protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Intrahepatic Cholestasis of Pregnancy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Guangyi Lan",
"phone": "13176881226",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yulong Li",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Yuan Wei",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Peking University Third Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100000"
},
{
"city": "Chengdu",
"contacts": [
{
"email": "[email protected]",
"name": "Guangyi Lan",
"phone": "13176881226",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yaoyao Zhang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Xue Xiao",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Sichuan University West China Second University Hospital",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "610001"
}
]
},
"descriptionModule": {
"briefSummary": "This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy",
"nctId": "NCT06366659",
"orgStudyIdInfo": {
"id": "M2024049",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progesterone metabolites (levels in plasma)"
},
{
"measure": "Itch intensity"
}
],
"secondaryOutcomes": [
{
"measure": "Total bile acids (levels in plasma)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Peking University Third Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Peking University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Competency-based intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Intervention",
"Knowledge, Attitudes, Practice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mersa Matruh",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Nursing, Matrouh University",
"geoPoint": {
"lat": 31.3529,
"lon": 27.23725
},
"state": null,
"status": null,
"zip": "002"
}
]
},
"descriptionModule": {
"briefSummary": "Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A quasi-experimental design",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "A quasi-experimental design utilized one group for pre-, post, and follow-up intervention.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Competency-based Intervention for Head Nurses",
"nctId": "NCT06366646",
"orgStudyIdInfo": {
"id": "035901",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire to measure head nurses' knowledge of leadership competency"
},
{
"measure": "Questionnaire to measure head nurses' ability to use leadership competency"
},
{
"measure": "Questionnaire to measure leadership effectiveness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Matrouh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Web-TIRELESS"
}
]
},
"conditionsModule": {
"conditions": [
"Orthopedic Disorder",
"Nontraumatic Injury",
"Substance Use",
"Upper Extremity Problem"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Jafar Bakhshaie, MD, PhD",
"phone": "617-643-7641",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Massachusetts General Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02129"
}
]
},
"descriptionModule": {
"briefSummary": "The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use.Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT.Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use",
"nctId": "NCT06366633",
"orgStudyIdInfo": {
"id": "2024P000713",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1K23AT012364-01",
"link": "https://reporter.nih.gov/quickSearch/1K23AT012364-01",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Credibility and Expectancy Questionnaire (CEQ)"
},
{
"measure": "Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment"
},
{
"measure": "The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery"
},
{
"measure": "The percent of patients that agree to participate to assess feasibility of recruitment"
},
{
"measure": "Rate at which program was accepted, measured by attendance to assess acceptability of treatment"
},
{
"measure": "Adherence to homework"
},
{
"measure": "Rate of participant's completion of self-report measures to assess feasibility of assessments"
},
{
"measure": "Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Graded Chronic Pain Scale (GCPS)"
},
{
"measure": "Disabilities of the Arm, Shoulder and Hand (DASH)"
},
{
"measure": "Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0"
},
{
"measure": "PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0"
},
{
"measure": "Pain Catastrophizing Scale (PCS)"
},
{
"measure": "Pain Anxiety Symptoms Scale - Short Form (PASS-20)"
},
{
"measure": "Pain Vigilance and Awareness Questionnaire (PVAQ)"
},
{
"measure": "Brief Experiential Avoidance Questionnaire (BEAQ)"
},
{
"measure": "Current Opioid Misuse Measure (COMM)"
},
{
"measure": "The Timeline Follow Back (TLFB)"
},
{
"measure": "Numerical Rating Scale (NRS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Center for Complementary and Integrative Health (NCCIH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Jafar Bakhshaie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "FAST-B PEERS"
},
{
"name": "FAST-B (First Approach Skills Training - Behavior)"
}
]
},
"conditionsModule": {
"conditions": [
"Child Disruptive Behavior Disorders",
"Parent Child Relationship",
"Parent Management Training",
"Peer Support",
"Child Behavior Problems",
"Challenging Behavior",
"Positive Parenting"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Doug Mason",
"phone": "206-987-7000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alissa D Hemke, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Seattle Children's",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": "RECRUITING",
"zip": "98115"
}
]
},
"descriptionModule": {
"briefSummary": "Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports",
"nctId": "NCT06366620",
"orgStudyIdInfo": {
"id": "STUDY00003416",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability of FAST-B PEERS"
},
{
"measure": "Acceptability of FAST-B"
},
{
"measure": "FAST-B PEERS support calls attended"
}
],
"secondaryOutcomes": [
{
"measure": "Weekly Assessment of Child Behavior - P"
},
{
"measure": "Coping with Child Negative Emotions Scale"
},
{
"measure": "Strengths and Difficulties Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Seattle Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "high-alert medication administration"
}
]
},
"conditionsModule": {
"conditions": [
"Knowledge",
"Practice Nurse's Scope",
"Competence",
"Nurse's Role",
"Error Disclosure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mersa Matruh",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Nursing, Matrouh University",
"geoPoint": {
"lat": 31.3529,
"lon": 27.23725
},
"state": null,
"status": null,
"zip": "002"
}
]
},
"descriptionModule": {
"briefSummary": "High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 300,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Managing High-alert Medication Administration and Errors",
"nctId": "NCT06366607",
"orgStudyIdInfo": {
"id": "0306066",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire to measure nurses' knowledge about high-alert medication administration"
},
{
"measure": "Questionnaire to measure medication safety climate"
},
{
"measure": "Questionnaire to measure nurses' competency"
},
{
"measure": "observational check list to measure nurses' practice during administration of high-alert medications"
},
{
"measure": "Questionnaire to measure errors associated with administering high-alert medications"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Matrouh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Authentic leadership training program"
}
]
},
"conditionsModule": {
"conditions": [
"Intervention"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mersa Matruh",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Nursing, Matrouh University",
"geoPoint": {
"lat": 31.3529,
"lon": 27.23725
},
"state": null,
"status": null,
"zip": "002"
}
]
},
"descriptionModule": {
"briefSummary": "Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "A quasi-experimental research design",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "A quasi-experimental design utilized one group for pre-, post, and follow-up intervention.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "First-line Nurse Manager Authentic Leadership Training Program",
"nctId": "NCT06366594",
"orgStudyIdInfo": {
"id": "0305897",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire to measure first-line nurse managers' knowledge about authentic leadership"
},
{
"measure": "questionnaire to measure authentic leadership behavior among first-line nurse managers"
},
{
"measure": "Questionnaire to measure nursing care self-efficacy"
},
{
"measure": "Questionnaire to measure nurses' trust in their workplace"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Matrouh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcriptomic analysis"
}
]
},
"conditionsModule": {
"conditions": [
"Incisional Hernia",
"Extracellular Matrix Alteration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Hua Dong Hospital Affiliated to Fu Dan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 36,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology",
"nctId": "NCT06366581",
"orgStudyIdInfo": {
"id": "HD20240307",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the gene expression list"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product"
},
{
"name": "fluoride toothpaste containing 1450 ppm of MFP in a PCC base"
}
]
},
"conditionsModule": {
"conditions": [
"Plaque, Dental"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dresden",
"contacts": null,
"country": "Germany",
"facility": "Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras",
"geoPoint": {
"lat": 51.05089,
"lon": 13.73832
},
"state": null,
"status": null,
"zip": "01307"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 86,
"type": "ACTUAL"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas",
"nctId": "NCT06366568",
"orgStudyIdInfo": {
"id": "CRO-2022-10-PG-MER-MW-JG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Turesky Modification of the Quigley & Hein Plaque Index"
}
],
"secondaryOutcomes": [
{
"measure": "questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Colgate Palmolive"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manual Acupuncture Twirling,"
},
{
"name": "Manual Acupuncture Sham"
}
]
},
"conditionsModule": {
"conditions": [
"Muscle Soreness",
"Stiffness of Elbow, Not Elsewhere Classified"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta",
"contacts": [
{
"email": null,
"name": "IMERI, Research Center",
"phone": "29189160",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": "DKI Jakarta",
"status": null,
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This research design used a randomized controlled single-blind crossover trial method (Crossover Single Blinded Randomized Control Trial). Reasons for choosing to use the Crossover method because apart from being able to implement it, it can also provide far more output results with a smaller number of subjects.The research subjects will then receive two treatments spaced 1 week apart which is called a wash out period to eliminate the carry-over effect of the treatment given. Research subjects will undergo randomization . Subjects in group A will undergo manual twisting acupuncture followed by sham manual acupuncture. The subject in group B will receive a sham acupuncture manual followed by a round of manual acupuncture twirling",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The Participant will be randomized using a computerized table and the Outcome Assessor dont know which Subjects receive the manual acupuncture twirling or sham manual acupuncture on each period",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals",
"nctId": "NCT06366555",
"orgStudyIdInfo": {
"id": "24-02-0268",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Range of Motion"
}
],
"primaryOutcomes": [
{
"measure": "Visual Analog Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Pain Pressure Threshold"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vestibular rehabilitation therapy"
},
{
"name": "Virtual reality exercises"
},
{
"name": "Optokinetic Stimulation exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Vestibular Dizziness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amman",
"contacts": null,
"country": "Jordan",
"facility": "Royal Medical Services",
"geoPoint": {
"lat": 31.95522,
"lon": 35.94503
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD). The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation. The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks. The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Virtual Reality in People With Persistent Postural-Perceptual Dizziness: RCT",
"nctId": "NCT06366542",
"orgStudyIdInfo": {
"id": "2/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)"
},
{
"measure": "The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)"
},
{
"measure": "The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)"
},
{
"measure": "Dizziness Handicap Inventory (DHI)"
},
{
"measure": "Dizziness Handicap Inventory (DHI)"
},
{
"measure": "Falls Efficacy Scale International (FES-I)"
},
{
"measure": "Falls Efficacy Scale International (FES-I)"
},
{
"measure": "Dynamic Gait Index (DGI)"
},
{
"measure": "Dynamic Gait Index (DGI)"
}
],
"secondaryOutcomes": [
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "Medical Outcomes Study Short Form 12 (SF-12)"
},
{
"measure": "Medical Outcomes Study Short Form 12 (SF-12)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Jordan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Renal Insufficiency, Chronic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Zhen Li, Doctor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tongji hospital, NO.1095 jiefang avenue",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": "RECRUITING",
"zip": "430074"
}
]
},
"descriptionModule": {
"briefSummary": "Currently, renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis, but it is invasive and carries the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias. The lack of reliable, comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs. Therefore, the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved.With the continuous development and update of technology, imaging provides a new way to non-invasively evaluate renal fibrosis. Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis, magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes. Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status, physical properties, and molecular properties of the kidney.In recent years, in the context of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis. It can extract and learn features in images with high throughput, make greater use of information in medical images that cannot be recognized by the human eye, and achieve disease diagnosis, prognosis assessment, and efficacy prediction by building models. However, most of the current research is in the preliminary stage, and there are still few studies on the assessment of renal insufficiency and renal fibrosis. I believe that with the continuous improvement of algorithms and the optimization of models, the progress of radiomics and machine learning will be great. To a certain extent, it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis."
},
"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": null,
"briefTitle": "Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction",
"nctId": "NCT06366529",
"orgStudyIdInfo": {
"id": "TJ-IRB202308123",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ESKD"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhen Li"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Methylation Test"
}
]
},
"conditionsModule": {
"conditions": [
"Precancerous Cervical Lesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Long Sui, Professor",
"phone": "0086-021-33189900",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Qing Cong, PHD",
"phone": "0086-021-33189900",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Obstetrics and Gynecology Hospital of Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200011"
}
]
},
"descriptionModule": {
"briefSummary": "The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "25 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MTTRIHPW",
"briefTitle": "Role of Methylation Test Triage in HPV Positive Women",
"nctId": "NCT06366516",
"orgStudyIdInfo": {
"id": "FUOBGY2024-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The sensitivity and specificity of methylation test in detecting CIN2+."
}
],
"secondaryOutcomes": [
{
"measure": "KAPPA value of methylation test."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Peking Union Medical College Hospital"
},
{
"name": "Chengdu Women's and Children's Central Hospital"
},
{
"name": "Guangdong Women and Children Hospital"
},
{
"name": "Second Hospital of Jilin University"
},
{
"name": "First Affiliated Hospital of Xinjiang Medical University"
},
{
"name": "Third Affiliated Hospital of Zhengzhou University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Obstetrics & Gynecology Hospital of Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fractional Ablative CO2 Laser"
},
{
"name": "Facial Cleanser"
},
{
"name": "Facial Moisturizer"
},
{
"name": "Sunscreen"
},
{
"name": "Basic Ointment"
}
]
},
"conditionsModule": {
"conditions": [
"Photoaging",
"Wrinkle",
"Skin Laxity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Blue Ash",
"contacts": null,
"country": "United States",
"facility": "The Dermatology Group",
"geoPoint": {
"lat": 39.232,
"lon": -84.37827
},
"state": "Ohio",
"status": null,
"zip": "45242"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device.A total of 22 healthy female subjects completed the study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, Single-Center, Double-Blinded, Split-Face, Controlled",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator anhydrous formulation on the opposite side of the face.The products were packaged in the same container and labelled post-procedure cream. This was a double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety were blinded to group during the study.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 23,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "35 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation",
"nctId": "NCT06366503",
"orgStudyIdInfo": {
"id": "RS-2023-05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Investigator Tolerability"
},
{
"measure": "Incidence of Adverse Events"
},
{
"measure": "Subject Tolerability"
}
],
"secondaryOutcomes": [
{
"measure": "Self-Assessment Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Revision Skincare"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Innocell Autologous Cellular Immunotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The study is a 2-part design. For each participant, Part 1 will involve tissue procurement and confirmation of the ability to manufacture the Innocell vaccine, followed by Part 2 which is the treatment phase, involving Innocell administration to patients.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Open label Phase I trial with no masking",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy in Recurrent Epithelial Ovarian Cancer",
"nctId": "NCT06366490",
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"id": "CIP2023-001",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Saferty and Immunogenicity of Innocell in Ovarian Cancer Patients"
},
{
"measure": "Safety of Innocell in Ovarian Cancer Patients"
},
{
"measure": "Immunogenicity of Innocell in Ovarian Cancer Patients"
},
{
"measure": "Immunogemicity in Ovarian Cancer Patients"
},
{
"measure": "Immunogenicity of Innocell Vaccine in Ovarian Cancer Patients"
}
],
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},
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"collaborators": null,
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"name": "PhotonPharma, Inc."
}
},
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},
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"date": "2024-06-01"
},
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}
}
} | false | null |
{
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{
"name": "Vibration stimulation combined with task-oriented training"
}
]
},
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"conditions": [
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"Stroke",
"Hand Grasp"
]
},
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"descriptionModule": {
"briefSummary": "There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores."
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},
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},
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},
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"measure": "Fugl-Meyer assessment - wrist and hand"
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"measure": "Box and Blocks Test"
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{
"measure": "Motor Activity Log"
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{
"measure": "Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index"
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},
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"date": "2017-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
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{
"name": "Pitolisant tablet"
},
{
"name": "Placebo tablet"
}
]
},
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]
},
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},
{
"email": "[email protected]",
"name": "Pooja Patel",
"phone": "(310) 586-0843",
"phoneExt": null,
"role": "CONTACT"
}
],
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"email": null,
"name": "David G. Robertson, MD",
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},
{
"email": "[email protected]",
"name": "Amanda Maxson",
"phone": "(404) 844-7775",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
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]
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},
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"ADULT",
"OLDER_ADULT"
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},
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"briefTitle": "A Study of Pitolisant in Patients With Prader-Willi Syndrome",
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"link": null,
"type": null
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},
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{
"measure": "Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score"
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],
"secondaryOutcomes": [
{
"measure": "Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain"
},
{
"measure": "Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS)"
},
{
"measure": "Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS)"
},
{
"measure": "Change in overall severity of irritable and disruptive behaviors as measured by the Caregiver Global Impression of Severity (CaGI-S) for Irritable and/or Disruptive Behaviors"
},
{
"measure": "Change in severity of hyperphagia as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), in conjunction with the Food Safe Zone Questionnaire (FSZQ)"
},
{
"measure": "Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score"
},
{
"measure": "Change in severity of other behavioral problems as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Hyperactivity/Noncompliance, Inappropriate Speech, Social Withdrawal, and Stereotypic Behavior Domains"
},
{
"measure": "Percentage of patients reporting TEAEs"
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]
},
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"leadSponsor": {
"class": "INDUSTRY",
"name": "Harmony Biosciences, LLC"
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},
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},
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"date": "2024-04-16"
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"date": "2026-07"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rilvegostomig"
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{
"name": "Volrustomig"
},
{
"name": "Sabestomig"
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{
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},
"conditionsModule": {
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},
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"contacts": [
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"name": "Clinical Research Supervisor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Arnaud Bewley, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"facility": "UC Davis",
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"lon": -121.4944
},
"state": "California",
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"zip": "95817"
},
{
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"contacts": [
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"name": "Research Coordinator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "LSU Health Sciences Center - Shreveport",
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"lon": -93.75018
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"zip": "71115"
},
{
"city": "Bronx",
"contacts": [
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"name": "Research Coordinator",
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"role": "CONTACT"
}
],
"country": "United States",
"facility": "Montefiore Medical Center",
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"state": "New York",
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},
{
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"name": "Research Coordinator",
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],
"country": "United States",
"facility": "University of North Carolina",
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{
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"contacts": [
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"role": "CONTACT"
}
],
"country": "United States",
"facility": "Oregon Health & Science University (OHSU)",
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{
"city": "Philadelphia",
"contacts": [
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"email": null,
"name": "Research Coordinator",
"phone": null,
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"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Pennsylvania",
"geoPoint": {
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"lon": -75.16379
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"state": "Pennsylvania",
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"zip": "19107"
},
{
"city": "Charleston",
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],
"country": "United States",
"facility": "Sarah Cannon Medical Center",
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],
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"lat": 59.59202,
"lon": 15.2304
},
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},
{
"city": "Linköping",
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"lat": 58.41086,
"lon": 15.62157
},
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},
{
"city": "Lomma",
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"country": "Sweden",
"facility": "Lomma kommun",
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"lat": 55.67244,
"lon": 13.06849
},
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"zip": "23431"
},
{
"city": "Lund",
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"country": "Sweden",
"facility": "Lunds kommun",
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"lat": 55.70584,
"lon": 13.19321
},
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"zip": "22223"
},
{
"city": "Mariestad",
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"country": "Sweden",
"facility": "Mariestads kommun",
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"lat": 58.70971,
"lon": 13.82367
},
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},
{
"city": "Märsta",
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"country": "Sweden",
"facility": "Sigtuna kommun",
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"lat": 59.62157,
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},
"state": null,
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"zip": "19547"
},
{
"city": "Nacka",
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"country": "Sweden",
"facility": "Nacka kommun",
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"lat": 59.31053,
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},
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},
{
"city": "Norrköping",
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"country": "Sweden",
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"lat": 58.59419,
"lon": 16.1826
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"state": null,
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"zip": "60224"
},
{
"city": "Norrtälje",
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"country": "Sweden",
"facility": "Norrtälje kommun",
"geoPoint": {
"lat": 59.75799,
"lon": 18.70496
},
"state": null,
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"zip": "76128"
},
{
"city": "Nynäshamn",
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"country": "Sweden",
"facility": "Nynäshamns kommun",
"geoPoint": {
"lat": 58.90337,
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},
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},
{
"city": "Skellefteå",
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"facility": "Skellefteå kommun",
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"lat": 64.75067,
"lon": 20.95279
},
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},
{
"city": "Skärholmen",
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"facility": "Skärholmen stadsdel",
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"lat": 59.27549,
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},
{
"city": "Skövde",
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"country": "Sweden",
"facility": "Skövde kommun",
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"lat": 58.39118,
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},
"state": null,
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},
{
"city": "Sollentuna",
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"country": "Sweden",
"facility": "Sollentuna kommun",
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"lat": 59.42804,
"lon": 17.95093
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"zip": "19147"
},
{
"city": "Stenungsund",
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"country": "Sweden",
"facility": "Stenungsunds kommun",
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"lat": 58.07046,
"lon": 11.8181
},
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},
{
"city": "Stockholm",
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"country": "Sweden",
"facility": "Kungsholmen stadsdel",
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"lat": 59.33258,
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},
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},
{
"city": "Stockholm",
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"country": "Sweden",
"facility": "Norra Real",
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"lat": 59.33258,
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},
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},
{
"city": "Stockholm",
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},
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{
"city": "Stockholm",
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"country": "Sweden",
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},
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{
"city": "Stockholm",
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{
"city": "Stockholm",
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"country": "Sweden",
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},
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"zip": "12068"
},
{
"city": "Sundbyberg",
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"country": "Sweden",
"facility": "Sundbybergs stad",
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"lat": 59.36128,
"lon": 17.97114
},
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"zip": "17458"
},
{
"city": "Sundsvall",
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"country": "Sweden",
"facility": "Sundsvalls kommun",
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"lat": 62.39129,
"lon": 17.3063
},
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},
{
"city": "Sävsjö",
"contacts": null,
"country": "Sweden",
"facility": "Sävsjö kommun",
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"lat": 57.40327,
"lon": 14.66244
},
"state": null,
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},
{
"city": "Tidaholm",
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"country": "Sweden",
"facility": "Tidaholms kommun",
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"lat": 58.18035,
"lon": 13.95824
},
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},
{
"city": "Trelleborg",
"contacts": null,
"country": "Sweden",
"facility": "Trelleborgs kommun",
"geoPoint": {
"lat": 55.37514,
"lon": 13.15691
},
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"zip": "23142"
},
{
"city": "Tumba",
"contacts": null,
"country": "Sweden",
"facility": "Botkyrka kommun",
"geoPoint": {
"lat": 59.19858,
"lon": 17.83317
},
"state": null,
"status": null,
"zip": "147 41"
},
{
"city": "Täby",
"contacts": null,
"country": "Sweden",
"facility": "Täby kommun",
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"lat": 59.4439,
"lon": 18.06872
},
"state": null,
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"zip": "18339"
},
{
"city": "Töreboda",
"contacts": null,
"country": "Sweden",
"facility": "Töreboda kommun",
"geoPoint": {
"lat": 58.70739,
"lon": 14.12597
},
"state": null,
"status": null,
"zip": "54530"
},
{
"city": "Vallentuna",
"contacts": null,
"country": "Sweden",
"facility": "Vallentuna kommun",
"geoPoint": {
"lat": 59.53436,
"lon": 18.07758
},
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"zip": "18686"
},
{
"city": "Visby",
"contacts": null,
"country": "Sweden",
"facility": "Gotlands kommun",
"geoPoint": {
"lat": 57.64089,
"lon": 18.29602
},
"state": null,
"status": null,
"zip": "12142"
},
{
"city": "Vällingby",
"contacts": null,
"country": "Sweden",
"facility": "Vällingbyskolan",
"geoPoint": {
"lat": 59.36441,
"lon": 17.87407
},
"state": null,
"status": null,
"zip": "16264"
},
{
"city": "Växjö",
"contacts": null,
"country": "Sweden",
"facility": "Växjö kommun",
"geoPoint": {
"lat": 56.87767,
"lon": 14.80906
},
"state": null,
"status": null,
"zip": "35230"
}
]
},
"descriptionModule": {
"briefSummary": "Parent training programs in groups and over internet can help parents improve their interaction and communication with their children. There is however a lack knowledge of how programs work for parents of teenagers, as most studies have concerned younger children. Furthermore, most studies have been conducted on programs for selective populations with elevated risk. The aim of this study was to investigate the effectiveness of two universal preventive parenting programs for teenagers: The group-based program 'ABC-teen' and the online-based 'ParentWeb'. Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication. The programs are developed in Sweden with content based on other established parenting programs (e.g., Comet, Incredible Years, the Triple P). The aim of the present study was to evaluate the effects of the the two programs, with adolescent mental health as primary outcome. Several secondary outcome measures concerning parenting and parent-adolescent relationship were also collected. Parents were randomized to ABC-teen, ParentWeb or a 6 months Wait-List control. Parent- and adolescent ratings were collected at baseline, after 4 and after 12 months. All data collection has now been completed and the next step is to process and analyze the data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants are randomized to one of the three arms upon allocation.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1247,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "19 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Trial of Two Universal Programs for Parents of Teenagers",
"nctId": "NCT06366438",
"orgStudyIdInfo": {
"id": "ABC vs Parentweb",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Demographics"
},
{
"measure": "Organizational and therapist factors"
}
],
"primaryOutcomes": [
{
"measure": "The Strength and Difficulties Questionnaire (SDQ)"
},
{
"measure": "Patient Health Questionnaire (PHQ-9)"
},
{
"measure": "Parental stress scale (PSS)"
},
{
"measure": "General Anxiety Disorder Scale (GAD-7)"
}
],
"secondaryOutcomes": [
{
"measure": "Conflict scale"
},
{
"measure": "Adult Child Relationship Scale (ACRS)"
},
{
"measure": "Adolescents' openness scale"
},
{
"measure": "Brief Family Relationship Scale"
},
{
"measure": "Positive and Negative Parenting Behaviors"
},
{
"measure": "Me as a Parent"
},
{
"measure": "Conflict Resolution Efficacy"
},
{
"measure": "School Adjustment Scale"
},
{
"measure": "Stockholmsenkaten"
},
{
"measure": "Satisfaction Questionnaire"
},
{
"measure": "Attendance and engagement measures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-12-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood sample then fibroscan"
}
]
},
"conditionsModule": {
"conditions": [
"Fibrosis, Liver"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montpellier",
"contacts": [
{
"email": "[email protected]",
"name": "Magdalena MESZAROS, MD",
"phone": ": 04 67 33 02 57",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Magdalena MESZAROS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU de Montpellier",
"geoPoint": {
"lat": 43.61092,
"lon": 3.87723
},
"state": null,
"status": null,
"zip": "34295"
}
]
},
"descriptionModule": {
"briefSummary": "Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 260,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HEPGEN",
"briefTitle": "Screening for Chronic Liver Diseases in General Population",
"nctId": "NCT06366425",
"orgStudyIdInfo": {
"id": "RECHMPL23_0272",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the liver fibrosis screening acceptability (FIB-4)"
},
{
"measure": "Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>2.67"
},
{
"measure": "Prevalence of excessive consumption of alcohol"
},
{
"measure": "Prevalence of a history or drug use"
},
{
"measure": "The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)"
},
{
"measure": "prevalence of viral hepatitis"
},
{
"measure": "Description of socio-demographic characteristics of participants"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "On-call medical home (MMG) Clermont-Hérault"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Montpellier"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine Hydrochloride"
},
{
"name": "normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Cognitive Impairment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minya",
"contacts": [
{
"email": "[email protected]",
"name": "Arwa essam Essam, assistant lecturer",
"phone": "+201017565658",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Arwa Essam",
"geoPoint": {
"lat": 28.10988,
"lon": 30.7503
},
"state": null,
"status": "RECRUITING",
"zip": "61111"
}
]
},
"descriptionModule": {
"briefSummary": "To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 94,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein.",
"nctId": "NCT06366412",
"orgStudyIdInfo": {
"id": "serum Tau-217 in elderly",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours"
},
{
"measure": "Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours"
}
],
"primaryOutcomes": [
{
"measure": "the effect of dexmedetomidine on serum Tau-217 protein value."
}
],
"secondaryOutcomes": [
{
"measure": "to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Minia University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Resistance Exercise Timing"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2",
"Insulin Resistance",
"Glucose Intolerance",
"Sleep Disturbance",
"Overweight or Obesity",
"Insulin Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": [
{
"email": "[email protected]",
"name": "Jason V Thomas, MS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tanya M Halliday, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Utah HPER E Buildling",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": "RECRUITING",
"zip": "84112"
}
]
},
"descriptionModule": {
"briefSummary": "The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \\~1.5 hours after habitual wake, and PM exercise will occur \\~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "74 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Acute T-Rex (Timing of Resistance Exercise) Study",
"nctId": "NCT06366399",
"orgStudyIdInfo": {
"id": "00156659",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Sleep Staging"
},
{
"measure": "Sleep Quality"
},
{
"measure": "Sleep Efficiency"
},
{
"measure": "Muscular Strength"
},
{
"measure": "Perceived Hunger"
},
{
"measure": "Perceived Fullness"
},
{
"measure": "Perceived Prospective Food Consumption"
},
{
"measure": "Glucose Area Under Curve"
},
{
"measure": "Insulin Area Under Curve"
}
],
"primaryOutcomes": [
{
"measure": "Insulin sensitivity"
}
],
"secondaryOutcomes": [
{
"measure": "Sleep Duration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Screening and treatment of hypertension among PLHIV in DSD models for HIV"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension",
"HIV"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kampala",
"contacts": [
{
"email": "[email protected]",
"name": "Martin Muddu, MMED",
"phone": "+256774004308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Uganda",
"facility": "Infectious Diseases Research Collaborations (IDRCUganda)",
"geoPoint": {
"lat": 0.31628,
"lon": 32.58219
},
"state": "Central",
"status": null,
"zip": "+256"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are:1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care?2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care?3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda?4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda?5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda?6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HTN-DSD",
"briefTitle": "Integrating Hypertension Management in DSD for HIV",
"nctId": "NCT06366386",
"orgStudyIdInfo": {
"id": "5K43TW011963-03",
"link": "https://reporter.nih.gov/quickSearch/5K43TW011963-03",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure)"
},
{
"measure": "% of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure)"
}
],
"secondaryOutcomes": [
{
"measure": "Mean blood pressure (both systolic and diastolic blood pressure)"
},
{
"measure": "Number and % of hypertensive PLHIV with suppressed Viral load"
},
{
"measure": "Number and % of patients retained in care"
},
{
"measure": "Number and % of PLHIV screened for HTN at least once in six months"
},
{
"measure": "Implementation costs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Infectious Diseases Research Collaboration, Uganda"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "A mental health art exhibition"
},
{
"name": "printed or online education materials"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Issue"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Mental health art exhibitions, as an intervention strategy integrating artistic expression and social contact, have the potential to positively impact the elimination of stigma and discrimination associated with mental health problems. This study will utilize a real-world quasi-randomized controlled trial design and a 6-month follow-up questionnaire survey to evaluate the intervention's impact on stigma/discrimination and related outcomes, such as mental health literacy. The evaluation will encompass four categories of people: those with lived experience of mental disorders, family members and friends of those with lived experience, health professionals, and the general public. Additionally, the cost-effectiveness of the art exhibition intervention will be analyzed."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The interventional study model for this clinical trial is a quasi-randomized controlled trial design. The intervention is the exhibition, organized by \"Qixi Charity,\" will publicly display offline artworks reflecting the diverse dimensions of mental health and ill-health. In contrast, the control group in this study will receive either printed or online educational materials, serving as a more traditional educational intervention. The study will include a baseline survey before the interventions (T0), a follow-up survey in the first month after the interventions (T1), and a follow-up survey in the sixth month after the interventions (T2) in both the experimental group (those who attend the offline exhibition) and the control group (those who are unable to attend the exhibition but will be provided with printed/online education materials).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Evaluation on a Mental Health Art Exhibition's Impact on Reducing Stigma",
"nctId": "NCT06366373",
"orgStudyIdInfo": {
"id": "531118232022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "intervention costs"
}
],
"primaryOutcomes": [
{
"measure": "Stigma/discrimination regarding mental disorders"
}
],
"secondaryOutcomes": [
{
"measure": "mental health literacy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Central South University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hunan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Immersive Virtual Reality Intervention"
},
{
"name": "Conventional rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Unilateral Spatial Neglect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint-Maurice",
"contacts": [
{
"email": "[email protected]",
"name": "Secretary",
"phone": "01 43 96 68 22",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpitaux de Saint-Maurice",
"geoPoint": {
"lat": 48.82182,
"lon": 2.42716
},
"state": null,
"status": "RECRUITING",
"zip": "94410"
}
]
},
"descriptionModule": {
"briefSummary": "Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space.The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol.To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Each patient was assigned to a group that received 2 rehabilitations for 4 weeks, 1) both Immersive virtual reality therapy and a conventional rehabilitation first, and then conventional rehabilitation alone, or 2) A conventional rehabilitation alone and then both Immersive virtual reality therapy, and conventional rehabilitation.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immersive Virtual Reality Treatment for Unilateral Spatial Neglect",
"nctId": "NCT06366360",
"orgStudyIdInfo": {
"id": "Piano-Neglect",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bells Test"
},
{
"measure": "Mesulam cancellation Task"
},
{
"measure": "Bisection Test"
},
{
"measure": "Copying Test"
},
{
"measure": "Scene description Task"
},
{
"measure": "Ecological scale of daily life activities"
},
{
"measure": "Piano bisection Task"
},
{
"measure": "Identifying the keys at the ends of the piano"
},
{
"measure": "Virtual reality Bells Test"
},
{
"measure": "Auditory Stimuli Localization Task in virtual reality"
},
{
"measure": "Ecological virtual reality bisection task"
},
{
"measure": "Virtual reality Baking Tray test"
}
],
"secondaryOutcomes": [
{
"measure": "Mood assessment"
},
{
"measure": "Situational motivation questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hopitaux de Saint-Maurice"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Abemaciclib"
},
{
"name": "Letrozole"
},
{
"name": "Pembrolizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Endometrial Cancer",
"Recurrent Endometrial Cancer",
"TP53"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Meghan Shea, MD",
"phone": "617-667-3723",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Meghan Shea, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Beth Israel Deaconess Medical Center",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Panagiotis Konstantinopoulos, MD, PhD",
"phone": "617-632-2334",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Panagiotis Konstantinopoulos, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Panagiotis Konstantinopoulos, MD, PhD",
"phone": "617-632-2334",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Panagiotis Konstantinopoulos, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Foxboro",
"contacts": [
{
"email": "[email protected]",
"name": "Natalie Sinclair, MD",
"phone": "508-543-1700",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Natalie Sinclair, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute at Foxborough",
"geoPoint": {
"lat": 42.06538,
"lon": -71.24783
},
"state": "Massachusetts",
"status": null,
"zip": "02035"
},
{
"city": "Milford",
"contacts": [
{
"email": "[email protected]",
"name": "Alexandra Bailey, MD",
"phone": "508-488-3700",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alexandra Bailey, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute at Milford",
"geoPoint": {
"lat": 42.13982,
"lon": -71.51617
},
"state": "Massachusetts",
"status": null,
"zip": "01757"
},
{
"city": "Weymouth",
"contacts": [
{
"email": "[email protected]",
"name": "Meredith Faggen, MD",
"phone": "781-624-4800",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Meredith Faggen, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute at South Shore Hospital",
"geoPoint": {
"lat": 42.22093,
"lon": -70.93977
},
"state": "Massachusetts",
"status": null,
"zip": "02190"
}
]
},
"descriptionModule": {
"briefSummary": "A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab.The names of the study drugs involved in this study are:* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)* Letrozole (a type of aromatase inhibitor)* Pembrolizumab (a type of monoclonal antibody)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab",
"nctId": "NCT06366347",
"orgStudyIdInfo": {
"id": "23-695",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Median Progression Free Survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Grade 3-5 Adverse Events (AE) Rate"
},
{
"measure": "Median Overall Survival (OS)"
},
{
"measure": "Objective Response Rate (ORR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eli Lilly and Company"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dana-Farber Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketamine Hydrochloride"
},
{
"name": "Normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Suicidal Ideation",
"Suicidal Ideas"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ottawa",
"contacts": [
{
"email": "[email protected]",
"name": "Maala Bhatt, MD, MSc.",
"phone": "6137377600",
"phoneExt": "4178",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Tyrus Crawford",
"phone": "6137377600",
"phoneExt": "4178",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Children's Hospital Of Eastern Ontario",
"geoPoint": {
"lat": 45.41117,
"lon": -75.69812
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "K1H 8L1"
}
]
},
"descriptionModule": {
"briefSummary": "Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "KSI",
"briefTitle": "Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation",
"nctId": "NCT06366334",
"orgStudyIdInfo": {
"id": "23/02E",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Safety Outcome 1: Clinically significant tachycardia"
},
{
"measure": "Safety Outcome 2: Clinically significant hypertension"
},
{
"measure": "Safety Outcome 3: Vomiting"
},
{
"measure": "Safety Outcome 4: Dissociation"
},
{
"measure": "Safety Outcome 5: Death"
}
],
"primaryOutcomes": [
{
"measure": "Proportion of eligible participants who complete the study protocol"
}
],
"secondaryOutcomes": [
{
"measure": "Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5)"
},
{
"measure": "Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10)"
},
{
"measure": "Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9)."
},
{
"measure": "Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9)."
},
{
"measure": "Assessment of blinding"
},
{
"measure": "Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5)"
},
{
"measure": "Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10)"
},
{
"measure": "Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9)"
},
{
"measure": "Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5)"
},
{
"measure": "Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10)"
},
{
"measure": "Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9)"
},
{
"measure": "Admission to Hospital"
},
{
"measure": "Length of Stay in Hospital"
},
{
"measure": "ED revisits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children's Hospital of Eastern Ontario"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "relining technique"
},
{
"name": "CAD/CAM milling technique"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Diseases",
"Dental Trauma",
"Bone Remodeling Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "El Shorouk",
"contacts": null,
"country": "Egypt",
"facility": "British University in Egypt",
"geoPoint": {
"lat": 30.13806,
"lon": 31.61556
},
"state": "Cairo",
"status": null,
"zip": "4914085"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture",
"nctId": "NCT06366321",
"orgStudyIdInfo": {
"id": "23-067",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "patient satisfaction using questionnaire"
},
{
"measure": "denture retention"
},
{
"measure": "denture adaptation to oral tissues"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "British University In Egypt"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transperineal Prostate Biopsy"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer",
"Pathology"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "40 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population",
"nctId": "NCT06366308",
"orgStudyIdInfo": {
"id": "ProBiox",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Positive rate of prostate biopsy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "West China Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "subgingival mechanotherapy with perioscopy"
},
{
"name": "classical subgingival mechanotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": [
{
"email": "[email protected]",
"name": "Bartlomiej Gorski, DDS, PhD",
"phone": "+48 22 502 20 99",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "Mazowieckie",
"status": "RECRUITING",
"zip": "02-097"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 26,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial",
"nctId": "NCT06366295",
"orgStudyIdInfo": {
"id": "WUM.Perio.05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Subgingival plaque pathogens (Aa, Pg, Td) levels"
},
{
"measure": "Gingival crevicular fluid levels of cytokines"
}
],
"primaryOutcomes": [
{
"measure": "Probing pocket depth (PPD)"
},
{
"measure": "Clinical attachment level (CAL)"
},
{
"measure": "Bleeding on probing (BoP)"
},
{
"measure": "Plaque index (PI)"
}
],
"secondaryOutcomes": [
{
"measure": "Width of keratinized tissue (KTW)"
},
{
"measure": "Gingival thickness (GT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Warsaw"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Caregiver Counseling for Childhood Traumatic Injury"
},
{
"name": "Standard of Care for Childhood Traumatic Injury"
}
]
},
"conditionsModule": {
"conditions": [
"Traumatic Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Winston-Salem",
"contacts": [
{
"email": "[email protected]",
"name": "Elizabeth White, MA, LCMHCS",
"phone": "336-716-2801",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elizabeth Shilling, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Wake Forest University Health Sciences",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina",
"status": null,
"zip": "27157"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PACTS",
"briefTitle": "Pediatric and Caregiver Traumatic Stress Intervention (PACTS)",
"nctId": "NCT06366282",
"orgStudyIdInfo": {
"id": "IRB00110030",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Kessler 6 Scores"
},
{
"measure": "Change in Patient Health Questionnaire - 9 (PHQ-9) Scores"
},
{
"measure": "Change in Child and Adolescent Trauma Screen (CATS) Scores"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Childress Institute for Pediatric Trauma"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Wake Forest University Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acupuncture"
},
{
"name": "Behavioral management"
},
{
"name": "Physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Pain Syndrome",
"Interstitial Cystitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.Participants will* complete surveys about their bladder pain symptoms* make behavioral changes that have been shown to improve bladder pain symptoms* attend six (6) weekly acupuncture sessions* attend six (6) weekly physical therapy sessions after finishing acupuncture"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded.",
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "89 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acupuncture First for IC/BPS",
"nctId": "NCT06366269",
"orgStudyIdInfo": {
"id": "STUDY20240374",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "O'Leary-Sant Interstitial Cystitis Index (OLSICI)"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Global Impression of Improvement (PGI-I)"
},
{
"measure": "Short Form (SF-36)"
},
{
"measure": "Genitourinary Pain Index (GUPI)"
},
{
"measure": "Number of additional treatments used during study period"
},
{
"measure": "Number of unscheduled interactions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "David Sheyn"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional ultrasound biofeedback"
},
{
"name": "Simplified ultrasound biofeedback"
}
]
},
"conditionsModule": {
"conditions": [
"Speech Sound Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cincinnati",
"contacts": [
{
"email": "[email protected]",
"name": "Suzanne E Boyce, PhD",
"phone": "513-558-8509",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sarah M Dugan, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Cincinnati",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "45220"
}
]
},
"descriptionModule": {
"briefSummary": "Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound \"r\" as in \"rabbit\". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good \"r\" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"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": "17 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "SUFSR",
"briefTitle": "Simplified Ultrasound Feedback for Speech Remediation",
"nctId": "NCT06366256",
"orgStudyIdInfo": {
"id": "1R01DC017301-01",
"link": "https://reporter.nih.gov/quickSearch/1R01DC017301-01",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in percent accurate words in probe list at beginning and midpoint of study"
},
{
"measure": "Change in percent accurate words in probe list at beginning and end of study"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Cincinnati"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emraclidine"
},
{
"name": "Esomeprazole"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Participants"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants",
"nctId": "NCT06366243",
"orgStudyIdInfo": {
"id": "CVL-231-HV-1012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum Observed Plasma Concentration (Cmax) of Emraclidine"
},
{
"measure": "Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine"
},
{
"measure": "Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine"
},
{
"measure": "Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants With Treatment-emergent Adverse Events (TEAEs)"
},
{
"measure": "Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values"
},
{
"measure": "Number of Participants With Clinically Significant Changes in Vital Sign Parameters"
},
{
"measure": "Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments"
},
{
"measure": "Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results"
},
{
"measure": "Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Cerevel Therapeutics, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Urea in the dialysate"
}
]
},
"conditionsModule": {
"conditions": [
"Dysequilibrium Syndrome",
"ESRD",
"Hyperkalemia",
"Metabolic Acidosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": [
{
"email": "[email protected]",
"name": "Ramin Sam, MD",
"phone": "628-206-6605",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Zuckerberg San Francisco General Hospital",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": null,
"zip": "94110"
}
]
},
"descriptionModule": {
"briefSummary": "At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adding Urea to the Final Dialysis Fluid",
"nctId": "NCT06366230",
"orgStudyIdInfo": {
"id": "24-41450",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disequilibrium"
},
{
"measure": "Serum potassium concentration"
},
{
"measure": "Serum CO2 concentration"
}
],
"secondaryOutcomes": [
{
"measure": "Serum BUN concentration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Francisco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MydCombi Device"
},
{
"name": "MydCombi Drug"
}
]
},
"conditionsModule": {
"conditions": [
"Dilation",
"Pupil Reaction Absent"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": null,
"country": "United States",
"facility": "University of California, San Francisco",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": null,
"zip": "94143"
}
]
},
"descriptionModule": {
"briefSummary": "To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops."
},
"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": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients",
"nctId": "NCT06366217",
"orgStudyIdInfo": {
"id": "20-32530A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percent change in Spherical equivalent"
},
{
"measure": "Percent Change in maximum pupil diameter"
},
{
"measure": "Percent Change in pupil constriction percentage"
}
],
"secondaryOutcomes": [
{
"measure": "Percent Change in Intraocular Pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Francisco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dietary Lysine Intakes"
}
]
},
"conditionsModule": {
"conditions": [
"Lactation",
"Breastfeeding, Exclusive",
"Breastfeeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vancouver",
"contacts": [
{
"email": "[email protected]",
"name": "Taylor Bailey, BSc",
"phone": "705-698-7648",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rajavel Elango, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "BC Children's Hospital Research Institute",
"geoPoint": {
"lat": 49.24966,
"lon": -123.11934
},
"state": "British Columbia",
"status": "RECRUITING",
"zip": "V5Z 4H4"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single day interventions; Repeated measures design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Lysine Requirements During Lactation",
"nctId": "NCT06366204",
"orgStudyIdInfo": {
"id": "H23-03119",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Carbon 13 Oxidation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canadian Institutes of Health Research (CIHR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of British Columbia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "prevention algorithm"
},
{
"name": "Standard care"
}
]
},
"conditionsModule": {
"conditions": [
"Psychological Trauma"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "A2P",
"briefTitle": "Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study",
"nctId": "NCT06366191",
"orgStudyIdInfo": {
"id": "2023/CHU/08",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "study acceptability rate"
}
],
"secondaryOutcomes": [
{
"measure": "Adherence of patient to the watch"
},
{
"measure": "Adherence of patient to the health watch"
},
{
"measure": "Patient satisfaction (quantitatif)"
},
{
"measure": "Patient satisfaction (qualitatif)"
},
{
"measure": "Strong points of the health watch"
},
{
"measure": "Evolution of the patient journey in experimental arm"
},
{
"measure": "Occurrence of post-traumatic stress disorder"
},
{
"measure": "Complications associated with post-traumatic stress disorder"
},
{
"measure": "Complications associated with post-traumatic stress disorder"
},
{
"measure": "Complications associated with post-traumatic stress disorder"
},
{
"measure": "Complications associated with post-traumatic stress disorder"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de la Réunion"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BONFIX system"
}
]
},
"conditionsModule": {
"conditions": [
"Craniosynostoses"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed.The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter.There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping \"freehand\", without a template. The result is therefore subject to the surgeon's experience and judgment.A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology.The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 5,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Months",
"minimumAge": "4 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "EPBONF",
"briefTitle": "EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses",
"nctId": "NCT06366178",
"orgStudyIdInfo": {
"id": "2024/864",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria."
},
{
"measure": "Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria."
},
{
"measure": "Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Besancon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "seemingly irrelevant funny videos and memes in teaching"
}
]
},
"conditionsModule": {
"conditions": [
"Learning Problem"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": [
{
"email": "[email protected]",
"name": "Ayat Gamal-AbdelNaser",
"phone": "01001874257",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Ahram Candian University",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "As Special care dentistry curriculum is very complicated and has a lot of details. Upon teaching it, the investigator will include memes and videos of movies and cartoons and will test the degree of retention of the information after years of passing the subject's exam."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Testing the procedure of using a different mode of teaching medical content",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 700,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Linking Special Care Dentistry Curriculum to Seemingly Irrelevant Comedy",
"nctId": "NCT06366165",
"orgStudyIdInfo": {
"id": "ACU-Med3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "degree of retention of information"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2021-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | 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": "NCT06366152",
"orgStudyIdInfo": {
"id": "43N2US2105",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiofrequency thermocoagulation of the trigeminal ganglion"
},
{
"name": "Maxillary/Mandibular nerve pulsed radiofrequency"
}
]
},
"conditionsModule": {
"conditions": [
"Trigeminal Neuralgia",
"Headache Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Diskapi Training and Research Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia",
"nctId": "NCT06366139",
"orgStudyIdInfo": {
"id": "Trigeminal RFT vs max/mand PRF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numerical rating scale (NRS)"
}
],
"secondaryOutcomes": [
{
"measure": "The Medication Quantification Scale III (MQS III)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Diskapi Teaching and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Child Abuse"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gamasa",
"contacts": null,
"country": "Egypt",
"facility": "Amira Hussin Mohammed",
"geoPoint": {
"lat": 31.44112,
"lon": 31.53675
},
"state": null,
"status": null,
"zip": "35712"
}
]
},
"descriptionModule": {
"briefSummary": "Based on research and studies, a broad conceptualization of child abuse and neglect has progressively been constructed, defining it as all actions carried out by caregivers that significantly interfere in the child's optimum development and do not adhere to social standards. This conceptualization contemplates aspects such as neglecting physical-biological, cognitive, emotional, and social needs, and the different types of child maltreatment are also classified.This study aimed too evaluate the psychological and social long-term effects of different types of child abuse."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 242,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "23 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long Term Impact of Child Abuse in University Students",
"nctId": "NCT06366126",
"orgStudyIdInfo": {
"id": "Child Abuse",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "tailored questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Delta University for Science and Technology"
}
},
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},
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"date": "2024-04-15"
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"date": "2023-08-31"
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"date": "2023-02-01"
},
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"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pulmonary rehabilitation"
}
]
},
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"conditions": [
"Respiratory Diseases"
]
},
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"locations": [
{
"city": "Lille",
"contacts": [
{
"email": "[email protected]",
"name": "Michaël RACODON, PhD",
"phone": "+33320223457",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Clinique la Mitterie",
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"lon": 3.05858
},
"state": null,
"status": "RECRUITING",
"zip": "59130"
}
]
},
"descriptionModule": {
"briefSummary": "Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.The program should not be improved by introducing new subjects such as circadian rhythm."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CHRONOBIO",
"briefTitle": "Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)",
"nctId": "NCT06366113",
"orgStudyIdInfo": {
"id": "2023-A00363-42",
"link": null,
"type": null
},
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"primaryOutcomes": [
{
"measure": "6-minute walk test (6MWT)"
}
],
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{
"measure": "Time limit test (Time-lim)"
},
{
"measure": "Sit to stand test (STT)"
},
{
"measure": "Single arm curl Test (SAC)"
},
{
"measure": "Single-leg stance test (SLT)"
},
{
"measure": "Hospital Anxiety and Depression Scale (HAD)"
},
{
"measure": "Pittsburgh Sleep Quality Index"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Michaël RACODON"
}
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"date": "2024-07-01"
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"date": "2024-04-17"
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"date": "2024-01-02"
},
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"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
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}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD)"
},
{
"name": "Unified Protocol (UP)"
}
]
},
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"conditions": [
"Implementation Science"
]
},
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"locations": [
{
"city": "Teruel",
"contacts": [
{
"email": "[email protected]",
"name": "María Vicenta Navarro Haro, PhD",
"phone": null,
"phoneExt": "861145",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University of Zaragoza",
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"lon": -1.10646
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"zip": "C/ Ciudad Escolar S/N44003"
}
]
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]
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"briefTitle": "Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction",
"nctId": "NCT06366100",
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"id": "2023I060",
"link": null,
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},
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"measure": "Acceptability and Intention to Use Survey"
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{
"measure": "Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM)"
},
{
"measure": "Normalization MeAsure Development Questionnaire (NoMAD)"
}
],
"secondaryOutcomes": [
{
"measure": "Copenhagen Burnout Inventory (CBI)"
},
{
"measure": "Brief Scale of Understanding Substance Abuse (SUSS)"
},
{
"measure": "Implementation Climate Scale (ICS)"
},
{
"measure": "Organizational Readiness for Implementing Change (ORIC)"
},
{
"measure": "Evidence-Based Practice Attitudes Scale (EBPAS)"
},
{
"measure": "Program sustainability assessment tool (PASAT)"
},
{
"measure": "Barriers to Implementation Inventory (BTI)"
}
]
},
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{
"name": "Ministerio de Sanidad, Servicios Sociales e Igualdad"
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],
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"name": "Universidad de Zaragoza"
}
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"date": "2025-12-31"
},
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"date": "2024-04-15"
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"date": "2025-06-30"
},
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},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
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"label": "Informed Consent Form",
"size": 419669,
"typeAbbrev": "ICF",
"uploadDate": "2024-04-09T12:23"
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"interventions": [
{
"name": "Atropine Sulfate Ophthalmic Solution USP, 1%"
},
{
"name": "Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL)"
}
]
},
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"conditions": [
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]
},
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{
"city": "Lenexa",
"contacts": [
{
"email": "[email protected]",
"name": "Carlos A Fierro, MD",
"phone": "913-825-4400",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mazen Zari",
"phone": "913-825-4400",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carlos A Fierro, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Johnson County Clin-Trials (JCCT)",
"geoPoint": {
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"lon": -94.73357
},
"state": "Kansas",
"status": null,
"zip": "66219"
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]
},
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"briefSummary": "A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers."
},
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},
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},
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},
"phases": [
"PHASE1"
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"studyType": "INTERVENTIONAL"
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"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": "SABER",
"briefTitle": "Sublingual Atropine Bioequivalence by Route of Administration (SABER)",
"nctId": "NCT06366087",
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"id": "BP-C-24-001",
"link": null,
"type": null
},
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},
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{
"measure": "The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf)."
},
{
"measure": "The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt)."
}
],
"secondaryOutcomes": [
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F)"
},
{
"measure": "The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka)"
}
]
},
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"collaborators": [
{
"name": "Rho Federal Systems Division, Inc."
},
{
"name": "Allucent"
}
],
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"class": "FED",
"name": "Biomedical Advanced Research and Development Authority"
}
},
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"date": "2024-05-24"
},
"lastUpdatePostDateStruct": {
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},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Watch-TEA group"
},
{
"name": "Tethered TEA device"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ann Arbor",
"contacts": [
{
"email": "[email protected]",
"name": "Colin Burnett",
"phone": "734-647-2806",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jiande Chen, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Michigan",
"geoPoint": {
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"lon": -83.74088
},
"state": "Michigan",
"status": null,
"zip": "48109"
}
]
},
"descriptionModule": {
"briefSummary": "This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Prevalence of delayed Chemotherapy-induced nausea, emesis, and dyspeptic symptoms (CINEDS) is 75% in women vs 51% in men (60% to 40% ratio). Therefore, every effort will be made to recruit at least 60% female subjects into the clinical study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
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},
"phases": [
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],
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},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device",
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"id": "HUM00252120",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Usability of the device for both groups day 3"
},
{
"measure": "Number of adverse events related to the device noted on the safety questionnaire"
},
{
"measure": "Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days"
},
{
"measure": "Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level"
},
{
"measure": "Number of non-treatment TEA adverse events for both groups"
}
],
"secondaryOutcomes": null
},
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"collaborators": [
{
"name": "Transtimulation Research, Inc"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Michigan"
}
},
"statusModule": {
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"date": "2025-08"
},
"lastUpdatePostDateStruct": {
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},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-08"
},
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"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
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"conditions": [
"Cardiac Functional Disturbances During Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Basel",
"contacts": [
{
"email": "[email protected]",
"name": "Michael Lampart, Prakt. med.",
"phone": "+41764006180",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "University Hospital Basel",
"geoPoint": {
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"lon": 7.57327
},
"state": "Basel Stadt",
"status": "RECRUITING",
"zip": "4000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning."
},
"designModule": {
"designInfo": {
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"maskingInfo": null,
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},
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"type": "ESTIMATED"
},
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"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING",
"nctId": "NCT06366061",
"orgStudyIdInfo": {
"id": "2020-02868",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Comparison of high Frame Rate (FR) vs. low FR of the following measures: [ i) S'STE AP4C supine, ii) GLS AP4C supine, iii) SR AP4C supine]"
},
{
"measure": "Comparison of the measured values in the cardiological gold standard (Left lateral decubitus (LLD)) vs. supine, for the following values [ i) S'TDI AP4C, ii) S'STE AP4C, iii) GLS]"
}
],
"primaryOutcomes": [
{
"measure": "S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine"
}
],
"secondaryOutcomes": [
{
"measure": "Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function?"
}
]
},
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"class": "OTHER",
"name": "Eckhard Mauermann"
}
},
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"date": "2024-12-01"
},
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"date": "2024-04-15"
},
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"date": "2024-07-01"
},
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"startDateStruct": {
"date": "2022-05-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
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"interventions": [
{
"name": "the different definitions of PHLF according to 50-50 criteria and ISGLS criteria"
}
]
},
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"conditions": [
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]
},
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{
"city": "Shanhai",
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"country": "China",
"facility": "The Third Affiliated Hospital of Naval Medical University",
"geoPoint": null,
"state": "Shanghai",
"status": null,
"zip": "201800"
}
]
},
"descriptionModule": {
"briefSummary": "The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice."
},
"designModule": {
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},
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},
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"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RNLV",
"briefTitle": "A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF)",
"nctId": "NCT06366048",
"orgStudyIdInfo": {
"id": "EHBHKY2022-K-025",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Probability of PHLF was predicted with our individual model based on RNLV."
}
],
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},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "National Natural Science Foundation of China"
}
},
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"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-05-31"
},
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"startDateStruct": {
"date": "2022-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LoVE4MUM mobile application"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Depression",
"Maternal Behavior",
"mHealth Intervention",
"Mental Health Issue"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Klang",
"contacts": [
{
"email": null,
"name": "Noor Fadzleeyanna Mohd Yahaya, MOG",
"phone": "03-3375 7000",
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"role": "CONTACT"
},
{
"email": null,
"name": "Noor Fadzleeyanna Mohd Yahaya, MOG",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Shalisah Sarip, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Norfazilah Ahmad, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Malaysia",
"facility": "Hospital Tengku Ampuan Rahimah",
"geoPoint": {
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"lon": 101.45
},
"state": "Selangor",
"status": null,
"zip": "41586"
},
{
"city": "Shah Alam",
"contacts": [
{
"email": "[email protected]",
"name": "Siti Sabrina Kamarudin",
"phone": "0355263000",
"phoneExt": "3305",
"role": "CONTACT"
},
{
"email": null,
"name": "Siti Sabrina Kamarudin, MBBS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "NNurul Syuhaida Abdul Razak, MOG",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Idayu Badilla Idris, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Malaysia",
"facility": "Hospital Shah Alam",
"geoPoint": {
"lat": 3.08507,
"lon": 101.53281
},
"state": "Selangor",
"status": null,
"zip": "40000"
}
]
},
"descriptionModule": {
"briefSummary": "Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Single Blinded, Pilot Randomized Control Trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "19 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "LoVE4MUM",
"briefTitle": "LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression",
"nctId": "NCT06366035",
"orgStudyIdInfo": {
"id": "NMRR ID-24-00924-HPO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postpartum Depression"
}
],
"secondaryOutcomes": [
{
"measure": "Postpartum Mental Health Literacy"
},
{
"measure": "Automatic Negative Frequency"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Institutes of Health, Ministry of Health Malaysia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The tunnel technique for root coverage with CTG with inner side of the graft"
},
{
"name": "The tunnel technique for root coverage with CTG with outer side of the graft"
}
]
},
"conditionsModule": {
"conditions": [
"Gingival Recession"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": [
{
"email": null,
"name": "Bartłomiej Górski, PhD",
"phone": "48225022099",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "MAzowsze",
"status": "RECRUITING",
"zip": "00-246"
}
]
},
"descriptionModule": {
"briefSummary": "Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft",
"nctId": "NCT06366022",
"orgStudyIdInfo": {
"id": "Warsaw.06",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical attachment level (CAL)"
},
{
"measure": "Recession height (RH)"
},
{
"measure": "Recession width (RW)"
},
{
"measure": "Width of keratinized tissue (KTW)"
},
{
"measure": "Thickness of keratinized tissue (GT"
},
{
"measure": "Average recession coverage (ARC)"
},
{
"measure": "Complete recession coverage"
}
],
"secondaryOutcomes": [
{
"measure": "Probing pocket depth (PPD)"
},
{
"measure": "Root coverage esthetic score (RES)"
},
{
"measure": "Post surgical pain and swelling"
},
{
"measure": "Patient's satisfaction with treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Warsaw"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NaoX in-ear EEG system"
}
]
},
"conditionsModule": {
"conditions": [
"Epilepsy",
"Focal Epilepsy",
"Drug Resistant Epilepsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": [
{
"email": null,
"name": "Przemysław Kunert, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Maja Kopytek-Beuzen, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Kliniki Neurochirurgii CSK UCK WUM",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE)."
},
"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": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes",
"nctId": "NCT06366009",
"orgStudyIdInfo": {
"id": "Warsaw Study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "determination of the starting point of focal temporal epileptic seizures"
}
],
"secondaryOutcomes": [
{
"measure": "Identification of subgroups of epileptic patterns"
},
{
"measure": "Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "NaoX Technologies"
},
{
"name": "Warsaw Medical University Clinical Center"
},
{
"name": "Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Przemyslaw Kunert"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Aging"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rzeszów",
"contacts": [
{
"email": "[email protected]",
"name": "Agnieszka Sozańska, professor",
"phone": "530172857",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "University of Rzeszow",
"geoPoint": {
"lat": 50.04132,
"lon": 21.99901
},
"state": "Podkarpacie",
"status": null,
"zip": "35-959"
}
]
},
"descriptionModule": {
"briefSummary": "Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Development and Validation of the Polish Geriatric Core Set.",
"nctId": "NCT06365996",
"orgStudyIdInfo": {
"id": "Core set geriatric ICF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ICF Geriatric core set"
}
],
"secondaryOutcomes": [
{
"measure": "Sociodemographic data of the sample"
},
{
"measure": "Disability - WHODAS 2.0 v 36 item"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Rzeszow"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Connective Tissue with Free Gingival Graft"
},
{
"name": "Connective Tissue with Linear Incision"
}
]
},
"conditionsModule": {
"conditions": [
"Connective Tissue",
"Gingiva",
"Gingival Recession",
"Humans"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Porto Alegre",
"contacts": [
{
"email": "[email protected]",
"name": "Cássio Cardona Orth",
"phone": "11999791876",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Brazil",
"facility": "Alex Nogueira Haas",
"geoPoint": {
"lat": -30.03306,
"lon": -51.23
},
"state": "RS",
"status": "RECRUITING",
"zip": "95780000"
}
]
},
"descriptionModule": {
"briefSummary": "A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.EXCLUSION CRITERIAIndividuals will not be considered eligible if they:* Present any form of immunological compromise;* Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;* Present active periodontitis, defined by presence of \\>=10% subgingival bleeding and probing depth and clinical attachment loss proximal \\>4mm (Tonetti et al. 2018);* Are current or ex-smokers;* Have allergies to ibuprofen and chlorhexidine digluconate.Research Objective:PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.SECONDARY OBJECTIVECompare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "All sample randomization procedures will be carried out by a researcher not involved in treatments and clinical examinations. An external researcher not affiliated with the study will be responsible for maintaining participant allocation confidentiality. Sides will be identified by numbers stored in opaque, sealed envelopes with the randomization sequence. Outcome assessors will be blinded to the experimental group to which participants belong.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Free Gingival Graft and Linear Incision for Connective Tissue",
"nctId": "NCT06365983",
"orgStudyIdInfo": {
"id": "UFRGS-Cassio",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of root coverage"
}
],
"secondaryOutcomes": [
{
"measure": "Recession depth"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Federal University of Rio Grande do Sul"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Niraparib"
},
{
"name": "Dostarlimab"
}
]
},
"conditionsModule": {
"conditions": [
"MMR-D/MSI-H Colorectal Cancers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Debra Diecks, MSN",
"phone": "412-623-8364",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ibrahim Sahin, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UPMC Hillman Cancer Center",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15232"
}
]
},
"descriptionModule": {
"briefSummary": "The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers",
"nctId": "NCT06365970",
"orgStudyIdInfo": {
"id": "HCC 23-056",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse Events Related to Treatment"
},
{
"measure": "Progression-free Survival (PFS)"
},
{
"measure": "Duration of Response (DoR)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GlaxoSmithKline"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ibrahim Halil Sahin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketone monoester supplementation"
},
{
"name": "High-intensity interval exercise"
},
{
"name": "Moderate-intensity continuous exercise"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity",
"Cognitive Change",
"Ketoses, Metabolic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acute Effects of Exercise Combined With Ketone Ester Supplement",
"nctId": "NCT06365957",
"orgStudyIdInfo": {
"id": "BSERE24-APP001-FED",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximal Oxygen Uptake"
},
{
"measure": "Systolic Blood Pressure"
},
{
"measure": "Diastolic Blood Pressure"
},
{
"measure": "Concentration of Blood Lipid"
},
{
"measure": "Concentration of Blood Glucose"
},
{
"measure": "Concentration of Blood Beta-Hydroxybutyrate"
},
{
"measure": "Concentration of Blood Lactic Acid"
},
{
"measure": "Concentration of Blood Insulin"
},
{
"measure": "Reaction Time of Stroop Task"
},
{
"measure": "Accuracy of Stroop Task"
},
{
"measure": "Reaction Time of N-back Task"
},
{
"measure": "Accuracy of N-back Task"
},
{
"measure": "Cerebral Hemoglobin Concentration"
}
],
"secondaryOutcomes": [
{
"measure": "Arousal Level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Macau"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Brain Concussion",
"Cerebral Concussion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bordeaux",
"contacts": [
{
"email": null,
"name": "Quentin LHUAIRE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Bordeaux University Hospital",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called \"Protocole carton blanc\", in this study we aim to describe the efficiency of this protocol."
},
"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": "PRECCOCE",
"briefTitle": "Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process",
"nctId": "NCT06365944",
"orgStudyIdInfo": {
"id": "CHUBX 2023/73",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Bordeaux"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Percutaneous neuromodulation"
},
{
"name": "Transcutaneous neuromodulation"
},
{
"name": "Placebo-percutaneous"
},
{
"name": "Placebo-transcutaneous"
},
{
"name": "Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke/Brain Attack"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Badajoz",
"contacts": null,
"country": "Spain",
"facility": "Mª Dolores Apolo Arenas",
"geoPoint": {
"lat": 38.87789,
"lon": -6.97061
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot.OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients.METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle.The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation",
"nctId": "NCT06365931",
"orgStudyIdInfo": {
"id": "160224",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Muscle activity"
},
{
"measure": "Displacement of the center of pressures (CoP)"
},
{
"measure": "Articular amplitude"
},
{
"measure": "Balance"
},
{
"measure": "Balance"
},
{
"measure": "Gait"
},
{
"measure": "Tissue oxygen in muscle"
},
{
"measure": "Muscular strength"
},
{
"measure": "Functionality"
},
{
"measure": "quality of life index"
},
{
"measure": "Spasticity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Extremadura"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VG2025"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumor",
"Carcinomatosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Siqing Fu, MD,PHD",
"phone": "713-792-4318",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Siqing Fu, MD,PHD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis",
"nctId": "NCT06365918",
"orgStudyIdInfo": {
"id": "2023-0836",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03236",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-03-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"conditionsModule": {
"conditions": [
"Endometrial Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Scottsdale",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kristina A. Butler, M.D., M.S.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Arizona",
"geoPoint": {
"lat": 33.50921,
"lon": -111.89903
},
"state": "Arizona",
"status": "NOT_YET_RECRUITING",
"zip": "85259"
},
{
"city": "Jacksonville",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher C. DeStephano, M.D., M.P.H.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"zip": "32224-9980"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gretchen E. Glaser, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "55 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding",
"nctId": "NCT06365905",
"orgStudyIdInfo": {
"id": "23-011680",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-02550",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic in Rochester",
"id": "23-011680",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "open-label placebo"
},
{
"name": "Treatment as usual"
}
]
},
"conditionsModule": {
"conditions": [
"Adolescent Idiopathic Scoliosis (AIS)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": null,
"country": "United States",
"facility": "University of California, San Francisco",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": null,
"zip": "94158"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Blinding of patients and providers will not be feasible due to the nature of the study.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis",
"nctId": "NCT06365892",
"orgStudyIdInfo": {
"id": "22-36548",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery"
}
],
"secondaryOutcomes": [
{
"measure": "Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6."
},
{
"measure": "Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6."
},
{
"measure": "Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6."
},
{
"measure": "The duration of time in days following surgery until patients establish Independence with Physical Therapy"
},
{
"measure": "The length of time in days following surgery until discharge from the hospital"
},
{
"measure": "The length of time in days following surgery until participant returns to school"
},
{
"measure": "Whether participants experience urinary retention following surgery."
},
{
"measure": "Whether participants experience constipation measured by the number of days between surgery and first bowel movement"
},
{
"measure": "Whether participants experience an oxygen requirement and the duration of the requirement following surgery."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Francisco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CMAB007"
},
{
"name": "Xolair"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Spontaneous Urticaria"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 392,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria",
"nctId": "NCT06365879",
"orgStudyIdInfo": {
"id": "CMAB007-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12"
}
],
"secondaryOutcomes": [
{
"measure": "Change From Baseline of Urticaria Activity Score (UAS7) At Week 12"
},
{
"measure": "Change From Baseline of Number of Hives Score (NHS7) At Week 12"
},
{
"measure": "Time to ISS7 MID Response by Week 12"
},
{
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"briefSummary": "Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 252,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ERAS for Gastric Cancer Patients After NACT",
"nctId": "NCT06365814",
"orgStudyIdInfo": {
"id": "ERASforNACT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "postoperative infectious complications"
}
],
"secondaryOutcomes": [
{
"measure": "postoperative recovery parameter"
},
{
"measure": "blood test result"
},
{
"measure": "3-year overall survival"
},
{
"measure": "3-years recurrence-free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Affiliated Hospital of Qingdao University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Irritable Bowel Syndrome"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics",
"nctId": "NCT06365801",
"orgStudyIdInfo": {
"id": "2022YFC3500401-IBS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain sensitivity"
},
{
"measure": "Thermal radiation characteristics"
},
{
"measure": "Microcirculation characteristics"
},
{
"measure": "Electrical characteristics"
},
{
"measure": "Biological ultra-weak luminescence"
}
],
"secondaryOutcomes": [
{
"measure": "Intestinal flora"
},
{
"measure": "Tryptophan metabolites"
},
{
"measure": "Bristol Fecal Traits Grading Scale"
},
{
"measure": "Severity of IBS (IBS-SSS)"
},
{
"measure": "IBS Quality of Life (IBS-QOL )"
},
{
"measure": "TCM Constitution Survey"
},
{
"measure": "Gastrointestinal Symptoms Rating Scale (GSRS)"
},
{
"measure": "Self-Rating Anxiety Scale (SAS)"
},
{
"measure": "Self-Rating Depression Scale (SDS)"
},
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Third Affiliated hospital of Zhejiang Chinese Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Abemaciclib"
},
{
"name": "Bicalutamide"
}
]
},
"conditionsModule": {
"conditions": [
"Triple Negative Breast Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Antwerp",
"contacts": [
{
"email": "[email protected]",
"name": "Sevilay Altintas, MD, PhD",
"phone": "+3238213250",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sevilay Altintas, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Antwerp University Hospital",
"geoPoint": {
"lat": 51.21989,
"lon": 4.40346
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Antwerp",
"contacts": [
{
"email": "[email protected]",
"name": "Kevin Punie, MD",
"phone": "+3234433737",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kevin Punie, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Gasthuiszusters Antwerpen",
"geoPoint": {
"lat": 51.21989,
"lon": 4.40346
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Brussel",
"contacts": [
{
"email": "[email protected]",
"name": "Christel Fontaine, MD",
"phone": "+3224776040",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christel Fontaine, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "University Hospital Brussels",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Ghent",
"contacts": [
{
"email": "[email protected]",
"name": "Hannelore Denys, MD, PhD",
"phone": "+3293322692",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hannelore Denys, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Ghent University Hospital",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Hasselt",
"contacts": [
{
"email": "[email protected]",
"name": "Annelies Requilé, MD",
"phone": "+3211337979",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Annelies Requilé, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Jessa Ziekenhuis",
"geoPoint": {
"lat": 50.93106,
"lon": 5.33781
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Leuven",
"contacts": [
{
"email": "[email protected]",
"name": "Patrick Neven, MD, PhD",
"phone": "+3216344750",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kristien Borremans, MD",
"phone": "+3216347795",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Patrick Neven, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "University Hospitals Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast 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": 53,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ABBICAR",
"briefTitle": "Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer",
"nctId": "NCT06365788",
"orgStudyIdInfo": {
"id": "S66466",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CT Number",
"id": "2022-502272-23-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with disease control at 16 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0"
},
{
"measure": "HRQoL change from baseline as measured by EORTC QLQ-C30"
},
{
"measure": "Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells."
},
{
"measure": "Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate"
},
{
"measure": "Number of participants with disease control at 24 weeks"
},
{
"measure": "Number of participants with partial or complete response at 16 weeks"
},
{
"measure": "Duration of response"
},
{
"measure": "Months of progression free survival"
},
{
"measure": "Months of overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kom Op Tegen Kanker"
},
{
"name": "Eli Lilly and Company"
},
{
"name": "Teva Pharma"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Sudden Sensorineural Hearing Loss",
"Hearing Loss, Sensorineural",
"Hearing Loss, Sudden"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* to find out which factor from multi-omics data relates to outcomes of SSNHL* to develop the best prognostics model based on the multi-omics data.Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss",
"nctId": "NCT06365775",
"orgStudyIdInfo": {
"id": "TJ-IRB20221229",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Variant detection efficiency"
},
{
"measure": "Exome coverage"
},
{
"measure": "Genome-wide variant distribution"
},
{
"measure": "Head MRI"
},
{
"measure": "Inner Ear MRI"
}
],
"primaryOutcomes": [
{
"measure": "Pure tone audiometry (PTA)"
}
],
"secondaryOutcomes": [
{
"measure": "Speech reception thresholds"
},
{
"measure": "Speech discrimination scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dan Bing"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EDTA Ophthalmic Solution 2.6%"
},
{
"name": "EDTA Ophthalmic Solution 1.3%"
},
{
"name": "Saline Solution (Placebo)"
}
]
},
"conditionsModule": {
"conditions": [
"Age Related Cataracts"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": null,
"country": "United States",
"facility": "St Mary's Eye Specialists, Inc.",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": null,
"zip": "94117"
},
{
"city": "Overland Park",
"contacts": null,
"country": "United States",
"facility": "Hunkeler Eye Institute",
"geoPoint": {
"lat": 38.98223,
"lon": -94.67079
},
"state": "Kansas",
"status": null,
"zip": "66210"
},
{
"city": "Lutherville",
"contacts": null,
"country": "United States",
"facility": "The Johns Hopkins Hospital & Health System, Wilmer Eye Institute",
"geoPoint": {
"lat": 39.42122,
"lon": -76.62608
},
"state": "Maryland",
"status": null,
"zip": "21093"
},
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Harvard Medical School, Massachusetts Eye and Ear Infirmary",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02114"
},
{
"city": "Charlotte",
"contacts": null,
"country": "United States",
"facility": "Charlotte Eye, Ear, Nose, and Throat Associates",
"geoPoint": {
"lat": 35.22709,
"lon": -80.84313
},
"state": "North Carolina",
"status": null,
"zip": "28210"
},
{
"city": "Salt Lake City",
"contacts": null,
"country": "United States",
"facility": "University of Utah, John Moran Eye Center",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": null,
"zip": "84132"
}
]
},
"descriptionModule": {
"briefSummary": "The study objectives were:* To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;* To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and* To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 111,
"type": "ACTUAL"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract",
"nctId": "NCT06365762",
"orgStudyIdInfo": {
"id": "CK-0103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Mean Change in Contrast Sensitivity (Mesopic)"
},
{
"measure": "Mean Change in Best-Corrected Visual Acuity (BCVA)"
},
{
"measure": "Pentacam Imaging"
}
],
"primaryOutcomes": [
{
"measure": "Contrast Sensitivity (Mesopic) Responder Analysis"
}
],
"secondaryOutcomes": [
{
"measure": "Cumulative Improvement in Contrast Sensitivity (Mesopic)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Livionex Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2007-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2006-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2006-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Congenital Hearing Loss",
"Congenital Deafness"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:* to present the genetic characteristics of the infant with hearing loss in the Chinese population* to build up a prognostic model base on diverse data.Participants will be asked to receive audiological tests and collection of the peripheral blood sample."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Months",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Genetic Feature of Congenital Hearing Loss in Chinese Population",
"nctId": "NCT06365749",
"orgStudyIdInfo": {
"id": "TJ-IRB20221228",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Whole exome sequencing data"
}
],
"secondaryOutcomes": [
{
"measure": "TEOAE-based otoacoustic emissions test outcome measure"
},
{
"measure": "Auditory brainstem response testing"
},
{
"measure": "Acoustic impedance"
},
{
"measure": "Audiogram"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dan Bing"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Contemplating in nature"
},
{
"name": "Walking in nature"
}
]
},
"conditionsModule": {
"conditions": [
"Spiritual Well-being",
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Enschede",
"contacts": [
{
"email": "[email protected]",
"name": "TALITHA RUARUS-BLANKERT",
"phone": "+31534891289",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ernst Bohlmeijer, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "University of Twente",
"geoPoint": {
"lat": 52.21833,
"lon": 6.89583
},
"state": "Overijssel",
"status": null,
"zip": "7522NB"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is:Does a 2-week contemplative nature intervention improve spiritual well-being?Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality.Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes.Participants in the active control condition will walk for 30 minutes without further instruction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being",
"nctId": "NCT06365736",
"orgStudyIdInfo": {
"id": "240310",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Client satisfaction of intervention condition assessed by Client Satisfaction Questionnaire (CSQ-8)"
},
{
"measure": "Client satisfaction of active control condition assessed by Client Satisfaction Questionnaire (CSQ-8)"
},
{
"measure": "Client satisfaction of passive control condition assessed by Client Satisfaction Questionnaire (CSQ-8)"
},
{
"measure": "Nature connectedness assessed by Connectedness to Nature Scale (CNS)"
},
{
"measure": "Nature connectedness assessed by Connectedness to Nature Scale (CNS)"
},
{
"measure": "Nature connectedness assessed by Connectedness to Nature Scale (CNS)"
},
{
"measure": "Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS)"
},
{
"measure": "Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS)"
},
{
"measure": "Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS)"
},
{
"measure": "Well-being assessed by Mental Health Continuum-Short Form (MHC-SF)"
},
{
"measure": "Well-being assessed by Mental Health Continuum-Short Form (MHC-SF)"
},
{
"measure": "Well-being assessed by Mental Health Continuum-Short Form (MHC-SF)"
},
{
"measure": "Psychological well-being assessed by Brief INSPIRE-O"
},
{
"measure": "Psychological well-being assessed by Brief INSPIRE-O"
},
{
"measure": "Psychological well-being assessed by Brief INSPIRE-O"
},
{
"measure": "Stress assessed by Perceived Stress Scale (PSS)"
},
{
"measure": "Stress assessed by Perceived Stress Scale (PSS)"
},
{
"measure": "Stress assessed by Perceived Stress Scale (PSS)"
}
],
"primaryOutcomes": [
{
"measure": "Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF)"
},
{
"measure": "Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF)"
},
{
"measure": "Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF)"
},
{
"measure": "Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES)"
},
{
"measure": "Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES)"
},
{
"measure": "Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Twente"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Green Walk"
},
{
"name": "Gray Walk"
}
]
},
"conditionsModule": {
"conditions": [
"PreDiabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Approximately 92 million U.S. adults (\\~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The study is a randomized crossover trial with a 4-week washout period.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 216,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial",
"nctId": "NCT06365723",
"orgStudyIdInfo": {
"id": "SPH-2023-32410",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measure of Anxiety"
},
{
"measure": "Perceived stress assessment"
},
{
"measure": "Mood assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Heart Rate variability"
},
{
"measure": "Salivary cortisol levels"
},
{
"measure": "Ambient Particulate Matter"
},
{
"measure": "Black Carbon levels"
},
{
"measure": "CMD risk"
},
{
"measure": "State and Trait anxiety"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Minnesota"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Telerehabilitation"
},
{
"name": "Traditional physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Helsinki",
"contacts": [
{
"email": "[email protected]",
"name": "Samuli Aspinen, M.D., Ph.D.",
"phone": "+358406360546",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Finland",
"facility": "Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital",
"geoPoint": {
"lat": 60.16952,
"lon": 24.93545
},
"state": "Uusimaa",
"status": "RECRUITING",
"zip": "00029"
}
]
},
"descriptionModule": {
"briefSummary": "Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture",
"nctId": "NCT06365710",
"orgStudyIdInfo": {
"id": "HUS/206/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient-Rated Wrist Evaluation (PRWE)"
}
],
"secondaryOutcomes": [
{
"measure": "Grip strength"
},
{
"measure": "Quick Disabilities of the arm, shoulder, and hand"
},
{
"measure": "Pain (Visual Analogue Scale)"
},
{
"measure": "Wrist range of motion (ROM)"
},
{
"measure": "Adverse events"
},
{
"measure": "Global improvement"
},
{
"measure": "Patient-rated Quality of Life (EQ-5D)"
},
{
"measure": "Cost-utility analysis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Töölö Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ton-bridge carotid stent"
},
{
"name": "WALLSTENT carotid stent"
}
]
},
"conditionsModule": {
"conditions": [
"Carotid Artery Stenosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shenyang",
"contacts": [
{
"email": null,
"name": "Peizhuo Zang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The People's Hospital of Liaoning Province",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
},
"state": "Liaoning",
"status": null,
"zip": null
},
{
"city": "Linyi",
"contacts": [
{
"email": null,
"name": "Hongxing Han",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Linyi People's Hospital",
"geoPoint": {
"lat": 35.06306,
"lon": 118.34278
},
"state": "Shandong",
"status": null,
"zip": null
},
{
"city": "Qingdao",
"contacts": [
{
"email": null,
"name": "Haicheng Yuan",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Qingdao Central Hospital",
"geoPoint": {
"lat": 36.06488,
"lon": 120.38042
},
"state": "Shandong",
"status": null,
"zip": null
},
{
"city": "Qingdao",
"contacts": [
{
"email": null,
"name": "Yong Zhang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Affiliated Hospital of Qingdao University",
"geoPoint": {
"lat": 36.06488,
"lon": 120.38042
},
"state": "Shandong",
"status": null,
"zip": null
},
{
"city": "Jinan",
"contacts": [
{
"email": null,
"name": "Liqun Jiao",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Central Hospital Affiliated to Shangdong First Medical University",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shangdong",
"status": null,
"zip": null
},
{
"city": "Lishui",
"contacts": [
{
"email": null,
"name": "Xueli Cai",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Lishui Central Hospital",
"geoPoint": {
"lat": 28.46042,
"lon": 119.91029
},
"state": "Zhejiang",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Bin Yang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Xuanwu Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 188,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis",
"nctId": "NCT06365697",
"orgStudyIdInfo": {
"id": "ZHTQ202301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of non-MAE(major adverse events) within 30 days post-procedure"
}
],
"secondaryOutcomes": [
{
"measure": "Technical success"
},
{
"measure": "Procedural success"
},
{
"measure": "Target lesion revascularization (TLR)"
},
{
"measure": "Ipsilateral stroke between 31 days and 1 year post-procedure"
},
{
"measure": "In-stent restenosis"
},
{
"measure": "mRS score"
},
{
"measure": "Device deficiency"
},
{
"measure": "Incidence of MAE"
},
{
"measure": "Incidence of Adverse events (AE)"
},
{
"measure": "Incidence of Serious adverse events (SAE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Zhuhai Tonbridge Medical Tech. Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sodium zirconium cyclosilicate"
}
]
},
"conditionsModule": {
"conditions": [
"Hyperkalemia",
"Diet Modification",
"Chronic Kidney Disease",
"Sodium Zirconium Cyclosilicate"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \\[1\\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \\> 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Single center, cross-over randomized clinical trial with non-inferiority design",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LIBRAL",
"briefTitle": "Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4",
"nctId": "NCT06365684",
"orgStudyIdInfo": {
"id": "133548",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-507823-52",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis."
}
],
"secondaryOutcomes": [
{
"measure": "Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours)"
},
{
"measure": "24 hours albuminuria"
},
{
"measure": "urinary potassium (mmol/l)"
},
{
"measure": "Plasma bicarbonate"
},
{
"measure": "Quality of life, using SF36 questionnaire"
},
{
"measure": "Effect on stool (assessed with Bristol Stool Chart)"
},
{
"measure": "Difference in serum potassium one week after start of study (SCZ free period)"
},
{
"measure": "Per protocol analysis of difference in serum potassium after six week (end of study)"
},
{
"measure": "Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia)"
},
{
"measure": "Incidence of hyperkalemia (serum potassium above 5.5 mmol/l)"
},
{
"measure": "Necessity for treatment of hyperkalemia"
},
{
"measure": "urinary sodium (mmol/l)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AstraZeneca"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Leiden University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel)"
}
]
},
"conditionsModule": {
"conditions": [
"B-NHL, Extranodal, TP53 Alterations, Bulky Mass"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors",
"nctId": "NCT06365671",
"orgStudyIdInfo": {
"id": "ASCT-CART",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Best Complete Response (CR) Rate in 3 months"
}
],
"secondaryOutcomes": [
{
"measure": "Objective remission rate (ORR) in 3months"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Progression-Free Survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Adverse Events rate as assessed by CTCAE version 5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ruijin Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Psychological assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Aphasia",
"Development, Human",
"Neuropathology"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gdansk",
"contacts": [
{
"email": "[email protected]",
"name": "Rafał Nowicki, M.A.",
"phone": "+48509805591",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Urszula Sajewicz-Radtke, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Bartosz M Radtke, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ariadna Łada-Maśko, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Beata Daniluk, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Piotr Markiewicz, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Paweł Jurek, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Michał Olech, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Artur Sawicki, M.A.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Rafał Nowicki, M.A.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Poland",
"facility": "Laboratory of Psychological and Educational Tests",
"geoPoint": {
"lat": 54.35205,
"lon": 18.64637
},
"state": "Pomerania",
"status": "RECRUITING",
"zip": "80-239"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.The main questions it aims to answer are:1. What is the profile of memory and learning among polish adults?2. Do gender and age moderates patterns of memory and learning functioning among polish adults?3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?Researchers will compare the following groups of adults:1. general population/control group2. with neurologically recognized aphasic syndromes3. seniors (over 60 y.o.)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective",
"nctId": "NCT06365658",
"orgStudyIdInfo": {
"id": "2024/PTPiP/1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Memory and learning"
},
{
"measure": "Language"
},
{
"measure": "Socio-demographic data"
}
],
"secondaryOutcomes": [
{
"measure": "General mental state"
},
{
"measure": "Health related data"
},
{
"measure": "Education data"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Bartosz M. Radtke"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "M.Bapp"
},
{
"name": "App-based parenting education"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Depression",
"Postpartum Anxiety",
"Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Providence",
"contacts": null,
"country": "United States",
"facility": "Women & Infants Hospital of Rhode Island",
"geoPoint": {
"lat": 41.82399,
"lon": -71.41283
},
"state": "Rhode Island",
"status": null,
"zip": "02905"
}
]
},
"descriptionModule": {
"briefSummary": "Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \\& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Participants who consent will be unaware of the existence of another version of M.Bapp. Obstetric care providers will be aware of participant's enrollment in this trial but not of the study group and will be encouraged to provide standardized care. The research team and outcomes assessors will be blindd to the randomization group.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention",
"nctId": "NCT06365645",
"orgStudyIdInfo": {
"id": "2138752",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "De novo psychiatric diagnosis"
},
{
"measure": "Screening positive on study survey"
}
],
"primaryOutcomes": [
{
"measure": "Feasibility"
},
{
"measure": "Acceptability"
}
],
"secondaryOutcomes": [
{
"measure": "Edinburgh Postnatal Depression Scale"
},
{
"measure": "General Anxiety Disorder-7"
},
{
"measure": "Perceived Stress-Scale 4"
},
{
"measure": "Dyadic Adjustment Scale"
},
{
"measure": "UCLA Loneliness Scale"
},
{
"measure": "Frequency of Mothers and Babies Skills Use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Women and Infants Hospital of Rhode Island"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus"
},
{
"name": "antegrade appendectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Abdominal Adhesions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minsk",
"contacts": [
{
"email": "[email protected]",
"name": "Olga Svetlitskaya",
"phone": "+375297752697",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yulia Shabalina",
"phone": "+375 (17) 287 00 15",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belarus",
"facility": "CITY CLINICAL EMERGENCY HOSPITAL of Minsk",
"geoPoint": {
"lat": 53.9,
"lon": 27.56667
},
"state": null,
"status": null,
"zip": "220024"
},
{
"city": "Minsk",
"contacts": [
{
"email": "[email protected]",
"name": "Olga Svetlitskaya",
"phone": "+375297752697",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yulia Shabalina",
"phone": "+375 (17) 287 00 15",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Stanislav Tretiak, Doctor of Medicine",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Alexander Zhura, Doctor of Medicine",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Belarus",
"facility": "CITY CLINICAL EMERGENCY HOSPITAL of Minsk",
"geoPoint": {
"lat": 53.9,
"lon": 27.56667
},
"state": null,
"status": null,
"zip": "220024"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug \"Antispike, gel, 100 g in a bottle\" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OLTOSPAN-02",
"briefTitle": "Clinical Study of the Effectiveness, Tolerability and Safety of the Drug \"Anti-spike, Gel, 100 g in Bottles in Package No. 1\" Produced by the Republican Unitary Enterprise \"Unitekhprom BSU\", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis",
"nctId": "NCT06365632",
"orgStudyIdInfo": {
"id": "OLTOSPAN-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "increase in the sliding distance of the cecum"
}
],
"primaryOutcomes": [
{
"measure": "Number of patients with acute phlegmonous appendicitis cured"
}
],
"secondaryOutcomes": [
{
"measure": "absence of signs of adhesions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Unitary Enterprise UNITEHPROM BSU"
},
{
"name": "City Clinical Hospital of Emergency Medical Care of Minsk"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Research Institute for Physical Chemical Problems of the Belarusian State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ipilimumab"
},
{
"name": "Nivolumab"
}
]
},
"conditionsModule": {
"conditions": [
"Melanoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": null,
"country": "United States",
"facility": "Huntsman Cancer Institute",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": null,
"zip": "84112"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy.Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NeoRelapse",
"briefTitle": "Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma",
"nctId": "NCT06365619",
"orgStudyIdInfo": {
"id": "HCI168525",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery."
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment."
},
{
"measure": "Rate of adverse events that occur within 30 days post-surgery."
},
{
"measure": "Rate of Event Free Survival (EFS)."
},
{
"measure": "Rate of Overall Survival (OS)."
},
{
"measure": "Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR and CR as defined by RECIST 1.1 prior to surgical resection."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "iStatis Syphilis Ab Test"
}
]
},
"conditionsModule": {
"conditions": [
"Syphilis Infection",
"Syphilis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hillcrest",
"contacts": [
{
"email": "[email protected]",
"name": "Cherie Cawood",
"phone": "+27 828202955",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Epicentre Health Research",
"geoPoint": null,
"state": "KwaZulu Natal",
"status": "RECRUITING",
"zip": "3650"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants and the healthcare providers are not aware of the syphilis status.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites",
"nctId": "NCT06365606",
"orgStudyIdInfo": {
"id": "CLS-015A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sensitivity and specificity of the iStatis Syphilis Ab Test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "bioLytical Laboratories"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Hereditary Transthyretin Amyloidosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kazan",
"contacts": null,
"country": "Russian Federation",
"facility": "Research Site",
"geoPoint": {
"lat": 55.78874,
"lon": 49.12214
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Moscow",
"contacts": null,
"country": "Russian Federation",
"facility": "Research Site",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Saint-Petersburg",
"contacts": null,
"country": "Russian Federation",
"facility": "Research Site",
"geoPoint": {
"lat": 59.93863,
"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": "194354"
}
]
},
"descriptionModule": {
"briefSummary": "A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients."
},
"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": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRIMER",
"briefTitle": "hATTR Polyneuropathy in Russia",
"nctId": "NCT06365593",
"orgStudyIdInfo": {
"id": "D8450R00005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP in the Russian Federation during retrospective follow-up period Mean changes in BMI at visits 2, 3 will be compared to baseline"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with newly diagnosed clinical manifestations will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period, Proportion of patients with different newly diagnosed clinical manifestations will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with each PND score at visits 2, 3 will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP, Proportion of patients with worsening of PND score at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with hospitalisations (one or more) will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of different reasons for hospitalisations will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with death for all causes will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients during follow-up period Proportion of patients with different causes of death will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients during retrospective follow-up period Proportion of patients with each score by each parameter of neurological examination at visits 2, 3 will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in MRS at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in INCAT scale at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with diagnosis of HFpEF at visits 2, 3 will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in LVEF at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in wall thickness of the LV at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in NT-proBNP at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in eGFR at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in UACR at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with a positive paraprotein blood test result at visits 2, 3 will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in BP at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in HR at visits 2, 3 compared to baseline will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with new concomitant diseases will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with different new concomitant diseases will be calculated"
},
{
"measure": "to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with presence of CTS surgery will be calculated"
}
],
"primaryOutcomes": [
{
"measure": "In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Mean age at the hATTR-PN or CIAP diagnosis information will be collected"
},
{
"measure": "In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of women and men will be collected"
},
{
"measure": "In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with each race and ethnicity will be collected"
},
{
"measure": "to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIA, information on Proportion of patients from each federal district of the Russian Federation will be collected"
},
{
"measure": "in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, tha following Anthropometric characteristics will be collected:"
},
{
"measure": "In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with underweight will be collected"
},
{
"measure": "in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with negative lifestyle factors will be collected:"
},
{
"measure": "in order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with positive family history in close relatives will be collected"
},
{
"measure": "to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from the first symptoms of neuropathy to the diagnosis of PN will be collected"
},
{
"measure": "to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, Proportion of patients with different firstly suspected etiology of PN will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from first PN manifestation/diagnosis to the hATTR-PN or CIAP diagnosis will be collected"
},
{
"measure": "To describe the baseline electrophysiological and clinical characteristics of patients, Proportion of patients with chronic sensory or sensorimotor polyneuropathy and progressive chronic polyneuropathy among patients with CIAP will be calculated"
},
{
"measure": "To describe the baseline clinical characteristics of patients with hATTR-PN and CIAP, Proportion of patients with each result of TTR gene testing will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each clinical manifestation will be calculated:"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each PND score will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each score by each parameter of neurological examination will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by MRS will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by INCAT scale (total score, arm disability, leg disability) will be collected"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean left ventricular ejection fraction (LVEF) will be collected"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean wall thickness of the left ventricular (LV) will be collected"
},
{
"measure": "To describe the baseline electrophysiological characteristics of patients with hATTR-PN and CIAP, information Mean variables based on the results of electrophysiological investigation, including the following (on both extremities) will be collected"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with diagnosis of HFpEF will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean NT-proBNP level will be collected"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean estimated glomerular filtration rate (eGFR) will be collected"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean urine albumin-to-creatinine ratio (UACR) in a spot urine sample will be collected"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with a positive paraprotein blood test result will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean blood pressure (BP) (systolic and diastolic) and Mean heart rate (HR)"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each concomitant disease will be calculated"
},
{
"measure": "To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients underwent surgery for CTS to the moment of diagnosis will be calculated"
}
],
"secondaryOutcomes": [
{
"measure": "To arrange a score to select patients with axonal neuropathy who deserve screening for TTR mutation."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AstraZeneca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kylo-0603 capsule"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Nonalcoholic Steatohepatitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "The first affiliated hospital, Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": "RECRUITING",
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 124,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dose Escalation Study of Kylo-0603 in Healthy Subjects",
"nctId": "NCT06365580",
"orgStudyIdInfo": {
"id": "Kylo-0603-I-C01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "incidence of adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)"
},
{
"measure": "PK parameter of time of maximum observed concentration (Tmax)"
},
{
"measure": "PK parameter of area under the concentration time curve (AUC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Kylonova (Xiamen) Biopharma co., LTD."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Pediatric Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Novara",
"contacts": [
{
"email": null,
"name": "Flavia Prodam, MD PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "SCDU Pediatria, AOU Ospedale Maggiore della Carità",
"geoPoint": {
"lat": 45.44694,
"lon": 8.62118
},
"state": null,
"status": "RECRUITING",
"zip": "28100"
}
]
},
"descriptionModule": {
"briefSummary": "The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a \"Western\" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week.Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition.The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "EO2022",
"briefTitle": "Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease.",
"nctId": "NCT06365567",
"orgStudyIdInfo": {
"id": "CE209/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "assessment of fructose intake with questionnaires"
},
{
"measure": "correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis"
},
{
"measure": "Correlation of fructose consumption with bone metabolism, detected through QUS"
}
],
"secondaryOutcomes": [
{
"measure": "Characterization of the concentration of intestinal microorganisms"
},
{
"measure": "Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Ospedaliero Universitaria Maggiore della Carita"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-21",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 972421,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-04-11T05:17"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remedy Robot"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebrovascular Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DEVICE_FEASIBILITY",
"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": "On-Premise and Remote Robotic Neurointervention",
"nctId": "NCT06365554",
"orgStudyIdInfo": {
"id": "2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Procedural safety"
},
{
"measure": "Procedural Technical Success"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Unity Health Toronto"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Remedy Robotics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dapagliflozin"
}
]
},
"conditionsModule": {
"conditions": [
"The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Maoming",
"contacts": [
{
"email": "[email protected]",
"name": "Mingsheng Zhu",
"phone": "15016656405",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The People's Hospital of Gaozhou",
"geoPoint": {
"lat": 21.65,
"lon": 110.9
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "525200"
}
]
},
"descriptionModule": {
"briefSummary": "Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Exploring the efficacy and safety of dapagliflozin in improving heart failure in dialysis patients by the analysis and comparison of patients' own data before and after dapagliflozin treatment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients",
"nctId": "NCT06365541",
"orgStudyIdInfo": {
"id": "GYLLPJ-2024006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "N-terminal B-type natriuretic peptide precursor (NT-proBNP)"
},
{
"measure": "Left ventricular ejection fraction (LVEF)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The People's Hospital of Gaozhou"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Subcutaneous tunnelling"
},
{
"name": "Non-tunnelling"
}
]
},
"conditionsModule": {
"conditions": [
"CLABSI - Central Line Associated Bloodstream Infection",
"Deep Vein Thrombosis",
"Dislodged Catheter",
"Occlusion",
"Catheter Rupture",
"Catheter (Other); Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Porto Alegre",
"contacts": [
{
"email": null,
"name": "Eneida R Rabelo da Silva, ScD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Brazil",
"facility": "Hospital de Clínicas de Porto Alegre",
"geoPoint": {
"lat": -30.03306,
"lon": -51.23
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Prospective Randomized Open, Blinded End-point (PROBE Study)",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 840,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes",
"nctId": "NCT06365528",
"orgStudyIdInfo": {
"id": "2023-0232",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "End of therapy or catheter removal free from complications"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hospital Moinhos de Vento"
},
{
"name": "Irmandade Santa Casa de Misericórdia de Porto Alegre"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hospital de Clinicas de Porto Alegre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Levodopa administration"
},
{
"name": "Placebo administration"
}
]
},
"conditionsModule": {
"conditions": [
"Hormonal Changes",
"Menstrual Cycle"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tübingen",
"contacts": [
{
"email": "[email protected]",
"name": "Andrea Heberle",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Department of Psychiatry & Psychotherapy, University of Tübingen",
"geoPoint": {
"lat": 48.52266,
"lon": 9.05222
},
"state": "BW",
"status": null,
"zip": "72076"
}
]
},
"descriptionModule": {
"briefSummary": "Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, we aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, we are testing the effects of hormonal status on metabolic indices and its effects on mood fluctuations in a period of a month.The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. We have exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explore if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The investigators will assess the effects of Levodopa administration on reward-learning using a double-blind randomized cross-over design. In a within-subject design, participants will get both conditions (Levodopa/placebo) at different time points (a few days apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional MR imaging) during effort-based decision making task.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Neither participants nor investigators will know at which time point the participant will receive Levodopa and placebo tablets. The tablets will be prepared by independent members of the university hospital.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dopamine, Reward Learning and Sex Hormones",
"nctId": "NCT06365515",
"orgStudyIdInfo": {
"id": "TUE010_IRTG_P5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making"
},
{
"measure": "Reward-related brain responses in the reward network during effort-based decision-making"
},
{
"measure": "Reward anticipation on a neural level"
},
{
"measure": "Execution of effort on a neural level"
}
],
"secondaryOutcomes": [
{
"measure": "Resting-state functional connectivity"
},
{
"measure": "Changes in reinforcement learning"
},
{
"measure": "Menstrual cycle induced changes in mood and food cravings"
},
{
"measure": "Changes in resting energy expenditure"
},
{
"measure": "Changes in metabolic hormone levels during the menstrual cycle"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "German Research Foundation"
},
{
"name": "Uppsala University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Tuebingen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Drug-coated balloon"
},
{
"name": "Guideline-directed medical treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Coronary Syndrome (ACS)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijin",
"contacts": [
{
"email": null,
"name": "Guangyao zhai",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Guangyao zhai",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Affiliated Beijing Luhe Hospital of Capital Medical University",
"geoPoint": null,
"state": "Beijing",
"status": null,
"zip": "101149"
},
{
"city": "Zunyi",
"contacts": null,
"country": "China",
"facility": "Affiliated Hospital of Zunyi Medical University",
"geoPoint": {
"lat": 27.68667,
"lon": 106.90722
},
"state": "Guizhou",
"status": null,
"zip": "563000"
},
{
"city": "Daqing",
"contacts": null,
"country": "China",
"facility": "Daqing Oilfield General Hospital",
"geoPoint": {
"lat": 46.58333,
"lon": 125
},
"state": "Heilongjiang",
"status": null,
"zip": "150000"
},
{
"city": "Harbin",
"contacts": [
{
"email": null,
"name": "Haibo Jia, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bo Yu, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Haibo Jia, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Harbin Medical University",
"geoPoint": {
"lat": 45.75,
"lon": 126.65
},
"state": "Heilongjiang",
"status": null,
"zip": "150000"
},
{
"city": "Jiamusi",
"contacts": [
{
"email": null,
"name": "Guangyuan Yang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Guangyuan Yang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Jiamusi University",
"geoPoint": {
"lat": 46.79927,
"lon": 130.31633
},
"state": "Heilongjiang",
"status": null,
"zip": "150000"
},
{
"city": "Mudanjiang",
"contacts": [
{
"email": null,
"name": "Kai Liu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kai Liu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Mudanjiang Cardiovascular Hospital",
"geoPoint": {
"lat": 44.58333,
"lon": 129.6
},
"state": "Heilongjiang",
"status": null,
"zip": "150000"
},
{
"city": "Zhengzhou",
"contacts": null,
"country": "China",
"facility": "Fuwai Central China Cardiovascular Hospital",
"geoPoint": {
"lat": 34.75778,
"lon": 113.64861
},
"state": "Henan",
"status": null,
"zip": "450000"
},
{
"city": "Zhengzhou",
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{
"email": null,
"name": "Chunguang Qiu",
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"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chunguang Qiu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Zhengzhou University",
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"lat": 34.75778,
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},
"state": "Henan",
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"zip": "450000"
},
{
"city": "Wuhan",
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"country": "China",
"facility": "Tongji Hospital Tongji Medical College of HUST",
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"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430022"
},
{
"city": "Changchun",
"contacts": [
{
"email": null,
"name": "Bin Liu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bin Liu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Third Second Hospital of Jilin University",
"geoPoint": {
"lat": 43.88,
"lon": 125.32278
},
"state": "Jilin",
"status": null,
"zip": "132000"
},
{
"city": "Dalian",
"contacts": [
{
"email": null,
"name": "Xiaoqun Zheng",
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"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Xiaoqun Zheng",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Dalian Municipal Central Hospital",
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"lat": 38.91222,
"lon": 121.60222
},
"state": "Liaoning",
"status": null,
"zip": "116000"
},
{
"city": "Dalian",
"contacts": [
{
"email": null,
"name": "Bo Zhang",
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"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bo Zhang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Dalian Medical University",
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"lat": 38.91222,
"lon": 121.60222
},
"state": "Liaoning",
"status": null,
"zip": "116000"
},
{
"city": "Shengyang",
"contacts": null,
"country": "China",
"facility": "The People's Hospital of Liaoning Province",
"geoPoint": null,
"state": "Liaoning",
"status": null,
"zip": "132000"
},
{
"city": "Hohhot",
"contacts": [
{
"email": null,
"name": "Fengying Chen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Fengying Chen",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Affiliated Hospital of Neimenggu Medical University",
"geoPoint": {
"lat": 40.81056,
"lon": 111.65222
},
"state": "Neimenggu",
"status": null,
"zip": "011500"
},
{
"city": "Jinan",
"contacts": [
{
"email": null,
"name": "Haitao Yuan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Haitao Yuan",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Shandong Provincial Hospital",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong",
"status": null,
"zip": "250000"
},
{
"city": "Jining",
"contacts": [
{
"email": null,
"name": "Lijun Gan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lijun Gan",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Affiliated Hospital of Jining Medical University",
"geoPoint": {
"lat": 35.405,
"lon": 116.58139
},
"state": "Shandong",
"status": null,
"zip": "250000"
},
{
"city": "Qingdao",
"contacts": [
{
"email": null,
"name": "Peng Li",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Peng Li",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Affiliated Hospital of Qingdao University",
"geoPoint": {
"lat": 36.06488,
"lon": 120.38042
},
"state": "Shandong",
"status": null,
"zip": "250000"
},
{
"city": "Yantai",
"contacts": [
{
"email": null,
"name": "Lin Zhong",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lin Zhong",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Yantai Yuhuangding Hospital",
"geoPoint": {
"lat": 37.47649,
"lon": 121.44081
},
"state": "Shandong",
"status": null,
"zip": "250000"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1860,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)",
"nctId": "NCT06365502",
"orgStudyIdInfo": {
"id": "KY2023-156",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Target lesion failure (TLF)"
}
],
"secondaryOutcomes": [
{
"measure": "Target lesion failure (TLF)"
},
{
"measure": "Target lesion failure (TLF)"
},
{
"measure": "Target lesion failure (TLF)"
},
{
"measure": "Major cardiac adverse event (MACE)"
},
{
"measure": "Major cardiac adverse event (MACE)"
},
{
"measure": "Major cardiac adverse event (MACE)"
},
{
"measure": "Major cardiac adverse event (MACE)"
},
{
"measure": "All-cause death"
},
{
"measure": "All-cause death"
},
{
"measure": "All-cause death"
},
{
"measure": "All-cause death"
},
{
"measure": "Cardiac death and target lesion MI"
},
{
"measure": "Cardiac death and target lesion MI"
},
{
"measure": "Cardiac death and target lesion MI"
},
{
"measure": "Cardiac death and target lesion MI"
},
{
"measure": "Cardiac death"
},
{
"measure": "Cardiac death"
},
{
"measure": "Cardiac death"
},
{
"measure": "Cardiac death"
},
{
"measure": "Target lesion myocardial infarction"
},
{
"measure": "Target lesion myocardial infarction"
},
{
"measure": "Target lesion myocardial infarction"
},
{
"measure": "Target lesion myocardial infarction"
},
{
"measure": "Periprocedural myocardial infarction"
},
{
"measure": "Periprocedural myocardial infarction"
},
{
"measure": "Periprocedural myocardial infarction"
},
{
"measure": "Periprocedural myocardial infarction"
},
{
"measure": "Periprocedural and non-periprocedural myocardial infarction"
},
{
"measure": "Periprocedural and non-periprocedural myocardial infarction"
},
{
"measure": "Periprocedural and non-periprocedural myocardial infarction"
},
{
"measure": "Periprocedural and non-periprocedural myocardial infarction"
},
{
"measure": "Target vessel failure (TVF)"
},
{
"measure": "Target vessel failure (TVF)"
},
{
"measure": "Target vessel failure (TVF)"
},
{
"measure": "Target vessel failure (TVF)"
},
{
"measure": "Minimal lumen area after DCB treatment"
},
{
"measure": "Plaque burden after DCB treatment"
},
{
"measure": "FCT after DCB treatment"
},
{
"measure": "Lipid arc after DCB treatment"
},
{
"measure": "FCT <75 μm after DCB treatment"
},
{
"measure": "PB >65% after DCB treatment"
},
{
"measure": "PB >70% after DCB treatment"
},
{
"measure": "MLA <3.5 mm^2 after DCB treatment"
},
{
"measure": "Maximal lipid arc >180° after DCB treatment"
},
{
"measure": "Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai Shenqi Medical Technology Co., Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Harbin Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Vascular Access Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gorgan",
"contacts": null,
"country": "Iran, Islamic Republic of",
"facility": "Pezhman Kharazm, MD",
"geoPoint": {
"lat": 36.8427,
"lon": 54.44391
},
"state": "Golestan",
"status": null,
"zip": "4917956808"
}
]
},
"descriptionModule": {
"briefSummary": "Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 78,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery",
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"id": "113293",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Early post operative WBI changes following AVF implantation"
},
{
"measure": "Two-week post operative WBI changes following AVF implantation"
},
{
"measure": "Three-month post operative WBI changes following AVF implantation"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between WBI changes following AVF implantation with age"
},
{
"measure": "Correlation between WBI changes following AVF implantation with sex"
},
{
"measure": "Correlation between WBI changes following AVF implantation with co-morbidities"
},
{
"measure": "Correlation between WBI changes following AVF implantation with steal syndrome"
}
]
},
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"class": "OTHER",
"name": "Golestan University of Medical sciences"
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},
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},
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},
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"date": "2023-02-20"
},
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"startDateStruct": {
"date": "2022-12-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
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"interventions": [
{
"name": "focused extracorporeal shock wave therapy (ESWT)"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Spasticity, Muscle"
]
},
"contactsLocationsModule": {
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{
"city": "Taipei",
"contacts": [
{
"email": "[email protected]",
"name": "Shu-mei Yang, MD",
"phone": "886-2- 23123456",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shu-mei Yang, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"state": null,
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"zip": "100"
}
]
},
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"briefSummary": "Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity."
},
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]
},
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"nctId": "NCT06365476",
"orgStudyIdInfo": {
"id": "202309126RIND",
"link": null,
"type": null
},
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},
"outcomesModule": {
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"measure": "passive range of motion for the wrist and finger joints"
},
{
"measure": "hand grip strength"
},
{
"measure": "Visual Analogue Scale (VAS)"
},
{
"measure": "modified Ashworth scale (MAS)"
},
{
"measure": "modified Tardieu scale (MTS)"
}
],
"secondaryOutcomes": [
{
"measure": "Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)"
},
{
"measure": "Action Research Arm Test (ARAT)"
},
{
"measure": "Barthel index"
},
{
"measure": "Functional Independence Measure (FIM)"
},
{
"measure": "ultrasound assessment"
},
{
"measure": "Box and Block Test"
},
{
"measure": "Wolf Motor Function Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
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}
},
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},
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},
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"date": "2026-04-15"
},
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"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Telerehabilitation"
}
]
},
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"conditions": [
"Hemorrhagic Stroke",
"Ischemic Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ljubljana",
"contacts": [
{
"email": "[email protected]",
"name": "Urška Puh, PT, PhD",
"phone": "+386 1 4758152",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Slovenia",
"facility": "University Rehabilitation Institute, Republic of Slovenia",
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"lon": 14.50513
},
"state": null,
"status": "RECRUITING",
"zip": "1000"
}
]
},
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},
"designModule": {
"designInfo": {
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},
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},
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},
"phases": [
"NA"
],
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},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TeleHome",
"briefTitle": "Telerehabilitation to Improve Balance and Mobility in Patients After Stroke",
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"orgStudyIdInfo": {
"id": "URIS202401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "Satisfaction with the remote training"
}
],
"primaryOutcomes": [
{
"measure": "Change in balance"
},
{
"measure": "Change in limits of stability"
},
{
"measure": "Change in weight-bearing symmetry"
}
],
"secondaryOutcomes": [
{
"measure": "Change in mobility"
},
{
"measure": "Change in walking speed"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Rehabilitation Institute, Republic of Slovenia"
}
},
"statusModule": {
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"date": "2024-05-31"
},
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},
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"date": "2024-05-31"
},
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"startDateStruct": {
"date": "2024-04-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Educational Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Cancer",
"Breast Cancer",
"Health Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": null,
"country": "United States",
"facility": "Johns Hopkins University School of Nursing",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": null,
"zip": "21205"
}
]
},
"descriptionModule": {
"briefSummary": "The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OCEAP",
"briefTitle": "Breast and Cervical Cancer Education Program",
"nctId": "NCT06365450",
"orgStudyIdInfo": {
"id": "IRB00315481",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool."
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants recruited from each community partner"
},
{
"measure": "Number of participants who preferred virtual or in person sessions"
},
{
"measure": "Number of participants who were lost of follow up"
},
{
"measure": "Number of participants who needed help redeeming their gift codes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Older Women Embracing Life"
},
{
"name": "The John G. Bartlett Specialty Practice"
}
],
"leadSponsor": {
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"name": "Johns Hopkins University"
}
},
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},
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"date": "2024-04-15"
},
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"primaryCompletionDateStruct": {
"date": "2024-02-28"
},
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"startDateStruct": {
"date": "2022-09-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TCD601"
},
{
"name": "Tacrolimus (TAC)"
},
{
"name": "Corticosteroids (CS)"
},
{
"name": "Mycophenolate Mofetil (MMF)"
},
{
"name": "ATG"
}
]
},
"conditionsModule": {
"conditions": [
"Kidney Transplantation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Innsbruck",
"contacts": [
{
"email": null,
"name": "Research Coordinator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Austria",
"facility": "Innsbruck Medical University",
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"lat": 47.26266,
"lon": 11.39454
},
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"status": "RECRUITING",
"zip": "A-6020"
},
{
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"email": null,
"name": "Research Coordinator",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Austria",
"facility": "University of Vienna",
"geoPoint": {
"lat": 48.20849,
"lon": 16.37208
},
"state": null,
"status": "RECRUITING",
"zip": "1090"
},
{
"city": "Barcelona",
"contacts": [
{
"email": null,
"name": "Research Coordinator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Clinic de Barcelona",
"geoPoint": {
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"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08036"
},
{
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{
"email": null,
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"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Universitari de Bellvitge",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08907"
},
{
"city": "Stockholm",
"contacts": [
{
"email": null,
"name": "Research Coordinator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Karolinska University Hospital",
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"lon": 18.0649
},
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"zip": "14157"
},
{
"city": "Göteborg",
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{
"email": null,
"name": "Research Coordinator",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Sahlgrenska University Hospital",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "RECRUITING",
"zip": "41345"
},
{
"city": "Malmö",
"contacts": [
{
"email": null,
"name": "Research Coordinator",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Skåne University Hospital",
"geoPoint": {
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"lon": 13.00073
},
"state": null,
"status": "RECRUITING",
"zip": "20502"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation",
"nctId": "NCT06365437",
"orgStudyIdInfo": {
"id": "TCD601B101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Number of participants with treatment-related adverse events as assessed by CTCAE v5.0."
},
{
"measure": "Measure Peak Plasma Concentration (Cmax) over time."
},
{
"measure": "Measure the Area under the plasma concentration versus time curve (AUC)."
}
],
"secondaryOutcomes": [
{
"measure": "Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time."
},
{
"measure": "Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time."
},
{
"measure": "Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "ITB-Med LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
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},
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"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fenofibrate"
},
{
"name": "UDCA"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Biliary Cholangitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xi'an",
"contacts": [
{
"email": null,
"name": "Ying Han",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xijing Hospital",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)"
},
"designModule": {
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"interventionModelDescription": null,
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"whoMasked": null
},
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
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"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)",
"nctId": "NCT06365424",
"orgStudyIdInfo": {
"id": "KY20151230-5-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment emergent adverse events (TEAEs)"
},
{
"measure": "Percentage of patients with biochemical response"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xijing Hospital of Digestive Diseases"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biomarker discovery and validation - with focus on genomic biomarkers"
}
]
},
"conditionsModule": {
"conditions": [
"Transplant Complication",
"Kidney Transplant Rejection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GEM-KiT",
"briefTitle": "GEnomic Medicine in Kidney Transplantation Study",
"nctId": "NCT06365411",
"orgStudyIdInfo": {
"id": "GEM-KiT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Death censored graft loss (DCGL)"
},
{
"measure": "Biopsy proven rejection (BPAR)"
}
],
"secondaryOutcomes": [
{
"measure": "All cause graft loss"
},
{
"measure": "Death"
},
{
"measure": "Treatment resistant rejection"
},
{
"measure": "Hospital admission or emergency attendance"
},
{
"measure": "Delayed Graft Function (DGF)"
},
{
"measure": "Kidney function"
},
{
"measure": "Albuminuria"
},
{
"measure": "Surrogate end-point markers"
},
{
"measure": "Borderline rejeciton"
},
{
"measure": "chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores"
},
{
"measure": "Recurrent disease"
},
{
"measure": "BK virus complications"
},
{
"measure": "Major cardiovascular complications"
},
{
"measure": "Major infectious complications"
},
{
"measure": "Malignancy post transplantation"
},
{
"measure": "Kidney biopsy transcriptomic signature"
},
{
"measure": "Kidney cell type composition"
},
{
"measure": "Proteinomic signature"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Western Sydney Local Health District"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2035-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Heparin"
},
{
"name": "Heparin Sodium Injection"
},
{
"name": "No heparinization"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Angiography",
"Heparinization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Xuanwu Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Xuanwu Hospital, Capital Medical University.",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": null,
"zip": "100053"
}
]
},
"descriptionModule": {
"briefSummary": "Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ACTUAL"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SELECT",
"briefTitle": "Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy",
"nctId": "NCT06365398",
"orgStudyIdInfo": {
"id": "SELECT",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Xuanwu Hospital, Capital Medical University",
"id": "XWHL-2018010",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "postoperative cerebral infarction"
}
],
"secondaryOutcomes": [
{
"measure": "Numerical Rating Scale (NRS) for back pain"
},
{
"measure": "the incidence of paralysis of surgical limb"
},
{
"measure": "the incidence of pain of surgical limb"
},
{
"measure": "the incidence of postoperative urethral catheterization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xuanwu Hospital, Beijing"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Carbohydrate-last meal pattern"
},
{
"name": "Carbohydrate-first meal pattern"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy",
"Nutrition, Healthy",
"Postprandial Hyperglycemia",
"Hunger",
"Craving"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Emerging evidence suggests that following a 'carbohydrate-last meal pattern', wherein foods rich in protein, fat, fiber, and/or polyphenols are consumed before sources of simple carbohydrate (CHO) in a meal, results in reduced postprandial glycaemic responses than the reverse food order or a co-ingestion pattern. This effect has been observed across the spectrum of glucose tolerance, from patients with diabetes to individuals with normal glucose tolerance (Kuwata et al., 2016; Nishino et al., 2018; Lu et al., 2019; Sun et al., 2020). Furthermore, reduced glucose excursions have been linked to decreased subsequent hunger and energy intake (Lu et al., 2019; Wyatt et al., 2021).However, to date, no studies on food intake sequence have targeted athletes, despite their increased CHO demands (Thomas et al., 2016) which could expose them to repeated episodes of hyperglycaemia and high glycaemic variability, known to increase the risk of adverse cardiovascular outcomes and all-cause mortality (Loader et al., 2015; Cavero-Redondo et al., 2017; Faerch et al., 2018). Additionally, athletes often face pressure to meet body composition standards and may benefit from strategies that enhance satiety and craving control. Finally, there is reason to believe that better glycaemic control could lead to improved performance, given that enhancements in endurance activities have been observed with a low-glycemic-index diet compared to a high-glycemic-index diet (Heung-Sang Wong et al., 2017).Therefore, this randomised crossover trial is part of a wider project which seeks to explore the impact of food intake sequence on metabolic health and performance in athletes. Specifically, this trial aims to investigate the acute, postprandial metabolic and appetite responses to consuming an identical meal in two intake sequences (CHO-last versus CHO-first) in athletes, while in the resting state."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This study is a randomised controlled trial with a counterbalanced crossover design. Block randomisation will be performed by an external researcher, and allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "This is a non-blind trial, since both participants and the investigator delivering the test-meal will be able to see the ingredients and the order in which they are consumed. However, outcome assessors will be blinded to the intervention sequence.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes",
"nctId": "NCT06365385",
"orgStudyIdInfo": {
"id": "FOODSEQ-MARS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postprandial blood glucose concentrations"
}
],
"secondaryOutcomes": [
{
"measure": "Postprandial subjective appetite ratings"
},
{
"measure": "Prospective ad libitum energy intake"
},
{
"measure": "Prospective ad libitum nutritional intake"
},
{
"measure": "Postprandial serum insulin concentrations"
},
{
"measure": "Postprandial plasma total GLP-1 concentrations"
},
{
"measure": "Postprandial plasma total GIP concentrations"
},
{
"measure": "Postprandial serum total ghrelin concentrations"
},
{
"measure": "Postprandial plasma total PYY concentrations"
},
{
"measure": "Postprandial serum triglyceride concentrations"
},
{
"measure": "Postprandial serum NEFA concentrations"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Federação Portuguesa de Futebol"
},
{
"name": "Fundação para a Ciência e a Tecnologia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universidade do Porto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Western blot"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jinan",
"contacts": [
{
"email": "[email protected]",
"name": "Panpan Hao, MD, PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hongyu Zhong, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "Qilu Hospital of Shandong University",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong",
"status": "RECRUITING",
"zip": "250012"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Circulating MrgD in Pulmonary Hypertension",
"nctId": "NCT06365372",
"orgStudyIdInfo": {
"id": "MrgD and PAH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Circulating MrgD level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qilu Hospital of Shandong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-15"
}
}
} | false | null |
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