protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ONC-841"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sacramento",
"contacts": [
{
"email": null,
"name": "Tianhong Li, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of California at Davis Cancer Center",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California",
"status": null,
"zip": "95817"
},
{
"city": "Louisville",
"contacts": [
{
"email": null,
"name": "John Hamm, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Norton Cancer Center",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky",
"status": null,
"zip": "40202"
},
{
"city": "Houston",
"contacts": [
{
"email": null,
"name": "John Knecht, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Tranquil Clinical Research",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77598"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors",
"nctId": "NCT06352359",
"orgStudyIdInfo": {
"id": "ONC-841-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose Limiting Toxicity (DLT)"
},
{
"measure": "Maximum Toxicity Dose (MTD)"
}
],
"secondaryOutcomes": [
{
"measure": "Cmax of ONC-841"
},
{
"measure": "The serum half-life of ONC-841"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "OncoC4, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Compensatory brain game supporting Goal Management Training intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Acquired Brain Injury",
"Depressive Symptoms",
"Anxiety",
"Executive Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wolfheze",
"contacts": [
{
"email": "[email protected]",
"name": "Bea Tiemens, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Floor Poerschke, MSc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Emily Vink, MSc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "ProPersona",
"geoPoint": {
"lat": 52.00333,
"lon": 5.79028
},
"state": "Gelderland",
"status": null,
"zip": "6874 BE Wolfheze"
}
]
},
"descriptionModule": {
"briefSummary": "The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "A randomized Single-case Experimental Design (SCED) with a follow-up period of 6 weeks. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure.Phase A acts as a control and is therefore compared with phase B.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria. Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population",
"nctId": "NCT06352346",
"orgStudyIdInfo": {
"id": "Plan Game_ABI&Psychiatry",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B"
}
],
"secondaryOutcomes": [
{
"measure": "Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up"
},
{
"measure": "Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)"
},
{
"measure": "Change in performance on two trained IADL task (treatment goals)"
},
{
"measure": "Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)"
},
{
"measure": "Change in strategy use during the performance of trained and untrained IADL tasks"
},
{
"measure": "Change in subjective experience of strategy use in daily life"
},
{
"measure": "Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "ProPersona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "supraclavicular ultrasound guided brachial plexus block"
}
]
},
"conditionsModule": {
"conditions": [
"Supraclavicular Brachial Plexus Block"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sohag",
"contacts": [
{
"email": null,
"name": "Magdy M Amin, professor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Sohag university Hospital",
"geoPoint": {
"lat": 26.55695,
"lon": 31.69478
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of \"looking\" across the first rib, with the apex of the lung visualized close to thePlexus .A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Inclusion criteria:* 18to60 yearsold* ASA grade I to II* Elective upper limb surgery",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Parasagittal Vs Cornerpocket Approaches",
"nctId": "NCT06352333",
"orgStudyIdInfo": {
"id": "Parasagittal Vs Cornerpocket",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Success rate"
},
{
"measure": "Complications"
}
],
"primaryOutcomes": [
{
"measure": "Needle visibility in both approaches"
}
],
"secondaryOutcomes": [
{
"measure": "Duration of sensory and motor block"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sohag University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagnosis of HCM"
},
{
"name": "Diagnosis of DCM"
},
{
"name": "Diagnosis of ARVC"
},
{
"name": "Diagnosis of NDLVC"
},
{
"name": "Diagnosis of RCM"
},
{
"name": "Diagnosis of LVNC"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiomyopathies"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xi'an",
"contacts": null,
"country": "China",
"facility": "First Affiliated Hospital of Xi'an Jiantong University",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi",
"status": null,
"zip": "710061"
}
]
},
"descriptionModule": {
"briefSummary": "This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH）",
"nctId": "NCT06352320",
"orgStudyIdInfo": {
"id": "XJTU1AF2023LSK-533",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in the incidence of mortality rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital Xi'an Jiaotong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-12-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagnosis of ACM"
}
]
},
"conditionsModule": {
"conditions": [
"Arrhythmogenic Cardiomyopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xi'an",
"contacts": [
{
"email": "[email protected]",
"name": "Guoliang Li",
"phone": "008613759982523",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yang Yan",
"phone": "+86.29.85323869",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "First Affiliated Hospital of Xi'an Jiantong University",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi",
"status": null,
"zip": "710061"
}
]
},
"descriptionModule": {
"briefSummary": "This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STARTER",
"briefTitle": "Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy",
"nctId": "NCT06352307",
"orgStudyIdInfo": {
"id": "XJTU1AF2023LSK-532",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in the incidence of mortality rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital Xi'an Jiaotong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-12-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Core stability training"
},
{
"name": "Core stability training and myofascial relase"
}
]
},
"conditionsModule": {
"conditions": [
"Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Merkez",
"contacts": [
{
"email": "[email protected]",
"name": "Muhammed Samed Dalakçı",
"phone": "905445325572",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Kırşehir Ahi Evran Üniversitesi",
"geoPoint": null,
"state": "Kırşehir",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Chronic neck pain is a musculoskeletal disorder that affects people frequently in life. Nov.Postural control is based on the process of correctly identifying and selectively focusing the incoming afferent input of the Central Nervous System (CNS).The main treatment options for people with neck pain include soft tissue and joint mobilizations, stabilization exercises for the neck, trunk and shoulder muscles, cervical Deckings, relaxation training, strengthening exercises and body awareness and posture training Nov.In this study, it was aimed to investigate the effects of myofascial relaxation on balance, pain, joint range of motion and functionality in individuals with chronic neck pain by dividing them into two groups in the form of core stabilization and core stabilization and myofascial relaxation.The study included 45 people between the ages of 18 and 65 Dec. In two groups, the core stabilization group will be 22 people, and the core stabilization and myofascial relaxation group will be 23 people. The study period is planned as 6 weeks and 3 sessions per week."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Myofascial Relaxation Technique Applied Together With Core Stabilization Trainings on Balance, Pain, Joint Range of Motion and Functionality in Individuals With Chronic Neck Pain",
"nctId": "NCT06352294",
"orgStudyIdInfo": {
"id": "MSDALAKCI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain severity"
},
{
"measure": "Pressure pain threshold (PPT)"
}
],
"secondaryOutcomes": [
{
"measure": "Balance"
},
{
"measure": "Range of motion"
},
{
"measure": "Neck Disability İndex"
},
{
"measure": "DASH"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kirsehir Ahi Evran Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CAR-T cells"
}
]
},
"conditionsModule": {
"conditions": [
"ITP - Immune Thrombocytopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kunming",
"contacts": [
{
"email": "[email protected]",
"name": "Wang Sanbin, Doctor",
"phone": "13187424131",
"phoneExt": "+86",
"role": "CONTACT"
}
],
"country": "China",
"facility": "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China",
"geoPoint": {
"lat": 25.03889,
"lon": 102.71833
},
"state": "Yunnan",
"status": "RECRUITING",
"zip": "650000"
}
]
},
"descriptionModule": {
"briefSummary": "It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of CAR-T Cells Therepy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)",
"nctId": "NCT06352281",
"orgStudyIdInfo": {
"id": "KM-007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Portion of patients with response (R)"
}
],
"secondaryOutcomes": [
{
"measure": "Portion of patients with complete response (CR)"
},
{
"measure": "Portion of patients with relapse"
},
{
"measure": "Time (in days) from treatment start to response (R)"
},
{
"measure": "Time (in days) from treatment to complete response (CR)"
},
{
"measure": "Duration (in days) of response (R)"
},
{
"measure": "Incidence of adverse events(AE) after infusion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pallidal, subthalamic or thalamic lesioning"
}
]
},
"conditionsModule": {
"conditions": [
"Dystonia",
"Parkinson Disease",
"Essential Tremor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Delhi",
"contacts": [
{
"email": "[email protected]",
"name": "Arunmozhimaran Elavarasi, MD DM",
"phone": "+919013844274",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "India",
"facility": "All India Institute of Medical Sciences, New Delhi",
"geoPoint": {
"lat": 28.63576,
"lon": 77.22445
},
"state": "Delhi",
"status": null,
"zip": "110029"
}
]
},
"descriptionModule": {
"briefSummary": "Dystonia is a rare syndrome with varying etiologies. Similarly, tremor conditions refractory to medical management and disabling that they need surgical interventions are rare in our setting. So far there are no randomized controlled trials of pallidotomy for management of dystonia. There is scant literature on the long term efficacy and safety of Pallidotomy, thalamotomy and other such lesioning procedures in the management of movement disorders. The current literature is significantly plagued by publication bias as case reports with successful outcomes are likely to be selectively published in journals or conference abstracts. Lesioning procedures though seem to be effective are often considered to be risky, especially bilateral pallidotomy is not preferred by several centres. However, our center routinely performs simultaneous bilateral pallidotomy. To generate long term data on the efficacy and safety of lesioning procedures in rare diseases like dystonias especially the effect of functional neurosurgery on varying etiologies of the disease, robust registries are required which collect data on all consecutive patients who undergo the procedure."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Lesioning Procedures for Movement Disorders",
"nctId": "NCT06352268",
"orgStudyIdInfo": {
"id": "IEC-368/17.07.2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Long term functional outcomes"
},
{
"measure": "Long term functional outcomes"
}
],
"secondaryOutcomes": [
{
"measure": "Predictors of outcomes"
},
{
"measure": "Demography"
},
{
"measure": "Clinical features"
},
{
"measure": "Laboratory findings"
},
{
"measure": "Imaging features"
},
{
"measure": "Treatment trends"
},
{
"measure": "Clinical features"
},
{
"measure": "Treatment trends"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "All India Institute of Medical Sciences, New Delhi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital block"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia, Local",
"Pain",
"Anxiety"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.Result: after the completion of the study CONCLUSIONS: After the completion of the study"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pain and Anxiety During Local Block",
"nctId": "NCT06352255",
"orgStudyIdInfo": {
"id": "AR1937",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Grade of Pain postinyection"
}
],
"secondaryOutcomes": [
{
"measure": "Anxiety before the intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Seville"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients"
},
{
"name": "Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers"
}
]
},
"conditionsModule": {
"conditions": [
"Diffuse Large B Cell Lymphoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic \"signature\" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 85,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARTROG",
"briefTitle": "Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?",
"nctId": "NCT06352242",
"orgStudyIdInfo": {
"id": "RECHMPL24-0076 UF 9572",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of a phenotypic \"signature\" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma."
}
],
"secondaryOutcomes": [
{
"measure": "Identification of a phenotypic \"signature\" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events"
},
{
"measure": "Identification of a phenotypic \"signature\" of trogocytosis predictive of the occurrence of serious hematological side effects."
},
{
"measure": "Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Montpellier"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Playful Learning in Infancy Program"
},
{
"name": "Postnatal care as usual"
}
]
},
"conditionsModule": {
"conditions": [
"Parent-Child Relations",
"Infant Development"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Mette S. Væver, PhD",
"phone": "+45 35324906",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maja Nyström-Hansen, PhD",
"phone": "+4535336499",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": "RECRUITING",
"zip": "1353"
}
]
},
"descriptionModule": {
"briefSummary": "In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2327,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PLIP",
"briefTitle": "The Playful Learning in Infancy Program",
"nctId": "NCT06352229",
"orgStudyIdInfo": {
"id": "514-0335/23-2000",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parental Playful interactions"
}
],
"secondaryOutcomes": [
{
"measure": "Parental Stress"
},
{
"measure": "Infant Socio-emotional Development"
},
{
"measure": "Infant Level of Play"
},
{
"measure": "Parental Mind-Mindedness"
},
{
"measure": "Parental Attachment Style"
},
{
"measure": "Parental Mental Well-Being"
},
{
"measure": "Infant Screen Time"
},
{
"measure": "Questions developed for the study regarding Parental Involvement"
},
{
"measure": "Questions developed for the study regarding Parental Knowledge of Play"
},
{
"measure": "Parental Experience of the PLIP"
},
{
"measure": "Health Visitors' Experience of the PLIP"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "LEGO Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Copenhagen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS)"
}
]
},
"conditionsModule": {
"conditions": [
"Haemophilia A",
"Synovitis",
"Hemophilia Arthropathy",
"Sonography"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bonn",
"contacts": [
{
"email": "[email protected]",
"name": "Andreas C. Strauss, PD Dr. med.",
"phone": "004922828714176",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andreas C. Strauss, PD Dr. med.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University Hospital Bonn",
"geoPoint": {
"lat": 50.73438,
"lon": 7.09549
},
"state": "NRW",
"status": "RECRUITING",
"zip": "53113"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SynoPrev",
"briefTitle": "Prevalence of Synovitis in Patients With Haemophilia A",
"nctId": "NCT06352216",
"orgStudyIdInfo": {
"id": "Elo-Ger-2023-1642",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Baseline Characteristics"
}
],
"primaryOutcomes": [
{
"measure": "Haemophilia early arthropathy detection with ultrasound (HEAD-US)"
}
],
"secondaryOutcomes": [
{
"measure": "The Hemophilia Joint Health Score version 2.1 (HJHS)"
},
{
"measure": "PROMIS-29 Questionaire"
},
{
"measure": "Haemophilia Activities List (HAL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Swedish Orphan Biovitrum"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Bonn"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Probiotic"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Neurodevelopmental Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.The duration of the study will be of 6 months approximately, including 6 months of product intake.Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group."
},
"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": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "7 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients",
"nctId": "NCT06352203",
"orgStudyIdInfo": {
"id": "AUT/23.02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of children with intestinal dysbiosis after 6 months of treatment."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "ProbiSearch SL"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "[14C] SY-5007"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Ruihua Dong, MD",
"phone": "86-010-63139033",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Friendship Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": null,
"zip": "100050"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
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"ADULT"
]
},
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"acronym": null,
"briefTitle": "A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China",
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"id": "SY-5007-I-04",
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"measure": "Total radioactivity in plasma PK: Cmax"
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{
"measure": "Total radioactivity in plasma PK: Tmax"
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"measure": "Total radioactivity in plasma PK: AUC0-t"
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"measure": "Total radioactivity in plasma PK: t½"
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{
"measure": "Total radioactivity in plasma PK: CL/F"
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{
"measure": "Whole blood to plasma total radioactivity ratio"
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{
"measure": "Cumulative total radioactivity in urine and faeces"
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{
"measure": "Metabolic profiling in plasma, urinary and fecal excretion"
}
],
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{
"measure": "Cmax of SY-5007 and its metabolites"
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"measure": "Tmax of SY-5007 and its metabolites"
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"measure": "AUC0-t of SY-5007 and its metabolites"
},
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"measure": "t½ of SY-5007 and its metabolites"
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"measure": "CL/F of SY-5007 and its metabolites"
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"measure": "Incidence of adverse events"
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"measure": "Clinically significant liver fat loss"
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"measure": "Sustained clinically significant body weight loss"
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"measure": "Sustained clinically significant body weight loss"
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"measure": "Liver fat and liver stiffness using imaging analysis"
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},
{
"measure": "Liver fat and liver stiffness using imaging analysis"
},
{
"measure": "Liver fat and liver stiffness using imaging analysis"
},
{
"measure": "Clinically meaningful improvement in liver fat and stiffness"
},
{
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},
{
"measure": "Clinically meaningful improvement in liver fat and stiffness"
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{
"measure": "Clinically meaningful improvement in liver fat and stiffness"
},
{
"measure": "Clinically meaningful improvement in liver fat and stiffness"
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{
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{
"measure": "Circulating biomarkers of hepatic injury"
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{
"measure": "Circulating biomarkers of hepatic injury"
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{
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"measure": "Circulating biomarkers of hepatic injury"
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{
"measure": "Circulating biomarkers of hepatic injury"
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"measure": "Circulating biomarkers of hepatic injury"
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{
"measure": "Circulating biomarkers of hepatic injury"
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{
"measure": "Circulating biomarkers of liver fibrosis and fibrogenesis"
},
{
"measure": "Circulating biomarkers of liver fibrosis and fibrogenesis"
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{
"measure": "Circulating biomarkers of liver fibrosis and fibrogenesis"
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{
"measure": "Circulating biomarkers of liver fibrosis and fibrogenesis"
},
{
"measure": "Circulating biomarkers of liver fibrosis and fibrogenesis"
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{
"measure": "Circulating biomarkers of liver fibrosis and fibrogenesis"
}
]
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}
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{
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},
{
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}
]
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]
},
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"email": null,
"name": "Aysenur Tuncer, PhD",
"phone": "+903422118080",
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},
{
"email": null,
"name": "Yasemin Kotevoglu, MSc",
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}
]
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]
},
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{
"measure": "Children's Sleep Habits Questionnaire"
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{
"measure": "The Health-Related Quality of Life Scale-KIDSCREEN-27"
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}
} | false | null |
{
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"interventions": [
{
"name": "Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration."
},
{
"name": "Active comparator: European Union licenced epoetin alfa"
}
]
},
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},
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"city": "Colonia Nicolich",
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"email": "[email protected]",
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}
],
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},
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]
},
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"measure": "Mean Absolute Change in Hemoglobin Levels"
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{
"measure": "Change in Mean Hb Level"
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"measure": "immunogenicity"
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},
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}
}
} | false | null |
{
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"interventions": [
{
"name": "TEG 6s Citrated K, KH, RTH, FFH Cartridge"
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{
"name": "Clauss Fibrinogen"
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},
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{
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{
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{
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{
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{
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]
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},
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},
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{
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{
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{
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{
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},
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"date": "2021-12-09"
},
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}
}
} | false | null |
{
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"interventions": [
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"name": "Pelvic Floor Muscle Training"
},
{
"name": "Hypopressive Exercises"
}
]
},
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]
},
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"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Research and Training Hospital",
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}
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},
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"briefSummary": "The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: \\[PFMT alone (n:15) and PFMT combined with HE(n:17)\\]. DuoBravo EMG device for evaluation of PFM activation and \"Pelvic Floor Distress Inventory-20\" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8."
},
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"stdAges": [
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},
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"link": null,
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"measure": "Pelvic Floor Muscle Activation"
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],
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"date": "2024-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dietary supplement with micronised diosmin, hesperidin and herbal extracts"
}
]
},
"conditionsModule": {
"conditions": [
"Cognitive Impairment",
"Old Age; Debility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Silvia Giovannini, MD, PhD",
"phone": "+390630154382",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Letizia Castelli, PhD",
"phone": "+390630154382",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario A. Gemelli IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": null,
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "In recent years, globally, there has been a growth in both the size and the proportion of older adults in the world population. The World Health Organization (WHO) has estimated that by 2030, 1 in 6 people will be 60 years of age or older, and that by 2050, the population of older adults will reach 2.1 billion. The population of older adults (over 80 years) will triple to 426 million by 2050. In particular, Italy represents the second country with the oldest population in the world.Age-related evolution is a gradual and continuous process involving a series of physical and cognitive changes, which, however, has no real 'onset' age. In fact, rather than chronological age, the concept of 'elderly' is based on the individual's degree of self-sufficiency and independence. From a biological point of view, ageing is the set of changes at the molecular and cellular level that occur over time and lead to multi-system functional impairment. It is a process directly related to frailty, falls, and disability.An important factor in counteracting frailty is nutritional intake. Humans ingest approximately 500 g of chemical compounds daily through their diet, most of which are components of plants or vegetables in general. In addition to the well-known macronutrients (proteins, fats, and carbohydrates) and micronutrients (minerals and vitamins), the plant world provides other elements, such as phenols, terpenes, terpenoids, alkaloids, purines, pyrimidines, nucleic acids, and steroids, that exert powerful biological activities. These components are generically called phytochemicals. Epidemiological studies have established that diets rich in plant-based foods help prevent many diseases, such as cardiovascular, metabolic, neurovegetative, and inflammatory diseases.Phytochemical compounds are an extremely diverse set of elements that, when taken at significant levels, have a protective effect on human health. These substances exert various biological functions, such as antioxidant activity, modulation of detoxifying enzymes, stimulation of the immune system, reduction of platelet aggregation, modulation of hormone metabolism, reduction of blood pressure, and antibacterial and antiviral activity.Among the phytochemical compounds, flavonoids represent a category of polyfunctional substances with high bioactivity, comprising more than 5000 compounds. They possess biochemical properties of functional interest in the nutritional and therapeutic fields; for example, rutin, diosmin, and hesperidin are present in some pharmaceutical specialties; flavonoids from ginkgo biloba, hawthorn, and red vine are the main components of many phytotherapeutic extracts. Flavonoids have been shown to play an important role in cardioprotection. Furthermore, in neuroprotection, anthocyanin-rich fruits play a protective role against age-related decline in cognitive functions.However, few studies have evaluated the effect of hesperidin and proanthocyanidins on motor, cognitive, and functional aspects in the elderly.Altemor® is a food supplement based on micronized diosmin, hesperidin, and herbal extracts that has an important integrative supporting action in optimising blood microcirculation.The aim of the study is to evaluate the contribution of dietary supplementation with Altemor® on cognitive function, balance, fatigue, and some domains of quality of life in elderly subjects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESPINS",
"briefTitle": "Dietary Supplementation and Cognitive Functions in the Elderly",
"nctId": "NCT06352099",
"orgStudyIdInfo": {
"id": "6315",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Trial Making Test (TMT)"
}
],
"secondaryOutcomes": [
{
"measure": "Short Physical Performance Battery (SPPB)"
},
{
"measure": "HandGrip Strenght Test (HGST)"
},
{
"measure": "Silver Index (SI)"
},
{
"measure": "Mental Deterioration battery (MDB)"
},
{
"measure": "Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "EuroQol- 5 Dimension (EQ-5D)"
},
{
"measure": "Modified Fatigue Impact Scale (MFIS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Vision Loss Partial",
"Vision; Loss, Both Eyes",
"Hemianopia, Homonymous",
"Hemianopia",
"Quadrantanopia",
"Stroke, Ischemic",
"Stroke - Occipital Infarction",
"Cortical Blindness",
"Occipital Lobe Infarct",
"Peripheral Visual Field Defect of Both Eyes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate how visual orientation discrimination and metacognition (i.e., perceptual confidence) are affected by occipital stroke that causes hemianopia and quadrantanopia in adults. This research will provide insight as to how the residual visual system, which not directly damaged by the occipital stroke, processes orientation (assayed in terms of orientation discrimination) and metacognition (by measuring perceptual confidence for orientation discrimination). These measures will be used to refine computational models that attempt to explain how the brain copes with loss of primary visual cortex (V1) as a result of stroke. This knowledge is essential to devise more effective visual rehabilitation therapies for patients suffering from occipital strokes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Understanding Visual Processing After Occipital Stroke",
"nctId": "NCT06352086",
"orgStudyIdInfo": {
"id": "STUDY00009227",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Orientation discrimination threshold"
},
{
"measure": "Perceptual Confidence in Orientation Discrimination"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Rochester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dupilumab"
}
]
},
"conditionsModule": {
"conditions": [
"Eosinophilic Esophagitis",
"EoE"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Julia Phillips",
"phone": "919-843-4453",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Hiwot Ekuban",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of North Carolina at Chapel Hill",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27599"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses.Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DESTRICT",
"briefTitle": "Dupilumab for Eosinophilic Esophagitis With Severe Strictures",
"nctId": "NCT06352073",
"orgStudyIdInfo": {
"id": "23-2625",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Regeneron",
"id": "R668-EE-2380",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Histologic Response to Dupilumab"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Minimum Esophageal Caliber"
},
{
"measure": "Decrease in Number of Dilations"
},
{
"measure": "Change in Endoscopic Severity"
},
{
"measure": "Change in Histologic Severity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Regeneron Pharmaceuticals"
},
{
"name": "Sanofi"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention or administration will be performed due to the observational nature of the study"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Overland Park",
"contacts": [
{
"email": null,
"name": "Donita Atkins",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Menorah Medical Center",
"geoPoint": {
"lat": 38.98223,
"lon": -94.67079
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66209"
},
{
"city": "Overland Park",
"contacts": [
{
"email": "[email protected]",
"name": "Donita Atkins",
"phone": "816-651-1969",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Naga Venkata K. Pothineni, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Kansas City Heart Rhythm Institute - Roe Clinic",
"geoPoint": {
"lat": 38.98223,
"lon": -94.67079
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66211"
},
{
"city": "Overland Park",
"contacts": [
{
"email": "[email protected]",
"name": "Donita Atkins",
"phone": "816-651-1969",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Naga Venkata K. Pothineni",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Overland Park Regional Medical Center",
"geoPoint": {
"lat": 38.98223,
"lon": -94.67079
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66215"
},
{
"city": "Independence",
"contacts": [
{
"email": null,
"name": "Donita Atkins",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Centerpoint Medical Center Clinic",
"geoPoint": {
"lat": 39.09112,
"lon": -94.41551
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "64057"
},
{
"city": "Independence",
"contacts": [
{
"email": null,
"name": "Donita Atkins",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Centerpoint Medical Center",
"geoPoint": {
"lat": 39.09112,
"lon": -94.41551
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "64057"
},
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "Donita Atkins",
"phone": "816-651-1969",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Naga Venkata K. Pothineni, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Research Medical Center Clinic",
"geoPoint": {
"lat": 39.09973,
"lon": -94.57857
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "64032"
},
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "Donita Atkins",
"phone": "816-651-1969",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Naga Venkata K. Pothineni, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Research Medical Center",
"geoPoint": {
"lat": 39.09973,
"lon": -94.57857
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "64032"
}
]
},
"descriptionModule": {
"briefSummary": "Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 2500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study",
"nctId": "NCT06352060",
"orgStudyIdInfo": {
"id": "KCHRRF_MONITOR AF_030",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "No.of patients with arrhythmia recurrence"
},
{
"measure": "No.of patients with redo ablation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kansas City Heart Rhythm Research Foundation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The effect of positioning on respiratory functions of preterm infants after extubation."
}
]
},
"conditionsModule": {
"conditions": [
"Premature Infants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trabzon",
"contacts": null,
"country": "Turkey",
"facility": "İlknur Kahriman",
"geoPoint": {
"lat": 41.005,
"lon": 39.72694
},
"state": null,
"status": null,
"zip": "61080"
},
{
"city": "Trabzon",
"contacts": null,
"country": "Turkey",
"facility": "Karadeniz Technical University Health Application and Research Center Farabi Hospital",
"geoPoint": {
"lat": 41.005,
"lon": 39.72694
},
"state": null,
"status": null,
"zip": "61080"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation.Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation.Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation.Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Simple randomization method was used in the sample of the study. In previous studies, there were no published data on the effect of supine and prone positioning after extubation on the pulmonary functions of premature infants. Therefore, the sample size was calculated using the G-power 3.1.3 program according to the SpO2 level and standard deviation values of 4 infants who were mechanically ventilated in the neonatal intensive care unit. The study was conducted with a total of 42 premature babies, two groups of 21 premature babies, each of whom had the characteristics of the research groups. Premature infants were divided into two groups, the supine position and the prone group, by randomization using a computer-based random number generator (www.randomizer.org).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "37 Weeks",
"minimumAge": "37 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions",
"nctId": "NCT06352047",
"orgStudyIdInfo": {
"id": "Karadeniz Tech. University",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Newborn Evaluation Form"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Karadeniz Technical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Empathy Training"
}
]
},
"conditionsModule": {
"conditions": [
"Empathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peking",
"contacts": null,
"country": "China",
"facility": "Peking University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100871"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the efficacy of empathy training for future psychological counselors in university students. The training contains 5 sessions of psychoeducation, three-role group exercises, and Q\\&A. Self-reported, listener-reported, and observer-reported measurements will be applied for empathy assessment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Empathy Training for Future Mental Health Practitioners in University Students",
"nctId": "NCT06352034",
"orgStudyIdInfo": {
"id": "Empathy Training for Students",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from counseling duration"
},
{
"measure": "Change from Baseline of 12-Item Version of the Barrett-Lennard Relationship Inventory"
},
{
"measure": "Change from consultation willingness question inquiry"
},
{
"measure": "Change from morphed emotion perception task"
},
{
"measure": "Change from Baseline of the Measure of Empathy Scale"
},
{
"measure": "Change from Baseline of the Emotion Perception Scale"
},
{
"measure": "Change from Baseline of the Peking Alexithymia Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline of the Patient Health Questionnaire"
},
{
"measure": "Change from Baseline of the Generalized Anxiety Disorder Scale"
},
{
"measure": "Change from Baseline of the Peking Irritability Scale"
},
{
"measure": "Change from Baseline of the the Fatigue Assessment Scale"
},
{
"measure": "Change from Baseline of the the Patient Health Questionnaire"
},
{
"measure": "Change from Baseline of the Cognitive-Emotion Regulation Questionnaire"
},
{
"measure": "Change from Baseline of the Difficulties in Emotion Regulation Scale"
},
{
"measure": "Change from Baseline of the the Satisfaction with Life Scale"
},
{
"measure": "Change from Baseline of the the Subjective Happiness Scale"
},
{
"measure": "Change from Baseline of the Connor-Davidson Resilience Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "kaleidoscope"
}
]
},
"conditionsModule": {
"conditions": [
"Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trabzon",
"contacts": null,
"country": "Turkey",
"facility": "Karadeniz Technical University Health Application and Research Center Farabi Hospital",
"geoPoint": {
"lat": 41.005,
"lon": 39.72694
},
"state": null,
"status": null,
"zip": "61080"
}
]
},
"descriptionModule": {
"briefSummary": "This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children",
"nctId": "NCT06352021",
"orgStudyIdInfo": {
"id": "KAHRİMAN İlknur",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Wong-Baker Pain Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "İlknur KAHRİMAN"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anlotinib"
}
]
},
"conditionsModule": {
"conditions": [
"Event-free Lifetime"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": [
{
"email": null,
"name": null,
"phone": "+008618526812877",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tianiin Medical University Cancer Institute & Hospital",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To explore the effectiveness of anrotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer",
"nctId": "NCT06352008",
"orgStudyIdInfo": {
"id": "Zhansheng Jiang",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "EFS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tianjin Medical University Cancer Institute and Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Combination of Neostigmine and Glycopyrrolate"
},
{
"name": "I-Box by Dynatronics"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injuries",
"Constipation",
"Fecal Incontinence",
"Neurogenic Bowel"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bronx",
"contacts": null,
"country": "United States",
"facility": "James J. Peters Veterans Affairs Medical Center",
"geoPoint": {
"lat": 40.84985,
"lon": -73.86641
},
"state": "New York",
"status": null,
"zip": "10468"
}
]
},
"descriptionModule": {
"briefSummary": "To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ACTUAL"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "89 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neostigmine and Glycopyrrolate by Iontophoresis",
"nctId": "NCT06351995",
"orgStudyIdInfo": {
"id": "KOR-19-22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Presence or absence of bowel evacuation"
},
{
"measure": "Time to bowel evacuation"
},
{
"measure": "Stool Consistency"
},
{
"measure": "Stool Quantity"
}
],
"secondaryOutcomes": [
{
"measure": "Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "James J. Peters Veterans Affairs Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2022-10-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-11-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Electro Medical Systems AIRFLOW® Prophylaxis Master Device"
},
{
"name": "Hand and ultrasonic scalers and curettes"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontal Pocket",
"Periodontitis",
"Gingival Diseases",
"Gingival Bleeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Dentistry, Cairo University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers",
"nctId": "NCT06351982",
"orgStudyIdInfo": {
"id": "211123PER3-3-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in probing pocket depth"
}
],
"secondaryOutcomes": [
{
"measure": "Bleeding On Probing"
},
{
"measure": "Clinical Attachment Level"
},
{
"measure": "Plaque index"
},
{
"measure": "Calculus index"
},
{
"measure": "Patient pain/discomfort"
},
{
"measure": "Patient satisfaction"
},
{
"measure": "Cost effectiveness"
},
{
"measure": "Treatment time"
},
{
"measure": "Number of healed pockets"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Post Partum Hemorrhage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banhā",
"contacts": [
{
"email": null,
"name": "Ashraf Ismail mohamed, professor",
"phone": "+201119709696",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Benha Univeristy",
"geoPoint": {
"lat": 30.45906,
"lon": 31.17858
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placenta attachment in the prediction of postpartum hemorrhage and to evaluate both of them as as parameters for identifying high-risk patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss",
"nctId": "NCT06351969",
"orgStudyIdInfo": {
"id": "Ms 9-12-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Benha University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cardiac Arrhythmia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.",
"nctId": "NCT06351956",
"orgStudyIdInfo": {
"id": "Arrhythmias in Septic Patients",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Risk Factors of cardiac arrhythmias in septic patients in CU."
},
{
"measure": "Fates of cardiac arrhythmia."
}
],
"secondaryOutcomes": [
{
"measure": "The frequent type of arrhythmias."
},
{
"measure": "Mortality rate due to new onset arrhythmia."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fracture classification annotations provided by the Turin group"
},
{
"name": "Fracture classification annotations provided by the AO expert surgeon group"
}
]
},
"conditionsModule": {
"conditions": [
"Proximal Femoral Fracture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dübendorf",
"contacts": null,
"country": "Switzerland",
"facility": "AO Foundation",
"geoPoint": {
"lat": 47.39721,
"lon": 8.61871
},
"state": null,
"status": null,
"zip": "8600"
}
]
},
"descriptionModule": {
"briefSummary": "The AO@AI Turin project is a collaborative project with a Turin group and the AO (Arbeitsgemeinschaft für Osteosynthesefragen, or in English, Association for the Study of Internal Fixation) foundation. An Image database (DB) has been built to host AP pelvic radiographs ready for artificial intelligence (AI) development.The goal of this project is to determine the agreement between the Turin annotation of fracture status and the annotation from an external group of AO expert surgeons for a random subset of the Turin images."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 2932,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Proximal Femur Image Database Validation",
"nctId": "NCT06351943",
"orgStudyIdInfo": {
"id": "ImageDB pilot",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Annotations of fracture status of the image"
},
{
"measure": "In case of fracture, Arbeitsgemeinschaft für Osteosynthesefragen (AO, in English, Association for the Study of Internal Fixation)/Orthopedic Trauma Association (OTA) classification: Type"
},
{
"measure": "In case of fracture, AO/OTA classification: Group"
},
{
"measure": "In case of fracture, AO/OTA classification: Subgroup"
},
{
"measure": "In case of fracture, AO/OTA classification: Qualifier for 31A1.1"
},
{
"measure": "In case of fracture, AO/OTA classification: Qualifier for 31B2"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Turin, Italy"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "AO Innovation Translation Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CBT-I + UC group"
}
]
},
"conditionsModule": {
"conditions": [
"Insomnia",
"ADHD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": null,
"name": "Waiyan Vivian CHIU, Clinical Psychologist",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Shirley X Li, PhD, DClinPsy",
"phone": "852-39177035",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomised, assessor-blind, parallel group controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CBT for Insomnia in Adolescents With ADHD",
"nctId": "NCT06351930",
"orgStudyIdInfo": {
"id": "EA210473",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Insomnia Symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Change in ADHD Symptoms (Self-report)"
},
{
"measure": "Change in Internalising and Externalising Symptoms (Parent-rated)"
},
{
"measure": "Change in depressive symptoms (Self-report)"
},
{
"measure": "Change in anxiety symptoms (Self-report)"
},
{
"measure": "Change in Sleep Diary Measure - Time in Bed (TIB)"
},
{
"measure": "Change in Sleep Diary Measure - Total Sleep Time (TST)"
},
{
"measure": "Change in Sleep Diary Measure - Sleep Onset Latency (SOL)"
},
{
"measure": "Change in Sleep Diary Measure - Wake After Sleep Onset (WASO)"
},
{
"measure": "Change in Sleep Diary Measure - Sleep Efficiency (SE)"
},
{
"measure": "Change in Objective Sleep Measures - Time in Bed (TIB)"
},
{
"measure": "Change in Objective Sleep Measures - Total Sleep Time (TST)"
},
{
"measure": "Change in Objective Sleep Measures - Sleep Onset Latency (SOL)"
},
{
"measure": "Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)"
},
{
"measure": "Change in Objective Sleep Measures - Sleep Efficiency (SE)"
},
{
"measure": "Change in Individual Beliefs and Attitude about Sleep"
},
{
"measure": "Change in Adolescent Sleep Hygiene"
},
{
"measure": "Change in Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kwai Chung Hospital, Hong Kong"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PlexoZome® Levagen® topical spray solution"
},
{
"name": "Placebo topical spray solution"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Joint Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brisbane",
"contacts": [
{
"email": "[email protected]",
"name": "Amanda Rao, PhD",
"phone": "+61 414 488 559",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "David Briskey, PhD",
"phone": "+61 421 784 077",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Amanda Rao, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Australia",
"facility": "RDC Clinical Pty Ltd",
"geoPoint": {
"lat": -27.46794,
"lon": 153.02809
},
"state": "Queensland",
"status": null,
"zip": "4006"
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain",
"nctId": "NCT06351917",
"orgStudyIdInfo": {
"id": "LEVEXE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Joint pain"
}
],
"secondaryOutcomes": [
{
"measure": "Time to pain relief"
},
{
"measure": "Number of Adverse Events"
},
{
"measure": "Severity of Adverse Events"
},
{
"measure": "Rescue medication use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "RDC Clinical Pty Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RAG-01"
}
]
},
"conditionsModule": {
"conditions": [
"Non-Muscle-Invasive Bladder Cancer (NMIBC)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "St Leonards",
"contacts": [
{
"email": "[email protected]",
"name": "Laurence Krieger, MBCHB",
"phone": "+61 2 8037 4100",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "GenesisCare North Shore",
"geoPoint": {
"lat": -33.82344,
"lon": 151.19836
},
"state": "New South Wales",
"status": "RECRUITING",
"zip": "2065"
}
]
},
"descriptionModule": {
"briefSummary": "This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy",
"nctId": "NCT06351904",
"orgStudyIdInfo": {
"id": "RAG-01-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and tolerability of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC)"
},
{
"measure": "Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of RAG-01"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ractigen Therapeutics."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "14-day bismuth quadruple regimen containing cefuroxime and tetracycline"
},
{
"name": "14-day bismuth quadruple regimen containing cefuroxime and levofloxacin"
}
]
},
"conditionsModule": {
"conditions": [
"Helicobacter Pylori Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jinan",
"contacts": [
{
"email": "[email protected]",
"name": "Yueyue Li, MD,PhD",
"phone": "86-18560089751",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Qilu Hospital of Shandong University",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong",
"status": null,
"zip": "250012"
}
]
},
"descriptionModule": {
"briefSummary": "The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 248,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin",
"nctId": "NCT06351891",
"orgStudyIdInfo": {
"id": "SHARE2402",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Eradication rate"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of adverse reactions"
},
{
"measure": "Patient compliance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qilu Hospital of Shandong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": [
{
"email": "[email protected]",
"name": "Alexis Schuettke",
"phone": "919-668-2842",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Duke University",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27705"
}
]
},
"descriptionModule": {
"briefSummary": "A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 125,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TipTraQ Home Sleep Test Validation Study",
"nctId": "NCT06351878",
"orgStudyIdInfo": {
"id": "Pro00113559",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Apnea Hypopnea Index(AHI)"
},
{
"measure": "Oxygen Desaturation Index(ODI)"
},
{
"measure": "Total Sleep Time(TST)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "PranaQ Pte. Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Complication of Surgical Procedure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Portsmouth",
"contacts": [
{
"email": "[email protected]",
"name": "Edward St John",
"phone": "02392286000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Queen Alexandra Hospital",
"geoPoint": {
"lat": 50.79899,
"lon": -1.09125
},
"state": "Hampshire",
"status": "RECRUITING",
"zip": "PO6 3LY"
}
]
},
"descriptionModule": {
"briefSummary": "Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRC",
"briefTitle": "Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent",
"nctId": "NCT06351865",
"orgStudyIdInfo": {
"id": "PHU/2023/21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of patients who respond to the feedback questionnaire"
},
{
"measure": "Final attrition rate"
}
],
"secondaryOutcomes": [
{
"measure": "Quoted risks in the consent to the incidence of complications"
},
{
"measure": "Frequency of PRC and CRCs (Consent Form Reported Complications)"
},
{
"measure": "Understanding of consent"
},
{
"measure": "Language used in patient reported complications"
},
{
"measure": "Accuracy of potential complications"
},
{
"measure": "Participant preparation for surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of East Anglia"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Portsmouth Hospitals NHS Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Combination of Neostigmine and Glycopyrrolate"
},
{
"name": "I-Box by Dynatronics"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injuries",
"Constipation",
"Fecal Incontinence",
"Neurogenic Bowel"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bronx",
"contacts": [
{
"email": "[email protected]",
"name": "Christopher P Cardozo, MD",
"phone": "718-584-9000",
"phoneExt": "1828",
"role": "CONTACT"
}
],
"country": "United States",
"facility": "James J. Peters Veterans Affairs Medical Center",
"geoPoint": {
"lat": 40.84985,
"lon": -73.86641
},
"state": "New York",
"status": "RECRUITING",
"zip": "10468"
}
]
},
"descriptionModule": {
"briefSummary": "Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "89 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transdermal Administration by a Novel Wireless Iontophoresis Device",
"nctId": "NCT06351852",
"orgStudyIdInfo": {
"id": "1678243",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Presence or absence of bowel evacuation"
},
{
"measure": "Time to bowel evacuation"
},
{
"measure": "Stool Consistency"
},
{
"measure": "Stool Quantity"
}
],
"secondaryOutcomes": [
{
"measure": "Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "James J. Peters Veterans Affairs Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sleep-Well despite persistent pain"
},
{
"name": "TAU (treatment-as-usual)"
}
]
},
"conditionsModule": {
"conditions": [
"Insomnia Chronic",
"Insomnia Due to Medical Condition",
"Pain, Chronic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tromsø",
"contacts": [
{
"email": "[email protected]",
"name": "Oddgeir Friborg, ph.d.",
"phone": "4777646772",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Svein Bergvik, ph.d.",
"phone": "4777646323",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Oddgeir Friborg, ph.d.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Jan H Rosenvinge, ph.d.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Svein Bergvik, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Norway",
"facility": "UiT The Arctic University of Norway",
"geoPoint": {
"lat": 69.6489,
"lon": 18.95508
},
"state": "Troms County",
"status": null,
"zip": "9037"
}
]
},
"descriptionModule": {
"briefSummary": "Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The \"Sleep-Well\" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality.Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "We randomize patients to receive either the Sleep-Well intervention or to the TAU condition (active waiting-list group). After 3 months, the TAU patients cross over and receive the Sleep-Well intervention; hence, the design is semi-crossover.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 106,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Sleep-Well",
"briefTitle": "Sleep Well Despite Persistent Pain Symptoms",
"nctId": "NCT06351839",
"orgStudyIdInfo": {
"id": "2024/500457(REK)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Mediator: Sleep hygiene (SHI)"
},
{
"measure": "Hyperactivity (HAS)"
},
{
"measure": "Mediator: Dysfunctional beliefs and attitudes about sleep (DBAS)"
},
{
"measure": "Mediator: Metacognitions about insomnia (MCQ-i)"
},
{
"measure": "Mediator: Insomnia catastrophizing Scale (ISC)"
},
{
"measure": "Mediator: Pain Catastrophizing Scale (PCS)"
}
],
"primaryOutcomes": [
{
"measure": "Insomnia symptoms"
},
{
"measure": "Insomnia diagnosis"
},
{
"measure": "Actigraphy insomnia indicators (SOL, WASO and EMA in minutes)"
},
{
"measure": "Actigraphy insomnia indicators (SE %)"
},
{
"measure": "Sleep diary insomnia indicators (SOL, WASO and EMA in minutes)"
}
],
"secondaryOutcomes": [
{
"measure": "Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST)"
},
{
"measure": "Anxiety and depression (HADS)"
},
{
"measure": "Quality of Life (EQ-5Q-5L)"
},
{
"measure": "Fatigue (Chalder Fatigue Scale)"
},
{
"measure": "Pain intensity, interference and locations (BPI)"
},
{
"measure": "Tolerance and Acceptance of chronic pain (CPAQ-R)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Hospital of North Norway"
},
{
"name": "Diakonhjemmet Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Tromso"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ELLASI"
},
{
"name": "Standard"
}
]
},
"conditionsModule": {
"conditions": [
"Polytrauma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta Pusat",
"contacts": [
{
"email": "[email protected]",
"name": "RSCM",
"phone": "062211500135",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "RSCM",
"geoPoint": {
"lat": -6.1818,
"lon": 106.8223
},
"state": "Jawa Barat",
"status": "RECRUITING",
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:1. Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?2. Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?3. Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:1. Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,2. Patient positioning and giving oxygen, head-up,3. Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring4. Assessment: re-assessment of pain and other main complaints5. Make sure informed consents are documented6. Inform patient and family for further interventionPolytrauma patients in the control group will receive the usual/standard intervention.Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department",
"nctId": "NCT06351826",
"orgStudyIdInfo": {
"id": "22070876",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Response time"
},
{
"measure": "Deterioration score"
},
{
"measure": "Acidic Level (pH)"
},
{
"measure": "Base Excess (BE)"
},
{
"measure": "Bicarbonate level (HCO3)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Acute Kidney Injury",
"Critical Illness",
"Kidney Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Shanghai Zhongshan Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 358,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers",
"nctId": "NCT06351813",
"orgStudyIdInfo": {
"id": "B2024-029R",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "AKI nonresolving subphenotype"
}
],
"secondaryOutcomes": [
{
"measure": "Major adverse kidney events at 30 days"
},
{
"measure": "Major adverse kidney events at 90 days"
},
{
"measure": "Major adverse kidney events at 365 days"
},
{
"measure": "Mortality"
},
{
"measure": "Receipt of renal replacement treatment"
},
{
"measure": "Moderate and severe AKI"
},
{
"measure": "AKI progression"
},
{
"measure": "Composite Outcome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Zhongshan Hospital (Xiamen), Fudan University"
},
{
"name": "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Zhongshan Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Predictplusprevent intervention"
},
{
"name": "Psychoeducational intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Anxiety Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group \"PredictPlusPrevent\". The \"PredictPlusPrevent\" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The \"PredictPlusPrevent\" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control \"PredictPlusPrevent\" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 9000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The PredictPlusPrevent Study",
"nctId": "NCT06351800",
"orgStudyIdInfo": {
"id": "PE-0280-2018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of depression and/or anxiety disorders."
}
],
"secondaryOutcomes": [
{
"measure": "Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)."
},
{
"measure": "Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)."
},
{
"measure": "Probability of depression measured by the Spanish predictD risk algorithm."
},
{
"measure": "Probability of anxiety measured by the Spanish predictA risk algorithm."
},
{
"measure": "Quality of life measured by the 12-item Short Form (SF-12)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Mediterranean Institute for the Advance of Biotechnology and Health Research"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Resting and movement-based focused awareness meditations"
}
]
},
"conditionsModule": {
"conditions": [
"Well-Being, Psychological"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Athens",
"contacts": null,
"country": "United States",
"facility": "Ohio University",
"geoPoint": {
"lat": 39.32924,
"lon": -82.10126
},
"state": "Ohio",
"status": null,
"zip": "45701"
}
]
},
"descriptionModule": {
"briefSummary": "In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan-\\>yoga intervention sequence compared to the yoga-\\>body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis",
"nctId": "NCT06351787",
"orgStudyIdInfo": {
"id": "22-X-97",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cortical activity"
},
{
"measure": "Interoceptive awareness"
},
{
"measure": "Mindful awareness"
},
{
"measure": "Pressure pain threshold and tolerance"
}
],
"secondaryOutcomes": [
{
"measure": "Healthy emotionality"
},
{
"measure": "Well-being"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ohio University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Back Pain Lower Back Chronic",
"Disability Physical"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Athens",
"contacts": null,
"country": "United States",
"facility": "Ohio University",
"geoPoint": {
"lat": 39.32924,
"lon": -82.10126
},
"state": "Ohio",
"status": null,
"zip": "45701"
}
]
},
"descriptionModule": {
"briefSummary": "In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "A 2 armed sequential, multiple-assignment randomized trial design",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The investigator was masked to the initial treatment assignment. The outcome assessor was not masked to treatment assignment and monitored treatment response at the mid-intervention in order to recommend continuation of current treatment or to augment treatment with the Healthy Mind Innovations training program for individuals who did not favorably respond to standalone PT.",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 13,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AdaPT",
"briefTitle": "Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain",
"nctId": "NCT06351774",
"orgStudyIdInfo": {
"id": "21-F-45",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Oswestry Disability Index"
},
{
"measure": "PROMIS Pain Interference"
}
],
"secondaryOutcomes": [
{
"measure": "Actigraphy"
},
{
"measure": "3D Motion Capture"
},
{
"measure": "Pain acceptance"
},
{
"measure": "Committed action"
},
{
"measure": "Healthy emotionality"
},
{
"measure": "Exercise behavior"
},
{
"measure": "Back pain screening tool 1"
},
{
"measure": "Back pain screening tool 1"
},
{
"measure": "Kinesiophobia"
},
{
"measure": "Attitudes towards complementary and alternative medicine"
},
{
"measure": "Treatment expectancy"
},
{
"measure": "Lumbar pressure pain threshold"
},
{
"measure": "Thermal method of limits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Wisconsin, Madison"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ohio University"
}
},
"statusModule": {
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"date": "2024-03-25"
},
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"date": "2024-04-08"
},
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"date": "2024-02-08"
},
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"startDateStruct": {
"date": "2022-05-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Investigational Device (Withings SCT02) 30 second Electrocardiogram recording"
},
{
"name": "Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boca Raton",
"contacts": null,
"country": "United States",
"facility": "FWD Clinical Research",
"geoPoint": {
"lat": 26.3669,
"lon": -80.13033
},
"state": "Florida",
"status": null,
"zip": "33486"
},
{
"city": "Miami",
"contacts": null,
"country": "United States",
"facility": "Diverse Clinical Research",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": null,
"zip": "33175"
},
{
"city": "Créteil",
"contacts": null,
"country": "France",
"facility": "Henri Mondor University Hospital",
"geoPoint": {
"lat": 48.78333,
"lon": 2.46667
},
"state": "Val De Marne",
"status": null,
"zip": "94000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 270,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "WIBOFA",
"briefTitle": "WIBOFA - Validation of SCT02 With ECG-App for Detection of AF",
"nctId": "NCT06351761",
"orgStudyIdInfo": {
"id": "SCT02-ECG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Co-primary outcome 1 - Sensitivity of Investigational Device"
},
{
"measure": "Co-primary outcome 2 - Specificity of Investigational Device"
}
],
"secondaryOutcomes": [
{
"measure": "Rhythm classification by ranges of heart rate"
},
{
"measure": "Quality of plots measured by the IMD - ECG Waveform Visibility"
},
{
"measure": "Quality of plots measured by the IMD - ECG Waveforms Polarity"
},
{
"measure": "Quality of plots measured by the IMD - ECG Waveforms Intervals"
},
{
"measure": "Quality of plots measured by the IMD - Heart Rate calculation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Withings"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Semaglutide"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": null,
"country": "China",
"facility": "Tianjin Medical University Chu Hsien-I Memorial Hospital",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \\[NRDL\\] in China\\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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},
"enrollmentInfo": {
"count": 27000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SCHOLAR",
"briefTitle": "Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR)",
"nctId": "NCT06351748",
"orgStudyIdInfo": {
"id": "NN9535-7877",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "World Health Organization (WHO)",
"id": "U1111-1296-3151",
"link": null,
"type": "OTHER"
}
]
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Haemoglobin A1c (HbA1c) level"
},
{
"measure": "Change in HbA1c level"
},
{
"measure": "Proportion of participants achieving HbA1c less than (<) 7.0%"
}
],
"secondaryOutcomes": [
{
"measure": "Change in HbA1c level"
},
{
"measure": "Change in HbA1c level"
},
{
"measure": "Proportion of participants achieving HbA1c <7.0%"
},
{
"measure": "Change in body weight"
},
{
"measure": "Change in body weight"
},
{
"measure": "Description of participants with different demographic characteristics"
},
{
"measure": "Description of participants with different clinical characteristics"
},
{
"measure": "Proportion of participants with different antidiabetic medications"
},
{
"measure": "Proportion of participants with different non-antidiabetic medications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novo Nordisk A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "ENROLLING_BY_INVITATION",
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"date": "2024-06-30"
},
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"startDateStruct": {
"date": "2024-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Deep cervical lymph node-vein bypass surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Evaluation of the Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in Patients With Amyotrophic Lateral Sclerosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"maskingInfo": null,
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},
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},
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},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis",
"nctId": "NCT06351735",
"orgStudyIdInfo": {
"id": "2024-0336",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "ALSFRS-R scale"
},
{
"measure": "Cognitive and Behavioral Scale (CAS)"
}
],
"secondaryOutcomes": [
{
"measure": "Baseline of slow vital capacity (SVC)"
},
{
"measure": "Evaluation of glymphatic and meningeal lymphatic drainage"
},
{
"measure": "Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Affiliated Hospital, School of Medicine, Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-05-01"
},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Before non-surgical periodontal treatment"
},
{
"name": "non-surgical periodontal treatment"
},
{
"name": "3rd month after non-surgical periodontal treatment"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
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"briefSummary": "The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate potential confounders that may mediate this relationship.The main questions it aims to answer are:question 1: Is there a relationship between the biomarkers mentioned above and periodontitis and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers?"
},
"designModule": {
"designInfo": {
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-surgical Periodontal Treatment in Smokers on SIRT-1, NLRP3 Inflammasome and LncRNAs",
"nctId": "NCT06351722",
"orgStudyIdInfo": {
"id": "smokingnlrp3inflasome",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Pre-treatment clinical and laboratory evaluation"
},
{
"measure": "Comparison of clinical measurements and laboratory measurements at 3 months post-treatment"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Necmettin Erbakan University"
}
},
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"completionDateStruct": {
"date": "2025-03-15"
},
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"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stretching"
},
{
"name": "Hot pack application"
},
{
"name": "Cold pack application"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "İstanbul Medipan Tıp Merkezi",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34218"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of our study is to investigate the effects of heat, cold and stretching on knee proprioception and vertical jump. 60 healthy individuals were randomized into hot, cold, stretching and control groups of 15 each. Pre-test and post-test measurements were made immediately after the application. Knee proprioception was measured with a digital goniometer using the EPD (joint position sense) test. Vertical jump heights were measured with contact mat by countermovement (CMJ) and squat splash (SQS) tests."
},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acute Effects of Heat, Cold and Stretching on Knee Proprioception and Vertical Jump",
"nctId": "NCT06351709",
"orgStudyIdInfo": {
"id": "UmutPaksoy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Vertical Jump Distance Measurement"
},
{
"measure": "Joint Position Sense Measurement"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Bilgi University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-02-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-11-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bromlein"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Ulcerative Colitis",
"Primary Sclerosing Cholangitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tehran",
"contacts": [
{
"email": "[email protected]",
"name": "Azita Hekmatdoost, MD, PhD",
"phone": "+989123065084",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Iran, Islamic Republic of",
"facility": "Azita Hekmatdoost",
"geoPoint": {
"lat": 35.69439,
"lon": 51.42151
},
"state": "Middle East",
"status": "RECRUITING",
"zip": "19835"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Bromelain Supplement in Patients With Ulcerative Colitis",
"nctId": "NCT06351696",
"orgStudyIdInfo": {
"id": "43008563",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SCCAIQ"
}
],
"secondaryOutcomes": [
{
"measure": "IBDQ"
},
{
"measure": "Serum TAC"
},
{
"measure": "Serum hsCRP"
},
{
"measure": "Serum TNF-a"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Nutrition and Food Technology Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MitoQ (mitoquinol mesylate)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Lower Urinary Tract Symptoms",
"Overactive Bladder Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Farmington",
"contacts": [
{
"email": "[email protected]",
"name": "Lisa Kenyon-Pesce",
"phone": "860-679-2305",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Peter C Albertsen, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "George A Kuchel, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jenna M Bartley, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Oh Sung Kwon, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UConn Health",
"geoPoint": {
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"lon": -72.83204
},
"state": "Connecticut",
"status": "RECRUITING",
"zip": "06030"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome. The main questions it aims to answer are:* Is the study design feasible and acceptable to participants?* Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)?Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Double-blinded. Pharmacy will randomize and dispense capsules.",
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Mito-LUTS",
"briefTitle": "Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome",
"nctId": "NCT06351683",
"orgStudyIdInfo": {
"id": "24-066-2",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "P30AG067988",
"link": "https://reporter.nih.gov/quickSearch/P30AG067988",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overactive Bladder Symptom Score (OABSS)"
}
],
"secondaryOutcomes": [
{
"measure": "Three-day bladder voiding diary"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Aging (NIA)"
},
{
"name": "American Urological Association"
},
{
"name": "Urology Care Foundation"
},
{
"name": "Claude D. Pepper Older Americans Independence Center (OAIC)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Iman Al-Naggar, PhD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Age-Related Macular Degeneration"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:* Identify and quantify focal and global alterations in the retina in regard to disease progression.* Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging.* Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD* Enhance the ability to classify AMD using artificial intelligence in addition to traditional models.All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:* Scanning Laser Fundus Photography* Color Fundus Photography (CFP)* Optical Coherence Tomography (OCT)* Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SUDETES",
"briefTitle": "Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression",
"nctId": "NCT06351670",
"orgStudyIdInfo": {
"id": "1109/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD."
}
],
"secondaryOutcomes": [
{
"measure": "To identify and quantify disease progression-related biomarkers"
},
{
"measure": "To evaluate monitoring of AMD progression assisted by AI algorithms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Medical Centre Ljubljana"
},
{
"name": "Centre Hospitalier Universitaire Dijon"
},
{
"name": "Queen's University, Belfast"
},
{
"name": "University of Zurich"
},
{
"name": "Vista Klinik"
},
{
"name": "Fundacion Clinic per a la Recerca Biomédica"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Vienna"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Age-Related Macular Degeneration",
"Geographic Atrophy"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:* Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.* Identify and quantify focal and global alterations in the retina in regard to disease progression.* Evaluate the monitoring of AMD progression using approved AI algorithms.All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:* Scanning Laser Fundus Photography* Color Fundus Photography (CFP)* Optical Coherence Tomography (OCT)* Optical Coherence Tomography Angiography (OCTA)Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "APENNINES",
"briefTitle": "Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression",
"nctId": "NCT06351657",
"orgStudyIdInfo": {
"id": "1088/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression"
}
],
"secondaryOutcomes": [
{
"measure": "To identify and quantify disease progression-related biomarkers"
},
{
"measure": "To evaluate monitoring AMD progression using approved AI algorithms."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Medical Centre Ljubljana"
},
{
"name": "Centre Hospitalier Universitaire Dijon"
},
{
"name": "University of Zurich"
},
{
"name": "Vista Klinik"
},
{
"name": "Queen's University, Belfast"
},
{
"name": "Fundacion Clinic per a la Recerca Biomédica"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Vienna"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ON 123300"
},
{
"name": "Dexamethasone"
}
]
},
"conditionsModule": {
"conditions": [
"Relapsed and/or Refractory Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Adriana Rossi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Katherine Vandris",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Adriana Rossi",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mount Sinai Health System",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10029"
}
]
},
"descriptionModule": {
"briefSummary": "Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is a single arm optimal biologic dose finding phase I/II clinical trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma",
"nctId": "NCT06351644",
"orgStudyIdInfo": {
"id": "STUDY-24-00244",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone"
},
{
"measure": "Phase I: Dose-Limiting Toxicity (DLT) rate"
},
{
"measure": "Phase II: Overall response rates (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Adverse events of Special Interest (AESI)"
},
{
"measure": "HbA1c"
},
{
"measure": "Fasting insulin levels"
},
{
"measure": "Lipid profiles"
},
{
"measure": "Free fatty acids"
},
{
"measure": "Best overall response (BOR)"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Time to Progression (TTP)"
},
{
"measure": "Progression-Free Survival (PFS)"
},
{
"measure": "Disease Control Rate (DCR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Adriana Rossi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bomedemstat"
}
]
},
"conditionsModule": {
"conditions": [
"Thrombocythemia, Essential",
"Primary Myelofibrosis",
"Myelofibrosis",
"Post-polycythemia Vera Myelofibrosis",
"Post-essential Thrombocythemia Myelofibrosis",
"Polycythemia Vera"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.No hypothesis testing will be conducted in this study."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)",
"nctId": "NCT06351631",
"orgStudyIdInfo": {
"id": "3543-017",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CT",
"id": "2023-506996-89",
"link": null,
"type": "OTHER"
},
{
"domain": "UTN",
"id": "U1111-1294-8621",
"link": null,
"type": "OTHER"
},
{
"domain": "Merck ID",
"id": "MK-3543-017",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of participants with one or more adverse events (AEs)"
},
{
"measure": "Percentage of participants who discontinued study treatment due to an AE"
}
],
"secondaryOutcomes": [
{
"measure": "For participants with ET or PV: Duration of clinicohematologic response"
},
{
"measure": "For participants with ET or PV: Duration of hematologic remission"
},
{
"measure": "For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML"
},
{
"measure": "For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML"
},
{
"measure": "For participants with MF, ET, or PV: Percentage of participants with thrombotic events"
},
{
"measure": "For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events"
},
{
"measure": "For participants with MF, ET, or PV: Event-Free Survival (EFS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Merck Sharp & Dohme LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-12-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-12-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention will be conducted."
}
]
},
"conditionsModule": {
"conditions": [
"Sport Injury",
"Ice-Skates Accident",
"Sports Accident",
"Female Athlete Triad",
"Female"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Malmö",
"contacts": [
{
"email": "[email protected]",
"name": "Amanda Lahti",
"phone": "0704854798",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "The Faculty of Medicine at Lund University",
"geoPoint": {
"lat": 55.60587,
"lon": 13.00073
},
"state": null,
"status": "RECRUITING",
"zip": "20213"
}
]
},
"descriptionModule": {
"briefSummary": "This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 225,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "110 Years",
"minimumAge": "16 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking",
"nctId": "NCT06351618",
"orgStudyIdInfo": {
"id": "2023-06114-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Injuries per 1000 training hours"
},
{
"measure": "Injuries per 1000 game hours"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Lund University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Valeda Light Delivery System"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Age-related Macular Degeneration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oslo",
"contacts": [
{
"email": "[email protected]",
"name": "Øygunn Utheim, MD",
"phone": "+47 93692578",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "Oslo University Hospital",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"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": "A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT)",
"nctId": "NCT06351605",
"orgStudyIdInfo": {
"id": "CSP006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Best-Corrected Visual Acuity (BCVA)"
}
],
"secondaryOutcomes": [
{
"measure": "OCT Imaging"
},
{
"measure": "FAF Imaging"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "LumiThera, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ALN-SOD"
},
{
"name": "Diluent"
},
{
"name": "Placebo (PB)"
}
]
},
"conditionsModule": {
"conditions": [
"Amyotrophic Lateral Sclerosis (ALS)",
"Mutation in the Superoxide Dismutase-1 (SOD1) Gene"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is researching an experimental drug called ALN-SOD (called \"study drug\"). This study is focused on people with amyotrophic lateral sclerosis (ALS) who have a mutation in a gene called the superoxide dismutase-1 (SOD1) gene. This type of ALS is known as \"SOD1-ALS\". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is.The study is looking at several other research questions, including:* The effect the study drug has on specific biomarkers, which are molecules in the blood or in the fluid that surrounds the brain and spinal cord, known as cerebrospinal fluid (CSF)* How much study drug is in the blood and in the CSF, at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)* What effects the study drug has on ALS symptoms"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "No masking during Open-Label Treatment Period after 4-week Double-Blind Treatment Period. This part of the study consists of a crossover design.",
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},
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)",
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"id": "ALN-SOD-ALS-2351",
"link": null,
"type": null
},
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"domain": "EU CT Number",
"id": "2023-510344-20-00",
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"type": "REGISTRY"
}
]
},
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"primaryOutcomes": [
{
"measure": "Incidence of treatment-emergent adverse event (TEAEs) in participants treated with ALN-SOD"
},
{
"measure": "Severity of TEAEs in participants treated with ALN-SOD"
}
],
"secondaryOutcomes": [
{
"measure": "Concentration of SOD1 protein in cerebrospinal fluid (CSF) over time"
},
{
"measure": "Change in concentration of SOD1 protein in CSF over time"
},
{
"measure": "Concentration of neurofilament light chain (NfL) in plasma over time"
},
{
"measure": "Change in concentration of NfL in plasma over time"
},
{
"measure": "Concentration of NfL in CSF over time"
},
{
"measure": "Change in concentration of NfL in CSF over time"
},
{
"measure": "Concentration of ALN-SOD in plasma over time"
},
{
"measure": "Concentration of ALN-SOD in CSF over time"
},
{
"measure": "Incidence of anti-drug antibodies (ADAs) to ALN-SOD in serum over time"
},
{
"measure": "Titer of ADAs to ALN-SOD in serum over time"
}
]
},
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"class": "INDUSTRY",
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}
},
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"date": "2029-04-28"
},
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},
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"date": "2029-04-28"
},
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"date": "2024-06-28"
},
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}
}
} | false | null |
{
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}
]
},
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"Radical Prostatectomy",
"BPH"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP."
},
"designModule": {
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},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "45 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ALTO",
"briefTitle": "Data Collection Post Radical Prostatectomy",
"nctId": "NCT06351579",
"orgStudyIdInfo": {
"id": "1010159",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Expanded Prostate Index Composite (EPIC-26) score."
}
],
"primaryOutcomes": [
{
"measure": "The change in average 24-hour pad weight over time"
}
],
"secondaryOutcomes": [
{
"measure": "Change in pad weight during a 1-hour provocative pad weight test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "RQMplus"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Levee Medical, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
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"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin D3"
},
{
"name": "Prebiotics"
},
{
"name": "Vitamin D3 placebo"
},
{
"name": "Prebiotics placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
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},
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"type": "ESTIMATED"
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],
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},
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"maximumAge": "69 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes",
"nctId": "NCT06351566",
"orgStudyIdInfo": {
"id": "VD3, Prebiotics in Diabetes",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Glycated hemoglobin (HbA1c)"
},
{
"measure": "Concentration of blood lipids"
},
{
"measure": "Metagenomic analysis of the gut microbiota"
}
],
"secondaryOutcomes": [
{
"measure": "Concentration of fasting glucose"
},
{
"measure": "Concentration of fasting insulin"
},
{
"measure": "Systolic and diastolic blood pressure"
},
{
"measure": "Estimated glomerular filtration rate (eGFR)"
},
{
"measure": "Concentration of C-reactive protein (CRP)"
},
{
"measure": "Concentration of procalcitonin"
},
{
"measure": "Concentration of interleukin-6 (IL-6)"
},
{
"measure": "Concentration of serum 25(OH)D"
},
{
"measure": "Body weight"
},
{
"measure": "Waist circumference"
},
{
"measure": "Hip circumference"
}
]
},
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"class": "OTHER",
"name": "Huazhong University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
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"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2024-04-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Pulmonary vein isolation exclusively with radiofrequency"
},
{
"name": "Pulmonary vein isolation exclusively with pulsed field ablation"
},
{
"name": "Combined pulmonary vein isolation"
}
]
},
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alicante",
"contacts": null,
"country": "Spain",
"facility": "Laura García Cano",
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"lon": -0.48149
},
"state": null,
"status": null,
"zip": "03010"
}
]
},
"descriptionModule": {
"briefSummary": "Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA."
},
"designModule": {
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},
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},
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],
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"stdAges": [
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},
"identificationModule": {
"acronym": "EASy-PULSE AF",
"briefTitle": "Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation",
"nctId": "NCT06351553",
"orgStudyIdInfo": {
"id": "2023-169",
"link": null,
"type": null
},
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"primaryOutcomes": [
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"measure": "Efficacy primary outcome: Alteration of autonomic function parameters"
}
],
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"measure": "Efficacy secondary outcome: Alteration of autonomic function parameters"
},
{
"measure": "Efficacy secondary outcome: Alteration of autonomic function parameters"
},
{
"measure": "Efficacy secondary outcome: Alteration of autonomic function parameters"
},
{
"measure": "Efficacy secondary outcome: Procedure duration."
}
]
},
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"name": "Hospital General Universitario de Alicante"
}
},
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"date": "2026-06"
},
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},
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"date": "2026-06"
},
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"startDateStruct": {
"date": "2024-06"
},
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"date": "2024-04-08"
}
}
} | false | null |
{
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"interventions": [
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"name": "Cannabis"
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]
},
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"conditions": [
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"Impaired Driving",
"Cognitive Impairment"
]
},
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{
"city": "Baltimore",
"contacts": null,
"country": "United States",
"facility": "Johns Hopkins Behavioral Pharmacology Research Unit",
"geoPoint": {
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"lon": -76.61219
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"state": "Maryland",
"status": null,
"zip": "21224"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users."
},
"designModule": {
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},
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},
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},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance",
"nctId": "NCT06351540",
"orgStudyIdInfo": {
"id": "IRB00332797",
"link": null,
"type": null
},
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{
"domain": null,
"id": "R21DA056687",
"link": "https://reporter.nih.gov/quickSearch/R21DA056687",
"type": "NIH"
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]
},
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"primaryOutcomes": [
{
"measure": "Commission Errors"
},
{
"measure": "Omission Errors"
},
{
"measure": "Reaction Time"
},
{
"measure": "Reaction Time Standard Error"
},
{
"measure": "Visuomotor Index"
}
],
"secondaryOutcomes": [
{
"measure": "Saccade Speed"
},
{
"measure": "Visually Guided Oculomotor Performance"
},
{
"measure": "Antisaccade"
},
{
"measure": "Memory-Guided"
}
]
},
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"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
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"class": "OTHER",
"name": "Johns Hopkins University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
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},
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"date": "2025-08-01"
},
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"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ICP-248"
}
]
},
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies"
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies",
"nctId": "NCT06351527",
"orgStudyIdInfo": {
"id": "ICP-CL-01202",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Maximum tolerated dose and/or recommended Phase 2 dose"
},
{
"measure": "To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria."
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "InnoCare Pharma Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-10-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Accelerated iTBS"
}
]
},
"conditionsModule": {
"conditions": [
"Schizophrenia; Negative Type"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": [
{
"email": "[email protected]",
"name": "Jenny Tay",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Singapore",
"facility": "Institute of Mental Health",
"geoPoint": {
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"lon": 103.85007
},
"state": null,
"status": "RECRUITING",
"zip": "539747"
}
]
},
"descriptionModule": {
"briefSummary": "Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"interventionModelDescription": null,
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},
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},
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},
"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NOBLE-TMS",
"briefTitle": "An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms",
"nctId": "NCT06351514",
"orgStudyIdInfo": {
"id": "2023/00745",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of Negative symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Trend of Negative symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institute of Mental Health, Singapore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months"
},
{
"name": "Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
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"locations": null
},
"descriptionModule": {
"briefSummary": "Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout.Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on \"Evidence Based Medicine\" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "multicentric, controlled, randomized, open trial with blinded assessment of the primary outcome measure (Prospective Open Blinding Endpoint PROBE study)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The evaluation of the main criterion by the CGAS will be administered by a psychologist trained on this scale who will not have knowledge of the adolescent's attribution group and will not have participated in their care, based on elements keys to the patient's file which will be provided to him without any element that could indicate his group to which he belongs or his original sex, and a telephone interview with the adolescent and with his parents where they will have been previously informed not to not reveal the group to which they belong or the sex of origin.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "TRANSADO",
"briefTitle": "Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria",
"nctId": "NCT06351501",
"orgStudyIdInfo": {
"id": "P170923J",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2019-000300-16",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Global functionning using the Children's Global Assessment Scale (CGAS)"
}
],
"secondaryOutcomes": [
{
"measure": "DEP-ADO"
},
{
"measure": "WISC-V (weschler Test)"
},
{
"measure": "UGDS (Utrecht Gender Dysphoria Scale )"
},
{
"measure": "Beck Depression Inventory (BDI)"
},
{
"measure": "Body Image Scale (BIS)"
},
{
"measure": "State and Anxiety Inventory for Children (STAI-C)"
},
{
"measure": "CBCL (Youth Self Report YSR) Child Behaviour Chekcklist"
},
{
"measure": "World Health Organization Quality Of Life (WHO QOL)"
},
{
"measure": "Satisfaction With Life Scale (SWLS)"
},
{
"measure": "Adolescent Depression Rating Scale (ADRS)"
},
{
"measure": "Mini International Neuropsychiatric Interview (MINI)"
},
{
"measure": "Inventory of Parents and Peers Attachment (IPPA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-06-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-06-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Kidney Transplant Patients Eligible for a Solid Biopsy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification.Several studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies/ml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 319,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DART-RREGREF",
"briefTitle": "Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection",
"nctId": "NCT06351488",
"orgStudyIdInfo": {
"id": "APHP231661",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The area under the ROC curve of ABMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
}
],
"secondaryOutcomes": [
{
"measure": "The area under the ROC curve of TCMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
},
{
"measure": "The area under the ROC curve of mixed rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
},
{
"measure": "The area under the ROC curve of glomerulitis-type rejection prediction models (≥g1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
},
{
"measure": "The area under the ROC curve of tubulitis-type rejection prediction models (≥t1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
},
{
"measure": "The area under the ROC curve of vascularitis-type rejection prediction models (≥v1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
},
{
"measure": "The area under the ROC curve of capillaritis-type rejection prediction models (≥ptc1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest"
},
{
"measure": "Areas under the ROC curve of rejection prediction models according to renal biopsy and with as covariates of interest the quantities of urinary chemokines (CXCL9 and CXCL10) determined by ELISA and expressed in pg/mL in urine"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "CGenetix"
},
{
"name": "Institut National de la Santé Et de la Recherche Médicale, France"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intra-operative albumin administration"
},
{
"name": "Control"
}
]
},
"conditionsModule": {
"conditions": [
"Peritoneal Neoplasms",
"Hyperthermic Intraperitoneal Chemotherapy",
"Intraoperative Care",
"Fluid Therapy",
"Postoperative Complications"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.Intervention* 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.* Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 146,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ALBUCHIP",
"briefTitle": "Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy",
"nctId": "NCT06351475",
"orgStudyIdInfo": {
"id": "APHP230864",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comprehensive Complication Index score"
}
],
"secondaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Comprehensive Complication Index score"
},
{
"measure": "Volume of intra operative and post operative fluid therapy"
},
{
"measure": "Cumulative incidence of surgical post operative complications"
},
{
"measure": "Cumulative incidence of medical post operative complications"
},
{
"measure": "Need for mechanical ventilation"
},
{
"measure": "Need for renal replacement therapy"
},
{
"measure": "Sequential organ failure assessment (SOFA) score variation"
},
{
"measure": "Number of days alive out of intensive care unit"
},
{
"measure": "Number of days alive out of hospital"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spermogram"
},
{
"name": "Hospital Anxiety and Depression Scale (HADS)"
},
{
"name": "SF36 Quality of life questionnaire"
},
{
"name": "Psychologist interview"
},
{
"name": "Optional sera banking"
},
{
"name": "Optional DNA banking"
}
]
},
"conditionsModule": {
"conditions": [
"Sickle Cell Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The long term burden of morbidity and mortality in the natural history of sickle cell disease has not been compared up to date to the risks and mortality of a curative option like bone marrow transplantation in severe sickle-cell disease patients. Given this lack of data, primary-care Sickle Cell Disease (SCD) physicians and transplant physicians are prevented from a factual debate over the benefit/risk ratio for each patient and refining indications of transplant in patients. Therefore, the present study seeks to describe and compare the very long-term outcomes after either Human Leukocyte Antigen (HLA) -matched sibling transplantation (study arm) and \"non-transplant care\" for severe sickle cell disease SCA patients in order to yield robust comparative data regarding both arms.The main objective is to assess the benefit of Hematopoietic stem cell transplantation (HSCT) regarding quality of life compared to standard care after 10 years, in patients with severe Sickle Cell Disease (SCD)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TRANSPLANTORN2",
"briefTitle": "Comparative Health Status and Quality of Life of Patients With Sickle Cell Disease (SCD) Who Underwent Matched-sibling Hematopoietic Stem Cell Transplantation Versus Non Transplanted SCD Case-control Patients",
"nctId": "NCT06351462",
"orgStudyIdInfo": {
"id": "APHP200008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of quality of life assessed by SF36"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of gonadal function"
},
{
"measure": "Evaluation of quality of life"
},
{
"measure": "Proportion of patients with anxiety and depression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The patch under study is photographed using the SkinCam®"
}
]
},
"conditionsModule": {
"conditions": [
"Allergic Contact Dermatitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®."
},
"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": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PatchCam",
"briefTitle": "Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool",
"nctId": "NCT06351449",
"orgStudyIdInfo": {
"id": "69HCL22_0489",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To highlight characteristics of allergic contact dermatitis (ACD)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospices Civils de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindfulness"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training.A single-group pre-post uncontrolled design will be employed. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single-group non-randomized uncontrolled trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "11 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing",
"nctId": "NCT06351436",
"orgStudyIdInfo": {
"id": "TBC20240402",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mental Well-Being in Youths"
}
],
"secondaryOutcomes": [
{
"measure": "Stress Level in Youths"
},
{
"measure": "Feasibility of Eligibility and Enrollment"
},
{
"measure": "Feasibility of Attendance Rate"
},
{
"measure": "Feasibility of Retention Rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Forest Bathing (FB)"
},
{
"name": "MIND diet"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety",
"Depression",
"Stress",
"Psychological Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Fabian Ling Ngai Tung, PhD",
"phone": "85239708732",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Fabian Ling Ngai Tung, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Queenie Pui Sze Law, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Katherine Ka Yin Yau, DHsC",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sam Kit San Yuen",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eric Tsz Fai Chan",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Hong Kong",
"facility": "Hong Kong Metropolitan University",
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"lon": 114.17469
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}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial aims to explore the effectiveness of the Mediterranean DASH Intervention for Neurodegenerative Delay (MIND) diet and Forest Bathing (FB) in reducing psychological stress among older Chinese individuals. The main questions it aims to answer are:1. what is the effect of FB on stress reduction2. what is the effect of MIND on stress reductionParticipants of the MIND-FB group will participate will receive1. FB: a two-hour FB session on four consecutive weekends in a country park,2. MIND: four nutrition sessions, and adhere to the MIND diet for 12 weeksResearchers will compare the FB and routine care groups to compare the effectiveness of MIND and FB in reducing psychological stress."
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": "a 3-arm randomized controlled study in a parallel design. Eligible participants will be randomly assigned into 3 interventions: (1) FB-MIND, (2) FB and (3) routine care-control.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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},
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"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of MIND Diet and Forest Bathing on Stress Reduction",
"nctId": "NCT06351423",
"orgStudyIdInfo": {
"id": "HE-NHS2023/03",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Emotional states"
}
],
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{
"measure": "Systolic Blood Pressure (SBP)"
},
{
"measure": "Salivary Cortisol"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Hong Kong Metropolitan University"
}
},
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"date": "2024-11-30"
},
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"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-08-31"
},
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"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Eye Wearing Contact Lens"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye",
"Dry Eye Syndromes",
"Contact Lens-induced Corneal Fluorescein Staining"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuala Lumpur",
"contacts": null,
"country": "Malaysia",
"facility": "Optometry Clinic",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": null,
"status": null,
"zip": "50300"
}
]
},
"descriptionModule": {
"briefSummary": "This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "18 participants will be fitted with 2 types of lenses on either eye at one time. There will be a 2-week wash-off period before another 2 set of fittings with another 4 types of lenses.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "29 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses",
"nctId": "NCT06351410",
"orgStudyIdInfo": {
"id": "JEP 2023-679",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess the quantity of tears in eyes wearing contact lenses"
},
{
"measure": "To asess the quality of tears in eyes wearing contact lenses"
},
{
"measure": "To assess corneal staining in eyes wearing contact lenses"
},
{
"measure": "To assess comfort level of participants using CL Discomfort Index Questionaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "National University of Malaysia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
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"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
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{
"date": "2024-04-02",
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"label": "Study Protocol",
"size": 837117,
"typeAbbrev": "Prot",
"uploadDate": "2024-04-01T23:49"
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{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mixed Reality (MR)"
}
]
},
"conditionsModule": {
"conditions": [
"Educational Problems"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palo Alto",
"contacts": [
{
"email": "[email protected]",
"name": "Astrid Suen, MMedSc",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Thomas Caruso, MD, PhD",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Lucile Packard Children's Hospital Stanford",
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},
"state": "California",
"status": null,
"zip": "94303"
}
]
},
"descriptionModule": {
"briefSummary": "This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum."
},
"designModule": {
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},
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},
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},
"phases": [
"NA"
],
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},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Empathy",
"briefTitle": "Immersive Mixed Reality Simulation to Evoke Empathy",
"nctId": "NCT06351397",
"orgStudyIdInfo": {
"id": "75021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in self-reported empathy from before and after the simulation"
}
],
"secondaryOutcomes": [
{
"measure": "Satisfaction of Design Features of the Simulation"
},
{
"measure": "Evaluation of the CHARM system's usability"
},
{
"measure": "Evaluation of the CHARM system's ergonomics"
}
]
},
"sponsorCollaboratorsModule": {
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"name": "Stanford University"
}
},
"statusModule": {
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"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
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"date": "2025-06-30"
},
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"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "miRNA detection test"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants."
},
"designModule": {
"designInfo": {
"allocation": null,
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"observationalModel": "COHORT",
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},
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},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform",
"nctId": "NCT06351384",
"orgStudyIdInfo": {
"id": "20230744",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"name": "Sir Run Run Shaw Hospital"
}
},
"statusModule": {
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"date": "2025-12-31"
},
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"date": "2024-04-08"
},
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"primaryCompletionDateStruct": {
"date": "2025-10-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Computed Tomography"
},
{
"name": "Erdafitinib"
},
{
"name": "Magnetic Resonance Imaging"
}
]
},
"conditionsModule": {
"conditions": [
"Malignant Solid Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": null,
"country": "United States",
"facility": "ECOG-ACRIN Cancer Research Group",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19103"
}
]
},
"descriptionModule": {
"briefSummary": "This phase II MATCH treatment trial tests how well erdafitinib (JNJ-42756493) works in treating patients with tumors that have FGFR mutations or fusions. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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},
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"primaryPurpose": "TREATMENT",
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},
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},
"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)",
"nctId": "NCT06351371",
"orgStudyIdInfo": {
"id": "NCI-2024-01153",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01153",
"link": null,
"type": "REGISTRY"
},
{
"domain": "ECOG-ACRIN Cancer Research Group",
"id": "EAY131-K2",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "EAY131-K2",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "U10CA180820",
"link": "https://reporter.nih.gov/quickSearch/U10CA180820",
"type": "NIH"
}
]
},
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"primaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "6-month progression-free survival (PFS) rate"
},
{
"measure": "Progression free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
"statusModule": {
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"date": "2024-06-30"
},
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},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-06-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sculptra treatment"
},
{
"name": "Restylane Treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Photoaging",
"Weight Loss",
"Skin Laxity",
"Photodamaged Skin",
"Volume Deficiency of the Midface"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Washington",
"contacts": null,
"country": "United States",
"facility": "Somenek + Pittman MD: Advanced Plastic Surgery",
"geoPoint": {
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},
"state": "District of Columbia",
"status": "ENROLLING_BY_INVITATION",
"zip": "20037"
},
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Paul Lorenc, MD",
"phone": "212-472-2900",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Allison Bonugli",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Paul Z Lorenc, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Lorenc Aesthetic Plastic Surgery Center",
"geoPoint": {
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"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10028"
}
]
},
"descriptionModule": {
"briefSummary": "Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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},
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},
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},
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],
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},
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"maximumAge": "65 Years",
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies",
"nctId": "NCT06351358",
"orgStudyIdInfo": {
"id": "GLI.04.US.SL.036",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Change in skin hydration from baseline"
},
{
"measure": "Change in skin radiance from baseline"
},
{
"measure": "Change in skin elasticity from baseline"
},
{
"measure": "Change in skin thickness from baseline"
}
],
"secondaryOutcomes": [
{
"measure": "Subject Treatment Satisfaction"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Galderma R&D"
}
},
"statusModule": {
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"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
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"date": "2024-10-31"
},
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"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "129Xe Hyperpolarized"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Hypertension",
"Pulmonary Arterial Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": null,
"country": "United States",
"facility": "Duke University Medical Center",
"geoPoint": {
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"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27710"
}
]
},
"descriptionModule": {
"briefSummary": "Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH)."
},
"designModule": {
"designInfo": {
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
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},
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},
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"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Sox-PH",
"briefTitle": "129 Xenon Imaging in Patients Treated With Sotatercept",
"nctId": "NCT06351345",
"orgStudyIdInfo": {
"id": "Pro00115215",
"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Xenon MRI Red Blood Cell (RBC) percentage"
},
{
"measure": "Change in cardiogenic oscillation amplitudes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Merck Sharp & Dohme LLC"
}
],
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"class": "OTHER",
"name": "Bastiaan Driehuys"
}
},
"statusModule": {
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"date": "2025-08-01"
},
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"date": "2024-04-08"
},
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"date": "2025-08-01"
},
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"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Azenosertib"
},
{
"name": "Carboplatin"
},
{
"name": "Pembrolizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Breast Cancer Female",
"Triple Negative Breast Cancer",
"Hormone Receptor Negative Malignant Tumor Breast Triple",
"HER2-negative Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
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{
"email": "[email protected]",
"name": "Filipa Lynce, MD",
"phone": "617-632-3800",
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},
{
"email": null,
"name": "Filipa Lynce, MD",
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}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
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"zip": "02215"
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]
},
"descriptionModule": {
"briefSummary": "This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib (ZN-C3) in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer.The names of the study drugs involved in this study are:* Azenosertib (a type of WEE1 inhibitor)* Carboplatin (a type of platinum compound)* Pembrolizumab (a type of monoclonal antibody)"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)",
"nctId": "NCT06351332",
"orgStudyIdInfo": {
"id": "24-005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants Experiencing Dose Limiting Toxicity (DLT)"
},
{
"measure": "Maximum Tolerated Dose (MTD)"
},
{
"measure": "Objective Response Rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical Beneficial Rate (CBR)"
},
{
"measure": "Median Progression Free Survival (PFS)"
},
{
"measure": "Median Overall Survival (OS)"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Grade 3-5 Treatment-Related Toxicity Rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Merck Sharp & Dohme LLC"
},
{
"name": "Zentalis Pharmaceuticals"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Filipa Lynce, MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SVM model"
}
]
},
"conditionsModule": {
"conditions": [
"Benign and Malignant Lymph Nodes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zhengzhou",
"contacts": null,
"country": "China",
"facility": "Department of Respiratory and Critical Care Medicine",
"geoPoint": {
"lat": 34.75778,
"lon": 113.64861
},
"state": "Henan",
"status": null,
"zip": "450000"
}
]
},
"descriptionModule": {
"briefSummary": "ABSTRACT Background and objective: To establish a ultrasound radiomics machine learning model based on endobronchial ultrasound (EBUS)to assistdoctors in distinguishing between benign and malignant diagnoses ofmediastinal and hilar lymph nodes.Methods: The clinical and ultrasonic image data of 197 patients wereretrospectively analyzed. The radiomics features were extracted by EBUS.based radiomics and dimensionality reduction was performed on thesefeatures by the least absolute shrinkage and selection operator (LASSO)EBUS-based radiomics model was established by support vector machine(SVM).205 lesions were randomly divided into a training group (n=143)and a validation group (n=62). The diagnostic efficiency was evaluated byreceiver operating characteristic (ROC).Results: A total of 13 stable features with non-zero coefficients wereselected. The support vector machine (SV) model exhibited promisingperformance in both the training and verification groups. In the traininggroup, the SVM model achieved an area under the curve (AUC) of 0.892(95% CI: 0.885-0.899), with an accuracy of 85.3%, sensitivity of 93.2%and specificity of 79.8%.In the verification group, the SVM modeldemonstrated an AUC of 0.906 (95% C: 0.890-0.923),along with anaccuracy of 74.2%,sensitivity of 70.3%, and specificity of 74.1% Conclusion:EBUS-based radiomics model can be used to differentiatemediastinal and hilar benign and malignant lymph nodes. The SVM modeldemonstrates superiority and holds potential as a diagnostic tool in clinical practice"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 197,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Endobronchial Ultrasound-based SVM Model for Differentiating Benign and Malignant Mediastinal and Hilar Lymph Nodes",
"nctId": "NCT06351319",
"orgStudyIdInfo": {
"id": "HenanPPH-zhangquncheng",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "AUC"
},
{
"measure": "accuracy"
},
{
"measure": "sensitivity"
},
{
"measure": "specificity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Quncheng Zhang"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thioguanine (Tabloid ®)"
},
{
"name": "DecitabineCedazuridine (Inqovi ®)"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Myeloid Leukemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Research Nurse Navigator",
"phone": "212-342-5162",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joseph G. Jurcic, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Columbia University",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10032"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory).This is a \"phase II trial with a safety lead-in.\" The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "DEC-C and Thioguanine for R/R AML",
"nctId": "NCT06351306",
"orgStudyIdInfo": {
"id": "AAAU5915",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Composite Complete Remission (CRc) Rate"
}
],
"secondaryOutcomes": [
{
"measure": "Duration of Remission"
},
{
"measure": "Time to Complete Remission (CR)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Joseph Jurcic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Defyne Treatment in Nasolabial Fold"
},
{
"name": "RHA3 Treatment in Nasolabial Fold"
}
]
},
"conditionsModule": {
"conditions": [
"Wrinkle"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santa Rosa Beach",
"contacts": null,
"country": "United States",
"facility": "The Aesthetic Clinique",
"geoPoint": {
"lat": 30.39603,
"lon": -86.22883
},
"state": "Florida",
"status": null,
"zip": "32459"
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomized, split-face, subject-blinded, comparative study. Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization.4 weeks after the initial treatment, subjects will receive optional touch-up on one side or both sides at the Investigator's discretion for optimal correction.Subjects to return to the site at Month 3, 6, and 12 for follow-ups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Subjects will be blinded to the treatment assignment, in which randomization and treatment side will be concealed in order to avoid bias in subjective assessment. The clinic staff will mask the product identity by covering the packaging and product name (e.g., using tape, marker, wipe-out, etc.) so that it is not visible to the subjects. The Investigator will not be blinded.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction",
"nctId": "NCT06351293",
"orgStudyIdInfo": {
"id": "GLI.04.US.SL.034",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Comparison of Nasolabial Fold Ultrasounds"
}
],
"secondaryOutcomes": [
{
"measure": "Volume Change Imaging Analysis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Galderma R&D"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standardised Physiotherapy Plan"
}
]
},
"conditionsModule": {
"conditions": [
"Laparotomy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "[email protected]",
"name": "Suman Sheraz, PhD*",
"phone": "03335646361",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sana Nasir, MS-CPPT*",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Suman Sheraz, PhD*",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Fauji Foundation Hospital",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": null,
"zip": "00666"
}
]
},
"descriptionModule": {
"briefSummary": "A laparotomy is a surgical technique, the increasing rate of this surgical interventions and the subsequent need to evaluate the post-surgical recovery and rehabilitation process comprehensively. This study aims to provide essential insights into the reliability, validity, and responsiveness of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery",
"nctId": "NCT06351280",
"orgStudyIdInfo": {
"id": "Sana Nasir Zaidi",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6MWT (Six-Minute Walk Test)"
},
{
"measure": "5 Times Sit to Stand"
},
{
"measure": "2MWT (Two-Minute Walk Test)"
},
{
"measure": "Timed Up and GO (TUG)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Core Stability Exercises"
},
{
"name": "Back Strengthening exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Ghulam Fatima, PhD*",
"phone": "+923034073057",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Society Hospital Nabipura",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "54700"
}
]
},
"descriptionModule": {
"briefSummary": "The study will be a Randomized controlled trial to check the combined effects of Core Stability Exercises with and without Back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females Non-probability convenience sampling technique will be used, subject following eligibility criteria from Society Hospital Nabipura Lahore will be randomly allocated in two groups. Group A participants will be given core stability exercises with back strengthening exercises, Group B participants will be given core stability exercises for 4 weeks. Assessment will be done via, Numeric Pain Rating Scale, Oswestry disability index questionnaire and Back pain Functional Scale."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain.",
"nctId": "NCT06351267",
"orgStudyIdInfo": {
"id": "REC/RCR & AHS/23/0568",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric Pain Rating Scale"
},
{
"measure": "Oswestry Disability Index Questionnaire"
},
{
"measure": "Back Pain Functional Scale (BPFS):"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sine sound waves"
},
{
"name": "Kinesthetic exercises"
},
{
"name": "Sine sound waves plus kinesthetic exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Spondylosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Muhammad Sanaullah",
"phone": "03224819253",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Riphah international university",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis",
"nctId": "NCT06351254",
"orgStudyIdInfo": {
"id": "REC/RCR & AHS/23/01101nayab",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "NPRS"
},
{
"measure": "Inclinometer"
},
{
"measure": "Goniometer"
},
{
"measure": "NDI"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Perfusion Index",
"Pleth Variability Index"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bornova",
"contacts": null,
"country": "Turkey",
"facility": "Nursen Karaca",
"geoPoint": {
"lat": 38.47921,
"lon": 27.2399
},
"state": "İzmir",
"status": null,
"zip": "35040"
}
]
},
"descriptionModule": {
"briefSummary": "BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia.METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 53,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "25 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum",
"nctId": "NCT06351241",
"orgStudyIdInfo": {
"id": "E.222840/280",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ege University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Conization plus nodal evaluation"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": null,
"country": "Italy",
"facility": "Fondazione IRCCS Istituto Nazionale dei Tumori di Milano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": "Lombardia",
"status": null,
"zip": "20133"
}
]
},
"descriptionModule": {
"briefSummary": "The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.The primary aim is to report outcomes of those patients.Other aims included:1. Evaluation about the effectiveness of different treatment modalities;2. Evaluation of outcomes according to different stages of disease;3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Eternity",
"briefTitle": "Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project",
"nctId": "NCT06351228",
"orgStudyIdInfo": {
"id": "5720",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "oncological outcomes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Istituto Nazionale dei Tumori, Milano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Methadone group"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Arthroscopic Knee Repair",
"Arthroscopic Hip Repair"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Alexander Chen, M.D.",
"phone": "323-442-7400",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Abigail Song, B.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Benjamin Liu, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Paul Lee, M.D., M.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "USC Healthcare Consultation 3",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90033"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.Participants will:Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PO Methadone Ortho Outpatient",
"nctId": "NCT06351215",
"orgStudyIdInfo": {
"id": "APP-24-00554",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Post-op opioid usage"
}
],
"secondaryOutcomes": [
{
"measure": "Post-op Pain Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Keck School of Medicine of USC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Abdominal massage"
}
]
},
"conditionsModule": {
"conditions": [
"Preterm Birth Complication",
"Digestive System Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Clermont-Ferrand",
"contacts": null,
"country": "France",
"facility": "CHU clermont-ferrand",
"geoPoint": {
"lat": 45.77966,
"lon": 3.08628
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication.At the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective.In this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively.The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Days",
"minimumAge": "3 Days",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PREMABDO",
"briefTitle": "Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms",
"nctId": "NCT06351202",
"orgStudyIdInfo": {
"id": "RBGP 2023 COLNE",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A02256-39",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical Abdominal assessment scale for Preterm infants score (ECAP score)"
}
],
"secondaryOutcomes": [
{
"measure": "Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes"
},
{
"measure": "Weight gain of preterm infants with feeding intolerance"
},
{
"measure": "Duration to reach the full ration"
},
{
"measure": "Duration of hospitalization in level 3"
},
{
"measure": "6-hour fasting windows"
},
{
"measure": "Incidence of occurrence of necrotizing enterocolitis"
},
{
"measure": "Evolution of digestive tolerance over time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Clermont-Ferrand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Observation"
}
]
},
"conditionsModule": {
"conditions": [
"Hyperextension Spasms",
"Involuntary Movements"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This study compares two modes of the NETTI wheelchair (dynamic or sitting) for patients with hyperkinetic syndromes, to discover which mode is the most comfortable and best suited to these patients.It is a prospective, single-center pilot study comparing two medical devices evaluated using SCED (Single Case Experimental Design) ABAB methodology: NETTI DYNAMIC chair in dynamic mode (intervention group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 5,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DYNAMIC SYSTEM",
"briefTitle": "NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ?",
"nctId": "NCT06351189",
"orgStudyIdInfo": {
"id": "CIVI/2022/AD-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Sex"
},
{
"measure": "Age"
},
{
"measure": "Height"
},
{
"measure": "Weight"
},
{
"measure": "Body mass index"
}
],
"primaryOutcomes": [
{
"measure": "Forward slippage in static mode (PHASE A)"
},
{
"measure": "Forward slippage in static mode (PHASE A)"
},
{
"measure": "Forward slippage in static mode (PHASE A)"
},
{
"measure": "Forward slippage in static mode (PHASE A)"
},
{
"measure": "Forward slippage in dynamic mode (PHASE B)"
},
{
"measure": "Forward slippage in dynamic mode (PHASE B)"
},
{
"measure": "Forward slippage in dynamic mode (PHASE B)"
},
{
"measure": "Forward slippage in dynamic mode (PHASE B)"
}
],
"secondaryOutcomes": [
{
"measure": "Peak force in static mode (PHASE A)"
},
{
"measure": "Peak force in static mode (PHASE A)"
},
{
"measure": "Peak force in static mode (PHASE A)"
},
{
"measure": "Peak force in static mode (PHASE A)"
},
{
"measure": "Peak force in dynamic mode (PHASE B)"
},
{
"measure": "Peak force in dynamic mode (PHASE B)"
},
{
"measure": "Peak force in dynamic mode (PHASE B)"
},
{
"measure": "Peak force in dynamic mode (PHASE B)"
},
{
"measure": "Maximum downward force in static mode (PHASE A)"
},
{
"measure": "Maximum downward force in static mode (PHASE A)"
},
{
"measure": "Maximum downward force in static mode (PHASE A)"
},
{
"measure": "Maximum downward force in static mode (PHASE A)"
},
{
"measure": "Maximum downward force in dynamic mode (PHASE B)"
},
{
"measure": "Maximum downward force in dynamic mode (PHASE B)"
},
{
"measure": "Maximum downward force in dynamic mode (PHASE B)"
},
{
"measure": "Maximum downward force in dynamic mode (PHASE B)"
},
{
"measure": "Patient's comfort in static mode (PHASE A)"
},
{
"measure": "Patient's comfort in static mode (PHASE A)"
},
{
"measure": "Patient's comfort in static mode (PHASE A)"
},
{
"measure": "Patient's comfort in static mode (PHASE A)"
},
{
"measure": "Patient's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Patient's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Patient's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Patient's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Caregiver's comfort in static mode (PHASE A)"
},
{
"measure": "Caregiver's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Caregiver's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Caregiver's comfort in dynamic mode (PHASE B)"
},
{
"measure": "Number of repositionings required in static mode (PHASE A)"
},
{
"measure": "Number of repositionings required in static mode (PHASE A)"
},
{
"measure": "Number of repositionings required in static mode (PHASE A)"
},
{
"measure": "Number of repositionings required in static mode (PHASE A)"
},
{
"measure": "Number of repositionings required in dynamic mode (PHASE B)"
},
{
"measure": "Number of repositionings required in dynamic mode (PHASE B)"
},
{
"measure": "Number of repositionings required in dynamic mode (PHASE B)"
},
{
"measure": "Number of repositionings required in dynamic mode (PHASE B)"
},
{
"measure": "Discomfort perceived by the caregiver in static mode (PHASE A)"
},
{
"measure": "Discomfort perceived by the caregiver in static mode (PHASE A)"
},
{
"measure": "Discomfort perceived by the caregiver in static mode (PHASE A)"
},
{
"measure": "Discomfort perceived by the caregiver in static mode (PHASE A)"
},
{
"measure": "Discomfort perceived by the caregiver in dynamic mode (PHASE B)"
},
{
"measure": "Discomfort perceived by the caregiver in dynamic mode (PHASE B)"
},
{
"measure": "Discomfort perceived by the caregiver in dynamic mode (PHASE B)"
},
{
"measure": "Discomfort perceived by the caregiver in dynamic mode (PHASE B)"
},
{
"measure": "Safety as perceived by the caregiver/carer in static mode (PHASE A)"
},
{
"measure": "Safety as perceived by the caregiver/carer in static mode (PHASE A)"
},
{
"measure": "Safety as perceived by the caregiver/carer in static mode (PHASE A)"
},
{
"measure": "Safety as perceived by the caregiver/carer in static mode (PHASE A)"
},
{
"measure": "Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)"
},
{
"measure": "Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)"
},
{
"measure": "Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)"
},
{
"measure": "Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)"
},
{
"measure": "Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Nīmes"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Clinical tests"
},
{
"name": "Biochemical tests"
},
{
"name": "DXA scan with TBS and VFA"
},
{
"name": "AGEReader"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 1",
"Bone Health",
"Bone Loss",
"Bone Diseases, Metabolic",
"Hyperglycaemia Due to Type 1 Diabetes Mellitus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": null,
"country": "Canada",
"facility": "Institut de recherches cliniques de Montréal (IRCM)",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H2W 1R7"
},
{
"city": "Quebec City",
"contacts": null,
"country": "Canada",
"facility": "Centre de recherche du CHU de Québec-Université Laval",
"geoPoint": {
"lat": 46.81228,
"lon": -71.21454
},
"state": "Quebec",
"status": null,
"zip": "G1V 4G2"
}
]
},
"descriptionModule": {
"briefSummary": "Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 163,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DenSiFy cohort",
"briefTitle": "Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes",
"nctId": "NCT06351176",
"orgStudyIdInfo": {
"id": "2024-6819",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Areal bone mineral density at the femoral neck, g/cm2"
},
{
"measure": "Areal bone mineral density at the femoral neck, T-Score"
},
{
"measure": "Areal bone mineral density at the femoral neck, Z-Score"
},
{
"measure": "Areal bone mineral density at the total hip, g/cm2"
},
{
"measure": "Areal bone mineral density at the total hip, T-score"
},
{
"measure": "Areal bone mineral density at the total hip, Z-score"
},
{
"measure": "Areal bone mineral density at the spine, g/cm2"
},
{
"measure": "Areal bone mineral density at the spine, T-Score"
},
{
"measure": "Areal bone mineral density at the spine, Z-score"
},
{
"measure": "Areal bone mineral density at the distal third of radius, g/cm2"
},
{
"measure": "Areal bone mineral density at the distal third of radius, T-score"
},
{
"measure": "Areal bone mineral density at the distal third of radius, Z-score"
},
{
"measure": "Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless)"
},
{
"measure": "Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture"
},
{
"measure": "Lean mass (arm, leg, trunk, android, gynoid and total) (g)"
},
{
"measure": "Fat mass (arm, leg, trunk, android, gynoid and total) (g)"
},
{
"measure": "C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL)"
},
{
"measure": "Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL)"
},
{
"measure": "Osteocalcin (ng/mL)"
},
{
"measure": "Sclerostin (pmol/mL)"
},
{
"measure": "Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL)"
},
{
"measure": "Change in osteocalcin (ng/mL)"
},
{
"measure": "Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL)"
},
{
"measure": "Change in sclerostin (pmol/mL)"
},
{
"measure": "Skin advanced glycation end-products (AGEs) (arbitrary units)"
},
{
"measure": "Glycated hemoglobin (HbA1c, %)"
},
{
"measure": "Fasting glucose (mmol/L)"
},
{
"measure": "Complete blood count"
},
{
"measure": "Thyroid-stimulating hormone (TSH) (mU/L)"
},
{
"measure": "Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L)"
},
{
"measure": "Creatinine (umol/L)"
},
{
"measure": "Microalbuminuria (mg/mmol)"
},
{
"measure": "Liver enzymes (AST, ALT) (U/L)"
},
{
"measure": "Calcium (mmol/L)"
},
{
"measure": "Albumine (g/L)"
},
{
"measure": "Phosphate (mmol/L)"
},
{
"measure": "25-hydroxyvitamin D3 (nmol/L)"
},
{
"measure": "Parathormone (PTH) (ng/L)"
},
{
"measure": "Antitransglutaminase antibodies (U/mL)"
},
{
"measure": "Immunoglobulin A (IgA) (g/L)"
},
{
"measure": "Insulin like growth factor-1 (IGF-1) (ng/mL)"
},
{
"measure": "Follicle stimulating hormone (FSH, women) (U/L)"
},
{
"measure": "Total testosterone (men) (nmol/L)"
},
{
"measure": "Sex hormone-binding globulin (SHBG, men) (nmol/L)"
}
],
"primaryOutcomes": [
{
"measure": "Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2"
}
],
"secondaryOutcomes": [
{
"measure": "Change in areal bone mineral density (aBMD) at the spine in g/cm2"
},
{
"measure": "Change in areal bone mineral density (aBMD) at the total hip in g/cm2"
},
{
"measure": "Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2"
},
{
"measure": "Change in Trabecular bone score (TBS) (unitless)"
},
{
"measure": "Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years"
},
{
"measure": "Glycemic control, assessed with skin advanced glycation end products (AGEs)"
},
{
"measure": "Presence of a microvascular complication (neuropathy, nephropathy, retinopathy)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Diabetes Canada"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "CHU de Quebec-Universite Laval"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-12-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Laparoscopic reduction"
},
{
"name": "Transumbilical mini-open reduction"
}
]
},
"conditionsModule": {
"conditions": [
"Intussusception"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hanoi",
"contacts": null,
"country": "Vietnam",
"facility": "The National Hospital of Pediatrics",
"geoPoint": {
"lat": 21.0245,
"lon": 105.84117
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Hanoi",
"contacts": null,
"country": "Vietnam",
"facility": "Vinmec Research Institute of Stem Cell and Gene Technology",
"geoPoint": {
"lat": 21.0245,
"lon": 105.84117
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 181,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "2 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study",
"nctId": "NCT06351163",
"orgStudyIdInfo": {
"id": "1451_03/BVNTW-VNCSKTE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Operating time"
},
{
"measure": "Intraoperative complications"
},
{
"measure": "Immediate postoperative complications"
},
{
"measure": "Time to feed"
},
{
"measure": "Hospital stays"
},
{
"measure": "Recurrence rate"
},
{
"measure": "Long-term complication rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vinmec Research Institute of Stem Cell and Gene Technology"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "National Children's Hospital, Vietnam"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Angiotensin II Injection"
},
{
"name": "0.9% sodium chloride injection"
}
]
},
"conditionsModule": {
"conditions": [
"Vasodilatory Shock"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Yun Long, M.D.",
"phone": "13911608699",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100730"
},
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Xiangdong Guan, M.D.",
"phone": "13802925067",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Sun Yat sen University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510062"
},
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Zhanguo Liu, M.D.",
"phone": "18520711669",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhujiang Hospital of Southern Medical University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510260"
},
{
"city": "Qingyuan",
"contacts": [
{
"email": "[email protected]",
"name": "Jingwen Yang, M.D.",
"phone": "13542498765",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Qingyuan Hospital Affiliated to Guangzhou Medical University",
"geoPoint": {
"lat": 23.7,
"lon": 113.03333
},
"state": "Guangdong",
"status": null,
"zip": "511518"
},
{
"city": "Shantou",
"contacts": [
{
"email": "[email protected]",
"name": "Yongru Chen, M.D.",
"phone": "13411969797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Shantou University Medical College",
"geoPoint": {
"lat": 23.36814,
"lon": 116.71479
},
"state": "Guangdong",
"status": null,
"zip": "515041"
},
{
"city": "Liuzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Guangyu Lv, M.D.",
"phone": "13977210130",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Liuzhou General Hospital",
"geoPoint": null,
"state": "Guangxi",
"status": null,
"zip": "545026"
},
{
"city": "Baoding",
"contacts": [
{
"email": "[email protected]",
"name": "Zhanbiao Yu, M.D.",
"phone": "15188655821",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Affiliated Hospital of Hebei University",
"geoPoint": {
"lat": 38.85111,
"lon": 115.49028
},
"state": "Hebei",
"status": null,
"zip": "050031"
},
{
"city": "Harbin",
"contacts": null,
"country": "China",
"facility": "The First Affiliated Hospital of Harbin Medical University",
"geoPoint": {
"lat": 45.75,
"lon": 126.65
},
"state": "Heilongjiang",
"status": null,
"zip": "150007"
},
{
"city": "Bengbu",
"contacts": [
{
"email": "[email protected]",
"name": "Yongsheng Zheng, M.D.",
"phone": "13955252796",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Bengbu Medical College",
"geoPoint": {
"lat": 32.94083,
"lon": 117.36083
},
"state": "Henan",
"status": null,
"zip": "233099"
},
{
"city": "Luoyang",
"contacts": [
{
"email": "[email protected]",
"name": "Qizhi Fu, M.D.",
"phone": "13837944687",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Henan University of Science and Technology",
"geoPoint": {
"lat": 34.68361,
"lon": 112.45361
},
"state": "Henan",
"status": null,
"zip": "450052"
},
{
"city": "Zhengzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Tongwen Sun, M.D.",
"phone": "13838516916",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Zhengzhou University",
"geoPoint": {
"lat": 34.75778,
"lon": 113.64861
},
"state": "Henan",
"status": null,
"zip": "450052"
},
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "You Shang, M.D.",
"phone": "15972127819",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Union Hospital, Tongji Medical College of huazhong university of science and technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430022"
},
{
"city": "Changsha",
"contacts": [
{
"email": "[email protected]",
"name": "Lina Zhang, M.D.",
"phone": "15874875763",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xiangya Hospital Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": null,
"zip": "140008"
},
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Quan Cao, M.D.",
"phone": "13851992695",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jiangsu Province Hospital",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": "210029"
},
{
"city": "Xi'an",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaochuang Wang, M.D.",
"phone": "13772152935",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Xi'an Jiaotong University",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi",
"status": null,
"zip": "710004"
},
{
"city": "Taiyuan",
"contacts": [
{
"email": "[email protected]",
"name": "Jing Cao, M.D.",
"phone": "13834691242",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Hospital of Shanxi Medical University",
"geoPoint": {
"lat": 37.86944,
"lon": 112.56028
},
"state": "Shanxi",
"status": null,
"zip": "030001"
},
{
"city": "Chengdu",
"contacts": [
{
"email": "[email protected]",
"name": "Yan Kang, M.D.",
"phone": "13808041931",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "West China Hospital of Sichuan University",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "610044"
},
{
"city": "Chengdu",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaobo Huang, M.D.",
"phone": "18140049936",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sichuan Provincial People's Hospital",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "610072"
},
{
"city": "Ürümqi",
"contacts": [
{
"email": "[email protected]",
"name": "Xiangyou Yu, M.D.",
"phone": "13009681003",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Xinjiang Medical University",
"geoPoint": {
"lat": 43.80096,
"lon": 87.60046
},
"state": "Xinjiang",
"status": null,
"zip": "830054"
}
]
},
"descriptionModule": {
"briefSummary": "A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 214,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock",
"nctId": "NCT06351150",
"orgStudyIdInfo": {
"id": "TQG3902-III-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of subjects with blood pressure response at 3 hours after administration of study drug"
}
],
"secondaryOutcomes": [
{
"measure": "Sequential Organ Failure Assessment (SOFA) total score"
},
{
"measure": "Cardiovascular SOFA subscore"
},
{
"measure": "Mortality at Day 7"
},
{
"measure": "Mortality at Day 28"
},
{
"measure": "Proportion of subjects with blood pressure response at 1 hour after administration"
},
{
"measure": "Proportion of subjects with blood pressure response at 2 hours after administration"
},
{
"measure": "Change in background vasoactive agent dose from 0 to 48 hours"
},
{
"measure": "Absolute change in blood lactate from 0 to 3 hours"
},
{
"measure": "Absolute change in blood lactate from 3 to 48 hours"
},
{
"measure": "Absolute change in heart rate from 0 to 3 hours"
},
{
"measure": "Absolute change in heart rate from 3 to 48 hours"
},
{
"measure": "Adverse events (AE)"
},
{
"measure": "Serious adverse events (SAE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Chia Tai Tianqing Pharmaceutical Group Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intravenous administration"
},
{
"name": "Intranasal administration"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Pain Due to Trauma",
"Analgesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amsterdam",
"contacts": [
{
"email": "[email protected]",
"name": "Midas N de Grunt, MD",
"phone": "+31205669111",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Markus W Hollmann, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Amsterdam UMC",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": "Noord-Holland",
"status": "RECRUITING",
"zip": "1105AZ"
}
]
},
"descriptionModule": {
"briefSummary": "Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain",
"nctId": "NCT06351137",
"orgStudyIdInfo": {
"id": "INIV2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time required for administration of analgesic (minutes)"
}
],
"secondaryOutcomes": [
{
"measure": "Total time spent on scene (minutes)"
},
{
"measure": "Time required for obtaining IV access"
},
{
"measure": "Time required preparing IN administration"
},
{
"measure": "Satisfaction of the navy nurse regarding the used route of administration."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease"
}
]
},
"conditionsModule": {
"conditions": [
"Crohn's Disease",
"Irritable Bowel Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Austin",
"contacts": [
{
"email": "[email protected]",
"name": "Michelle Stickler, Associate Vice President, DEd",
"phone": "512-475-6323",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Thomas Street, Executive Director",
"phone": "512 495 5142",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Texas at Austin",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas",
"status": null,
"zip": "78712"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.The main questions it aims to answer are:* BHB supplementation will be feasible and acceptable to patients.* BHB supplementation will be associated with a reduction in systemic inflammation.* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.Participants will:* Take 3 capsules x 3 times per day for 4 weeks.* Document food consumption using a 24-hour food recall questionnaire.* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This will be a prospective, open-label, randomized, two-arm pilot trial of adults",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BHB",
"briefTitle": "Beta-Hydroxybutyrate Feasibility Treating IBS",
"nctId": "NCT06351124",
"orgStudyIdInfo": {
"id": "00005294",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ability to enroll patients who meet the inclusion criteria within the target time frame"
},
{
"measure": "Adherence to proposed study timelines and anticipated study costs"
},
{
"measure": "Patient adherence to the intervention"
}
],
"secondaryOutcomes": [
{
"measure": "Microbial Diversity"
},
{
"measure": "BHB Blood Levels"
},
{
"measure": "Gastrointestinal Symptoms"
},
{
"measure": "Quality of Life"
},
{
"measure": "Clinical Response"
},
{
"measure": "Systemic Inflammation"
},
{
"measure": "Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Texas at Austin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | 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": "NCT06351111",
"orgStudyIdInfo": {
"id": "IRB-24-240",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "nap"
}
]
},
"conditionsModule": {
"conditions": [
"Memory"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "College Park",
"contacts": [
{
"email": "[email protected]",
"name": "Tracy Riggins, Ph.D.",
"phone": "301-405-5905",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Postdoctoral Fellow",
"phone": "301-405-5922",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Maryland",
"geoPoint": {
"lat": 38.98067,
"lon": -76.93692
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "20742"
},
{
"city": "Amherst",
"contacts": [
{
"email": "[email protected]",
"name": "Rebecca MC Spencer, PhD",
"phone": "413-577-6128",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Postdoctoral Fellow",
"phone": "413-545-4831",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Massachusetts",
"geoPoint": {
"lat": 42.36723,
"lon": -72.51852
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "01003"
}
]
},
"descriptionModule": {
"briefSummary": "To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:* Examine neural markers that predict the sleep transition (Aim 1);* Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);* Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)* Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Months",
"minimumAge": "36 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "HSR",
"briefTitle": "Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition",
"nctId": "NCT06351098",
"orgStudyIdInfo": {
"id": "2024579",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Memory"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Massachusetts, Amherst"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Maryland, College Park"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pre-Visit Planner"
},
{
"name": "Pre-Visit Planner + MyChart"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sacramento",
"contacts": [
{
"email": "[email protected]",
"name": "Moon Chen, M.P.H, Ph.D",
"phone": "916-548-3928",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Moon Chen, M.P.H, Ph.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of California, Davis",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California",
"status": "RECRUITING",
"zip": "95817"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to further understand the factors involved in increasing lung cancer screening."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Biostatistician created a randomized table to allocate patient in either intervention 1 or 2.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2869,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ELFE",
"briefTitle": "Enhancing Lung Cancer Screening Through Human-Centered Intervention",
"nctId": "NCT06351085",
"orgStudyIdInfo": {
"id": "1937769-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Lung Cancer Screening"
}
],
"secondaryOutcomes": [
{
"measure": "Completion of Interviews with Staff and Patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Davis"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Analgesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Treviso",
"contacts": [
{
"email": "[email protected]",
"name": "Federico Linassi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Treviso Regional Hospital",
"geoPoint": {
"lat": 45.66673,
"lon": 12.2416
},
"state": "TV",
"status": "RECRUITING",
"zip": "31100"
}
]
},
"descriptionModule": {
"briefSummary": "qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.No trials have compared them, so with this trial authors want to explore the correlations between them."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ANI",
"briefTitle": "Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia",
"nctId": "NCT06351072",
"orgStudyIdInfo": {
"id": "NOXANI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correlation between qNOX and ANI values"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain"
},
{
"measure": "Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Padova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-08"
}
}
} | false | null |
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