERALL SURVIVAL"
},
{
"measure": "SAFETY and complication of all treatments"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pegfilgrastim"
},
{
"name": "Dactinomycin"
},
{
"name": "Methotrexate"
},
{
"name": "Etoposide"
},
{
"name": "Cisplatin"
},
{
"name": "Epirubicin"
}
]
},
"conditionsModule": {
"conditions": [
"Testicular Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "Barts and the London NHS Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "EC1A 7BE"
}
]
},
"descriptionModule": {
"briefSummary": "St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ACTUAL"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "16 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "GAMEC-II",
"briefTitle": "GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)",
"nctId": "NCT06309732",
"orgStudyIdInfo": {
"id": "4491",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2006-001963-52",
"link": null,
"type": "EUDRACT_NUMBER"
},
{
"domain": "Barts and the London NHS Trust",
"id": "TE 2006-09",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Response rate to GAMEC-S or GAMEC-A"
}
],
"secondaryOutcomes": [
{
"measure": "Relapse-free survival"
},
{
"measure": "Overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2014-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2013-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2006-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA)"
},
{
"name": "Periodontal Access Flap (AF)"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontal Diseases",
"Wound Heal",
"Periodontal Inflammation",
"Periodontal Pocket",
"Periodontal Attachment Loss"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Vandana Luthra",
"phone": "+44(0)207 882 6348",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Elena Calciolari, DDS, MS, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Barts Health NHS Trust Dental Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "E1 1BB"
},
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Vandana Luthra",
"phone": "+44(0)207 882 6348",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Elena Calciolari, DDS, MS, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Centre for Oral Clinical Research (COCR)",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "E1 2AD"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hyaluronic Acid and Polynucleotides for Supra-bony Defects",
"nctId": "NCT06309719",
"orgStudyIdInfo": {
"id": "339479",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Early wound healing molecular events through GCF"
},
{
"measure": "Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA"
}
],
"secondaryOutcomes": [
{
"measure": "Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery"
},
{
"measure": "Probing pocket depth (PPD)"
},
{
"measure": "Gingival recession (REC)"
},
{
"measure": "Clinical attachment level (CAL)"
},
{
"measure": "Suppuration"
},
{
"measure": "Gingival phenotype"
},
{
"measure": "Keratinized tissue (KT)"
},
{
"measure": "Full mouth plaque score (FMPS)"
},
{
"measure": "Full mouth bleeding score (FMBS)"
},
{
"measure": "Early Healing Index (EHI)"
},
{
"measure": "Gingival morphometric changes"
},
{
"measure": "Oral impact on daily performance (OIDP)"
},
{
"measure": "Dentine/root sensitivity"
},
{
"measure": "Food impaction"
},
{
"measure": "Patient perception about therapy"
},
{
"measure": "Global ratings of Periodontal Health and Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Geistlich Pharma AG"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Lateral Wall Thickness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": null,
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Later, 1000 CBCT images were further measured and analyzed, and indicators such as maxillary sinus buccal wall thickness, morphology, whether there is blood vessel or not, whether there is bone septa or not were counted. The variation rules and related factors were summarized by SPSS analysis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 1000,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Retrospective Cone Beam Computed Tomography Study of The Lateral Wall Bony Window",
"nctId": "NCT06309706",
"orgStudyIdInfo": {
"id": "JXHU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Lateral wall thickness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Dental Hospital of Zhejiang University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Quadratus Lumborum (QL) Block"
},
{
"name": "Enhanced Recovery After Surgical (ERAS) Protocol"
}
]
},
"conditionsModule": {
"conditions": [
"Pelvic Organ Prolapse",
"Post Operative Pain"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study will be a randomized control trial in which patients undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy will be randomized to one of two standard of care approaches for postoperative pain management: the enhanced recovery after surgery (ERAS) protocol and the quadratus lumborum truncal nerve block. Subjects will undergo one of two standard of care approaches to postoperative pain management and be asked about their pain postoperatively.",
"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": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy",
"nctId": "NCT06309693",
"orgStudyIdInfo": {
"id": "IRB-300011310",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU)"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum postoperative patient reported pain score in PACU"
},
{
"measure": "Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit"
},
{
"measure": "Rates of postoperative nausea and vomiting (PONV) in PACU"
},
{
"measure": "Rates of overnight admission"
},
{
"measure": "Total time spent in PACU"
},
{
"measure": "Rates of initial active voiding trial failures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Alabama at Birmingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Infective Endocarditis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Innocent M Bvekerwa",
"phone": "07852209005",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Simon Woldman",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "St Bartholomew's Hospital. West Smithfield",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "EC1A 7BE"
}
]
},
"descriptionModule": {
"briefSummary": "Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs.We are very keen to improve the treatment of this disease and we are measuring the impact of the treatments that we give to patients so that we have a very clear idea of which treatments work best and also which treatments are less successful.A key part of the treatment is the accurate determination of the causative organism which allows appropriate targeted antibiotic and antifungal medication to be administered.Accurate antibiotic regimes require detection of the causative organism and its sensitivities to each antibiotic. Antibiotic choice is then based on effectiveness, toxicity, ease of use and national guidelines. The current best technique for identifying bacteria is blood culture where organisms are identified by growing them from blood samples. However, this takes up to 5 days from sampling, resulting in delays to the correct diagnosis. Until this time, treatment requires the use of generic, more toxic antibiotic regimes.New techniques are emerging to identify causative organisms from blood. Metagenomics allows the sequencing of bacterial DNA allowing precise identification of the infecting organism."
},
"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": "AMetIP",
"briefTitle": "Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients",
"nctId": "NCT06309680",
"orgStudyIdInfo": {
"id": "280992",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "diagnostic accuracy of CMg in blood"
}
],
"secondaryOutcomes": [
{
"measure": "to evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE"
},
{
"measure": "1. Optimal timing of blood sampling"
},
{
"measure": "3. Metagenomic Techniques"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Barts & The London NHS Trust"
},
{
"name": "Quadram Institute Bioscience"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary University of London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-24"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PG-102(MG12)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy",
"Overweight"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seocho",
"contacts": [
{
"email": "[email protected]",
"name": "Kyunghwa Son, Ph.D",
"phone": "02-6098-2818",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Korea, Republic of",
"facility": "Catholic University Seoul St.Mary Hospital,",
"geoPoint": {
"lat": 37.49056,
"lon": 127.02
},
"state": "Seoul",
"status": "RECRUITING",
"zip": "06591"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers",
"nctId": "NCT06309667",
"orgStudyIdInfo": {
"id": "SL-MG12-P1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with treatment-emergent adverse events (TEAEs) for Part A"
},
{
"measure": "Number of participants with treatment-emergent adverse events (TEAEs) for Part B"
},
{
"measure": "Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A"
},
{
"measure": "Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B"
},
{
"measure": "Number of participants with clinically significant abnormalities in vital signs for Part A"
},
{
"measure": "Number of participants with clinically significant abnormalities in vital signs for Part B"
},
{
"measure": "Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A"
},
{
"measure": "Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum plasma concentration (Cmax) for Part A"
},
{
"measure": "Maximum plasma concentration (Cmax) for Part B"
},
{
"measure": "Time to maximum plasma concentration (tmax) for Part A"
},
{
"measure": "Time to maximum plasma concentration (tmax) for Part B"
},
{
"measure": "Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A"
},
{
"measure": "Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B"
},
{
"measure": "Terminal half-life (t1/2) for Part A"
},
{
"measure": "Terminal half-life (t1/2) for Part B"
},
{
"measure": "Apparent total clearance (CL/F) for Part A"
},
{
"measure": "Apparent total clearance (CL/F) for Part B"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "ProGen. Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "12-week home-based circuit training (HBCT)"
},
{
"name": "Standard of care (CONT)"
}
]
},
"conditionsModule": {
"conditions": [
"Aerobic Exercise",
"Strength Training",
"Glycemic Control",
"Blood Pressure",
"Oxidative Stress",
"Metabolic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Riyadh",
"contacts": null,
"country": "Saudi Arabia",
"facility": "Princess Nourah bint Abdulrahman University",
"geoPoint": {
"lat": 24.68773,
"lon": 46.72185
},
"state": null,
"status": null,
"zip": "11671"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Obesity and type 2 diabetes mellitus (T2DM) are considered two of the most prevalent metabolic diseases linked to the onset of knee pain caused by osteoarthritis. Regular exercise has been documented as a principal component of a prevention, management, and treatment strategy for knee osteoarthritis (KOA) patients. However, evidence-based exercise protocols for individuals with comorbidities such as obesity, T2DM, and KOA are scarce. Thus, the present pragmatic randomized controlled trial aimed to investigate the effectiveness of a 12-week home-based circuit training (HBCT) protocol on various indicators related to KOA and cardiometabolic health among overweight/obese older adult patients with KOA and T2DM during the COVID-19 lockdown. Methods: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention. Results: HBCT significantly improved HBCT improved the vast majority of outcomes related to cardiometabolic health and knee osteoarthritis symptoms compared to CON (p\\<0.05). No significant differences were detected in total bilirubin, sodium, urea, resting heart rate, or KOOS-sport between HBCT and CON. Conclusion: These findings suggest that an injury-free HBCT program may improve several cardiometabolic health- and KOA-related indices in overweight/obese patients with T2DM and KOA. Such results may encourage clinicians and practitioners to adopt real-world exercise training approaches when prescribing physical exercise to patients characterized by impaired metabolic and musculoskeletal health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Home-Based Circuit Training in Overweight/Obese Older Adult Patients With Knee Osteoarthritis and Type 2 Diabetes",
"nctId": "NCT06309654",
"orgStudyIdInfo": {
"id": "PNU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood pressure"
},
{
"measure": "The A1C test"
},
{
"measure": "blood oxygen levels"
},
{
"measure": "cardiorespiratory fitness"
},
{
"measure": "interleukin 6 (IL-6)"
},
{
"measure": "Superoxide dismutases (SOD)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Princess Nourah Bint Abdulrahman University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-09-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood sample after treatment"
},
{
"name": "Case reports"
}
]
},
"conditionsModule": {
"conditions": [
"Methemoglobinemia",
"Anemia",
"Iron Deficiencies",
"Side Effect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Falun",
"contacts": [
{
"email": "[email protected]",
"name": "Claudia Seiler, MD",
"phone": "+46 70 2896416",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Center of Clinical Research Dalarna",
"geoPoint": {
"lat": 60.60357,
"lon": 15.62597
},
"state": null,
"status": null,
"zip": "79182"
}
]
},
"descriptionModule": {
"briefSummary": "Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Methemoglobinemia Following Intravenous Iron Treatment",
"nctId": "NCT06309641",
"orgStudyIdInfo": {
"id": "MetHb 001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in methemoglobin after ferric derisomaltose"
},
{
"measure": "Difference in methemoglobin after ferric carboxymaltose"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in methemoglobin depending on drug dosage"
},
{
"measure": "Difference in methemoglobin depending on age"
},
{
"measure": "Difference in methemoglobin depending on sex"
},
{
"measure": "Difference in methemoglobin depending on hemoglobin level before treatment"
},
{
"measure": "Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron."
},
{
"measure": "Association between difference in methemoglobin and venous lactate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Claudia Seiler"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Breathe sample"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Transplant Rejection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": null,
"country": "United States",
"facility": "Duke University",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27710"
}
]
},
"descriptionModule": {
"briefSummary": "This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy",
"nctId": "NCT06309628",
"orgStudyIdInfo": {
"id": "PGX-006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Volatile Organic Compound profile"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Picomole Inc"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Paragonix Technologies"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CROSSOVER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "23 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PDxBRUTILITY",
"briefTitle": "Decision Impact Study of PreciseDx Breast",
"nctId": "NCT06309615",
"orgStudyIdInfo": {
"id": "PDX-001_2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Decision Impact Study of PreciseDx Breast on treating Oncologist"
},
{
"measure": "Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist"
}
],
"secondaryOutcomes": [
{
"measure": "Decision Impact on long term outcomes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Cleveland Clinic"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Precise Dx, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Free Water Protocol"
},
{
"name": "Control / Standard Care"
}
]
},
"conditionsModule": {
"conditions": [
"Oropharyngeal Dysphagia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Loveland",
"contacts": [
{
"email": "[email protected]",
"name": "Emily Main, MS, CCC-SLP",
"phone": "970-624-4369",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Brian Daily, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Cordelie Witt, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lucie Uncapher, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Brandon Petrun, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Medical Center of the Rockies",
"geoPoint": {
"lat": 40.39776,
"lon": -105.07498
},
"state": "Colorado",
"status": null,
"zip": "80538"
}
]
},
"descriptionModule": {
"briefSummary": "Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 136,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of a Free Water Protocol",
"nctId": "NCT06309602",
"orgStudyIdInfo": {
"id": "22-0465",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dysphagia Handicap Index"
},
{
"measure": "Oral Assessment Guide"
},
{
"measure": "Qualitative data"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse events: Aspiration pneumonia/pneumonitis"
},
{
"measure": "Liquid intake"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Poudre Valley Health System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin D"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Biliary Cholangitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Urumqi",
"contacts": null,
"country": "China",
"facility": "People's Hospital of Xinjiang Uygur Autonomous Region",
"geoPoint": {
"lat": 43.80096,
"lon": 87.60046
},
"state": "Xinjiang",
"status": null,
"zip": "830001"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis."
},
"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": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis",
"nctId": "NCT06309589",
"orgStudyIdInfo": {
"id": "YIHM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "UDCA response: Paris I criteria"
},
{
"measure": "UDCA response: Barcelona criteria"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yilihamu·Abilitifu"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fasting-refeeding cycle"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Underweight"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either underweight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation."
},
"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": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "DIP",
"briefTitle": "Experimental Approach to Test Predictions of Body Weight Regulation Models",
"nctId": "NCT06309576",
"orgStudyIdInfo": {
"id": "PBRC 2023-069",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compensatory response"
}
],
"secondaryOutcomes": [
{
"measure": "Timing of the compensatory response"
},
{
"measure": "Protein balance"
},
{
"measure": "Carbohydrate balance"
},
{
"measure": "Lipid balance"
},
{
"measure": "Overall appetite"
},
{
"measure": "Food preference"
},
{
"measure": "Physical activity"
},
{
"measure": "Sleeping metabolic rate"
},
{
"measure": "Leptin"
},
{
"measure": "Appetite-regulating hormones"
},
{
"measure": "Metabolites"
},
{
"measure": "Gonadotrophic axis"
},
{
"measure": "Thyroid axis"
},
{
"measure": "Hypothalamic-pituitary-adrenal axis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Tulane University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Pennington Biomedical Research Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Aminoacid supplementation"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity Morbid",
"Weight Loss"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oggebbio",
"contacts": [
{
"email": "[email protected]",
"name": "Amelia Brunani, MD",
"phone": "390323514232",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano, Site Piancavallo",
"geoPoint": {
"lat": 45.99088,
"lon": 8.64663
},
"state": "Verbania",
"status": "RECRUITING",
"zip": "28921"
}
]
},
"descriptionModule": {
"briefSummary": "The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing."
},
"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": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AMINOB",
"briefTitle": "Metabolic Effects of a Diet Replaced With Essential Amino Acids",
"nctId": "NCT06309563",
"orgStudyIdInfo": {
"id": "31J301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Muscle mass"
}
],
"secondaryOutcomes": [
{
"measure": "6 minute walking test (6MWT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "exercise test"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure With Preserved Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Sergio Caravita, MD, PhD",
"phone": "+39 02 61911 2930",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale San Luca IRCCS Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20149"
}
]
},
"descriptionModule": {
"briefSummary": "Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TEST-PEF",
"briefTitle": "Provocative Tests for HFpEF",
"nctId": "NCT06309550",
"orgStudyIdInfo": {
"id": "09W002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Hospitalization for heart failure"
},
{
"measure": "Atrial fibrillation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "chemoreflex evaluation"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure With Preserved Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "Ospedale San Luca IRCCS Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20149"
}
]
},
"descriptionModule": {
"briefSummary": "Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CHEMO-HFpEF",
"briefTitle": "Chemoreflex Sensitivity in HFpEF",
"nctId": "NCT06309537",
"orgStudyIdInfo": {
"id": "09C830",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "difference in chemoreflex sensitivity between HFpEF and healthy controls"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tricuspid transcatheter edge-to-edge repair"
}
]
},
"conditionsModule": {
"conditions": [
"Tricuspid Regurgitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Michele Tomaselli",
"phone": "+3902619112992",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": "Lombardia",
"status": "RECRUITING",
"zip": "20149"
}
]
},
"descriptionModule": {
"briefSummary": "In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 17,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HERITAGE",
"briefTitle": "Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair",
"nctId": "NCT06309524",
"orgStudyIdInfo": {
"id": "09C332",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Inverse remodeling of right heart chambers"
},
{
"measure": "Heart failure hospitalization"
},
{
"measure": "Death"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Arterial tonometry"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mascalucia",
"contacts": [
{
"email": "[email protected]",
"name": "Antonino Di Guardo, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Massimo Catanuso, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Centro di Prevenzione e Cura dell'Ipertensione Arteriosa \"Alessandro Filippi\"",
"geoPoint": {
"lat": 37.57465,
"lon": 15.04964
},
"state": "Catania",
"status": "RECRUITING",
"zip": null
},
{
"city": "Bari",
"contacts": [
{
"email": "[email protected]",
"name": "Pietro Nazzaro, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sebastiano Cicco, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa \"Anna Maria Pirrelli\", Università degli Studi di Bari \"Aldo Moro\". Policlinico Consorziale di Bari",
"geoPoint": {
"lat": 41.11148,
"lon": 16.8554
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Paolo Salvi, MD",
"phone": "+390261911",
"phoneExt": "2968",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano IRCCS",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20145"
},
{
"city": "Reggio Emilia",
"contacts": [
{
"email": "[email protected]",
"name": "Angelo Ghirarduzzi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Chiara Grasselli, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia",
"geoPoint": {
"lat": 44.69825,
"lon": 10.63125
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Andrea Grillo, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Bruno Fabris, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SEVR-HT",
"briefTitle": "Subendocardial Viability Ratio in Hypertension",
"nctId": "NCT06309511",
"orgStudyIdInfo": {
"id": "09C218",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Buckberg index"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "blood test"
}
]
},
"conditionsModule": {
"conditions": [
"Adrenal Insufficiency"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Valentina Morelli",
"phone": "02619112547",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20135"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.11-deoxycortisol levels will be assessed in all recruited patients"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ADD-RES",
"briefTitle": "Residual Adrenal Function in Addison's Disease",
"nctId": "NCT06309498",
"orgStudyIdInfo": {
"id": "05C307",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "prevalence of RAF"
}
],
"secondaryOutcomes": [
{
"measure": "prevalence of adrenal crisis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "WGI-0301 at MTD/RP2D dose IV infusion, QW"
},
{
"name": "WGI-0301 at MTD/RP2D -1 dose IV infusion, QW"
},
{
"name": "Sorafenib 400 mg PO, BID continuously"
},
{
"name": "Sorafenib 400 mg PO, BID"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Hepatocellular Carcinoma (HCC)"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"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": "Phase 2 Study of WGI-0301 in Combination With Sorafenib for Advanced HCC",
"nctId": "NCT06309485",
"orgStudyIdInfo": {
"id": "WGI0301-P2G-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1."
}
],
"secondaryOutcomes": [
{
"measure": "Safety of each dose group."
},
{
"measure": "Tolerability of each dose group."
},
{
"measure": "Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR."
},
{
"measure": "Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR."
},
{
"measure": "Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR."
},
{
"measure": "Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS."
},
{
"measure": "Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1."
},
{
"measure": "Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Zhejiang Haichang Biotech Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mirtazapine"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Major Depressive Disorder",
"Inflammatory Bowel Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD.The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies.The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation.If successful, this trial will support an application for a larger version of the study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Mirtazapine and placebo manufactured to appear identical through over-encapsulation",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "125 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MDIBD",
"briefTitle": "Trial of Mirtazapine for Depression in IBD",
"nctId": "NCT06309472",
"orgStudyIdInfo": {
"id": "NIHR302528",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recruitment feasibility"
},
{
"measure": "Trial adherence"
},
{
"measure": "Treatment adherence"
},
{
"measure": "Study procedures acceptability and compliance"
},
{
"measure": "Overall acceptability"
}
],
"secondaryOutcomes": [
{
"measure": "Quick Inventory for Depressive Symptomatology-16 Questionnaire"
},
{
"measure": "Patient Health Questionnaire-9 questionnaire"
},
{
"measure": "Generalised Anxiety Disorder-7 questionnaire"
},
{
"measure": "Inflammatory Bowel Disease Control questionnaire"
},
{
"measure": "Inflammatory Bowel Disease Fatigue Assessment Scale"
},
{
"measure": "Chalder Fatigue Scale"
},
{
"measure": "Maudsley 3-item Visual Analogue Scale"
},
{
"measure": "Pittsburgh Sleep Quality Index"
},
{
"measure": "9-item Avoidant Restrictive Food Intake Disorder Screen"
},
{
"measure": "Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Questionnaire"
},
{
"measure": "Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ) items on employment and healthcare contacts"
},
{
"measure": "Birmingham Irritable Bowel Syndrome Symptoms Questionnaire"
},
{
"measure": "Harvey Bradshaw Index (Crohn's disease patients only)"
},
{
"measure": "Simple Clinical Colitis Activity Index (ulcerative colitis patients only)"
},
{
"measure": "Dietary Screener Questionnaire"
},
{
"measure": "Concentration of faecal calprotectin"
},
{
"measure": "Concentration of serum high-sensitivity C-reactive protein"
},
{
"measure": "Concentration of serum interleukin-23"
},
{
"measure": "Concentration of serum interleukin-22"
},
{
"measure": "Concentration of serum granulocyte-macrophage colony-stimulating factor"
},
{
"measure": "Concentration of serum interleukin-5"
},
{
"measure": "Concentration of serum interleukin-13"
},
{
"measure": "Concentration of serum interleukin-17A"
},
{
"measure": "Concentration of serum tumor necrosis factor alpha"
},
{
"measure": "Concentration of serum interferon-gamma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "King's College Hospital NHS Trust"
},
{
"name": "Imperial College London"
},
{
"name": "London North West Healthcare NHS Trust"
},
{
"name": "Imperial College Healthcare NHS Trust"
},
{
"name": "Guy's and St Thomas' NHS Foundation Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "King's College London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Carbonic anhydrase staining levels"
}
]
},
"conditionsModule": {
"conditions": [
"Triple Negative Breast Cancer",
"Carbonic Anhydrase IX"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kahramanmaraş",
"contacts": null,
"country": "Turkey",
"facility": "Kahramanmaraş Sütçü İmam University",
"geoPoint": {
"lat": 37.5847,
"lon": 36.92641
},
"state": null,
"status": null,
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma",
"nctId": "NCT06309459",
"orgStudyIdInfo": {
"id": "IRB 2023/04-34",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Poor prognostic factors in patients with TNBC"
},
{
"measure": "The treatment success with inhibiting the CA IX enzyme levels' effectiveness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kahramanmaras Sutcu Imam University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-13"
}
}
} | false | null |
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