protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Resilience training"
}
]
},
"conditionsModule": {
"conditions": [
"Takotsubo Cardiomyopathy",
"Acute Coronary Syndrome",
"Psychological Resilience"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 130,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease",
"nctId": "NCT06332859",
"orgStudyIdInfo": {
"id": "FOR-0022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Resilience scale-13 (RS-13)"
},
{
"measure": "Brief Resilience scale - German Version (BRS)"
}
],
"secondaryOutcomes": [
{
"measure": "European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)"
},
{
"measure": "Patient Health Questionnaire-4 (PHQ-4)"
},
{
"measure": "Maximal incremental exercise test"
},
{
"measure": "Work ability index (WAI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pensionsversicherungsanstalt"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "oral examination"
},
{
"name": "oral examination"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Disease",
"Stroke, Ischemic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Szczecin",
"contacts": null,
"country": "Poland",
"facility": "Pomeranian Medical University in Szczecin",
"geoPoint": {
"lat": 53.42894,
"lon": 14.55302
},
"state": null,
"status": null,
"zip": "70-111"
}
]
},
"descriptionModule": {
"briefSummary": "Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population.The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 118,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "89 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oral Health in Patients Hospitalized Because of Ischemic Stroke",
"nctId": "NCT06332846",
"orgStudyIdInfo": {
"id": "KB-0012/06/10",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Oral health status"
},
{
"measure": "Oral hygiene assessment"
},
{
"measure": "Periodontal status- periodontal pockets"
},
{
"measure": "Periodontal status-tooth mobility"
},
{
"measure": "Periodontal status- bleeding"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pomeranian Medical University Szczecin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Varicose Veins",
"Peripheral Arterial Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Moscow",
"contacts": [
{
"email": "[email protected]",
"name": "Veronika Golovina, MD, PHD",
"phone": "+79776051708",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Veronika Golovina",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": "Pirogov Russian National Research Medical University",
"status": "RECRUITING",
"zip": "109044"
}
]
},
"descriptionModule": {
"briefSummary": "Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery",
"nctId": "NCT06332833",
"orgStudyIdInfo": {
"id": "235",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "availability of saphenous trunks as possible grafts"
}
],
"secondaryOutcomes": [
{
"measure": "presence of varicose veins"
},
{
"measure": "type of previous invasive procedure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pirogov Russian National Research Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Obstructive Airway Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": null,
"country": "Taiwan",
"facility": "National Taiwan University Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": null,
"zip": "100"
}
]
},
"descriptionModule": {
"briefSummary": "The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise",
"nctId": "NCT06332820",
"orgStudyIdInfo": {
"id": "202401226RINB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Inspiratory capacity during exercise"
}
],
"secondaryOutcomes": [
{
"measure": "Change of FEV1 and symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Taiwan University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NGGT002"
}
]
},
"conditionsModule": {
"conditions": [
"Phenylketonurias"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is an rAAV8 based vector carrying a functional copy of the human PAH gene.Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AAV Gene Therapy Clinical Study in Adult Classic PKU",
"nctId": "NCT06332807",
"orgStudyIdInfo": {
"id": "NGGT002-P-2301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence and severity of Adverse Events (AEs)"
},
{
"measure": "Change from baseline in clinical laboratory values"
},
{
"measure": "Change from baseline in 12-lead electrocardiograms (ECGs), vital signsand physical examinations"
},
{
"measure": "Change from baseline in Plasma Phe Concentration"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of sustained plasma Phe concentration of ≤360 μmol/L at Week 12, Week 28, Week 52 and during Year 1 to 5 post dose"
},
{
"measure": "Change from baseline in total protein intake at at Week 28, Week 52 and during Year 1 to 5 post dose"
},
{
"measure": "Change in PKU Profile of Mood States (POMS)"
},
{
"measure": "Change in Phenylketonuria Quality of Life Questionnaire (PKU-QOL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "NGGT (Suzhou) Biotechnology Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "KOKU4PD"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson's Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newcastle upon Tyne",
"contacts": [
{
"email": "[email protected]",
"name": "Gill Barry, PhD",
"phone": "01912277635",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Julia Das",
"phone": "01912373343",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Northumbria University",
"geoPoint": {
"lat": 54.97328,
"lon": -1.61396
},
"state": "Tyne & Wear",
"status": null,
"zip": "NE1 8ST"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).The main aims of the study are to:1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "KOKU4PD",
"briefTitle": "Keep On Keep Up for Parkinson's",
"nctId": "NCT06332794",
"orgStudyIdInfo": {
"id": "H-2201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Usability of the KOKU app"
}
],
"secondaryOutcomes": [
{
"measure": "Executive clock drawing task (CLOX 1, 2) (mean Change from baseline)"
},
{
"measure": "Trail Making Test (mean Change from baseline)"
},
{
"measure": "Freezing of Gait Questionnaire (mean Change from baseline)"
},
{
"measure": "Falls Efficacy scale (mean Change from baseline)"
},
{
"measure": "Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline)"
},
{
"measure": "Mini-BESTest (mean Change from baseline)"
},
{
"measure": "Two minute walk test, single and dual task (mean Change from baseline)"
},
{
"measure": "EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline)"
},
{
"measure": "Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline)"
},
{
"measure": "Multidimensional Fatigue Inventory (MFI) (mean Change from baseline)"
},
{
"measure": "Technology Acceptance questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Manchester"
},
{
"name": "Northumbria Healthcare NHS Foundation Trust"
},
{
"name": "Newcastle University"
},
{
"name": "Reason Digital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Northumbria University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gentamicin"
},
{
"name": "Nitrofurantoin"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent Uti"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intravesical Gentamicin to Prevent Recurrent UTI",
"nctId": "NCT06332781",
"orgStudyIdInfo": {
"id": "2126175",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "urobiome analysis"
},
{
"measure": "urobiome analysis"
}
],
"primaryOutcomes": [
{
"measure": "UTIs"
}
],
"secondaryOutcomes": [
{
"measure": "Patient reported outcome measures"
},
{
"measure": "Patient reported outcome measures"
},
{
"measure": "Patient reported outcome measures"
},
{
"measure": "Patient reported outcome measures"
},
{
"measure": "Patient reported outcome measures"
},
{
"measure": "Patient reported outcome measures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Women and Infants Hospital of Rhode Island"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Respiratory support"
}
]
},
"conditionsModule": {
"conditions": [
"Mechanical Ventilation Complication",
"Weaning Failure",
"Acute Respiratory Distress Syndrome",
"High-flow Oxygenation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Arkhangelsk",
"contacts": null,
"country": "Russian Federation",
"facility": "City hospital # 1",
"geoPoint": {
"lat": 64.5401,
"lon": 40.5433
},
"state": "Arkhangelsk Region",
"status": null,
"zip": "163000"
}
]
},
"descriptionModule": {
"briefSummary": "The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized assignment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients",
"nctId": "NCT06332768",
"orgStudyIdInfo": {
"id": "WEAN_2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Weaning failure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Northern State Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LB-LR1109"
}
]
},
"conditionsModule": {
"conditions": [
"Non-small Cell Lung Cancer(NSCLC)",
"Head and Neck Squamous Cell Carcinoma(HNSCC)",
"Renal Cell Carcinoma(RCC)",
"Urothelial Carcinoma",
"Malignant Melanoma"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose(RP2D) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancer(NSCLC), head and neck squamous cell carcinoma(HNSCC), renal cell carcinoma(RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LB-LR1109",
"briefTitle": "Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors",
"nctId": "NCT06332755",
"orgStudyIdInfo": {
"id": "LG-LRCL001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors"
},
{
"measure": "Incidence of Treatment-Emergent Adverse Events of LB-LR1109"
}
],
"secondaryOutcomes": [
{
"measure": "Preliminary efficacy of LB-LR1109"
},
{
"measure": "Anti-tumor efficacy of LB-LR1109"
},
{
"measure": "Pharmacokinetic profile of LB-LR1109"
},
{
"measure": "Characterize PK of LB-LR1109"
},
{
"measure": "Immunogenicity of LB-LR1109"
},
{
"measure": "Quality of life of participants"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "LG Chem"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Decreased Ovarian Reserve"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Chen Yun",
"phone": "8613675167221",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210023"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 178,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "25 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased",
"nctId": "NCT06332742",
"orgStudyIdInfo": {
"id": "QXZS for DOR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Traditional Chinese medicine syndrome score"
},
{
"measure": "serum sex hormone levels"
},
{
"measure": "serum AMH levels"
},
{
"measure": "transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)"
}
],
"secondaryOutcomes": [
{
"measure": "Seven items of thyroid function"
},
{
"measure": "natural pregnancy rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yun Chen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
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"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "universal exercis unit"
},
{
"name": "functional electrical stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kafr Ash Shaykh",
"contacts": [
{
"email": "[email protected]",
"name": "Mahmoud R Elsharkawy, bachelor",
"phone": "01021417889",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Physical Therapy",
"geoPoint": {
"lat": 31.11174,
"lon": 30.93991
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Summary:Inclusion Criteria:* Children aged four to eight years.* Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.* Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).* Ability to follow verbal commands and instructions.Exclusion Criteria:* Previous neurological or orthopedic surgery in the lower extremities.* Botox injection in the lower extremities within the past six months.* Fixed deformity in the joints of the lower limb.* Genu recarvatum secondary to surgery.* Severe hearing and visual defects.Materials for Subject Selection and Evaluation:* Modified Ashworth Scale for muscle tone assessment.* Gross Motor Functional Classification System (GMFCS) for functional activity classification.* Digital goniometer for measuring the angle of knee hyperextension.* Lafayette Manual Muscle Tester for quantifying muscle strength.Methods:* Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in calf muscles and hip/knee extensors.* Evaluation of gross motor function using the GMFCS.* Assessment of genu recarvatum using a digital goniometer.* Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on hamstrings and tibialis anterior muscles.* Assessment of range of motion in the knee joint using Kinovea software.* Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group (Group A and Group B).Group A Treatment:- Designed physical therapy program combined with pulley therapy for muscle strengthening.Group B Treatment:- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation.The interventions in both groups aim to improve muscle strength, range of motion, and functional abilities in children with cerebral palsy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy",
"nctId": "NCT06332729",
"orgStudyIdInfo": {
"id": "EG,KFS,lab reserach 6",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "muscle strength using muscle tester device"
},
{
"measure": "Range of motion using kinoviea software and digital goniometer"
},
{
"measure": "range of motion for the joint using digital geniometer"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mahmoud Reda Elsharkawy"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time."
}
]
},
"conditionsModule": {
"conditions": [
"Gastrointestinal Tumors，3D Organoids，Drug Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xi'an",
"contacts": [
{
"email": "[email protected]",
"name": "Jianjun Yang",
"phone": "13756154175",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "XijingH",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors",
"nctId": "NCT06332716",
"orgStudyIdInfo": {
"id": "KY20222234",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival（PFS）"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival（OS）"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jianjun Yang,MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Acanthamoeba Keratitis",
"Artificial Intelligence"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 151,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acanthamoeba and Artificial Intelligence",
"nctId": "NCT06332703",
"orgStudyIdInfo": {
"id": "IACA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images."
}
],
"secondaryOutcomes": [
{
"measure": "Correlation assessment between IVCM images and laboratory results."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Ospedale San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "dexamethasone implant"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetic Macular Edema",
"Macular Edema Due to Diabetes Mellitus",
"Retinal Vein Occlusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Stela Vujosevic, MD",
"phone": "+39 02 85 99 4601",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "GAbriele Piccoli",
"phone": "+39 02 85 99 4601",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "MultiMedica IRCCS Multimedica",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20123"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO",
"nctId": "NCT06332690",
"orgStudyIdInfo": {
"id": "514.2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure)"
}
],
"secondaryOutcomes": [
{
"measure": "Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AbbVie"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Multimedica"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "the main genes and expression by comparing the transcriptomic lipidomic profile"
}
]
},
"conditionsModule": {
"conditions": [
"NAFLD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Luca Vittorio Carlo Valenti",
"phone": "02 5503 6595",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20122"
}
]
},
"descriptionModule": {
"briefSummary": "Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "study the cellular and molecular mechanisms of correlation between the SUV420H1/H2 methyltransferase and the progression of liver damage in mice (San Raffaele Institute) and to confirm these findings in human samples and in vitro 3D liver models.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 260,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Target of Suv420h1/2 in Hepatocytes",
"nctId": "NCT06332677",
"orgStudyIdInfo": {
"id": "TERS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the main genes and expression by comparing the transcriptomic lipidomic profile"
},
{
"measure": "the main genes and expression by comparing the transcriptomic lipidomic profile"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
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"date": "2023-03-01"
},
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}
}
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{
"date": "2023-01-26",
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} |
{
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"interventions": [
{
"name": "Early Nutrition Intervention"
}
]
},
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"conditions": [
"Nutrition",
"Cancer Metastatic"
]
},
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"locations": [
{
"city": "Chengdu",
"contacts": [
{
"email": "[email protected]",
"name": "XingChen Peng, Ph.D",
"phone": "+8618980606753",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "West China Hospital, Sichuan Universit",
"geoPoint": {
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"lon": 104.06667
},
"state": "Sichuan",
"status": "RECRUITING",
"zip": "610041"
}
]
},
"descriptionModule": {
"briefSummary": "In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting M1 advanced-stage cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice."
},
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"type": "ESTIMATED"
},
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],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "Early Nutrition Intervention for M1 Stage Cancer Patients",
"nctId": "NCT06332664",
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"id": "2023-2330",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the incidence of cachexia"
}
],
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{
"measure": "overall survival ；progression-free survival"
},
{
"measure": "Physical Fitness Status"
},
{
"measure": "BMI"
},
{
"measure": "Nutritional risk and malnutrition status"
},
{
"measure": "Patient's emotional changes"
},
{
"measure": "Caregiver psychological burden"
},
{
"measure": "Patient's physical, social, and cognitive functioning"
},
{
"measure": "incidence of Sarcopenia"
},
{
"measure": "Nutritional risk and malnutrition status"
},
{
"measure": "Patient's emotional changes"
}
]
},
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"collaborators": null,
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"class": "OTHER",
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},
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"date": "2025-01-01"
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"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Black beans"
},
{
"name": "Milk"
},
{
"name": "Sorghum"
}
]
},
"conditionsModule": {
"conditions": [
"Ageing"
]
},
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"locations": [
{
"city": "Wageningen",
"contacts": [
{
"email": "[email protected]",
"name": "Fenna Hinssen, MSc",
"phone": "+031648043165",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Karen Fransen, MSc",
"phone": "+031648043165",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Wageningen University & Research",
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"lon": 5.66667
},
"state": "Gelderland",
"status": "RECRUITING",
"zip": "6708PB"
}
]
},
"descriptionModule": {
"briefSummary": "The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
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"maskingInfo": {
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},
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"minimumAge": "20 Years",
"sex": "MALE",
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"ADULT",
"OLDER_ADULT"
]
},
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"acronym": "YOMA",
"briefTitle": "Metabolic Availability in Older and Younger Men",
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"id": "NL84684.091.23",
"link": null,
"type": null
},
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},
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{
"measure": "Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method."
}
],
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},
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"collaborators": null,
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"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Tegoprazan 12.5mg"
},
{
"name": "Tegoprazan 25mg"
},
{
"name": "Famotidine 20mg"
}
]
},
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"conditions": [
"Healthy"
]
},
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"locations": [
{
"city": "Busan",
"contacts": null,
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"facility": "Inje University Busan Paik Hospital",
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},
"state": null,
"status": null,
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}
]
},
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},
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"minimumAge": "19 Years",
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]
},
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"id": "IN_APA_124",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
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"measure": "Cmax of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "AUC0-t of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "AUC0-∞ of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "Tmax of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "t1/2β of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "CL/F of tegoprazan"
},
{
"measure": "Vd/F of tegoprazan"
},
{
"measure": "Css,max of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "Css,min of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "Css,avg of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "AUCtau,ss of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "Tmax,ss of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "t1/2β,ss of tegoprazan and tegoprazan's metabolite M1"
},
{
"measure": "CLss/F of tegoprazan"
},
{
"measure": "Vdss/F of tegoprazan"
},
{
"measure": "Accumulation index of tegoprazan"
},
{
"measure": "Fluctuation of tegoprazan"
}
],
"secondaryOutcomes": [
{
"measure": "24-hour, daytime and nighttime mean pH"
},
{
"measure": "24-hour, daytime and nighttime median pH"
},
{
"measure": "24-hour, daytime and nighttime TpH>3(%)"
},
{
"measure": "24-hour, daytime and nighttime TpH>4(%)"
},
{
"measure": "24-hour, daytime and nighttime Δ TpH>3(%)"
},
{
"measure": "24-hour, daytime and nighttime Δ TpH>4(%)"
},
{
"measure": "24-hour, daytime and nighttime Δ mean pH"
},
{
"measure": "24-hour, daytime and nighttime Δ median pH"
}
]
},
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"class": "INDUSTRY",
"name": "HK inno.N Corporation"
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"date": "2024-07-31"
},
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},
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},
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"startDateStruct": {
"date": "2024-03-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Brain quantitative magnetic resonance imaging"
}
]
},
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Troina",
"contacts": [
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"email": null,
"name": "Maurizio Elia",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Associazione Oasi Maria SS Troina",
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"lon": 14.59605
},
"state": "Enna",
"status": "RECRUITING",
"zip": "94018"
},
{
"city": "Milano",
"contacts": [
{
"email": null,
"name": "Cristina Baldoli",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20132"
},
{
"city": "Milano",
"contacts": [
{
"email": null,
"name": "Stefania Magri",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Istituto Neurologico Carlo Besta",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20133"
}
]
},
"descriptionModule": {
"briefSummary": "Inherited leukoencephalopathies are a broad spectrum of genetically determined disorders, characterized by specific involvement of the white matter of the central nervous system. These pathologies are almost as common as other acquired white matter disorders, such as acute disseminated encephalomyelitis and multiple sclerosis. The onset can occur at any age, from prenatal life to adulthood, and the clinical picture is mostly progressive, but can also be non-evolving or, rarely, improve over time. Thanks to new diagnostic approaches, including next-generation genetic sequencing and recognition of magnetic resonance imaging patterns, in recent years the investigators have witnessed a significant increase in the number of genetically defined leukoencephalopathies. However, despite advances in genetic studies, inherited leukoencephalopathies include a large number of inherited white matter diseases in children and adults and remain of unknown cause in many patients (about 40%). This significant percentage of cases of unknown etiology represents a major challenge for public health, both in prognostic terms and, consequently, economically. However, even in leukoencephalopathies of genetically determined cause, the absence of specific biomarkers can be a limiting factor in the design and execution of clinical studies in search of promising therapies. As in other fields of neurology, the integration of clinical and genetic data with brain MRI data plays a fundamental role in the diagnostics of subjects affected by these pathologies. Currently, the methodologies commonly used in magnetic resonance imaging are qualitative, and evaluate brain lesions through the contrast between white and gray matter. The lack of specific biomarkers is therefore a limiting factor in the design of therapeutic challenges. In this regard, the development of new multiparametric quantitative magnetic resonance imaging (qMRI) methods could allow the investigators to identify new biomarkers to assess the etiology behind leukodystrophies, increasing diagnostic power and understanding the progression or improvement of leukoencephalopathy for both future trials and existing therapies. In this perspective, recent rapid \"transient-state\" magnetic resonance imaging methods, such as MR Fingerprinting (MRF), have proven effective in efficiently separating different components of brain tissue. These techniques consist of rapid and highly undersampled acquisitions performed by continuously changing the MR sequence parameters, thus obtaining a signal evolution that is unique for each combination of underlying tissue properties. Furthermore, if these techniques have already shown their validity at 3 Tesla, they could be even more informative in 7T MRI where the use of qMRI could provide more details thanks to the high image resolution.The project's objective is to evaluate and validate new and innovative quantitative magnetic resonance imaging (qMRI) methodologies at both clinical and ultra-high fields in inherited leukodystrophies and those of unknown etiology.This is a national, multi-institutional, multicenter exploratory study on the potential identification and predictability of early structural and metabolic markers in quantitative MRI at 3T and 7T in the diagnosis and follow-up of leukodystrophy and leukoencephalopathy in adults and during development.The study will include multiple sub-studies:1. A cross-sectional study in leukoencephalopathies at clinical fields.2. A longitudinal study in leukoencephalopathies at 3T: natural history and therapy outcomes.3. A cross-sectional and longitudinal study at 7T: The added value of ultra-high-field Magnetic Resonance Imaging in leukoencephalopathies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
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"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "FIABA",
"briefTitle": "The Fingerprinting of Inherited Leukoencephalopathies: A New Brain Imaging, Genetic and Clinical Assessment",
"nctId": "NCT06332625",
"orgStudyIdInfo": {
"id": "PNRR-MR1-2022-12375648",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quantitative Susceptibilty Mapping, QSM"
},
{
"measure": "Fractional Anisotropy, FA"
},
{
"measure": "Mean Diffusivity, MD"
},
{
"measure": "Relaxation times"
},
{
"measure": "Myelin water fraction, MWF"
},
{
"measure": "Neuromotor skills"
},
{
"measure": "Neuromotor skills"
}
],
"secondaryOutcomes": [
{
"measure": "Epilepsy symptoms"
},
{
"measure": "Electroencephalography features"
},
{
"measure": "Neuro-psychological profile"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Oasi Research Institute-IRCCS"
},
{
"name": "Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta"
},
{
"name": "IRCCS Ospedale San Raffaele"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Fondazione Stella Maris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Metformin Hydrochloride"
},
{
"name": "betamethasone dipropionate"
},
{
"name": "Pentoxifylline"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Submucous Fibrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karachi",
"contacts": [
{
"email": "[email protected]",
"name": "Afifa Razi, FCPS OMFS",
"phone": "+92 300 2247389",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Shumaila Usman, PhD",
"phone": "+92 336 1882779",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Afifa Razi, FCPS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Shumaila Usman, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Yamna Khurshid, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Ziauddin University",
"geoPoint": {
"lat": 24.8608,
"lon": 67.0104
},
"state": "Sindh",
"status": null,
"zip": "74700"
}
]
},
"descriptionModule": {
"briefSummary": "OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.Groups:* Metformin-treated* Control (untreated)* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "It would be a single-blind, placebo-controlled design",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MROSF",
"briefTitle": "Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial",
"nctId": "NCT06332612",
"orgStudyIdInfo": {
"id": "8420224AROM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cell Viability"
},
{
"measure": "Cytotoxicity"
},
{
"measure": "Morphological Changes Cell Shape"
},
{
"measure": "Morphological Change Cell Density"
},
{
"measure": "Morphological Change Extracellular Matrix (ECM) Structure"
},
{
"measure": "Cell Migration Assays"
},
{
"measure": "Cell Invasion Assays"
},
{
"measure": "Apoptosis Analysis"
},
{
"measure": "Assess Signaling pathway with optimal metformin concentration"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical Oral Mucosal Characteristics"
},
{
"measure": "Patient Burning sensation pain"
},
{
"measure": "Patient Mouth Opening"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ziauddin University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BQT"
},
{
"name": "EBM4M4"
},
{
"name": "EBM3M3"
},
{
"name": "EBM2M4"
},
{
"name": "EBM2M3"
}
]
},
"conditionsModule": {
"conditions": [
"Helicobacter Pylori Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Yu Huang",
"phone": "0198621791879",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Renji Hospital, School of Medicine, Shanghai Jiao Tong University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "200127"
}
]
},
"descriptionModule": {
"briefSummary": "Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Minocycline for Helicobacter Pylori Rescue Treatment",
"nctId": "NCT06332599",
"orgStudyIdInfo": {
"id": "rjhy20240001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Helicobacter pylori eradication rate"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of adverse effects"
},
{
"measure": "Compliance rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Jiao Tong University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diversified teaching"
}
]
},
"conditionsModule": {
"conditions": [
"Triage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": null,
"country": "Taiwan",
"facility": "Taiwan",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": null,
"zip": "Taiwan"
}
]
},
"descriptionModule": {
"briefSummary": "\"Triage\" is the first process of emergency treatment. It is mainly based on the severity of the disease and the appropriate allocation of limited people, time, place, and medical resources. It is very important and related to the quality of medical care. In order to accurately judge the severity of patients, reduce the individual errors of artificial memory and increase the consistency of the judgment of triage levels, the new emergency five-level triage classification standard (Taiwan Triage and Acuity Scale) was implemented in 2010. , TTAS), the purpose is to allocate medical resources in the most appropriate manner at the appropriate time. It has been revised many times so far, so correct injury classification can maximize the safety of people's lives. This article reviews the relevant literature and finds that to have an efficient injury classification so that each patient receives appropriate medical allocation, an organized, effective and systematic injury inspection process structure is needed to enable the injury nurse to perform correct inspections. Injury skills and cognition should be actively promoted, and this policy must require traumatization nurses to continuously update their traumatization cognition and skills, and must also continue to conduct regular assessments and reviews to continuously improve the quality of traumatization grading by traumatization nurses. It can be seen that triage nurses must have skills, knowledge, attitudes and systems to improve the accuracy of triage levels and ensure the treatment of patients who need priority treatment . Therefore, this study can be used to understand the learning effectiveness of trauma care before and after diversified teaching, which can be used as a basis for teaching new trauma care nurses."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Learning Effect of Applying Diversified Teaching in Emergency Injury Classification -Taking the Emergency Nurse of a Regional Hospital in Yunlin County as an Example",
"nctId": "NCT06332586",
"orgStudyIdInfo": {
"id": "202311087RINA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improving the injury diagnosis ability of triage diagnosis nurses through diversified teaching"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Taiwan University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-04-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Onco-sexology support"
},
{
"name": "Onco-sexology support"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Marseille",
"contacts": [
{
"email": "[email protected]",
"name": "Myriam BENNANI",
"phone": "0413428351",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Européen Marseille",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Onco-sexology as a supportive care for patients treated for cancer is still rarely discussed or even non-existent in 2022. However, it's recommended to integrate the preservation of sexual health throughout the treatment and post-cancer process, given the impact of cancer, treatments and the importance of intimate life for a majority of patients.Onco-sexology is one of the supportive care services validated by The French National Cancer Institute (INCa). It is also an objective of the 2014-2019 cancer plan and the 2017-2030 national sexual health strategy plan.Although sexuality is one of the fundamental needs of the human being, including in the case of a chronic disease or cancer diagnosis, the lack of training of health professionals to deal with intimate life, the difficulty to exchange on this subject between caregivers and patients, the lack of financial support for onco-sexology consultations, are all obstacles to the global management of oncology patients. However, it's a request from patients to be able to discuss the subject in an intimate way with a professional.While onco-sexology is already recommended as supportive care, a study on the impact of the delay in the management of sexual difficulties on quality of life could provide a sufficient level of evidence to change the practices and the care pathway of the oncology patient. Our objective is to study whether early management in onco-sexology has an impact on quality of life compared to late management (ie onco-sexology consultation before vs. after introduction of systemic oncological treatment)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 168,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SEXOCARE",
"briefTitle": "Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer",
"nctId": "NCT06332573",
"orgStudyIdInfo": {
"id": "24-06",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire"
},
{
"measure": "Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men)"
},
{
"measure": "Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men)"
},
{
"measure": "Evaluation of the body image, at the end of the onco-sexology support through the \"Body Image Scale \"."
},
{
"measure": "Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the \"Body Image Scale\"."
},
{
"measure": "Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care"
},
{
"measure": "Rate of patients expressing sexual difficulties during the consultation of announcement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hôpital Européen Marseille"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anti-inflammatory diet (DI)"
},
{
"name": "Cognitive behavioral therapy (CBT)"
}
]
},
"conditionsModule": {
"conditions": [
"Endometriosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nijmegen",
"contacts": [
{
"email": null,
"name": "E Huijs, B",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "A.W. Nap, MD PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Radboud University Medical Center",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome.Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy.Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 170,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "17 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PEARL",
"briefTitle": "Pain in Endometriosis And the Relation to Lifestyle",
"nctId": "NCT06332560",
"orgStudyIdInfo": {
"id": "NL86247.091.24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change in sleep quality assessed by the PSQI"
},
{
"measure": "Change in physical activity level assessed by the IPAQ-SF"
},
{
"measure": "Change in Subjective stress assessed by the Perceived Stress Scale"
},
{
"measure": "Changes in pain cognitions assessed by the Pain anxiety symptom scale"
},
{
"measure": "Changes in pain cognitions assessed by the pain catastrophizing Scale"
},
{
"measure": "Changes in Fatigue assessed by the checklist individual strength"
},
{
"measure": "Anti-inflammatory diet rating"
}
],
"primaryOutcomes": [
{
"measure": "Change in Pain intensity assessed by the Numerical Rating Scale"
},
{
"measure": "Change in inflammatory characteristics in menstruum"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30"
},
{
"measure": "Change in general Quality of Life assessed by the Short Form 36"
},
{
"measure": "Change in the composition of vaginal and intestinal microbiome"
},
{
"measure": "Change in Objective stress assessed by measuring scalp hair cortisol levels"
},
{
"measure": "Adherence and anti-inflammatory status of the diet"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ZonMw: The Netherlands Organisation for Health Research and Development"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Radboud University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Restrictive Transfusion Strategy"
},
{
"name": "Liberal Transfusion Strategy"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Surgery With Cardiopulmonary Bypass",
"Valve Heart Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Huang Huanlei, Phd",
"phone": "765 714 9765",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Huang huanlei, Phd",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Zhao Junfei, Phd",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "He Biaochuan, Phd",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Zhang Zhaolong, BD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Wang Zhenzhong, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Wang Qiuji, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Guangdong Provincial People's Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510145"
}
]
},
"descriptionModule": {
"briefSummary": "This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1600,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TICVS",
"briefTitle": "Transfusion in Cardiac Valve Surgery",
"nctId": "NCT06332547",
"orgStudyIdInfo": {
"id": "TICVS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "A composite of postoperative morbidity and mortality"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of reoperation"
},
{
"measure": "Length of ICU Stays"
},
{
"measure": "Length of Postoperative Hospital Stay"
},
{
"measure": "Number of Blood Transfusion"
},
{
"measure": "Duration of mechanical ventilation"
},
{
"measure": "Postoperative thoracic fluid volume in the first 24 hours"
},
{
"measure": "Number of participants with postoperative atrial fibrillation"
},
{
"measure": "Number of participants with new-onset renal failure with dialysis"
},
{
"measure": "Number of participants with acute kidney injury"
},
{
"measure": "Number of participants with delirium"
},
{
"measure": "Hospitalization expense"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangdong Provincial People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Upadacitinib"
}
]
},
"conditionsModule": {
"conditions": [
"Crohn's Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease",
"nctId": "NCT06332534",
"orgStudyIdInfo": {
"id": "M14-671",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64"
},
{
"measure": "Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12."
},
{
"measure": "Number of Participants with Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Achievement of clinical remission per PCDAI"
},
{
"measure": "Achievement of endoscopic response"
},
{
"measure": "Achievement of endoscopic remission"
},
{
"measure": "Achievement of clinical response per PCDAI"
},
{
"measure": "Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12"
},
{
"measure": "Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12"
},
{
"measure": "Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AbbVie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-12-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2032-03-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acoustic signal analysis method"
}
]
},
"conditionsModule": {
"conditions": [
"Newborn; Vitality",
"Premature Infants",
"Infant Development"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint-Étienne",
"contacts": [
{
"email": null,
"name": "Hugues PATURAL, MD-PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Chu de Saint-Etienne",
"geoPoint": {
"lat": 45.43389,
"lon": 4.39
},
"state": null,
"status": "RECRUITING",
"zip": "42055"
}
]
},
"descriptionModule": {
"briefSummary": "Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "4 Days",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "BABYCRY_1000",
"briefTitle": "Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment",
"nctId": "NCT06332521",
"orgStudyIdInfo": {
"id": "23CH296",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "2024-A00286-41",
"id": "ANSM",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fundamental frequency f0 (Hz)"
},
{
"measure": "Bailey-4 quantitative scale"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage voiced frames"
},
{
"measure": "Harmonics of f0 (Hz)"
},
{
"measure": "Median pitch f0 (Hz)"
},
{
"measure": "Harmonicity (dB)"
},
{
"measure": "Jitter (Percentage),"
},
{
"measure": "Q25 (Percentage)"
},
{
"measure": "Median Cepstral Peak Prominence (CPP) (dB)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Saint Etienne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pulsed electromagnetic fields (PEMFs)"
},
{
"name": "Anthracycline-based chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": [
{
"email": "[email protected]",
"name": "Joline Si Jing Lim",
"phone": "69082222",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joline Si Jing Lim",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Singapore",
"facility": "National University Hospital",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null,
"status": "RECRUITING",
"zip": "119074"
}
]
},
"descriptionModule": {
"briefSummary": "To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)",
"nctId": "NCT06332508",
"orgStudyIdInfo": {
"id": "2022/00406",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment response as assessed by clinical measurement of tumor size using calipers"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National University of Singapore"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "National University Hospital, Singapore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questioning the patient during hygiene care"
}
]
},
"conditionsModule": {
"conditions": [
"Nurse-Patient Relations"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nantes",
"contacts": [
{
"email": "[email protected]",
"name": "Pia SECHER-CAILLETEAU",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Nantes University Hospital",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": "Loire Atlantique",
"status": null,
"zip": "44093"
},
{
"city": "Cholet",
"contacts": [
{
"email": "[email protected]",
"name": "Nelly DIXNEUF",
"phone": "(+33) 2 41 49 69 85",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Cholet",
"geoPoint": {
"lat": 47.06667,
"lon": -0.88333
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Laval",
"contacts": [
{
"email": "[email protected]",
"name": "ROMAIN CHAMPAGNE",
"phone": "(+33) 672091548",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Laval",
"geoPoint": {
"lat": 48.06667,
"lon": -0.76667
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Le Mans",
"contacts": [
{
"email": "[email protected]",
"name": "Emmanuelle Lecompte",
"phone": "(+33) 681220543",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CH Le Mans",
"geoPoint": {
"lat": 48,
"lon": 0.2
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Orléans",
"contacts": [
{
"email": "[email protected]",
"name": "Guillaume FOSSAT",
"phone": "(+33) 2 38.65.13.18",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Orleans",
"geoPoint": {
"lat": 47.90289,
"lon": 1.90389
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "the hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RIDAECUBA",
"briefTitle": "Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers",
"nctId": "NCT06332495",
"orgStudyIdInfo": {
"id": "RC23_0573",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM (IDRCB)",
"id": "2024-A00025-42",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan."
}
],
"secondaryOutcomes": [
{
"measure": "Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3"
},
{
"measure": "Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan."
},
{
"measure": "Assess patient discomfort on the bedpan"
},
{
"measure": "Assess alteration of skin condition at the seat of the patient using the bedpan"
},
{
"measure": "Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan."
},
{
"measure": "Assess the risk factors associated with the onset of pain when placing a bedpan."
},
{
"measure": "Assess the difficulty of positioning and removing the bedpan."
},
{
"measure": "Assess bedpan stability during use"
},
{
"measure": "Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nantes University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Implant supported screw retained prosthesis"
}
]
},
"conditionsModule": {
"conditions": [
"Prosthesis Durability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": null,
"country": "Egypt",
"facility": "Mansoura University ,Faculty of dentistry",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": null,
"status": null,
"zip": "P.O.Box:35516"
}
]
},
"descriptionModule": {
"briefSummary": "This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration",
"nctId": "NCT06332482",
"orgStudyIdInfo": {
"id": "M0303023RP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "measurement of occlusal prematurity"
},
{
"measure": "prosthestic complications"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Internet based education and support program for patients awaiting kidney transplantation"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Kidney Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The intervention group gets immediate access to the 9 week program, and the waitlist control group gets access after a 9 week waiting period.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "INSERT",
"briefTitle": "Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation",
"nctId": "NCT06332469",
"orgStudyIdInfo": {
"id": "INSERT feasibility",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Kidney transplant understanding tool (K-TUT)"
},
{
"measure": "Self-care in chronic illness inventory v.4c"
},
{
"measure": "The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G"
},
{
"measure": "Pearlin Mastery Scale"
},
{
"measure": "The Depression Anxiety Stress Scales 21 (DASS-21)"
},
{
"measure": "Acceptance of chronic health conditions scale (ACHC)"
},
{
"measure": "EQ-5D-5L"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Linkoeping University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Renal Microcirculation With Rubidium Positron Emission Tomography"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Matthieu Pelletier-Galarneau",
"phone": "5143763330",
"phoneExt": "4418",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Montreal Heart Institute",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "H1T 1C8"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RESIST",
"briefTitle": "Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography",
"nctId": "NCT06332456",
"orgStudyIdInfo": {
"id": "ICM 2023-3169",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Renal blood flow in units of mL/min/100g"
}
],
"secondaryOutcomes": [
{
"measure": "Renal vascular resistance in units of mmHg/mL/min/100g"
},
{
"measure": "Correlation between renal vascular resistance measured with PET and measured with echography"
},
{
"measure": "Coefficient of repeatability of renal blood flow"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Matthieu Pelletier-Galarneau, MD MSc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spinal anesthesia"
},
{
"name": "Sedation epidural anesthesia"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Injuries and Disorders",
"Hip Injuries",
"Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montreal",
"contacts": [
{
"email": "[email protected]",
"name": "Serge Marquis, RN",
"phone": "5142523400",
"phoneExt": "5701",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Janie Barry, MSc",
"phone": "5142523400",
"phoneExt": "4567",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Hopital Maisonneuve Rosemont",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "H1T 2M4"
}
]
},
"descriptionModule": {
"briefSummary": "To our knowledge, no study has compared the difference between these two NA techniques. Early postoperative adverse events like uncontrolled pain, orthostatic hypotension, urinary retention, and prolonged motor block are linked to late patient mobilization, prolong hospitalization and failure to discharge in outpatient setting. The type of anesthesia used may have an important impact. Therefore, this study has the potential to improve the already established ERAS program and improve patients care perioperative and postoperative. Showing that SED-EA and SA are equivalent will allow for a more efficient and reliable technique for THA/TKA ERAS program that can be further translated into other lower limb surgeries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "The group assignment will be given to the intraoperative anesthesia team by writing, by a research team member who will not participate in postoperative assessments. The intraoperative anesthesia team will not be blinded to the group assignment, but surgeons, patients, and assessors will be blinded. For the SA group, a sham epidural catheter will be placed on the patient's back by the anesthesia team in order to keep the surgeons, patients and assessors blind to the randomization group.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 132,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RCT SEA vs SA",
"briefTitle": "Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.",
"nctId": "NCT06332443",
"orgStudyIdInfo": {
"id": "CER-CEMTL-2023-3086",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Time needed by the anesthesiologist to perform the technique"
},
{
"measure": "Time needed for the SA or SED-EA to achieve adequate sensory block"
},
{
"measure": "Intraoperative blood loss"
},
{
"measure": "intraoperative muscle tension"
},
{
"measure": "Extra Lidocaine needed"
},
{
"measure": "Conversion to GA"
},
{
"measure": "Total dose of the sedation"
},
{
"measure": "Hemodynamic stability measured"
},
{
"measure": "Time to return of motor and sensory function"
},
{
"measure": "Post-operative nausea"
},
{
"measure": "PONV and anti-emetics"
},
{
"measure": "Urinary retention"
},
{
"measure": "Opioid consumption"
},
{
"measure": "Length of stay"
},
{
"measure": "Failed discharded"
},
{
"measure": "Complications related to the technique performed."
},
{
"measure": "Adverse event"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Mina Wahba Morcos"
},
{
"name": "Issam Tanoubi"
},
{
"name": "Pierre Drolet"
},
{
"name": "Ariane Clairoux"
},
{
"name": "Veronique Brulotte"
},
{
"name": "Marie-Eve Bélanger"
},
{
"name": "Philippe Richebé"
},
{
"name": "Karina Pellei"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Maisonneuve-Rosemont Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CAN2109"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumor",
"Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": null,
"country": "China",
"facility": "Sun Yat-Sen University Sun Yat-Sen Memorial Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510535"
}
]
},
"descriptionModule": {
"briefSummary": "A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intratumoral CAN2109 in Subjects With Solid Tumors or Lymphomas",
"nctId": "NCT06332430",
"orgStudyIdInfo": {
"id": "CW-202",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and tolerability"
},
{
"measure": "Recommended Phase 2 Dose (RP2D)"
}
],
"secondaryOutcomes": [
{
"measure": "To determine the efficacy of CAN2109"
},
{
"measure": "To evaluate the pharmacodynamics of CAN2109"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Canwell Biotech Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ba-Duan-Jin Based Deep Breathing Exercises"
},
{
"name": "FET (Forced Expiratory Technique)"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Obstructive Pulmonary Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Faisal Rehman, MBBS",
"phone": "+924299230227",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Social Security Teaching Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punhab",
"status": "RECRUITING",
"zip": "42000"
}
]
},
"descriptionModule": {
"briefSummary": "This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique",
"nctId": "NCT06332417",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0364",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "36-Item Short Form Survey (SF-36)"
},
{
"measure": "FEV1/FVC ratio"
},
{
"measure": "Exercise Tolerance : 6 minute walk test"
},
{
"measure": "Forced vital capacity (FVC)"
},
{
"measure": "Forced expiratory volume (FEV1)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea",
"Sleep Apnea",
"Apnea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Edegem",
"contacts": [
{
"email": "[email protected]",
"name": "Dorine Van Loo, Msc",
"phone": "+3238215780",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Olivier Vanderveken, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Antwerp University Hospital",
"geoPoint": {
"lat": 51.15662,
"lon": 4.44504
},
"state": "Antwerp",
"status": null,
"zip": "2650"
}
]
},
"descriptionModule": {
"briefSummary": "Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital."
},
"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": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "B-HNS",
"briefTitle": "Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry",
"nctId": "NCT06332404",
"orgStudyIdInfo": {
"id": "B3002024000047",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Delta apnea-hypopnea index (AHI) as measured by a polysomnography"
}
],
"secondaryOutcomes": [
{
"measure": "% of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h"
},
{
"measure": "Therapy adherence defined by the amount of hours therapy usage per night."
},
{
"measure": "Delta oxygen desaturation index (ODI) as measured by a polysomnography"
},
{
"measure": "Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire"
},
{
"measure": "Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire"
},
{
"measure": "Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Antwerp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise-similar cardiac pacing"
},
{
"name": "Sham cardiac pacing"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure, Systolic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A \"dose-response\" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, single blinded, randomized, controlled trial. Randomization to intervention versus sham groups in a 1:1 ratio.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Subjects and outcomes assessors are blinded to study group (intervention vs. sham) but investigator is not. During intervention vs. sham, subjects do not have access to vital sign data and sham procedures follow intervention procedures exactly with the exception that no change in pacing rate is delivered. A blinding questionnaire is given to subjects to assess adequacy of blinding.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 52,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HeartExcel",
"briefTitle": "Paced Heart Rate Acceleration for Cardiac Conditioning",
"nctId": "NCT06332391",
"orgStudyIdInfo": {
"id": "202308349",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01HL168752",
"link": "https://reporter.nih.gov/quickSearch/R01HL168752",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in left ventricular ejection fraction by echocardiogram"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of Life score on the Minnesota Living with Heart Failure questionnaire"
},
{
"measure": "Quality of Life score on the Kansas City Cardiomyopathy Questionnaire"
},
{
"measure": "6-minute walk distance"
},
{
"measure": "Cardiopulmonary exercise test maximum oxygen consumption"
},
{
"measure": "Cardiopulmonary exercise test metabolic equivalents achieved"
},
{
"measure": "Cardiopulmonary exercise test peak power output achieved"
},
{
"measure": "Cardiopulmonary exercise test total exercise time"
},
{
"measure": "daily minutes of sedentary activity"
},
{
"measure": "daily minutes of low activity"
},
{
"measure": "daily minutes of moderate activity"
},
{
"measure": "daily minutes of vigorous activity"
},
{
"measure": "major adverse cardiac events"
},
{
"measure": "symptom score during the intervention/sham procedure"
},
{
"measure": "maximum achieved pacing rate during the intervention/sham procedure"
},
{
"measure": "presence of significant arrhythmia during the intervention/sham procedure"
},
{
"measure": "vital signs - systolic blood pressure during the intervention/sham procedure"
},
{
"measure": "vital signs - oxygen saturation in the blood during the intervention/sham procedure"
},
{
"measure": "tolerability - vital signs - cardiac output"
},
{
"measure": "vital signs - cardiac output during the intervention/sham procedure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Cleveland Clinic"
},
{
"name": "National Institutes of Health (NIH)"
},
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Denice Hodgson-Zingman, MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental group 1 :Ball training"
},
{
"name": "Experimental group 2 :Frenkel Exercises"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetic Neuropathies"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..The main question it aims to answer are:1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.2. Effectiveness of exercises using Swiss ball in lowering waist circumference, and BMI.3. Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients.4. Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients.By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients",
"nctId": "NCT06332378",
"orgStudyIdInfo": {
"id": "sHasan",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "One Leg Stance"
},
{
"measure": "Berg Balance Scale"
},
{
"measure": "Timed Up and Go Test:"
},
{
"measure": "Diabetic Neuropathy Symptom Score"
},
{
"measure": "Hemoglobin A1C"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dr. Sobia Hasan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acetonide triamcinolone 0.2% +hyaluronicacid 1%"
},
{
"name": "Corticoid Acetonide triamcinolone 0.2%"
},
{
"name": "Hyaluronic acid 1%"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Lichen Planus",
"Oral Lichen Planus Related Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Murcia",
"contacts": null,
"country": "Spain",
"facility": "Pia Lopez Jornet",
"geoPoint": {
"lat": 37.98704,
"lon": -1.13004
},
"state": null,
"status": null,
"zip": "30004"
}
]
},
"descriptionModule": {
"briefSummary": "Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "salivaLichen",
"briefTitle": "Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers",
"nctId": "NCT06332365",
"orgStudyIdInfo": {
"id": "ID: 3938/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain assessment scale"
}
],
"secondaryOutcomes": [
{
"measure": "OHIP-14 questionnaire"
},
{
"measure": "reduction of clinical signs measure"
},
{
"measure": "Salivary level of oxidative stress biomarker"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pia Lopez Jornet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PRP"
}
]
},
"conditionsModule": {
"conditions": [
"Acetabular Labrum Tear"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": [
{
"email": "[email protected]",
"name": "Luke A Johnson, BS",
"phone": "801-213-3379",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniel Cushman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Derek Stokes, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Utah - Department of Orthopaedics",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": "RECRUITING",
"zip": "84108"
}
]
},
"descriptionModule": {
"briefSummary": "Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage \"suction cup\" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PRP for ALT",
"briefTitle": "Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears",
"nctId": "NCT06332352",
"orgStudyIdInfo": {
"id": "00173470",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain & Function Improvements"
}
],
"secondaryOutcomes": [
{
"measure": "Visual Analog Scale (VAS)"
},
{
"measure": "Harris Hip Scores (HHS)"
},
{
"measure": "International Hip Outcome Tool (iHOT-12)"
},
{
"measure": "EQ-5D (EuroQual 5D)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "16055 NFL delta Gly4 trimer"
},
{
"name": "Trimer 4571"
},
{
"name": "Ad4-Env145NFL, 5 x 108 viral particles (vp)"
}
]
},
"conditionsModule": {
"conditions": [
"HIV"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": [
{
"email": "[email protected]",
"name": "Heather Logan, ANP",
"phone": "205-873-8686",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Alabama CRS",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama",
"status": "NOT_YET_RECRUITING",
"zip": "35222"
},
{
"city": "Atlanta",
"contacts": [
{
"email": "[email protected]",
"name": "Erika Patrick, MSN",
"phone": "404-616-6313",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The Ponce de Leon Center CRS",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia",
"status": "NOT_YET_RECRUITING",
"zip": "30308"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Jose Licona, MD",
"phone": "617-525-9433",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Brigham and Women's Hospital Vaccine CRS (BWH VCRS)",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "NOT_YET_RECRUITING",
"zip": "02115"
},
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Mascha Elskamp",
"phone": "212-305-2201",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Columbia Partnership for Prevention and Control of HIV/AIDS CTU",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "NOT_YET_RECRUITING",
"zip": "10032"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Catherine Bunce, RN MS, CCRC",
"phone": "585-275-5871",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Rochester HIV/AIDS CTU",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York",
"status": "NOT_YET_RECRUITING",
"zip": "14642"
},
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Debora Dunbar, MSN, CRNP",
"phone": "215-746-3713",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.The main question\\[s\\] it aims to answer are:* Are these vaccine regimens safe and well tolerated?* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.",
"nctId": "NCT06332339",
"orgStudyIdInfo": {
"id": "HVTN 313",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Local reactogenicity signs and symptoms"
},
{
"measure": "Systemic reactogenicity signs and symptoms"
},
{
"measure": "Number of adverse events (AEs) reported for 30 days after receipt of any study product"
},
{
"measure": "Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc)"
},
{
"measure": "Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.)"
},
{
"measure": "Response Rate of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.)"
}
],
"secondaryOutcomes": [
{
"measure": "Occurrence of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086)"
},
{
"measure": "Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086)"
},
{
"measure": "Response Rate of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086)"
},
{
"measure": "Occurrence of serum antibody neutralization of HIV-1 strains"
},
{
"measure": "Magnitude of serum antibody neutralization of HIV-1 strains"
},
{
"measure": "Response Rate of serum antibody neutralization of HIV-1 strains"
},
{
"measure": "Flow cytometry analysis of the frequency of Env-specific IgG+ B cells"
},
{
"measure": "Occurrence of serum IgG binding antibodies as measured by BAMA"
},
{
"measure": "Magnitude of serum IgG binding antibodies as measured by BAMA"
},
{
"measure": "Response Rate of serum IgG binding antibodies as measured by BAMA"
},
{
"measure": "Number of Isolation of CD4bs bnAb specific VH and VL alleles and characteristic mutations"
},
{
"measure": "Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination"
},
{
"measure": "Occurrence of serum IgG binding antibodies"
},
{
"measure": "Magnitude of serum IgG binding antibodies"
},
{
"measure": "Response Rate of serum IgG binding antibodies"
},
{
"measure": "Occurrence of serum antibody neutralization to tier 2 HIV-1 strains"
},
{
"measure": "Magnitude of serum antibody neutralization to tier 2 HIV-1 strains"
},
{
"measure": "Response Rate of serum antibody neutralization to tier 2 HIV-1 strains"
},
{
"measure": "Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute of Allergy and Infectious Diseases (NIAID)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "non-invasive vagus nerve stimulation"
},
{
"name": "vestibular rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Vestibular Diseases",
"Vestibular Vertigo",
"Vertigo"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "tuğba türk kalkan, MD",
"phone": "+905334956459",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "tugba türk kalkan, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Istanbul Medipol University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients",
"nctId": "NCT06332326",
"orgStudyIdInfo": {
"id": "E-10840098-772.02-4966",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Modified-CTSIB"
},
{
"measure": "Semitandem test"
},
{
"measure": "tandem test"
},
{
"measure": "one-leg standing test"
},
{
"measure": "Unterberger test"
},
{
"measure": "VAS Visual Analogue Scale (dizziness severity)"
},
{
"measure": "Dynamic visual acuity test"
}
],
"secondaryOutcomes": [
{
"measure": "Dizziness Handicap Inventory Scale"
},
{
"measure": "Tampa Kinesiophobia Scale"
},
{
"measure": "Hospital Anxiety and Depression Scale (HAD)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medipol University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "erector spina plane block"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Postoperative"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Erector Spina Plane Block Volume Comparison",
"nctId": "NCT06332313",
"orgStudyIdInfo": {
"id": "2023/10/05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kahramanmaras Sutcu Imam University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adebelimumab+Famitinib + FOLFIRI+Ariely"
}
]
},
"conditionsModule": {
"conditions": [
"NSCLC"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Shengcun Fang, PhD",
"phone": "+86 13404163638",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jian Zhang, Master",
"phone": "+86 13095457871",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shengcun Fang",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed non-squamous non-small cell lung cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Chemotherapy in Patients With NSCLC",
"nctId": "NCT06332300",
"orgStudyIdInfo": {
"id": "ADBL-LC-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ORR"
}
],
"secondaryOutcomes": [
{
"measure": "iPFS"
},
{
"measure": "iDoR"
},
{
"measure": "PFS"
},
{
"measure": "OS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jiangsu Province Nanjing Brain Hospital"
}
},
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"date": "2026-02-01"
},
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"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
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"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "combination of Trilaciclib and Pemetrexed"
}
]
},
"conditionsModule": {
"conditions": [
"NSCLC"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Suzhou",
"contacts": [
{
"email": "[email protected]",
"name": "fang S cun, M.D.",
"phone": "83728558",
"phoneExt": "025",
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fang Shencun",
"geoPoint": {
"lat": 31.30408,
"lon": 120.59538
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210029"
}
]
},
"descriptionModule": {
"briefSummary": "To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Trilaciclib",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis",
"nctId": "NCT06332287",
"orgStudyIdInfo": {
"id": "2023-NSCLC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Duration of severe neutropenia (DSN)"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of Treatment-Emergent Adverse Events"
},
{
"measure": "Incidence of grade 3 and 4 hematologic toxicity"
},
{
"measure": "Incidence of G-CSF treatment"
},
{
"measure": "Incidence of platelet transfusion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jiangsu Province Nanjing Brain Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tislelizumab"
},
{
"name": "Blood sampling"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer",
"Lung Cancer",
"Colo-rectal Cancer",
"Pancreas Cancer",
"Soft Tissue Sarcoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Villejuif",
"contacts": null,
"country": "France",
"facility": "Gustave Roussy",
"geoPoint": {
"lat": 48.7939,
"lon": 2.35992
},
"state": "Val De Marne",
"status": null,
"zip": "94800"
}
]
},
"descriptionModule": {
"briefSummary": "Numerous studies have shown that even when imaging does not reveal the presence of cancer cells, traces of tumor DNA (i.e. originating from cancer cells) can be detected in the blood of certain patients: this is called molecular residual disease (MRD). When such traces are detected (we speak of MRD+ status), the risk of relapse is much higher than when there is no circulating tumor DNA (MRD - status). Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage.UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD+ status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor. Residual disease (MRD) will be determined by optimized detection and precise monitoring of circulating tumor DNA, enabling early detection of recurrence and disease monitoring, including in patients without MRD \\[MRD(-)\\]."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a double-blinded, randomized, placebo-controlled, multi-center, national, Phase 3 biology-driven trial designed to investigate the impact of systemic treatment with tislelizumab or placebo following detection of MRD minimum 3 months and maximum 4.5 months after completion of curative-intent therapy.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
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"CARE_PROVIDER",
"INVESTIGATOR",
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]
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 717,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "UMBRELLA",
"briefTitle": "tislelizUMaB in canceR Patients With molEcuLar residuaL Disease",
"nctId": "NCT06332274",
"orgStudyIdInfo": {
"id": "2023-503316-33-00",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CSET number",
"id": "2023/3720",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival)"
}
],
"secondaryOutcomes": [
{
"measure": "Estimation of DFS in subjects without MRD"
},
{
"measure": "Estimation of overall survival (OS)"
},
{
"measure": "Percentage of MRD (+) subject's completion of standard curative-intent therapy"
},
{
"measure": "Time between detection of MRD and detection of relapse at imaging."
},
{
"measure": "Percentage of subjects with MRD assessment failure."
},
{
"measure": "Estimation of the time to become MRD (-) for MRD(+) patients"
},
{
"measure": "Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30"
},
{
"measure": "Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L"
},
{
"measure": "Cost effectiveness analysis: incremental cost"
},
{
"measure": "Cost effectiveness analysis: QALY"
},
{
"measure": "Cost effectiveness analysis: ICER"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "BeiGene"
},
{
"name": "C2i Genomics"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Gustave Roussy, Cancer Campus, Grand Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Major Depressive Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": null,
"country": "Sweden",
"facility": "Stockholm Health Care Services, Region Stockholm",
"geoPoint": {
"lat": 59.33258,
"lon": 18.0649
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to evaluate current practices in depression treatment in psychiatric services in Stockholm, Sweden.The main questions it aims to answer are:* Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?* What are the present conditions for implementing measurement-based care in depression treatment in this setting?Data will be collected retrospectively from medical records of patients having received psychological or pharmacological treatment for depression from 2020 to 2023. Frequency of standardized assessments (not scores) using the Montgomery-Åsberg Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale-Self Assessment, and the Patient Health Questionnaire-9 is collected, together with information on patient, clinician, and treatment characteristics."
},
"designModule": {
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},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Standardized Assessment in Depression Treatment in Routine Psychiatric Services",
"nctId": "NCT06332261",
"orgStudyIdInfo": {
"id": "2024-BB-01",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Montgomery-Åsberg Depression Rating Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Montgomery-Åsberg Depression Rating Scale-Self Assessment"
},
{
"measure": "The Patient Health Questionnaire-9"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Region Stockholm"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Magnesium"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Health Promotion"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:* Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?* Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants received either 375 mg nutritional supplement magnesium or placebo pill.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1013,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Possible Effects of the Dietary Supplement Magnesium Compared to Placebo",
"nctId": "NCT06332248",
"orgStudyIdInfo": {
"id": "2014/1023-31/4 & 2014/274-31/5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Time x group difference in Oldenburg Burnout Inventory (questionnaire)"
},
{
"measure": "Time x group difference in Karolinska Sleep Questionnaire"
},
{
"measure": "Time x group difference in Pure Tone Audiogram (clinical hearing test)"
},
{
"measure": "Time x group difference in Speech in noise test (clinical hearing test)"
},
{
"measure": "Time x group difference in Uncomfortable loudness level (clinical hearing test)"
},
{
"measure": "Time x group difference in single questionnaire item assessing sick leave"
},
{
"measure": "Time x group difference in single questionnaire item assessing sickness presenteeism"
},
{
"measure": "Time x group difference in prevalence of pain (questionnaire)"
},
{
"measure": "Time x group difference in pain frequency (questionnaire)"
},
{
"measure": "Time x group difference in pain discomfort (questionnaire)"
},
{
"measure": "Time x group difference in pain intensity (questionnaire)"
},
{
"measure": "Time x group difference in functional impairment due to pain (questionnaire)"
}
],
"primaryOutcomes": [
{
"measure": "Time x group difference in HealthWatch-11 (questionnaire)"
}
],
"secondaryOutcomes": [
{
"measure": "Intervention compliance measure 1 (objective, number of pills left)"
},
{
"measure": "Intervention compliance measure 2 (subjective, marked days in calendar)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Stiftelsen Stressmottagningen"
},
{
"name": "AFA Insurance"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dan Hasson"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2015-05-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2015-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2014-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Silodosin 8 mg"
}
]
},
"conditionsModule": {
"conditions": [
"Human Trichinellosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kaohsiung",
"contacts": [
{
"email": "[email protected]",
"name": "Chen Yu Chen, MS",
"phone": "0911884597",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Kaohsiung Medical University Chung-Ho Memorial Hospital",
"geoPoint": {
"lat": 22.61626,
"lon": 120.31333
},
"state": "Sanmin District",
"status": "RECRUITING",
"zip": "807"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.",
"nctId": "NCT06332235",
"orgStudyIdInfo": {
"id": "KMUHIRB-F(I)-20220023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment criteria Efficacy"
},
{
"measure": "Assessment criteria Safety"
}
],
"secondaryOutcomes": [
{
"measure": "Assessment criteria Efficacy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kaohsiung Medical University Chung-Ho Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tart Cherry"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Exercise Recovery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newcastle Upon Tyne",
"contacts": null,
"country": "United Kingdom",
"facility": "Northumbria University",
"geoPoint": {
"lat": 54.97328,
"lon": -1.61396
},
"state": "Tyne And Wear",
"status": null,
"zip": "NE1 8ST"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare recovery in healthy, active runners.The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated:* muscle function* inflammation* soreness following a marathon run.Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via:* maximal voluntary contractions* counter movement jumps* visual analog scales to assess soreness* blood samples"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Recovery With Tart Cherry Supplementation Following a Marathon.",
"nctId": "NCT06332222",
"orgStudyIdInfo": {
"id": "1987",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximal Voluntary Contraction"
}
],
"secondaryOutcomes": [
{
"measure": "Counter Movement Jump"
},
{
"measure": "Active Muscle Soreness"
},
{
"measure": "Serum Concentration of High-Sensitive C-Reactive Protein"
},
{
"measure": "Serum Concentration of Creatine Kinase"
},
{
"measure": "Perceptual Measures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Iprona Lana SpA"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Northumbria University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Trauma Focused Cognitive Behavioral Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Post-Traumatic Stress Disorder"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico",
"nctId": "NCT06332209",
"orgStudyIdInfo": {
"id": "Pro00135303",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Telehealth Center of Excellence",
"id": "U66RH31458",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Traumatic Stress Symptoms"
},
{
"measure": "Traumatic Stress Symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Anxiety and Depression Symptoms"
},
{
"measure": "Anxiety and Depression Symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of South Carolina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Analysis of biological sample and clinical data"
}
]
},
"conditionsModule": {
"conditions": [
"Immune Deficiency"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": null,
"country": "Italy",
"facility": "AOU Malpighi IRCCS",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": "ACTIVE_NOT_RECRUITING",
"zip": null
},
{
"city": "Florence",
"contacts": [
{
"email": "[email protected]",
"name": "Eleonora Gambineri",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Pisa",
"contacts": null,
"country": "Italy",
"facility": "AOU Pisana",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null,
"status": "ACTIVE_NOT_RECRUITING",
"zip": null
},
{
"city": "Roma",
"contacts": null,
"country": "Italy",
"facility": "Ospedale Pediatrico Bambin Gesù IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "ACTIVE_NOT_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Inborn Errors of Immunity (IEI) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. Lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of IEI, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. Lymphomas, especially non-Hodgkin's lymphomas (NHL) are frequently associated with congenital defects of the immune system, in particular diffuse large B-cell lymphoma and Burkitt's lymphoma. Preliminary analyses conducted on 6 patients diagnosed with NHL allowed the identification of genetic variants in genes associated with IEI. In clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. The identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. The study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. Through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Patients diagnosed with non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) aged and patients with previous lymphoma and signs of immunodeficiency",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immunodeficiency and Cancer: Identification of Congenital Immune System Defects Underlying Paediatric Lymphomas",
"nctId": "NCT06332196",
"orgStudyIdInfo": {
"id": "L-IEI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To unravel inborn error of immunity behind Lymphoid neoplasm in children"
}
],
"secondaryOutcomes": [
{
"measure": "Identification of lymphoma-specific biomarkers"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meyer Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Presence of polymorphisms"
}
]
},
"conditionsModule": {
"conditions": [
"Erdheim-Chester Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Julien Haroche",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hopital Pitié Salpetrière",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Florence",
"contacts": [
{
"email": "[email protected]",
"name": "Augusto Vaglio",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Milano",
"contacts": [
{
"email": null,
"name": "Lorenzo Dagna",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Parma",
"contacts": [
{
"email": null,
"name": "Davide Martorana",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "AOU Parma",
"geoPoint": {
"lat": 44.79935,
"lon": 10.32618
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Granada",
"contacts": [
{
"email": null,
"name": "Javier Martin",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Genetics Lab, CSIC",
"geoPoint": {
"lat": 37.18817,
"lon": -3.60667
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. Susceptibility to developing rare diseases like ECD is typically associated with genetic factors, including DNA polymorphisms and epigenetic modifications.This study aims to analyze the entire genome of a large cohort of patients with ECD and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. The study could thus clarify the genetic predisposition to ECD development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "GWAS and EWAS in Patients With Erdheim-Chester Disease",
"nctId": "NCT06332183",
"orgStudyIdInfo": {
"id": "ECDGWAS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Polymorphisms and genetic variants correlated with disease development"
},
{
"measure": "Methylation in Erdheim-Chester disease"
},
{
"measure": "Gene expression in Erdheim-Chester disease"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Augusto Vaglio"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-07-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HS-20093"
},
{
"name": "Adebrelimab"
},
{
"name": "Cisplatin/ Carboplatin"
},
{
"name": "Cetuximab"
},
{
"name": "Enzalutamide"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumor"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 610,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors",
"nctId": "NCT06332170",
"orgStudyIdInfo": {
"id": "HS-20093-103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum tolerated dose (MTD) for combination-treatments"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence and severity of adverse events (AEs)"
},
{
"measure": "Objective response rate (ORR) determined by investigators"
},
{
"measure": "Disease control rate (DCR) determined by investigators"
},
{
"measure": "Duration of response (DoR) determined by investigators"
},
{
"measure": "Progression-free survival (PFS) determined by investigators according to RECIST 1.1"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3"
},
{
"measure": "Time to PSA progression (TTPP)"
},
{
"measure": "Prostate-specific cancer antigen (PSA) response rate"
},
{
"measure": "Time to first subsequent therapy (TFST)"
},
{
"measure": "Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor"
},
{
"measure": "Time to reach maximum plasma concentration (Tmax) of HS-20093"
},
{
"measure": "Terminal half-life (T1/2) of HS-20093 following the first dose"
},
{
"measure": "Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093"
},
{
"measure": "Percentage of participants with antibodies to HS-20093 in serum"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hansoh BioMedical R&D Company"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remimazolam besylate"
},
{
"name": "Propofol Injection Emulsion"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia Recovery Period"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 126,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postoperative Quality of Recovery After General Anesthesia With Remimazolam",
"nctId": "NCT06332157",
"orgStudyIdInfo": {
"id": "2023-ke-715-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "15-item quality of recovery scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beijing Chao Yang Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Structural vs. Random sequences of stimuli"
},
{
"name": "Intact vs. Degraded speech"
},
{
"name": "Repeating 5-syllable nonwords or 2-syllable nonwords"
},
{
"name": "Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data."
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder",
"Language Development",
"Literacy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Brynn Siles, BS",
"phone": "617-830-1530",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zhenghan Qi, MD/PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Northeastern University",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02115"
},
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Boston University",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "ENROLLING_BY_INVITATION",
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are:1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;2. how children's brains automatically learn patterns from speech and prints;3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.First-grade students will participate in the study twice across three months.During Time 1, children will complete* a battery of language, reading, and cognitive assessments* a series of computer-based statistical learning games both inside and outside of functional MRI scanner.During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months.Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth."
},
"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": "90 Months",
"minimumAge": "72 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PLAUSL",
"briefTitle": "Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning",
"nctId": "NCT06332144",
"orgStudyIdInfo": {
"id": "1R56DC020208-01A1",
"link": "https://reporter.nih.gov/quickSearch/1R56DC020208-01A1",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Neural activation to statistical regularities during the language tasks"
}
],
"primaryOutcomes": [
{
"measure": "Language Composite Score"
},
{
"measure": "Reading Composite Score"
},
{
"measure": "Language/Literacy Disorder Status"
},
{
"measure": "Neural similarity between language and statistical learning tasks"
},
{
"measure": "Orthographic statistical sensitivity"
},
{
"measure": "Phonological statistical sensitivity"
}
],
"secondaryOutcomes": [
{
"measure": "Linguistic SL composite scores"
},
{
"measure": "Neural sensitivity to statistical regularities during the statistical learning tasks"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Delaware"
},
{
"name": "Boston University"
},
{
"name": "Cornell University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Northeastern University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Melanoma",
"Coronary Microvascular Dysfunction",
"Cardiotoxicity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": null,
"country": "United States",
"facility": "Abramson Cancer Center at University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature",
"nctId": "NCT06332131",
"orgStudyIdInfo": {
"id": "UPCC07623",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of new abnormal myocardial blood flow reserve (MBFR)"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of major cardiovascular events"
},
{
"measure": "Coronary calcium score"
},
{
"measure": "All cause mortality"
},
{
"measure": "Cardiovascular specific mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Abramson Cancer Center at Penn Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ice massage group"
}
]
},
"conditionsModule": {
"conditions": [
"Hemodialysis Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "Ercan Bakır, PhD",
"phone": "05444252111",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ercan Bakır, PhD",
"phone": "05443047186",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ercan Bakır",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": "Yakutiye",
"status": null,
"zip": "25010"
},
{
"city": "Erzurum",
"contacts": null,
"country": "Turkey",
"facility": "Ercan Bakır",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": "Yakutiye",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The research is quasi-experimental and relationship-seeking in a pretest-posttest format.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction",
"nctId": "NCT06332118",
"orgStudyIdInfo": {
"id": "avf ice massage",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain score"
}
],
"secondaryOutcomes": [
{
"measure": "Ecchymosis degree"
},
{
"measure": "Hematoma degree"
},
{
"measure": "Patient satisfaction score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erzurum Technical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Glytactin"
},
{
"name": "L-AA"
}
]
},
"conditionsModule": {
"conditions": [
"Phenylketonurias"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": null,
"country": "United Kingdom",
"facility": "Birmingham Women and Children's Hospital",
"geoPoint": {
"lat": 52.48142,
"lon": -1.89983
},
"state": "West Midlands",
"status": null,
"zip": "B4 6NH"
},
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "Great Ormond Street Hospital for Children",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "WC1N 3JH"
}
]
},
"descriptionModule": {
"briefSummary": "Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "2-stage, 15-week randomized crossover trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 19,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Low Phenylalanine Formulas",
"nctId": "NCT06332105",
"orgStudyIdInfo": {
"id": "CUK001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in blood Phe in"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Birmingham Children's Hospital"
},
{
"name": "Great Ormond Street Hospital for Children NHS Foundation Trust"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Ajinomoto Co., Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "FID007"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Canton",
"contacts": [
{
"email": null,
"name": "Nashat Gabrail, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Gabrail Cancer Center Research",
"geoPoint": {
"lat": 40.79895,
"lon": -81.37845
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44718"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HNSCC",
"briefTitle": "FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma",
"nctId": "NCT06332092",
"orgStudyIdInfo": {
"id": "FID-007-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)"
}
],
"secondaryOutcomes": [
{
"measure": "BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)"
},
{
"measure": "Duration of Response (DoR) measurement"
},
{
"measure": "Progression-free Survival (PFS) measurement"
},
{
"measure": "Overall Survival (OS) measurement"
},
{
"measure": "Disease Control Rate (DCR) analysis"
},
{
"measure": "Adverse Events (AEs) graded according to the CTCAE version 5.0"
},
{
"measure": "Vital Signs safety assessments"
},
{
"measure": "Clinical Laboratory safety assessments"
},
{
"measure": "ECGs safety assessment"
},
{
"measure": "Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007"
},
{
"measure": "Peak Plasma Concentration (Cmax)"
},
{
"measure": "Terminal/elimination half-life (t1/2)"
},
{
"measure": "Clearance (CL)"
},
{
"measure": "Volume of Distribution (Vd)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Fulgent Pharma LLC."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "166Holmium TARE"
},
{
"name": "Cetuximab"
},
{
"name": "Panitumumab"
},
{
"name": "5-Fluorouracil"
},
{
"name": "Bevacizumab"
},
{
"name": "Capecitabine"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer Metastatic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pisa",
"contacts": [
{
"email": "[email protected]",
"name": "Beatrice Borelli, MD, PhD",
"phone": "+39050992192",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gianluca Masi, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Beatrice Borelli, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Pisana",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null,
"status": "RECRUITING",
"zip": "56126"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab).A total of 23 patients will be enrolled in each cohort.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HAITI",
"briefTitle": "Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients",
"nctId": "NCT06332079",
"orgStudyIdInfo": {
"id": "HAITI 2023-505356-22-00",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival (PFS) Rate"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Toxicity rate"
},
{
"measure": "Grade 3/ Grade 4 Toxicity rate"
},
{
"measure": "Post-treatment Disease Control Rate (DCR)"
},
{
"measure": "Progression free survival"
},
{
"measure": "Overall Survival"
},
{
"measure": "Dose-response relationships"
},
{
"measure": "Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire"
},
{
"measure": "Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire"
},
{
"measure": "Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gruppo Oncologico del Nord-Ovest"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oxytocin nasal spray"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Therapists"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Misgav",
"contacts": [
{
"email": "[email protected]",
"name": "Ayelet Nir,, M.A.",
"phone": "972-4-6025050",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Galit",
"phone": "972-4-6026050",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Mental Health Clinic, Teradion",
"geoPoint": {
"lat": 32.86017,
"lon": 35.26165
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness",
"nctId": "NCT06332066",
"orgStudyIdInfo": {
"id": "0046-24-COM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Attunement and Responsiveness towards patients"
}
],
"secondaryOutcomes": [
{
"measure": "Attachment with Therapist"
},
{
"measure": "Working Alliance with Therapist"
},
{
"measure": "Patient Symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Clalit Health Services"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shalvata Mental Health Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SY-5007"
},
{
"name": "Itraconazole"
},
{
"name": "SY-5007"
},
{
"name": "Rifampin"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": [
{
"email": "[email protected]",
"name": "Li Zheng",
"phone": "86-28-85423655",
"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": "610041"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects",
"nctId": "NCT06332053",
"orgStudyIdInfo": {
"id": "SY-5007-I-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cmax for SY-5007"
},
{
"measure": "Tmax for SY-5007"
},
{
"measure": "AUC0-t for SY-5007"
},
{
"measure": "AUC0-∞ for SY-5007"
},
{
"measure": "t½ for SY-5007"
},
{
"measure": "CL/F for SY-5007"
},
{
"measure": "Vz/F for SY-5007"
}
],
"secondaryOutcomes": [
{
"measure": "Safety of SY-5007"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shouyao Holdings (Beijing) Co. LTD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gentamicin"
}
]
},
"conditionsModule": {
"conditions": [
"Catheter Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phoenix",
"contacts": [
{
"email": "[email protected]",
"name": "Kristina Kupanoff, PhD",
"phone": "602-406-5192",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "St. Jpseph's Hospital and Medical Center",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85013"
}
]
},
"descriptionModule": {
"briefSummary": "Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \\& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Gentamicin Bladder Instillation on CAUTI",
"nctId": "NCT06332040",
"orgStudyIdInfo": {
"id": "22-500-243-50-35",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "CAUTI as primary outcome"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "St. Joseph's Hospital and Medical Center, Phoenix"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hystro-Salpingo-Foam-Sonography (HYFOSY)"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility, Female"
]
},
"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": "Tubal patency testing is an essential part of female subfertility evaluation . Tubal abnormalities are seen in 30-40% of female subfertility patients . Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure .Laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia.Traditionally, Hysterosalpingography(HSG) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain.Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced as an alternative using either contrast media or saline. The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are either no longer available or not licensed for tubal patency testing.Hysterosalpingo-Foam Sonography (HyFoSy) was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical Ventures BV, Rotterdam, TheNetherlands) with 5ml purified ExEm_-water.The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing.In 2017, HyLiFoSy combined with power Doppler (PD)(HyLiFoSy-PD) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (HyCoSy), hysterosalpingo-foam sonography (HyFoSy), and hysterosalpingo-lidocaine-foam sonography (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% with lap-and-dye test.In addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 122,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients",
"nctId": "NCT06332027",
"orgStudyIdInfo": {
"id": "Soh-Med-24-03-03MD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the accuracy of HyFoSy in the assessment of tubal patency"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sohag University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Prolia"
}
]
},
"conditionsModule": {
"conditions": [
"Osteoporosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "30 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China",
"nctId": "NCT06332014",
"orgStudyIdInfo": {
"id": "20210123",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12"
}
],
"secondaryOutcomes": [
{
"measure": "Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12"
},
{
"measure": "Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12"
},
{
"measure": "Percent change from baseline in total hip and femoral neck BMD at month 6 and 12"
},
{
"measure": "Percent change from baseline in lumbar spine BMD at month 6"
},
{
"measure": "Number of participants with adverse events (AE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Amgen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental Group"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Neoplasm Malignant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Giuseppe Petralia",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IEO Istituto Europeo di Oncologia",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20141"
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance",
"nctId": "NCT06332001",
"orgStudyIdInfo": {
"id": "IEO 1403",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition."
}
],
"secondaryOutcomes": [
{
"measure": "Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-12-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Davide Ciardiello, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "European Institute of Oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20141"
}
]
},
"descriptionModule": {
"briefSummary": "Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%.Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so.A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices.It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 320,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MITICO",
"briefTitle": "Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer",
"nctId": "NCT06331988",
"orgStudyIdInfo": {
"id": "IEO 1341",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Relapse free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-07-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiomic signature"
}
]
},
"conditionsModule": {
"conditions": [
"Non Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "European Institute of Oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 91,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Radiomics and Radiogenomics of Non-small Cell Lung Cancer",
"nctId": "NCT06331975",
"orgStudyIdInfo": {
"id": "IEO 0836",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status"
},
{
"measure": "Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)"
},
{
"measure": "Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-06-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "remote home-based exercise therapy group"
},
{
"name": "supervised exercise therapy group"
},
{
"name": "regular care group"
}
]
},
"conditionsModule": {
"conditions": [
"Digestive Tract Cancer",
"Chemotherapy-induced Peripheral Neuropathy",
"Remote Exercise"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tainan",
"contacts": [
{
"email": null,
"name": "Cheng-Feng Lin, Ph.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Department of Physical Therapy, National Cheng-Kung University",
"geoPoint": {
"lat": 22.99083,
"lon": 120.21333
},
"state": null,
"status": "RECRUITING",
"zip": "701"
}
]
},
"descriptionModule": {
"briefSummary": "According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Digestive Tract Cancer and CIPN",
"nctId": "NCT06331962",
"orgStudyIdInfo": {
"id": "B-ER-112-010",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Basic information"
},
{
"measure": "gene"
},
{
"measure": "body height"
},
{
"measure": "body weight"
},
{
"measure": "body mass index"
},
{
"measure": "blood data"
},
{
"measure": "Questionnaire of Quality of Life"
},
{
"measure": "Questionnaire of Chemotherapy-Induced Peripheral Neuropathy"
}
],
"secondaryOutcomes": [
{
"measure": "Muscle Strength"
},
{
"measure": "Dynamic Balance"
},
{
"measure": "Sensation Test"
},
{
"measure": "Cardiovascular Endurance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cheng Kung University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "National Cheng-Kung University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "video assisted training"
}
]
},
"conditionsModule": {
"conditions": [
"First Pregnancy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "49 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Video Supported Training on Non-Stress Test Application to Pregnant Women",
"nctId": "NCT06331949",
"orgStudyIdInfo": {
"id": "TR TOKAT02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "State-Trait Anxiety Scale"
},
{
"measure": "Prenatal Attachment Inventory (PAI)"
}
],
"primaryOutcomes": [
{
"measure": "State-Trait Anxiety Scale"
},
{
"measure": "Prenatal Attachment Inventory (PAI)"
}
],
"secondaryOutcomes": [
{
"measure": "State-Trait Anxiety Scale"
},
{
"measure": "Prenatal Attachment Inventory (PAI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hilal Özbek"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emotion regulation"
}
]
},
"conditionsModule": {
"conditions": [
"Emotion Regulation",
"Parent-Child Relations",
"Happiness",
"Positive Affect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Nancy Xiaonan YU, Ph.D.",
"phone": "(852)34429436",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "City University of Hong Kong",
"geoPoint": {
"lat": 22.39407,
"lon": 114.13737
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Children will be randomly assigned to two groups: intervention and waitlist control groups. Children in the waitlist control group will receive experimental intervention after treatment for the experimental group finishes.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "At the recruitment phase, the participants and the social workers who lead the intervention will not know which arm the participants will be assigned. A cluster of approximately 10 participants formed a group based on their attendance date in the intervention program. This group will be randomly assigned to one of the two intervention arms through pre-prepared randomization list calculated by random allocation software.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen",
"nctId": "NCT06331936",
"orgStudyIdInfo": {
"id": "Shenzhen Project",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "10-item Emotional Management Strategy Questionnaire"
},
{
"measure": "10-item Positive and Negative Affect Schedule"
},
{
"measure": "Patient Health Questionnaire-9"
},
{
"measure": "Generalized Anxiety Disorder Scale"
},
{
"measure": "Subjective Happiness Scale"
},
{
"measure": "Connor-Davidson Resilience Scale 10-Item"
},
{
"measure": "Child-Parent Relationship Scale"
},
{
"measure": "Family Harmony Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "International Social Service Hong Kong Branch"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "City University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Continuous glucose monitoring (CGM) device"
}
]
},
"conditionsModule": {
"conditions": [
"Comprehensive Complication Index"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Zhifeng Gao, MD",
"phone": "18756235568",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhifeng Gao",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "102218"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this multi-center, pragmatic, randomized controlled trial is to assess the effectiveness of continuous glucose monitoring (CGM) compared with conventional monitoring in enhancing surgical outcomes for diabetic patients. The main questions it aims to answer are:* To assess the effectiveness of CGM compared with conventional monitoring in reducing the comprehensive complication index (CCI) for patients with diabetes or impaired glucose tolerance (IGT) within 30 days after surgery.* To analyze the impact of different age groups, types of surgery, preoperative levels of HbA1c, and preoperative 24h glycemic variations on the improvement of surgical outcomes under the CGM model.Participants will receive CGM prescribed by the attending physician for at least 6 hours before surgery. Glucose monitoring should be continued until the 7th day after surgery or discharge.The investigators will compare conventional monitoring group to see if CGM could reduce the CCIs for patients with diabetes or impaired glucose tolerance within 30 days after 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": 10168,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Diabetic Patients",
"nctId": "NCT06331923",
"orgStudyIdInfo": {
"id": "U1111-1305-0484",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comprehensive complication index"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative complications"
},
{
"measure": "Morality"
},
{
"measure": "The length of the stay in the intensive care unit"
},
{
"measure": "The length of hospital stay"
},
{
"measure": "The overall hospitalization cost"
},
{
"measure": "Perioperative glucose level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Peking University International Hospital"
},
{
"name": "Wang Jing Hospital"
},
{
"name": "ZhuHai Hospital"
},
{
"name": "Beijing Hospital"
},
{
"name": "Siyang County Hospital of Traditional Chinese Medicine"
},
{
"name": "Second Hospital of Shanxi Medical University"
},
{
"name": "Henan Provincial Chest Hospital"
},
{
"name": "Fuzhou First Hospital"
},
{
"name": "Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital"
},
{
"name": "The First Affiliated Hospital of Anhui University of Chinese Medicine"
},
{
"name": "The First Affiliated Hospital of Zhengzhou University"
},
{
"name": "Mindong Hospital of Ningde"
},
{
"name": "The Fifth Hospital of Xiamen"
},
{
"name": "People's Hospital of Ningxia Hui Autonomous Region"
},
{
"name": "The First People's Hospital of Changzhou"
},
{
"name": "The Fifth hospital of Deyang"
},
{
"name": "Suzhou Municipal Hospital"
},
{
"name": "Tang-Du Hospital"
},
{
"name": "Yiyang Central Hospital"
},
{
"name": "First Affiliated Hospital of Xinjiang Medical University"
},
{
"name": "Peng Ding Shan Shi Zhong Yi Yi Yuan"
},
{
"name": "Yueyang Central Hospital"
},
{
"name": "The First People's Hospital of Lianyungang"
},
{
"name": "Haimen District Traditional Chinese Medicine Hospital"
},
{
"name": "The 910th Hospital"
},
{
"name": "The Second Affiliated Hospital of Zhejiang Chinese Medical University"
},
{
"name": "Beijing Tiantan Hospital"
},
{
"name": "Affiliated Hospital of Jiangsu University"
},
{
"name": "Liaocheng People's Hospital"
},
{
"name": "Beijing Chao Yang Hospital"
},
{
"name": "Jilin City Hospital of Chemical Industry"
},
{
"name": "Creen Hospital-465"
},
{
"name": "Wuhan Central Hospital"
},
{
"name": "Air Force Military Medical University, China"
},
{
"name": "Shanghai Tong Ren Hospital"
},
{
"name": "Beijing Anzhen Hospital"
},
{
"name": "Emergency General Hospital"
},
{
"name": "Beijing Tongren Hospital"
},
{
"name": "Civil Aviation General Hospital"
},
{
"name": "Peking University Shougang Hospital"
},
{
"name": "The First Affiliated Hospital of Anhui Medical University"
},
{
"name": "Chinese PLA Central Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Beijing Tsinghua Chang Gung Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "insulin eye drops"
}
]
},
"conditionsModule": {
"conditions": [
"Neurotrophic Keratopathy"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers",
"nctId": "NCT06331910",
"orgStudyIdInfo": {
"id": "TITNCUES",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Decrease in ulcer size and the increase in visual acuity ."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Bronchial Asthma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Our goals is to assess :1¬_ the role of spirometer in case of asthma exacerbation 2_hematological parameters (N/L ratio \\& platelet indices \\&CRP )in asthma exacerbation for diagnosing and classifying asthma severity and its exacerbation"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bronchial Asthma & Its Exacerbation",
"nctId": "NCT06331897",
"orgStudyIdInfo": {
"id": "Bronchial asthma",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AK1967 (Procizumab)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Safety and Tolerability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nijmegen",
"contacts": [
{
"email": null,
"name": "Peter Pickkers, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Radboud University Medical Center",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": "Gelderland",
"status": "RECRUITING",
"zip": "6525"
}
]
},
"descriptionModule": {
"briefSummary": "Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock.Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects."
},
"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": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab)",
"nctId": "NCT06331884",
"orgStudyIdInfo": {
"id": "PCZ_Phase1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reported number of adverse events from baseline (start of Procizumab administration) up until the last follow-up visit after Procizumab administration"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "4TEEN4 Pharmaceuticals GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence."
},
{
"name": "Manual physiotherapy protocol based on available evidence."
}
]
},
"conditionsModule": {
"conditions": [
"Ultrasound-Guided Percutaneous Electrical Nerve Stimulation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "MARIO J ABRIL SERVÁN",
"phone": "+34636707810",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "FERNANDO GARCÍA SANZ",
"phone": "+34917355757",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "MARIO J ABRIL SERVÁN",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "ADRIÁN CASES",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Clinica Cemtro",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "RECRUITING",
"zip": "28049"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (US-PENS) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain.This is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a US-PENS session was added (n=35).The intervention and follow-up period of the participants took place over 12 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "70 patients with shoulder pain undergoing arthroscopic surgery were recruited. They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of ultrasound-guided percutaneous nerve stimulation (US-PENS) were added (n=35).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of US-PENS for Patients With Post-surgical Shoulder Pain",
"nctId": "NCT06331871",
"orgStudyIdInfo": {
"id": "2004202111621",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Numeric Pain Rating Scale (NPRS)"
},
{
"measure": "Disabilities of the Arm, Shoulder and Hand (DASH)"
},
{
"measure": "The Shoulder Pain and Disability Index (SPADI)"
},
{
"measure": "GONIOMETRY"
},
{
"measure": "DINAMOMETRY"
},
{
"measure": "PAIN THRESHOLD ON PRESSURE"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Rey Juan Carlos"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hip device-assisted concentric abductor strengthening (HDACAS)"
},
{
"name": "knee device-assisted concentric flexor-extensor strengthening (KDACFES)"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis",
"Pain",
"Physical Disability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kutahya",
"contacts": [
{
"email": "[email protected]",
"name": "Hasan Huseyin Gokpinar, Ass. Prof.",
"phone": "+905052842222",
"phoneExt": null,
"role": "CONTACT"
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"measure": "Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)"
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{
"measure": "Evaluation of blood levels of Galectin-3 (Gal-3)"
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{
"measure": "Evaluation of Enhanced Liver Fibrosis score (ELF)"
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{
"measure": "Evaluation of CMR imaging marker of fibrosis"
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"measure": "Evaluation of response to heart failure treatment"
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"measure": "Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)"
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"date": "2018-02-22"
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{
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"name": "Active AlgoCare"
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{
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"email": "[email protected]",
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"orgStudyIdInfo": {
"id": "IEO 1849",
"link": null,
"type": null
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"measure": "Wound healing timing"
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{
"measure": "Accommodative response measured with closed-field aberrometer with different displayed targets"
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"designModule": {
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],
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"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
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]
},
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"link": null,
"type": null
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"measure": "Acceptability"
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{
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{
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{
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{
"measure": "Appropriateness"
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"name": "Brigham and Women's Hospital"
}
},
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},
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"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
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"name": "Technology-enabled blood pressure management"
}
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]
},
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},
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"minimumAge": "18 Years",
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"OLDER_ADULT"
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"acronym": null,
"briefTitle": "Technology-Enabled Remote Hypertension Management To Advance Health Equity",
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"orgStudyIdInfo": {
"id": "ATMANHEALTH001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "Home measured change in SBP and DBP"
},
{
"measure": "Patient satisfaction"
},
{
"measure": "Provider satisfaction"
},
{
"measure": "Mean time required per patient for provider"
},
{
"measure": "Mean time required per patient for navigator"
},
{
"measure": "Proportion of patients measuring blood pressure at directed frequency"
},
{
"measure": "Resource utilization"
}
],
"primaryOutcomes": [
{
"measure": "Difference in SBP change"
}
],
"secondaryOutcomes": [
{
"measure": "HEDIS proportion"
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{
"measure": "Difference in DBP change"
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},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
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"interventions": [
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"name": "Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane"
},
{
"name": "Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group)"
},
{
"name": "Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity"
}
]
},
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"contacts": [
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"email": "[email protected]",
"name": "Marina M Lipina, MD, PhD",
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],
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}
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},
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},
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"link": null,
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},
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{
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{
"measure": "Anterior Cruciate Ligament OsteoArthritis Score"
},
{
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{
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},
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}
}
} | false | null |
{
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"interventions": [
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]
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"link": null,
"type": null
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"measure": "Incidence and Severity of Treatment Emergent Adverse Events"
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{
"measure": "Number of Participants with Clinically significant Changes from Baseline - Hematology"
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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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{
"measure": "Changes Over Time to Anti-drug Antibodies"
}
]
},
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},
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},
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"startDateStruct": {
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},
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}
}
} | false | null |
{
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"interventions": [
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]
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
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"acronym": null,
"briefTitle": "Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg",
"nctId": "NCT06331715",
"orgStudyIdInfo": {
"id": "ML1005",
"link": null,
"type": null
},
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"date": "2024-08-31"
},
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},
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},
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"date": "2024-03-26"
}
}
} | false | null |
{
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"interventions": [
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"name": "Vero cell-drived inactive Japanese encephalitis vaccine"
},
{
"name": "Measles-Mumps-Rubella Vaccine"
}
]
},
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"conditions": [
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"Measles",
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Zhiguo Wang, Master",
"phone": "+86 18118996978",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zhiguo Wang, Master",
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],
"country": "China",
"facility": "Jiangsu Provincial Center for Disease Control and Prevention",
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"state": "Jiangsu",
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}
]
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"descriptionModule": {
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},
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},
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},
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"minimumAge": "8 Months",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR)",
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"id": "CDBJEIV2023001",
"link": null,
"type": null
},
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},
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"measure": "Antibody Titer for Post Vaccination"
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}
],
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},
{
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},
{
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]
},
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"name": "Liaoning Chengda Biotechnology CO., LTD"
}
},
"statusModule": {
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"date": "2024-12-31"
},
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"date": "2024-09-30"
},
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"startDateStruct": {
"date": "2024-03-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
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"conditionsModule": {
"conditions": [
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]
},
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{
"city": "Kütahya",
"contacts": null,
"country": "Turkey",
"facility": "Kütahya Health Sciences University",
"geoPoint": {
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"lon": 29.98333
},
"state": null,
"status": null,
"zip": "43100"
}
]
},
"descriptionModule": {
"briefSummary": "Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation."
},
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"type": "ACTUAL"
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},
"identificationModule": {
"acronym": "Hip fractures",
"briefTitle": "EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE",
"nctId": "NCT06331689",
"orgStudyIdInfo": {
"id": "HP-epidemıology",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"measure": "mortalite ratio"
}
],
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},
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"name": "Kutahya Health Sciences University"
}
},
"statusModule": {
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"date": "2021-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
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"date": "2021-04-01"
},
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"startDateStruct": {
"date": "2021-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Tissue collection"
},
{
"name": "Data collection"
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]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bron",
"contacts": [
{
"email": "[email protected]",
"name": "Charles-André PHILIP, MD, PhD",
"phone": "04 27 85 51 70",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Femme Mère Enfant / GHE",
"geoPoint": {
"lat": 45.73333,
"lon": 4.91667
},
"state": null,
"status": null,
"zip": "69500"
},
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Gil DUBERNARD, MD, PhD",
"phone": "04 72 07 16 42",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital de la Croix-Rousse / GHN",
"geoPoint": {
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"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69004"
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]
},
"descriptionModule": {
"briefSummary": "Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants enrolled in this study will be given an eutopic and ectopic endometrium biopsies, blood and peritoneal fluid sampling and should answer to a questionnaire on menstrual health and history of hormone treatments for the research purpose..",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "OTEndo",
"briefTitle": "Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care",
"nctId": "NCT06331676",
"orgStudyIdInfo": {
"id": "69HCL23_1120",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID RCB",
"id": "2023-A02339-36",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering."
}
],
"secondaryOutcomes": [
{
"measure": "Change in protein expression"
},
{
"measure": "Change in gene expression"
},
{
"measure": "Change in inflammation"
},
{
"measure": "Change in histological tissue structure"
},
{
"measure": "Change in histological tissue structure"
},
{
"measure": "Change in tissue elasticity"
},
{
"measure": "Change in steroid hormone physiology"
},
{
"measure": "Steroid hormones in peritoneal fluid"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospices Civils de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remifentanil"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Procedural"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kaohsiung",
"contacts": [
{
"email": "[email protected]",
"name": "Zhi-Fu Wu, MD",
"phone": "07-3121101",
"phoneExt": "7035",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Kaohsiung Medical University Chung-Ho Memorial Hospital",
"geoPoint": {
"lat": 22.61626,
"lon": 120.31333
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \\> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\\>100bpm and arterial blood pressure(ABP)\\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SPI and Remifentanil in Skull Pin Fixation",
"nctId": "NCT06331663",
"orgStudyIdInfo": {
"id": "KMUHIRB-F(II)-20240055",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "50% effect concentration of remifentanil"
},
{
"measure": "90% effect concentration of remifentanil"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kaohsiung Medical University Chung-Ho Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "cadonilimab"
}
]
},
"conditionsModule": {
"conditions": [
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangdong",
"contacts": [
{
"email": "[email protected]",
"name": "zhou chegnzhi, doctor",
"phone": "13560351186",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Guangzhou Medical University",
"geoPoint": null,
"state": "Guangzhou",
"status": "RECRUITING",
"zip": "510000"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer",
"nctId": "NCT06331650",
"orgStudyIdInfo": {
"id": "CROC202314",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety assessments and ORR"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangzhou Institute of Respiratory Disease"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transanal Transection and Single-Stapled anastomosis (TTSS)"
},
{
"name": "Double-stapled anastomosis"
}
]
},
"conditionsModule": {
"conditions": [
"Ulcerative Colitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rozzano",
"contacts": [
{
"email": "[email protected]",
"name": "Annalisa Maroli, PhD",
"phone": "02 8224 7776",
"phoneExt": "0039",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Stefano De Zanet, MS",
"phone": "02 8224 4623",
"phoneExt": "0039",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Humanitas Research Hospital",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": "MI",
"status": null,
"zip": "20089"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 174,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TTSS-Pouch",
"briefTitle": "Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis",
"nctId": "NCT06331637",
"orgStudyIdInfo": {
"id": "3782",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pouch Function Score (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Pouch Function Score (PFS)"
},
{
"measure": "Pouch Function Score (PFS)"
},
{
"measure": "Postoperative complications"
},
{
"measure": "Anastomotic leak"
},
{
"measure": "Patients fit for stoma closure"
},
{
"measure": "Healthcare costs"
},
{
"measure": "Rectal cuff lenght"
},
{
"measure": "Pouch complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Clinico Humanitas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tazarotene (GRI-0621)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Idiopathic Pulmonary Fibrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newport Beach",
"contacts": [
{
"email": "[email protected]",
"name": "Brandon Vu",
"phone": "949-791-8599",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Newport Native MD, Inc.",
"geoPoint": {
"lat": 33.61891,
"lon": -117.92895
},
"state": "California",
"status": "RECRUITING",
"zip": "92663"
},
{
"city": "Winston-Salem",
"contacts": [
{
"email": "[email protected]",
"name": "Karen McCutcheon",
"phone": "336-659-8414",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Southeastern Research Center",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27103"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects complete 6 weeks of treatment (approximately 8 placebo subjects)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF",
"nctId": "NCT06331624",
"orgStudyIdInfo": {
"id": "GRI-0621-IPF-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory - Pulmonary Function"
}
],
"primaryOutcomes": [
{
"measure": "Safety and Tolerability of oral GRI-0621"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline biomarkers"
},
{
"measure": "Plasma concentrations of GRI-0621"
},
{
"measure": "Pharmacodynamics of GRI-0621 in blood (Study Population)"
},
{
"measure": "Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "GRI Bio Operations, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TOF monitoring"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia,General",
"Neuromuscular Blockade",
"Tracheal Intubation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To date there is still little scientific evidence regarding neuromuscular block monitoring in pediatric anesthesia and indications for safe reversal. Although the use of rocuronium and sugammadex is becoming wide, qualitative monitoring or clinical practice are applied instead of quantitative monitoring (acceleromyography-electromyography EMG). The use of neuromuscular monitoring leads to better control of intraoperative paralysis, proper timing of extubation, and reduced risk of residual postoperative paralysis-paralysis (PORC) and related complications.The main objective of the study is to analyse the incidence of sugammadex use and the total dose/kg, with and without the aid of quantitative neuromuscular monitoring.Secondary objectives are:* the time required to extubate different patients,* the incidence of respiratory complications at extubation,* the need to administer additional doses of sugammadex. A prospective RCT. Patients will be divided into two study groups; in the first group, quantitative neuromuscular monitoring based on electromyography (EMG) will be used, while in the second group, the same monitoring will be applied but covered (blinded to the anesthetist) and the pharmacological strategy is based exclusively on the clinical practice All children aged between 2 months and 6 years, scheduled to undergo elective non-cardiac surgical procedures, lasting approximately from one to two hours(anesthesia time), with general anesthesia and tracheal intubation receiving a non-depolarizing blockade agent.* Children between 2 months and 6 years* Children who will undergo elective non cardiac surgery (maximum two hours of anesthesia time with tracheal intubation receiving a non depolarizing blockade agent),* Acquisition of informed consent by a legally recognized representative capable of understanding the document and providing consent on behalf of the participant. * Children under 2 months of age or over 12 years of age, * Children with an ASA classification \\> 3, * Presence of neuromuscular disease, channelopathy, or any clinical condition that contraindicates the administration of neuromuscular muscle relaxants, * Confirmed or suspected allergy to sugammadex or rocuroniumt, * Presence of amputation or limb malformations that make placement of neuromuscular monitoring impossible, * Any specific contraindication to any aspect of the protocol. 12 months The randomization process will performed using numbers randomized by a computer-generated random number sequence. The randomization list will be prepared by independent statistician . The subjects will be assigned to the treatment arm in a sequence as per the randomization code provided in a closed envelope in a 1:1 ratio. The investigator will administered the treatment as per the randomization codes.One hundred children undergo in the clinically guided group and 100 children in the neuromuscular monitoring groups with the aim to include 200 children in total.Demographics and baseline characteristics with mean, median, standard deviation, and range (minimum, maximum) will generated for each arm. Subject disposition, including the number of subjects withdrawn or discontinued from the study, for each arm will summarized. The study will follow the CONSORT guidelines for statistical analysis and reporting. Chi squared test or Fisher's exact test and Student's t-test or Mann Whitney test will applied to categorical and continuous data, respectively, with a significance level of 5% by two-sided test. Statistical analysis was performed using SPSS software (ver. 21.0) (IBM, Armonk, NY, USA)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "MOTOR",
"briefTitle": "MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA",
"nctId": "NCT06331611",
"orgStudyIdInfo": {
"id": "Motor",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sugammadex administration"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Giannina Gaslini"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Atezolizumab"
},
{
"name": "Tiragolumab"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitari Vall dHebron; Oncology",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08035"
},
{
"city": "Sevilla",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Virgen; Servicio de Oncologia",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": null,
"status": "RECRUITING",
"zip": "41013"
}
]
},
"descriptionModule": {
"briefSummary": "This study is being conducted to evaluate efficacy parameters (disease free survival \\[DFS\\] and overall survival \\[OS\\]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMperator",
"briefTitle": "A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors With Resectable Disease With Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)",
"nctId": "NCT06331598",
"orgStudyIdInfo": {
"id": "ML43332",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2022-003708-33",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease Free Survival (DFS) Rate at 24 Months"
}
],
"secondaryOutcomes": [
{
"measure": "DFS Rate at 36, 48 and 60 Months"
},
{
"measure": "OS (Overall Survival)"
},
{
"measure": "Percentage of Participants With Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hoffmann-La Roche"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-10-20"
},
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"startDateStruct": {
"date": "2024-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "low dose radiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Low-dose Radiotherapy",
"Tumor Microenvironment",
"Non-Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hetian",
"contacts": null,
"country": "China",
"facility": "Hetian District People's Hospital",
"geoPoint": null,
"state": "Xinjiang Uygur Autonomous Region",
"status": null,
"zip": "848000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this phase Ⅱ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. All will take part at Hetian District People's Hospital."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 0,
"type": "ACTUAL"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC After Immunotherapy",
"nctId": "NCT06331585",
"orgStudyIdInfo": {
"id": "KY-2024004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Analysis of the tumor immune microenvironment"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy"
},
{
"measure": "Progression Free Survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hetian District People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "WITHDRAWN",
"primaryCompletionDateStruct": {
"date": "2025-03-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "17-HAMD"
}
]
},
"conditionsModule": {
"conditions": [
"Psychiatric Disorder",
"Major Depressive Disorder",
"Metabolic Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": null,
"country": "China",
"facility": "The First Affiliated Hospital of Chongqing Medical University",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Province",
"status": null,
"zip": "400000"
}
]
},
"descriptionModule": {
"briefSummary": "This study contributes new evidence for the identification of adolescent TRD and sheds light on differing pathophysiologies by delineating distinct plasma metabolic profiles between adolescent TRD and FEDN-MDD."
},
"designModule": {
"designInfo": {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 162,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression",
"nctId": "NCT06331572",
"orgStudyIdInfo": {
"id": "1stChongqingMU-TRD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "17 items Hamilton Depression Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Hamilton Anxiety Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital of Chongqing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
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"primaryCompletionDateStruct": {
"date": "2021-10-25"
},
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"startDateStruct": {
"date": "2021-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-26"
}
}
} | false | null |
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