protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Fibromyalgia",
"Disabilities Multiple"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rzeszów",
"contacts": [
{
"email": "[email protected]",
"name": "Agnieszka Sozańska, professor",
"phone": "+48 530172857",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "University of Rzeszow",
"geoPoint": {
"lat": 50.04132,
"lon": 21.99901
},
"state": "Podkarpacie",
"status": "RECRUITING",
"zip": "35-310"
}
]
},
"descriptionModule": {
"briefSummary": "Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called \"tender points\" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CROSSOVER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 700,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Disability of People With Fibromyalgia in Poland",
"nctId": "NCT06296446",
"orgStudyIdInfo": {
"id": "disability fibromyalgia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "disability"
}
],
"secondaryOutcomes": [
{
"measure": "functioning"
},
{
"measure": "depression"
},
{
"measure": "Sociodemographic data"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Rzeszow"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VR rehabilitation"
},
{
"name": "VR video application"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Pain",
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "IDIBAPS",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": "08036"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "XR-PAIN",
"briefTitle": "Extended Reality-Assisted Therapy for Chronic Pain Management",
"nctId": "NCT06296433",
"orgStudyIdInfo": {
"id": "HCB_2023_1196",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Spinal Range of motion"
},
{
"measure": "Adherence to treatment"
},
{
"measure": "Embodiment"
}
],
"primaryOutcomes": [
{
"measure": "Brief Pain Inventory"
}
],
"secondaryOutcomes": [
{
"measure": "Roland-Morris Disability Questionnaire"
},
{
"measure": "Short-Form 12"
},
{
"measure": "Patient Global Impression of Change"
},
{
"measure": "Pain Catastrophization Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut d'Investigacions Biomèdiques August Pi i Sunyer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Goiter",
"Thyroid Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Stefano Scarano, MD",
"phone": "+3902619116717",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": "MI",
"status": "RECRUITING",
"zip": "20122"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 420,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DYSPHATHYR",
"briefTitle": "Dysphagia After Thyroidectomy",
"nctId": "NCT06296420",
"orgStudyIdInfo": {
"id": "24C304",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself."
}
],
"secondaryOutcomes": [
{
"measure": "Patient and Observer Scar Assessment Scale (POSAS) 2.0."
},
{
"measure": "Depression Anxiety Stress Scales-21 (DASS-21)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standard metabolic integrated rehabilitation protocol - duration 3 weeks"
},
{
"name": "Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity, Childhood"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oggebbio",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandro Sartorio, MD",
"phone": "+390261911",
"phoneExt": "2426",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano, Site Piancavallo",
"geoPoint": {
"lat": 45.99088,
"lon": 8.64663
},
"state": "Verbania",
"status": "RECRUITING",
"zip": "28824"
}
]
},
"descriptionModule": {
"briefSummary": "Specifically, the project aims to pursue the following objectives:1. To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;2. To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.The final objective of this project is to define and propose \"take home\" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PSICOFISADOL",
"briefTitle": "Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB).",
"nctId": "NCT06296407",
"orgStudyIdInfo": {
"id": "01C319",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fat mass"
},
{
"measure": "Fat-free mass"
},
{
"measure": "Maximal Inspiratory Pressure"
},
{
"measure": "Maximal Expiratory Pressure"
},
{
"measure": "Interoceptive awareness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Parenthood"
}
]
},
"conditionsModule": {
"conditions": [
"Cystic Fibrosis",
"Parenthood Status"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": [
{
"email": null,
"name": "George M Solomon, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Alabama-Birmingham",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama",
"status": null,
"zip": "35294"
},
{
"city": "Denver",
"contacts": null,
"country": "United States",
"facility": "National Jewish Health",
"geoPoint": {
"lat": 39.73915,
"lon": -104.9847
},
"state": "Colorado",
"status": null,
"zip": "80206"
},
{
"city": "Evanston",
"contacts": [
{
"email": null,
"name": "Manu Jain, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Northwestern University",
"geoPoint": {
"lat": 42.04114,
"lon": -87.69006
},
"state": "Illinois",
"status": null,
"zip": "60208"
},
{
"city": "Indianapolis",
"contacts": [
{
"email": null,
"name": "Cynthia Brown, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Indiana University",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana",
"status": null,
"zip": "46202"
},
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "Megan Behrman",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Amanda Bruce, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Kansas Medical Center",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas",
"status": null,
"zip": "66160"
},
{
"city": "Baltimore",
"contacts": null,
"country": "United States",
"facility": "Johns Hopkins University",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": null,
"zip": "21218"
},
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Massachusetts General Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02114"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Jonathan Greenberg",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Manuela Cernadas, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Boston Children's Hospital/Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
},
{
"city": "Ann Arbor",
"contacts": [
{
"email": null,
"name": "Shijing Jia, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Michigan",
"geoPoint": {
"lat": 42.27756,
"lon": -83.74088
},
"state": "Michigan",
"status": null,
"zip": "48109"
},
{
"city": "Minneapolis",
"contacts": null,
"country": "United States",
"facility": "University of Minnesota",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
},
"state": "Minnesota",
"status": null,
"zip": "55455"
},
{
"city": "Saint Louis",
"contacts": [
{
"email": null,
"name": "Daniel Rosenbluth, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Washington University School of Medicine",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": null,
"zip": "63110"
},
{
"city": "Chapel Hill",
"contacts": null,
"country": "United States",
"facility": "University of North Carolina",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27599"
},
{
"city": "Portland",
"contacts": [
{
"email": null,
"name": "Aaron Trimble, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Oregon Health and Science University",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon",
"status": null,
"zip": "97239"
},
{
"city": "Philadelphia",
"contacts": [
{
"email": null,
"name": "Denis Hadjiliadis, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
},
{
"city": "Pittsburgh",
"contacts": null,
"country": "United States",
"facility": "University of Pittsburgh",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15213"
},
{
"city": "Charleston",
"contacts": [
{
"email": null,
"name": "Patrick Flume, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Medical University of South Carolina",
"geoPoint": {
"lat": 32.77657,
"lon": -79.93092
},
"state": "South Carolina",
"status": null,
"zip": "29425"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "University of Texas-Southwestern",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75390"
},
{
"city": "Seattle",
"contacts": null,
"country": "United States",
"facility": "University of Washington",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": null,
"zip": "98195"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stressH3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulatorsParticipants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 146,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HOPeCF",
"briefTitle": "Health Outcomes of Parents With Cystic Fibrosis-Aim 2",
"nctId": "NCT06296394",
"orgStudyIdInfo": {
"id": "STUDY23080161",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1R01HL161164-01A1",
"link": "https://reporter.nih.gov/quickSearch/1R01HL161164-01A1",
"type": "NIH"
},
{
"domain": "Cystic Fibrosis Foundation",
"id": "KAZMER22A0",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Forced Expiratory Volume (FEV1)"
}
],
"secondaryOutcomes": [
{
"measure": "Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC)"
},
{
"measure": "Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1)"
},
{
"measure": "Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75)"
},
{
"measure": "History of CF Diagnosis"
},
{
"measure": "History of CF Genotype Information"
},
{
"measure": "History of CF Mutation"
},
{
"measure": "Number of Hospitalizations"
},
{
"measure": "Length of Hospitalizations"
},
{
"measure": "Number of Pulmonary Exacerbations"
},
{
"measure": "Severity of Pulmonary Exacerbations"
},
{
"measure": "Treatment of Pulmonary Exacerbations"
},
{
"measure": "Rate of Hospitalizations Due to Pulmonary Exacerbations"
},
{
"measure": "Clinic Visit Attendance"
},
{
"measure": "Microbiologic Profile"
},
{
"measure": "Medication use"
},
{
"measure": "History of CF-Related Diabetes Status"
},
{
"measure": "CF-Related Diabetes Control - Hemoglobin A1C"
},
{
"measure": "CF-Related Diabetes Control - Glucose Tolerance"
},
{
"measure": "CF-Related Diabetes Control - Insulin Prescription Usage"
},
{
"measure": "Liver Disease Status"
},
{
"measure": "Transplantation Status"
},
{
"measure": "Transplantation Type"
},
{
"measure": "BMI"
},
{
"measure": "Sleep Quality"
},
{
"measure": "Parental Stress"
},
{
"measure": "Life Stressors"
},
{
"measure": "Cystic Fibrosis Questionnaire to evaluate quality of life domains"
},
{
"measure": "Parental Responsibility"
},
{
"measure": "Daily Care Check-In"
},
{
"measure": "Social Support"
},
{
"measure": "Anxiety"
},
{
"measure": "Depression"
},
{
"measure": "Self-Reported Adherence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Cystic Fibrosis Foundation"
},
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pittsburgh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Intensive Care Unit",
"Muscle Strength"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Recife",
"contacts": [
{
"email": "[email protected]",
"name": "Shirley Campos",
"phone": "+5581999413087",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Pedro Vinicius Porfirio",
"phone": "+5581993954400",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lucas Rafael da Silva Fraga",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Brazil",
"facility": "Federal University of Pernambuco (UFPE)",
"geoPoint": {
"lat": -8.05389,
"lon": -34.88111
},
"state": "PE",
"status": "RECRUITING",
"zip": "50740-600"
},
{
"city": "Recife",
"contacts": [
{
"email": "[email protected]",
"name": "Shirley L Campos",
"phone": "+5581999413087",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Brazil",
"facility": "Hospital Otávio de Freitas",
"geoPoint": {
"lat": -8.05389,
"lon": -34.88111
},
"state": "PE",
"status": "NOT_YET_RECRUITING",
"zip": "50920-460"
},
{
"city": "Recife",
"contacts": [
{
"email": "[email protected]",
"name": "Lidier Roberta Moraes Nogueira",
"phone": "+5581995479644",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Shirley L Campos",
"phone": "+5581999413087",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jose Douglas de Souza Cordeiro",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Brazil",
"facility": "Hospital Nossa Senhora das Graças",
"geoPoint": {
"lat": -8.05389,
"lon": -34.88111
},
"state": "PE",
"status": "RECRUITING",
"zip": "51030-020"
}
]
},
"descriptionModule": {
"briefSummary": "Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. The aim of this study is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"maskingInfo": null,
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"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HHD-ICU",
"briefTitle": "Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals",
"nctId": "NCT06296381",
"orgStudyIdInfo": {
"id": "6.131.540",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Peripheral muscle strength measured by hand held dynamometer"
},
{
"measure": "Peripheral muscle strength measured by Medical Research Council score"
}
],
"secondaryOutcomes": [
{
"measure": "Peripheral muscle strength measured by hand grip dynamometer"
},
{
"measure": "Mobility in ICU measured by Perme Intensive Care Unit Mobility Score"
},
{
"measure": "Level of frailty in older adults by the Multidimensional Assessment of Older People (AMPI-AB)"
},
{
"measure": "Level of physical activity in young adults by the International Physical Activity Questionnaire - Short Form"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universidade Federal de Pernambuco"
},
{
"name": "Conselho Nacional de Desenvolvimento Científico e Tecnológico"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pernambuco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Preference Reporting to Improve Management and Experience (PRIME)"
}
]
},
"conditionsModule": {
"conditions": [
"Hematologic Malignancies",
"Lymphoma",
"Multiple Myeloma",
"Leukemia",
"Blood Cancers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Mireille L Leone",
"phone": "919-445-0768",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniel R Richardson,, MD, MA, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Lineberger Comphrehensive Cancer Center at University of North Carolina",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27516"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DISCOVERY",
"briefTitle": "DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics",
"nctId": "NCT06296368",
"orgStudyIdInfo": {
"id": "LCCC2305",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in COLLABORATE scores between arms"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in COLLABORATE scores between arms in a subgroup of patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "UNC Lineberger Comprehensive Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Health Warning Label"
},
{
"name": "Identity Warning Label"
},
{
"name": "Barcode Label"
}
]
},
"conditionsModule": {
"conditions": [
"Health Behavior",
"Diet, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Violet Noe",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UNC Carolina Population Center",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27516"
}
]
},
"descriptionModule": {
"briefSummary": "Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).Participants: \\~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impacts of Warning Labels on Ultra-Processed Foods",
"nctId": "NCT06296355",
"orgStudyIdInfo": {
"id": "24-0300d",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of a product as ultra-processed"
}
],
"secondaryOutcomes": [
{
"measure": "Perceived product healthfulness of ultra-processed products"
},
{
"measure": "Intentions to purchase ultra-processed products"
},
{
"measure": "Perceived message effectiveness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Robert Wood Johnson Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exposure to information framing message"
},
{
"name": "Exposure to healthier choices framing message"
},
{
"name": "Exposure to industry framing message"
}
]
},
"conditionsModule": {
"conditions": [
"Diet, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Marissa G Hall",
"phone": "919-445-1310",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of North Carolina at Chapel Hill's Gillings School of Global Public Health",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27599"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Message Framing and Policy Support for Front-of-package Labeling",
"nctId": "NCT06296342",
"orgStudyIdInfo": {
"id": "24-0300c",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Support for the front-of-package labeling policy, proportion"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Duke University"
},
{
"name": "Stanford University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rubber Hand Illusion"
}
]
},
"conditionsModule": {
"conditions": [
"Anorexia Nervosa"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Piancavallo",
"contacts": [
{
"email": "[email protected]",
"name": "Federica Scarpina, PhD",
"phone": "+39032351",
"phoneExt": "4003",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe",
"geoPoint": null,
"state": "VCO",
"status": "RECRUITING",
"zip": "28824"
}
]
},
"descriptionModule": {
"briefSummary": "The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "RHI_size_AN",
"briefTitle": "Rubber Hand Illusion in Anorexia Nervosa",
"nctId": "NCT06296329",
"orgStudyIdInfo": {
"id": "21C309",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proprioceptive drift in centimeters"
}
],
"secondaryOutcomes": [
{
"measure": "Score at the Embodiment questionnaires"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Turin, Italy"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Restorelle Polypropylene Mesh"
}
]
},
"conditionsModule": {
"conditions": [
"Genital Prolapse"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Avranches",
"contacts": [
{
"email": null,
"name": "Frédéric Dubois, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Frédéric Dubois, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Polyclinique de la Baie",
"geoPoint": {
"lat": 48.68333,
"lon": -1.36667
},
"state": "Choisir Une Région",
"status": "NOT_YET_RECRUITING",
"zip": "50300"
},
{
"city": "Bordeaux",
"contacts": [
{
"email": null,
"name": "Claude Hocké, Pr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Claude Hocké, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Centre Aliénor d'Aquitaine",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "33076"
},
{
"city": "Bordeaux",
"contacts": [
{
"email": null,
"name": "Grégoire Capon, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Grégoire Capon, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU Pellegrin",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "33076"
},
{
"city": "Issoire",
"contacts": [
{
"email": null,
"name": "Clément Bruhat, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Clément Bruhat, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Aslam Mansoor, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CH Paul Ardier d'Issoire",
"geoPoint": {
"lat": 45.55,
"lon": 3.25
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "63500"
},
{
"city": "La Rochelle",
"contacts": [
{
"email": null,
"name": "Philippe Ferry, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Philippe Ferry, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Yannick Thirouard, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CH La Rochelle",
"geoPoint": {
"lat": 46.16667,
"lon": -1.15
},
"state": null,
"status": "RECRUITING",
"zip": "17019"
},
{
"city": "Le Puy-en-Velay",
"contacts": [
{
"email": null,
"name": "Jacques Philippe Largeron, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jacques Philippe Largeron, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Marlène Guandalino, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Clinique Bon Secours",
"geoPoint": {
"lat": 45.04366,
"lon": 3.88523
},
"state": null,
"status": "RECRUITING",
"zip": "43000"
},
{
"city": "Libourne",
"contacts": [
{
"email": null,
"name": "Michel Briex, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michel Briex, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CH Général Robert Boulin",
"geoPoint": {
"lat": 44.91667,
"lon": -0.23333
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "33505"
},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Isabelle Sauret",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christine Louis Sylvestre, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Yael Levy Zauberman, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Camille Baraud, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mathilde Allanche, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Institut Mutualiste Montsouris",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "75014"
},
{
"city": "Saint-Grégoire",
"contacts": [
{
"email": null,
"name": "Frédéric Dubois, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Frédéric Dubois, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CH privé Saint Grégoire",
"geoPoint": {
"lat": 48.15085,
"lon": -1.68706
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "35760"
},
{
"city": "Saintes",
"contacts": [
{
"email": null,
"name": "Damien Emeriau, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Damien Emeriau, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CH de Saintonge",
"geoPoint": {
"lat": 45.75,
"lon": -0.63333
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "17108"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 428,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "REPAIR",
"briefTitle": "Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair",
"nctId": "NCT06296316",
"orgStudyIdInfo": {
"id": "IU022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence rate of surgical reintervention related to Restorelle mesh use in patients"
},
{
"measure": "Number of patients who have only had surgical reintervention not related to Restorelle mesh use"
},
{
"measure": "Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use"
},
{
"measure": "Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use)"
},
{
"measure": "Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use)"
},
{
"measure": "Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use)"
},
{
"measure": "Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention"
},
{
"measure": "Number of Adverse Device Effect"
},
{
"measure": "Percentage of Adverse Device Effect"
},
{
"measure": "Number of Restorelle mesh Device Deficiencies"
},
{
"measure": "Percentage of Restorelle mesh Device Deficiencies"
},
{
"measure": "Description of Restorelle mesh Device Deficiencies"
},
{
"measure": "Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire"
},
{
"measure": "Changes of prolapse symptoms"
},
{
"measure": "Prolapse symptoms - number"
},
{
"measure": "Prolapse symptoms - percentage"
},
{
"measure": "Assessment of health related quality of life using the EQ-5D-5L questionnaire"
},
{
"measure": "Assessment of health related quality of life using the PFIQ-7 questionnaire"
},
{
"measure": "Assessment of the sexual functioning by the PISQ-IR questionnaire"
},
{
"measure": "Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active."
},
{
"measure": "Number of patients defining success via patient global impression of improvement (PGI-I) scale"
},
{
"measure": "Percentage of patients defining success via patient global impression of improvement (PGI-I) scale"
},
{
"measure": "Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)."
},
{
"measure": "Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "International Clinical Trials Association"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Coloplast A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pulsed electromagnetic therapy"
},
{
"name": "Ultrasound phonophoresis"
},
{
"name": "Conventional physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Lumbar Radiculopathy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Purposes of the studyTo investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients",
"nctId": "NCT06296303",
"orgStudyIdInfo": {
"id": "MBH24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain"
},
{
"measure": "Disability"
},
{
"measure": "Sciatic nerve cross sectional area"
}
],
"secondaryOutcomes": [
{
"measure": "H-reflex amplitude"
},
{
"measure": "H-reflex side-to-side amplitude (H/H) ratio"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Hypothermia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Caen",
"contacts": null,
"country": "France",
"facility": "CHU Caen Normandie",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": "14000"
}
]
},
"descriptionModule": {
"briefSummary": "A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming.The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARDIOCOLD",
"briefTitle": "Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function",
"nctId": "NCT06296290",
"orgStudyIdInfo": {
"id": "CARDIOCOLD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Heart rate from a resting ECG recording"
},
{
"measure": "Heart rate from a 5-minute ECG recording"
},
{
"measure": "Transthoracic echocardiography (TTE) analysis"
},
{
"measure": "Change in Body Core Temperature"
}
],
"secondaryOutcomes": [
{
"measure": "Body composition, body fat mass"
},
{
"measure": "Body composition, fat-free mass"
},
{
"measure": "Duration"
},
{
"measure": "Individual characteristics, gender"
},
{
"measure": "Individual characteristics, age"
},
{
"measure": "Individual characteristics, training in cold environment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Caen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-06-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intraoperative mechanical ventilation for surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Surgery",
"Ventilator Lung",
"Postoperative Complications"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MEET VENUS",
"briefTitle": "Mechanical Ventilation in Surgical Patients",
"nctId": "NCT06296277",
"orgStudyIdInfo": {
"id": "UPO#1!",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative pulmonary complications (PPCs)"
}
],
"secondaryOutcomes": [
{
"measure": "Intraoperative adverse events (IAEs)"
},
{
"measure": "Intraoperative mechanical ventilation practice"
},
{
"measure": "Postoperative clinical outcome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Of Perugia"
},
{
"name": "University of Chieti"
},
{
"name": "Medical University of Vienna"
},
{
"name": "The Netherlands Cancer Institute"
},
{
"name": "Monash University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Ospedaliero Universitaria Maggiore della Carita"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standard ultrasound"
},
{
"name": "Ultra-portable ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"IV Line Placement With Ultrasound"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Emmanuel VIVIER, MD",
"phone": "0033478618209",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Fanny DOROSZEWSKI, Mrs",
"phone": "0033478618398",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Emmanuel VIVIER, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Raphaël STREIFF, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Guillaume MARCOTTE, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "Saint Joseph Saint Luc Hospital",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": "Rhone-alpes",
"status": null,
"zip": "69007"
}
]
},
"descriptionModule": {
"briefSummary": "The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture",
"nctId": "NCT06296264",
"orgStudyIdInfo": {
"id": "ULTRACATHLON",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Intravenous (IV) line placement time"
}
],
"secondaryOutcomes": [
{
"measure": "Placement of the IV line successfully obtained from the first puncture"
},
{
"measure": "Number of skin perforations"
},
{
"measure": "Overall success rate after 3 punctures"
},
{
"measure": "Use an alternative solution (central catheter)"
},
{
"measure": "Patient satisfaction with IV line placement"
},
{
"measure": "Nurse satisfaction with IV line placement"
},
{
"measure": "Immediate complications related to intravenous access"
},
{
"measure": "Delayed complications related to intravenous access"
},
{
"measure": "Date of IV line placement and removal"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Saint Joseph Saint Luc de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Placebo treatment"
},
{
"name": "Plant derived phenolics"
}
]
},
"conditionsModule": {
"conditions": [
"Dyslipidemias",
"Pre-diabetes"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo."
},
"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": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dietary Supplementation on Body Fat Composition",
"nctId": "NCT06296251",
"orgStudyIdInfo": {
"id": "BIO-2313",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Body fat mass"
}
],
"secondaryOutcomes": [
{
"measure": "Body composition"
},
{
"measure": "Android fat mass"
},
{
"measure": "Gynoid fat mass"
},
{
"measure": "Abdominal visceral fat mass"
},
{
"measure": "Abdominal circumference"
},
{
"measure": "Hip circumference"
},
{
"measure": "Chest circumference"
},
{
"measure": "Upper thigh circumference"
},
{
"measure": "Upper arm circumference"
},
{
"measure": "Waist to hip ratio"
},
{
"measure": "Fasting glucose"
},
{
"measure": "Fasting insulin"
},
{
"measure": "HbA1c"
},
{
"measure": "FGF21"
},
{
"measure": "Systolic blood pressure"
},
{
"measure": "Diastolic blood pressure"
},
{
"measure": "Total-Cholesterol"
},
{
"measure": "HDL-C"
},
{
"measure": "LDL-C"
},
{
"measure": "VLDL-C"
},
{
"measure": "non-HDL-C"
},
{
"measure": "Triglycerides"
},
{
"measure": "Body Weight"
},
{
"measure": "Physical functioning"
},
{
"measure": "Bodily pain"
},
{
"measure": "Role limitations due to physical health"
},
{
"measure": "Role limitation due to personal or emotional problems"
},
{
"measure": "Emotional well-being"
},
{
"measure": "Social functioning"
},
{
"measure": "Energy/Fatigue"
},
{
"measure": "General health perceptions"
},
{
"measure": "Total kcals"
},
{
"measure": "Total fat"
},
{
"measure": "Total protein"
},
{
"measure": "Total carbohydrates"
},
{
"measure": "Fiber"
},
{
"measure": "Healthy Eating Index (HEI) score"
},
{
"measure": "ALT"
},
{
"measure": "AST"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Brightseed"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Prenatal Exposure Delayed Effects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Harvard Medical School",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
},
{
"city": "Addis Ababa",
"contacts": null,
"country": "Ethiopia",
"facility": "Addis Continental Institute of Public Health",
"geoPoint": {
"lat": 9.02497,
"lon": 38.74689
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.Participants are the offspring of mothers in the main study entitled \"Enhancing Nutrition and Antenatal Infection Treatment (ENAT)\" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.The main questions it aims to answer are:1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "27 Months",
"minimumAge": "9 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia",
"nctId": "NCT06296238",
"orgStudyIdInfo": {
"id": "2023P000461",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Evoked Potential (VEP) P1 Latency"
}
],
"secondaryOutcomes": [
{
"measure": "EEG Functional Connectivity"
},
{
"measure": "Cecile Attention Task"
},
{
"measure": "Infant Head Circumference"
},
{
"measure": "Bayley III, Cognition"
},
{
"measure": "MAAP - Accuracy and Speed"
},
{
"measure": "Hammersmith Infant Neurological Exam (HINE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Addis Continental Institute of Public Health"
},
{
"name": "Boston Children's Hospital"
},
{
"name": "New York University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Brigham and Women's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vibration"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Stroke, Acute",
"Fatigue"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chartres",
"contacts": [
{
"email": "[email protected]",
"name": "Valentin BOHOTIN, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Valentin BOHOTIN, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CH de Chartres",
"geoPoint": {
"lat": 48.44685,
"lon": 1.48925
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Orleans",
"contacts": [
{
"email": "[email protected]",
"name": "Canan OZSANCAK, Ph",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andreea AIGNATOAIE, Ph",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU d'ORLEANS",
"geoPoint": {
"lat": 47.90289,
"lon": 1.90389
},
"state": null,
"status": "RECRUITING",
"zip": "45067"
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Charlotte ROSSO, Pr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Charlotte ROSSO, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hopital Pitie Salpetriere",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Tours",
"contacts": [
{
"email": "[email protected]",
"name": "Marco PASI, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marco PASI, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU de Tours",
"geoPoint": {
"lat": 47.38333,
"lon": 0.68333
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.The investigations will be carried out by a specialized physiotherapist from the neurology department.The experiment consists of three successive phases:* First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.* Second : Rest period* Third: control phase with measurement of the maximum grip force every ten minutes without vibration."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VIBRAMAIN1",
"briefTitle": "Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase",
"nctId": "NCT06296225",
"orgStudyIdInfo": {
"id": "CHRO-2023-07",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum handgrip strength measured by a digital dynamometer"
}
],
"secondaryOutcomes": [
{
"measure": "Fatigue evolution"
},
{
"measure": "Evolution of handgrip strength during the vibration session measured by a digital dynamometer"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Régional d'Orléans"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TAD® 600 mg/4 mL powder and solvent for solution for injection"
},
{
"name": "Saline solution 0.9% of sodium chloride"
}
]
},
"conditionsModule": {
"conditions": [
"Pneumonia",
"Myocardial Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pisa",
"contacts": [
{
"email": null,
"name": "Massimiliano Desideri",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero-Universitaria Pisana",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": "PI",
"status": null,
"zip": "56126"
},
{
"city": "Roma",
"contacts": [
{
"email": null,
"name": "Francesco Grigioni",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario Campus Bio-Medico",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": null,
"zip": "00128"
},
{
"city": "Roma",
"contacts": [
{
"email": null,
"name": "Francesco Barillà",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliera Universitaria Policlinico Tor Vergata",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": null,
"zip": "00133"
},
{
"city": "Roma",
"contacts": [
{
"email": null,
"name": "Pasquale Pignatelli",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero-Universitaria Policlinico Umberto I",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": null,
"zip": "00161"
},
{
"city": "Roma",
"contacts": [
{
"email": null,
"name": "Alberto Ricci",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero-Universitaria Sant'Andrea",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": null,
"zip": "00189"
},
{
"city": "Terni",
"contacts": [
{
"email": null,
"name": "Giacomo Pucci",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliera Santa Maria",
"geoPoint": {
"lat": 42.56335,
"lon": 12.64329
},
"state": "TR",
"status": null,
"zip": "05100"
},
{
"city": "Treviso",
"contacts": [
{
"email": null,
"name": "Marcello Rattazzi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale Ca' Foncello",
"geoPoint": {
"lat": 45.66673,
"lon": 12.2416
},
"state": "TV",
"status": null,
"zip": "31100"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia.The main question it aims to answer is:• could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment.Eligible patients who meet the study inclusion criteria and complete the required Screening \\& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \\& Patient blinded.TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered:* intravenously (with an infusion rate of 10 mL/min)* 2 times a day (with a dosing interval of 8 hours ± 30 minutes)* for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5)* patients will then be required to undergo five Follow-up Visits."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 178,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia.",
"nctId": "NCT06296212",
"orgStudyIdInfo": {
"id": "GLT-07-22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VR"
},
{
"name": "Music only"
}
]
},
"conditionsModule": {
"conditions": [
"Aging",
"Disorder, Neurologic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Music, Virtual Reality for Inpatients in IUGM",
"nctId": "NCT06296199",
"orgStudyIdInfo": {
"id": "2024-2064",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasability"
}
],
"secondaryOutcomes": [
{
"measure": "Emotions variation"
},
{
"measure": "Affect variation"
},
{
"measure": "Well-Being Variation"
},
{
"measure": "Quality of life variation"
},
{
"measure": "Anxiety variation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Prolonged Exposure Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Stress Disorders, Post-Traumatic",
"Substance Use Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": [
{
"email": "[email protected]",
"name": "Sonya Norman, PhD",
"phone": "858-518-8266",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "VA San Diego Healthcare System",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": null,
"zip": "92161"
},
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Brittany Davis, PhD",
"phone": "813-972-2000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "VA Tampa Healthcare System",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": null,
"zip": "33612"
},
{
"city": "Atlanta",
"contacts": [
{
"email": "[email protected]",
"name": "Kristin Lamp, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "VA Atlanta Healthcare System",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia",
"status": null,
"zip": "30033"
},
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Jonathan Bayer, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Hines VA Healthcare System",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60141"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PREVAIL",
"briefTitle": "Massed Prolonged Exposure for PTSD in Substance Use Treatment",
"nctId": "NCT06296186",
"orgStudyIdInfo": {
"id": "HT94252310669",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinician Administered PTSD Scale for DSM-5 (CAPS-5)"
},
{
"measure": "Time Line Follow back (TLFB)"
},
{
"measure": "Psychotherapy Completion Rates"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Health Questionnaire-9 (PHQ-9)"
},
{
"measure": "Brief Psychosocial Functioning Inventory (B-IPF)"
},
{
"measure": "Client Satisfaction Questionnaire-8 (CSQ-8)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Minnesota"
},
{
"name": "Center for Veterans Research and Education"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Veterans Medical Research Foundation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Protective \"open-lung\" extubation"
},
{
"name": "Conventional extubation"
}
]
},
"conditionsModule": {
"conditions": [
"Intra-abdominal Surgery",
"Anesthesia",
"Lung Injury",
"Ventilator-Induced Lung Injury",
"Atelectasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ottawa",
"contacts": [
{
"email": "[email protected]",
"name": "Daniel I. McIsaac, MD",
"phone": "613-761-4940",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Manoj Lalu, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniel I. McIsaac, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Manoj Lalu, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "The Ottawa Hospital",
"geoPoint": {
"lat": 45.41117,
"lon": -75.69812
},
"state": "Ontario",
"status": null,
"zip": "K1H 8L6"
},
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Michael C. Sklar, MD",
"phone": "416-864-5071",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ashwin Sankar, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael C. Sklar, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ashwin Sankar, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Unity Health Network",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5B 1W8"
},
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Martin Girard, MD",
"phone": "514-890-8000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Eva Amzallag, MSC",
"phone": "514-890-8000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Chassé, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "François Martin Carrier, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Centre Hospitalier de l'Université de Montréal (CHUM)",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H2X 0C1"
},
{
"city": "Québec",
"contacts": [
{
"email": "[email protected]",
"name": "Alexis F. Turgeon, MD",
"phone": "418-525-4444",
"phoneExt": "66058",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Michael Verret, MD",
"phone": "418-525-4444",
"phoneExt": "66847",
"role": "CONTACT"
},
{
"email": null,
"name": "Alexis F. Turgeon, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Michael Verret, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "CHU de Québec - Université Laval",
"geoPoint": {
"lat": 46.81228,
"lon": -71.21454
},
"state": null,
"status": null,
"zip": "G1V 4G2"
}
]
},
"descriptionModule": {
"briefSummary": "Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective \"open lung\" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various \"open lung\" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in \"open lung\" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "During surgical closure, the definitive ARISCAT score and exclusion criteria will be assessed. Patients will be randomized equally (1:1) using web-based allocation-concealed methods, with stratification by center and ARISCAT risk category. An unblinded research assistant will reveal group allocation to the anesthesiologist and monitor the emergence procedure.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Until surgical closure, all will be blinded to treatment allocation. Only specific healthcare professionals (anesthesiologist, respiratory therapist, operating room nurses, unblinded research assistant) will be present during emergence to maintain blinding. Other healthcare team members will remain blinded. Outcome adjudicators, Executive and Steering committee members, and the data analyst will also be blinded. No mechanism for unblinding is planned, as both interventions follow the same diagnostic and treatment algorithms for adverse effects.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 216,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OLEXT-3",
"briefTitle": "Open Lung Protective Extubation Following General Anesthesia",
"nctId": "NCT06296173",
"orgStudyIdInfo": {
"id": "MP-02-2024-12094",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Lowest oxygen saturation post-extubation in the operating room"
},
{
"measure": "Time in minutes with oxygen saturation < 85% post-extubation in the operating room"
},
{
"measure": "Re-intubation rate in the operating room and in the post-anesthesia care unit"
}
],
"primaryOutcomes": [
{
"measure": "Average weekly patient recruitment rate"
},
{
"measure": "Protocol adherence rate"
},
{
"measure": "Postoperative pulmonary complications outcome completion rate"
}
],
"secondaryOutcomes": [
{
"measure": "Accuracy of self-reported protocol adherence compared to directly observed protocol adherence"
},
{
"measure": "Postoperative pulmonary complications"
},
{
"measure": "Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit"
},
{
"measure": "Quality of recovery"
},
{
"measure": "Discharge disposition"
},
{
"measure": "Days alive and out of hospital"
},
{
"measure": "Health-related quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "CHU de Quebec-Universite Laval"
},
{
"name": "The Ottawa Hospital"
},
{
"name": "University Health Network, Toronto"
},
{
"name": "Canadian Institutes of Health Research (CIHR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre hospitalier de l'Université de Montréal (CHUM)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention Group"
}
]
},
"conditionsModule": {
"conditions": [
"End Stage Renal Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bruxelles",
"contacts": [
{
"email": "[email protected]",
"name": "Nortier Joelle, PHD",
"phone": "+33643250634",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Kaysi Saleh",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": "Van Gehuchten",
"status": "RECRUITING",
"zip": "1020"
}
]
},
"descriptionModule": {
"briefSummary": "Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study will compare two groups according to the dry weight determination method:(1) Control arm- modification of dry weight according to standardized care only. The standard of care to modify dry weight is what nephrologists use actually to define the best theoretical dry weight, including clinical (blood pressure, edema, shortness of breath, lung auscultation, etc.) and laboratory measures (Protein concentration before and after dialysis sessions ...). (2) Intervention arm- modify patient's dry weight according to standard of care + B lines score on lung ultrasound BLS obtained after the midweek dialysis session, considered as Day one (Day 1)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "It is a single-blinded trial as the treatment is blinded by Subjects only, meaning that the type of dry weight modification will not be disclosed to the subject, and they will not know which group he/she will be in at the time of consenting to limit the bias in opinion. The investigator and the research team must know the type of treatment, as the investigator will modify the dry weight according to the treatment group.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis",
"nctId": "NCT06296160",
"orgStudyIdInfo": {
"id": "MRC-01-23-035",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "COMITE D'ETHIQUE du CHU BRUGMANN c/o Direction Médicale",
"id": "LUSAM-HD",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess the effectiveness of adding B-line score evaluation through lung ultrasound to the standard of care to improve pulmonary congestion (measured by B lines score) in hemodialysis patients"
}
],
"secondaryOutcomes": [
{
"measure": "The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure."
},
{
"measure": "The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Brugmann University Hospital"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hamad Medical Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual Reality Headset"
},
{
"name": "Aromatherapy Patch"
},
{
"name": "Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Divya Natesan, BS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "John Myrga, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bruce Jacobs, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pittsburgh Medical Center Shadyside Hospital",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "15232"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 208,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy",
"nctId": "NCT06296147",
"orgStudyIdInfo": {
"id": "STUDY23080006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure."
},
{
"measure": "Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure."
},
{
"measure": "Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure."
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure."
},
{
"measure": "Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pittsburgh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "perineal massage"
}
]
},
"conditionsModule": {
"conditions": [
"Pelvic Floor Disorders",
"Levator Ani Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Udine",
"contacts": [
{
"email": "[email protected]",
"name": "Serena Xodo",
"phone": "0432-559699",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Serena Xodo",
"geoPoint": {
"lat": 46.0693,
"lon": 13.23715
},
"state": null,
"status": null,
"zip": "33100"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 58,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "CO-LAM23",
"briefTitle": "Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation",
"nctId": "NCT06296134",
"orgStudyIdInfo": {
"id": "17501",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test."
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups"
},
{
"measure": "percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Sanitaria Universitaria Friuli Centrale"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BCD-264"
},
{
"name": "Darzalex"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chelyabinsk",
"contacts": [
{
"email": "[email protected]",
"name": "Alexander Korobkin",
"phone": "+7 (351) 749-37-10",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Chelyabinsk Regional Clinical Hospital",
"geoPoint": {
"lat": 55.15402,
"lon": 61.42915
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Ekaterinburg",
"contacts": [
{
"email": "[email protected]",
"name": "Tatiana Konstantinova",
"phone": "+7 (343) 363-03-03",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Sverdlovsk Regional Clinical Hospital No. 1",
"geoPoint": {
"lat": 56.8519,
"lon": 60.6122
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kemerovo",
"contacts": [
{
"email": "[email protected]",
"name": "Marina Kosinova",
"phone": "8(384-2)39-65-33",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Kuzbass Regional Clinical Hospital named after S.V. Belyaev",
"geoPoint": {
"lat": 55.33333,
"lon": 86.08333
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Krasnoyarsk",
"contacts": [
{
"email": "[email protected]",
"name": "Elena Martynova",
"phone": "+7 (391) 202-68-50",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Regional Clinical Hospital",
"geoPoint": {
"lat": 56.01839,
"lon": 92.86717
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Moscow",
"contacts": [
{
"email": "[email protected]",
"name": "Elena Misyurina",
"phone": "+7 (495) 870-36-04",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Moscow City Clinical Hospital 52",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
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{
"email": "[email protected]",
"name": "Vadim Doronin",
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"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "S.P. Botkin Moscow City Clinical Hospital",
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},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
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{
"email": "[email protected]",
"name": "Yuri Osipov",
"phone": "+7 (812) 660-37-06",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Almazov National Medical Research Centre",
"geoPoint": {
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"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Saint Petersburg",
"contacts": [
{
"email": "[email protected]",
"name": "Ilya Zyuzgin",
"phone": "+7(812)43-99-555",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
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},
"state": null,
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"zip": null
},
{
"city": "Saint Petersburg",
"contacts": [
{
"email": "[email protected]",
"name": "Sergei Voloshin",
"phone": "+78123097982",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency",
"geoPoint": {
"lat": 59.93863,
"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Saint Petersburg",
"contacts": [
{
"email": "[email protected]",
"name": "Ivan Moiseev",
"phone": "(812) 338 67 48",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "St Petersburg State I.P. Pavlov Medical University",
"geoPoint": {
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"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Saint Petersburg",
"contacts": [
{
"email": "[email protected]",
"name": "Margarita Ulyanova",
"phone": "8 (812) 670-18-88",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "State budgetary healthcare institution Leningrad Regional Clinical Hospital",
"geoPoint": {
"lat": 59.93863,
"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Samara",
"contacts": [
{
"email": "[email protected]",
"name": "Igor Davydkin",
"phone": "8 (846) 374-91-00",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Samara State Medical University",
"geoPoint": {
"lat": 53.20007,
"lon": 50.15
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Sochi",
"contacts": [
{
"email": "[email protected]",
"name": "Dmitrii Kirtbaya",
"phone": "(862) 261-43-89",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory",
"geoPoint": {
"lat": 43.59917,
"lon": 39.72569
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Ufa",
"contacts": [
{
"email": "[email protected]",
"name": "Bulat Bakirov",
"phone": "8 (347) 272-41-73",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Bashkir State Medical University",
"geoPoint": {
"lat": 54.74306,
"lon": 55.96779
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 252,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DARVIVA",
"briefTitle": "A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma",
"nctId": "NCT06296121",
"orgStudyIdInfo": {
"id": "BCD-264-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Incidence and characteristics of adverse events"
},
{
"measure": "Proportion of subjects with BAbs/Nabs"
},
{
"measure": "Time to BAb/NAb development"
},
{
"measure": "AUC0-168"
},
{
"measure": "AUC0-∞"
},
{
"measure": "AUC0-336, ss"
},
{
"measure": "Cmax"
},
{
"measure": "Cmax, ss"
},
{
"measure": "Tmax"
},
{
"measure": "T1/2"
},
{
"measure": "Vd"
},
{
"measure": "Ctrough, ss"
}
],
"primaryOutcomes": [
{
"measure": "Overall response rate according to IMWG (International Myeloma Working Group) criteria"
}
],
"secondaryOutcomes": [
{
"measure": "Stringent complete response rate according to IMWG criteria"
},
{
"measure": "Complete response (CR) rate according to IMWG criteria"
},
{
"measure": "Very good partial response (VGPR) rate according to IMWG criteria"
},
{
"measure": "Duration of response"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Time to progression"
},
{
"measure": "Time to response"
},
{
"measure": "Overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Biocad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "acute kidney injury"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Acute Kidney Injury",
"Arthroplasty"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara University Medical School Anesthesiology and ICU Department",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The authors aimed to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 911,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risk Factors for Acute Kidney Injury in Patients Undergoing Arthroplasty",
"nctId": "NCT06296108",
"orgStudyIdInfo": {
"id": "I05-310-22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acute kidney injury in patients undergoing arthroplasty surgery"
}
],
"secondaryOutcomes": [
{
"measure": "Risk factors causing acute kidney injury in patients undergoing arthroplasty surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cell therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Cirrhosis, Liver"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hefei",
"contacts": null,
"country": "China",
"facility": "Anhui province hospital",
"geoPoint": {
"lat": 31.86389,
"lon": 117.28083
},
"state": "Anhui",
"status": null,
"zip": "230000"
}
]
},
"descriptionModule": {
"briefSummary": "The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 9,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis",
"nctId": "NCT06296095",
"orgStudyIdInfo": {
"id": "KDS-CUD-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "MELD（Model for End-stage Liver Disease）"
}
],
"primaryOutcomes": [
{
"measure": "DLT,MTD"
}
],
"secondaryOutcomes": [
{
"measure": "fibrosis staging and inflammatory grading"
},
{
"measure": "All-cause mortality"
},
{
"measure": "TE（Transient elastography）"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Anhui Provincial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Botulinum toxin type A"
},
{
"name": "Dry Needling"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Spasticity as Sequela of Stroke"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeksTrial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in \\~30° flexion; 7) being able to walk independently with or without aids.Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Each group will be assessed equally during the 19 weeks of the study duration.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participant will be randomized but ultimately will know which treatment he/she receives. A distinct investigator/assessor and intervention therapist wil be selected to treat or assess the participant",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STROKEPOC",
"briefTitle": "Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial",
"nctId": "NCT06296082",
"orgStudyIdInfo": {
"id": "49317",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Frequency and Severity of Adverse Events for DN and BTX A"
},
{
"measure": "Sample size"
},
{
"measure": "Sample size and drop out"
}
],
"primaryOutcomes": [
{
"measure": "tonic stretch reflex threshold"
}
],
"secondaryOutcomes": [
{
"measure": "Passive Resistance"
},
{
"measure": "Ultrasound Imaging: Morphometric Analysis"
},
{
"measure": "Ultrasound Imaging: Eco-textural Analysis of Muscle:"
},
{
"measure": "Dynamometry"
},
{
"measure": "Gait Analysis"
},
{
"measure": "10 Meter Walk Test (10MWT)"
},
{
"measure": "Timed up and Go Assessment (TUG)"
},
{
"measure": "Quality of Life EuroQoL 5D"
},
{
"measure": "EQ visual analogue scale (EQ VAS)"
},
{
"measure": "Cost-effectiveness"
},
{
"measure": "Patient Acceptance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "McGill University"
},
{
"name": "Aragon Institute of Health Sciences"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universiteit Antwerpen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "exergame-based cognitive-motor training on an unstable surface"
},
{
"name": "exergame-based cognitive-motor training on an stable surface"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zihlschlacht-Sitterdorf",
"contacts": [
{
"email": null,
"name": "Detlef Marks",
"phone": "071 424 37 51",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "Rehaklinik Zihlschlacht",
"geoPoint": {
"lat": 47.51401,
"lon": 9.26776
},
"state": "Thurgau",
"status": "RECRUITING",
"zip": "8588"
}
]
},
"descriptionModule": {
"briefSummary": "Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"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": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exergames on an Unstable Surface in Stroke Inpatients",
"nctId": "NCT06296069",
"orgStudyIdInfo": {
"id": "SwingIT-stroke",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Security incidents"
},
{
"measure": "Attrition rate"
},
{
"measure": "Adherence rate"
},
{
"measure": "Usability"
},
{
"measure": "Training Load"
},
{
"measure": "Enjoyment"
},
{
"measure": "User experience"
},
{
"measure": "Training Goals"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in cognitive flexibility"
},
{
"measure": "Changes in psychomotor speed"
},
{
"measure": "Changes in selective attention"
},
{
"measure": "Changes in inhibition and brain activity"
},
{
"measure": "Changes in functional mobility"
},
{
"measure": "Changes in coordination"
},
{
"measure": "Changes in dynamic balance"
},
{
"measure": "Changes in static balance"
},
{
"measure": "Changes in gait"
},
{
"measure": "Changes in leg proprioception"
},
{
"measure": "Changes in balance confidence"
},
{
"measure": "Changes in gait confidence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Eleftheria Giannouli"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Combi"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer Stage IV",
"Metastatic Colorectal Cancer"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care",
"nctId": "NCT06296056",
"orgStudyIdInfo": {
"id": "SDH-combi",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Patients with grade 1-5 adverse events and list of adverse event frequency"
},
{
"measure": "immune response"
},
{
"measure": "potential efficacy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nyamdavaa Tuul"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Progressive Muscle Relaxation Exercise Group"
},
{
"name": "Su-Jok Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Premenstrual Syndrome"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Three groups with su-jok group, progressive muscle relaxation exercise group and control group",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Double (Participant, Outcomes Assessor) Since the application will be performed by the researcher, participant will be blinded in this study. The statistician will be blinded in the evaluation of the data.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 135,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome",
"nctId": "NCT06296043",
"orgStudyIdInfo": {
"id": "SBU-FUT-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10)"
},
{
"measure": "FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10)"
},
{
"measure": "SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10)"
},
{
"measure": "NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10)"
},
{
"measure": "Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined)."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Saglik Bilimleri Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-15"
},
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"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "POOF ACT program"
},
{
"name": "Classic ACT program"
}
]
},
"conditionsModule": {
"conditions": [
"Stress Disorders, Traumatic",
"Anxiety",
"Anxiety Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Azusa",
"contacts": null,
"country": "United States",
"facility": "Azusa Pacific University",
"geoPoint": {
"lat": 34.13362,
"lon": -117.90756
},
"state": "California",
"status": null,
"zip": "91702"
}
]
},
"descriptionModule": {
"briefSummary": "Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "This project's research design is a two-by-two factorial design. Factor one, the type of ACT intervention delivered, has two levels - POOF delivery (level 1) and a classic ACT delivery (level 2). Factor two, the facilitator's first group treatment delivery, also has two levels. There are four (4) group facilitators. The first two facilitators deliver traditional ACT first (level 1), and the second two facilitators deliver POOF first (level 2). Each facilitator providing group treatment will facilitate two groups (classic and POOF), one after the next. However, facilitators will be randomized to the order in which they deliver their first group to reduce experimenter/ clinician history bias. All of the facilitators are licensed, mental health clinicians.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Culturally Tailored ACT for Black Trauma",
"nctId": "NCT06296030",
"orgStudyIdInfo": {
"id": "22-0010",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Race-Based Traumatic Stress"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Azusa Pacific University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "WITHDRAWN",
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"date": "2022-09-01"
},
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"startDateStruct": {
"date": "2021-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental: Extracorporeal Shock Wave Therapy"
},
{
"name": "Trigger Finger Splint"
},
{
"name": "Extracorporeal Shock Wave Therapy+ Trigger Finger Splint"
}
]
},
"conditionsModule": {
"conditions": [
"Trigger Finger",
"Stenosing Tenosynovitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Feray Karademir",
"phone": "90 505 313 75 82",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Feray Karademir",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Feray Karademir",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"maskingInfo": {
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"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Conservative Interventions in the Treatment of Trigger Finger",
"nctId": "NCT06296017",
"orgStudyIdInfo": {
"id": "AEŞH- EK1- 2023-115",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Visual analog scale"
}
],
"secondaryOutcomes": [
{
"measure": "Grip and pinch strength"
},
{
"measure": "Number of trigger"
},
{
"measure": "Functional assessment"
},
{
"measure": "Treatment satisfaction"
},
{
"measure": "Functional assessment"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
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"startDateStruct": {
"date": "2023-10-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S"
}
]
},
"conditionsModule": {
"conditions": [
"Behçet's Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease",
"nctId": "NCT06296004",
"orgStudyIdInfo": {
"id": "CAPILLAROSCOPY behcet disease",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "measuring parameter of Nail Fold Capillaroscopy in behcet disease"
},
{
"measure": "measuring parameter of Optical Coherence Tomography Angiography in behcet disease"
},
{
"measure": "measuring parameter of Femoral Vein Wall Thickness in behcet disease"
}
],
"secondaryOutcomes": [
{
"measure": "relation between Nail Fold Capillaroscopy and activity of behcet disease"
},
{
"measure": "relation between Optical Coherence Tomography Angiography and activity of behcet disease"
},
{
"measure": "relation between Femoral Vein Wall Thickness and activity of behcet disease"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lycra garment"
}
]
},
"conditionsModule": {
"conditions": [
"Balanced; Rearrangement",
"Respiratory Function Test"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis",
"nctId": "NCT06295991",
"orgStudyIdInfo": {
"id": "2023/005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Balance parameters"
},
{
"measure": "Respiratory functions"
},
{
"measure": "Respiratory muscle strength measurement"
}
],
"secondaryOutcomes": [
{
"measure": "Gross motor function measurement"
},
{
"measure": "Functional independence assessment"
},
{
"measure": "Assessment of activity restriction"
},
{
"measure": "Quality of life assessment"
},
{
"measure": "Assessment of posture"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biochemical marker assays"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Disease Other"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "ANDREA PICCIONI, Dr.",
"phone": "0630153161",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario \"A. Gemelli\" IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a \"multimarker\" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation."
},
"designModule": {
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},
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"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Multimarker Approach in Acute Chest Pain",
"nctId": "NCT06295978",
"orgStudyIdInfo": {
"id": "4896",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The predictive value of markers for the risk of cardiovascular events in chest pain"
}
],
"secondaryOutcomes": [
{
"measure": "Multimarker approach to improve cardiovascular risk stratification"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent Fallopian Tube Carcinoma",
"Recurrent Ovarian Carcinoma",
"Recurrent Primary Peritoneal Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Swisher Lab Research Coordinators",
"phone": "206-616-8927",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elizabeth Swisher",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Fred Hutch/University of Washington Cancer Consortium",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": "RECRUITING",
"zip": "98109"
}
]
},
"descriptionModule": {
"briefSummary": "This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer."
},
"designModule": {
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},
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"type": "ESTIMATED"
},
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"studyType": "OBSERVATIONAL"
},
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"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers",
"nctId": "NCT06295965",
"orgStudyIdInfo": {
"id": "RG1123813",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2023-10315",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Fred Hutch/University of Washington Cancer Consortium",
"id": "FHIRB0020162",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "R01CA272594",
"link": "https://reporter.nih.gov/quickSearch/R01CA272594",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients"
},
{
"measure": "Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors"
},
{
"measure": "Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Washington"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pasireotide"
}
]
},
"conditionsModule": {
"conditions": [
"Prolactin-Producing Pituitary Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Basking Ridge",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.70621,
"lon": -74.54932
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07920"
},
{
"city": "Middletown",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Monmouth (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.39652,
"lon": -74.09211
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07748"
},
{
"city": "Montvale",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Bergen (Limited Protocol Activities)",
"geoPoint": {
"lat": 41.04676,
"lon": -74.02292
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07645"
},
{
"city": "Commack",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.84288,
"lon": -73.29289
},
"state": "New York",
"status": "RECRUITING",
"zip": "11725"
},
{
"city": "Harrison",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Westchester (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.96899,
"lon": -73.71263
},
"state": "New York",
"status": "RECRUITING",
"zip": "10604"
},
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andrew Lin, MD",
"phone": "212-639-8392",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Cancer Center",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10065"
},
{
"city": "Uniondale",
"contacts": [
{
"email": null,
"name": "Eliza Geer, MD",
"phone": "646-608-3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Nassau (Limited Protocol Activities)",
"geoPoint": {
"lat": 40.70038,
"lon": -73.59291
},
"state": "New York",
"status": "RECRUITING",
"zip": "11553"
}
]
},
"descriptionModule": {
"briefSummary": "The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is an open label single-center pilot study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"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 Pasireotide in People With Prolactinoma",
"nctId": "NCT06295952",
"orgStudyIdInfo": {
"id": "23-371",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "biochemical response rate"
}
],
"secondaryOutcomes": [
{
"measure": "radiographic response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Evergreen Theragnostics"
},
{
"name": "Recordati Pharmaceutical company"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Memorial Sloan Kettering Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "social support program"
},
{
"name": "Routine nursing care"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Loss",
"Grief",
"Social Support"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ubon Ratchathani",
"contacts": null,
"country": "Thailand",
"facility": "Sanpasitthiprasong Hospital",
"geoPoint": {
"lat": 15.23844,
"lon": 104.84866
},
"state": null,
"status": null,
"zip": "34000"
}
]
},
"descriptionModule": {
"briefSummary": "Research Question:Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion? Research hypothesis1. The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care.2. The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program.Primary Objectives:To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs, in comparison to those who have received regular nursing care.Secondary Objectives:1. To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs.2. To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.3. To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "1. The researcher provided information about a research project involving pregnant women diagnosed with fetal demise or abnormalities, who are recommended to undergo pregnancy termination at the third trimester abortion clinic.2. Pregnant women voluntarily consent to participate in the research by signing the informed consent form.3. Volunteer participants providing consent will be randomly divided into two groups using the randomization technique with Excel program.4. Divide into groups of 45 individuals each, totaling 90 participants in the entire sample.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital",
"nctId": "NCT06295939",
"orgStudyIdInfo": {
"id": "CA code 016/2565, 012/2566",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Perinatal Grief Assessment Questionnaire."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Sanpasitthiprasong Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Serplulimab"
}
]
},
"conditionsModule": {
"conditions": [
"Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Serplulimab Combined With CCRT for LS-SCLC.",
"nctId": "NCT06295926",
"orgStudyIdInfo": {
"id": "K5236",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0"
},
{
"measure": "objective response rate (ORR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Group 1, hydroxytyrosol-rich extract capsule (Hytolive®)"
},
{
"name": "Group 2, capsule of placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight",
"PreDiabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Raquel Mateos, PhD",
"phone": "+34 915492300",
"phoneExt": "436341",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mª Ángeles Martín, PhD",
"phone": "+34 915492300",
"phoneExt": "436340",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": "Comunidad Autónoma De Madrid",
"status": "RECRUITING",
"zip": "28040"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Group 1, hydroxytyrosol-rich extract pill (Hytolive®); Group 2, placebo pill",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HYTOLIVE15",
"briefTitle": "Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases",
"nctId": "NCT06295913",
"orgStudyIdInfo": {
"id": "HYTOLIVE15",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "LDL-ox as marker of oxidative status"
}
],
"secondaryOutcomes": [
{
"measure": "Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale"
},
{
"measure": "Sleep quality determined by Pittsburgh Sleep Quality Index"
},
{
"measure": "Fatigue test determined by Borg Rating Of Perceived Exertion"
},
{
"measure": "Fasting glucose"
},
{
"measure": "Fasting insulin"
},
{
"measure": "Glycated hemoglobin (HbA1c)"
},
{
"measure": "Glucagon-like peptide-1 (GLP-1)"
},
{
"measure": "Total cholesterol"
},
{
"measure": "High density lipoproteins (HDL)"
},
{
"measure": "Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B)"
},
{
"measure": "Triglycerides"
},
{
"measure": "Apoliporpotein A1"
},
{
"measure": "Apoliporpotein B"
},
{
"measure": "Total antioxidant status (TAS)"
},
{
"measure": "Total oxidative status (TOS)"
},
{
"measure": "Oxides of nitrogen (NOx)"
},
{
"measure": "Thiobarbituric acid reactive substances (TBARS)"
},
{
"measure": "C reactive protein"
},
{
"measure": "Interleukine 6 (IL-6)"
},
{
"measure": "Tumor necrosis factor alpha (TNF-α)"
},
{
"measure": "Interleukine 10 (IL-10)"
},
{
"measure": "Alanine aminotransfesare (transaminases ALT)"
},
{
"measure": "Aspartate aminotransferase (transaminase AST)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Genosa I+D"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "National Research Council, Spain"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention 1 Group"
},
{
"name": "Intervention 2 Group"
},
{
"name": "Placebo Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus",
"Respiratory Failure",
"Pneumonia",
"Respiratory Disease",
"Stroke, Ischemic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nigde",
"contacts": [
{
"email": "[email protected]",
"name": "nilgun erdogan, researcher",
"phone": "5312599220",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ömer Halisdemir University Training and Research Hospital",
"geoPoint": {
"lat": 37.96583,
"lon": 34.67935
},
"state": null,
"status": "RECRUITING",
"zip": "51100"
}
]
},
"descriptionModule": {
"briefSummary": "Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "It will be conducted as a randomized controlled single-blind study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 62,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Aromatherapy Massage on Sleep Quality",
"nctId": "NCT06295900",
"orgStudyIdInfo": {
"id": "19.10.2023/63",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Visual Comparison Sleep Scale"
}
],
"primaryOutcomes": [
{
"measure": "Patient Introduction Form"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Follow-up Form"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nilgün Erdoğan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Educational Program using VR or simulator designed to improve medical intern's performance managing emergency situation"
}
]
},
"conditionsModule": {
"conditions": [
"Simulation Training"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man.In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training.After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "control group vs. test group, 1:1",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 166,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Educational Efficacy of VR vs. Simulator in Emergency Medical Training",
"nctId": "NCT06295887",
"orgStudyIdInfo": {
"id": "E-2402",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "self-rated confidence for managing emergency situation"
},
{
"measure": "self-rated confidence for managing emergency situation"
},
{
"measure": "performance in managing emergency situation"
}
],
"secondaryOutcomes": [
{
"measure": "usability of Virtual Reality simulation program using User Experience Questionnaire Short"
},
{
"measure": "usability of Virtual Reality simulation program using Simulator Sickness Questionnaire"
},
{
"measure": "usability of Virtual Reality simulation program using System Usability Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Seoul National University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level"
}
]
},
"conditionsModule": {
"conditions": [
"Respiratory Insufficiency",
"Pulmonary Disease, Chronic Obstructive",
"Diabetes Mellitus, Type 2",
"High Blood Pressure",
"Stroke, Ischemic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nigde",
"contacts": [
{
"email": "[email protected]",
"name": "nilgun erdogan, researcher",
"phone": "5312599220",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ömer Halisdemir University Training and Research Hospital",
"geoPoint": {
"lat": 37.96583,
"lon": 34.67935
},
"state": null,
"status": "RECRUITING",
"zip": "51100"
}
]
},
"descriptionModule": {
"briefSummary": "Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized controlled single blind study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 61,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort",
"nctId": "NCT06295874",
"orgStudyIdInfo": {
"id": "12.10.2022/50",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Drug Monitoring Form"
},
{
"measure": "Visual Pain Scale"
},
{
"measure": "Face Anxiety Scale"
},
{
"measure": "Comfort Rating Scale"
}
],
"primaryOutcomes": [
{
"measure": "Patient Introduction Form"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Follow-up Form"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nilgün Erdoğan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "no different intervention between the two cohort."
}
]
},
"conditionsModule": {
"conditions": [
"ASCVD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": null,
"zip": "310000"
},
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "Second Affiliated Hospital, School of Medicine, Zhejiang University",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": null,
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prospective Cohort Study of Panvascular Disease",
"nctId": "NCT06295861",
"orgStudyIdInfo": {
"id": "2023-1194",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cardiovascular adverse events"
},
{
"measure": "Cardiovascular mortality"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of receiving vascular revascularization"
},
{
"measure": "Readmission rate for vascular reasons"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Affiliated Hospital, School of Medicine, Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Rehabilitation",
"Rheumatoid Arthritis",
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": [
{
"email": "[email protected]",
"name": "HAVVA TALAY ÇALIŞ, PROFESSOR",
"phone": "+905326874541",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "PROFESSOR",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Health Sciences University, Kayseri Medicine Faculty",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": "Kocasinan",
"status": "RECRUITING",
"zip": "38080"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARDIRA",
"briefTitle": "The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients",
"nctId": "NCT06295848",
"orgStudyIdInfo": {
"id": "KayseriCH005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Framingham Risk Score(FRS)"
},
{
"measure": "QRISK-3 Risk Score"
},
{
"measure": "24-Hour Ambulatory Blood Pressure"
},
{
"measure": "DAS28"
},
{
"measure": "Maximal oxygen consumption (VO2max)"
}
],
"secondaryOutcomes": [
{
"measure": "The Six-Minute Walk Test (6MWT)"
},
{
"measure": "The 36-Item Short Form Survey (SF-36)"
},
{
"measure": "International Physical Activity Questionnaire (IPAQ) - Short Form"
},
{
"measure": "Beck Depression Inventory (BDI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Kayseri City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fingerstick blood draw"
}
]
},
"conditionsModule": {
"conditions": [
"Potassium (K) and Ionized Calcium (iCa) in Capillary Whole Blood"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Method comparison study for Potassium (K) and ionized calcium (iCa)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood",
"nctId": "NCT06295835",
"orgStudyIdInfo": {
"id": "CS-2024-0001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Performance comparison"
},
{
"measure": "Performance comparison"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Abbott Point of Care"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nuan-gong-ye"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Chinese Medicine",
"Primary Dysmenorrhea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taichung",
"contacts": [
{
"email": "[email protected]",
"name": "HSUAN HSUAN WU",
"phone": "+886928030693",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "China Medical University Hospital",
"geoPoint": {
"lat": 24.1469,
"lon": 120.6839
},
"state": null,
"status": "RECRUITING",
"zip": "404"
}
]
},
"descriptionModule": {
"briefSummary": "Primary dysmenorrhea is a common under-diagnosed complaint, with a prevalence of about 45-95% in women of childbearing age and about 10-25% in severe cases. Menstrual pain can be classified as primary or secondary. Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology, which usually occurs 6 to 12 months after the first menstruation. Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours. The cause is still unknown, but studies suggest that it may be related to increased prostaglandins, which cause painful contractions of the uterus. The pain is often accompanied by other menstrual discomfort symptoms, including headache, breast tenderness, drowsiness, nausea, vomiting, constipation or diarrhea, and psychological anxiety, depression or irritability. In the case of secondary menstrual pain, there are clear pelvic pathologies, such as endometriosis, uterine fibroids, and pelvic inflammatory disease."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 82,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea",
"nctId": "NCT06295822",
"orgStudyIdInfo": {
"id": "CMUH112-REC2-063",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analogue Scale (VAS)"
}
],
"secondaryOutcomes": [
{
"measure": "Short Form McGill Pain Questionnaire (MPQ-SF)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "China Medical University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pembrolizumab"
},
{
"name": "V940"
},
{
"name": "Surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Carcinoma, Squamous Cell",
"Skin Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nedlands",
"contacts": [
{
"email": null,
"name": "Study Coordinator",
"phone": "+61862799466",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "One Clinical Research ( Site 3211)",
"geoPoint": {
"lat": -31.98184,
"lon": 115.8073
},
"state": "Western Australia",
"status": "RECRUITING",
"zip": "6009"
},
{
"city": "Jerusalem",
"contacts": [
{
"email": null,
"name": "Study Coordinator",
"phone": "97226777825",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Hadassah Medical Center ( Site 2201)",
"geoPoint": {
"lat": 31.76904,
"lon": 35.21633
},
"state": null,
"status": "RECRUITING",
"zip": "9112001"
},
{
"city": "Petah Tikva",
"contacts": [
{
"email": null,
"name": "Study Coordinator",
"phone": "97235305201",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Rabin Medical Center ( Site 2202)",
"geoPoint": {
"lat": 32.08707,
"lon": 34.88747
},
"state": null,
"status": "RECRUITING",
"zip": "4941 492"
}
]
},
"descriptionModule": {
"briefSummary": "This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In the Phase 2 of the study design, approximately 600 participants will be randomly assigned into 3 arms in an approximate 5:5:2 ratio (250 to V940 plus pembrolizumab with SOC, 250 participants to SOC only, and 100 participants to pembrolizumab monotherapy with SOC). If the decision is made to expand the study to Phase 3, the 600 participants enrolled in Phase 2 will keep their originally assigned study intervention arms in the Phase 3 Expansion, and 412 new participants will be enrolled and randomly assigned in a 1:1 ratio to receive treatment with either V940 plus pembrolizumab with SOC or SOC only. New participants will not be randomized into the pembrolizumab monotherapy with SOC arm during the Phase 3 Expansion.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1012,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)",
"nctId": "NCT06295809",
"orgStudyIdInfo": {
"id": "V940-007",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CT",
"id": "2023-505712-37",
"link": null,
"type": "OTHER"
},
{
"domain": "UTN",
"id": "U1111-1292-3589",
"link": null,
"type": "OTHER"
},
{
"domain": "Merck",
"id": "V940",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Event Free Survival (EFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall response rate (ORR)"
},
{
"measure": "Freedom from surgery (FFS) rate"
},
{
"measure": "Pathological complete response (pCR) rate"
},
{
"measure": "Major pathological response (mPR) rate"
},
{
"measure": "Disease-free survival (DFS)"
},
{
"measure": "Disease-specific survival (DSS)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Percentage of participants who experience and adverse event (AE)"
},
{
"measure": "Percentage of participants who discontinue study intervention due to AEs"
},
{
"measure": "Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30)"
},
{
"measure": "Change from baseline in physical functioning score of QLQ (C30 Items 1-5)"
},
{
"measure": "Change from baseline in Role functioning score of QLQ-C30 Items 6-7"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Moderna TX"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Merck Sharp & Dohme LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MK-8527"
}
]
},
"conditionsModule": {
"conditions": [
"Renal Impairment"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)",
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"id": "8527-008",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Merck",
"id": "MK-8527-008",
"link": null,
"type": "OTHER"
}
]
},
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"primaryOutcomes": [
{
"measure": "Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma"
},
{
"measure": "Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma"
},
{
"measure": "Maximum concentration (Cmax) of MK-8527 in plasma"
},
{
"measure": "Time to Maximum concentration (Tmax) of MK-8527 in plasma"
},
{
"measure": "Apparent terminal half-life (t1/2) of MK-8527 in plasma"
},
{
"measure": "Apparent Clearance (CL/F) of MK-8527 in plasma"
},
{
"measure": "Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants who experience one or more adverse events (AEs)"
},
{
"measure": "Number of participants who discontinue study due to an AE"
},
{
"measure": "AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs)"
},
{
"measure": "AUC0-inf of MK-8527-TP in PBMCs"
},
{
"measure": "Cmax of MK-8527-TP in PBMCs"
},
{
"measure": "Concentration at 168 hours (C168) of MK-8527-TP in PBMCs"
},
{
"measure": "Concentration at 672 hours (C672) of MK-8527-TP in PBMCs"
},
{
"measure": "Tmax of MK-8527-TP in PBMCs"
},
{
"measure": "t1/2 of MK-8527-TP in PBMCs"
}
]
},
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"class": "INDUSTRY",
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"date": "2025-04-14"
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"date": "2025-04-14"
},
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"date": "2024-06-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
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"interventions": [
{
"name": "MDASI-HN"
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{
"name": "EORTC QLQ-C30"
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{
"name": "EORTC HN35"
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},
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"conditions": [
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{
"city": "Houston",
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{
"email": "[email protected]",
"name": "Amy Moreno, MD",
"phone": "713-745-4590",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Amy Moreno, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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"primaryPurpose": null,
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},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect",
"nctId": "NCT06295783",
"orgStudyIdInfo": {
"id": "2023-1059",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-01955",
"link": null,
"type": "OTHER"
}
]
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
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"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Obinutuzumab"
}
]
},
"conditionsModule": {
"conditions": [
"Fibrillary Glomerulonephritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Angela Reinke",
"phone": "507-266-1047",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nicholas Geroux",
"phone": "507-266-0956",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ladan Zand",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic",
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"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN)."
},
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"designInfo": {
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"whoMasked": null
},
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},
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"minimumAge": "18 Years",
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"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
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"id": "23-006712",
"link": null,
"type": null
},
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},
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{
"measure": "Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab"
}
],
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{
"measure": "Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab"
},
{
"measure": "Rate of complete or partial remission"
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{
"measure": "Improvement in serum albumin"
},
{
"measure": "Stabilization of kidney function"
},
{
"measure": "Serious Adverse Events (SAEs)"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Mayo Clinic"
}
},
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"date": "2027-04-01"
},
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"date": "2024-03-06"
},
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"date": "2026-04-01"
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Cigarettes"
}
]
},
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"conditions": [
"Tobacco Use",
"Cigarette Smoking",
"Nicotine Dependence"
]
},
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"locations": null
},
"descriptionModule": {
"briefSummary": "Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes."
},
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},
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},
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"NA"
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},
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"minimumAge": "21 Years",
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"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures",
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"id": "2023LS102",
"link": null,
"type": null
},
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{
"measure": "Average Nicotine Level"
}
],
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{
"measure": "Average Puff Volume"
}
]
},
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"collaborators": [
{
"name": "National Institutes of Health (NIH)"
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},
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"date": "2027-01-01"
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"date": "2026-01-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
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{
"name": "Radiation Therapy"
}
]
},
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"conditions": [
"Early-stage Breast Cancer"
]
},
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"locations": [
{
"city": "Madison",
"contacts": null,
"country": "United States",
"facility": "UW Carbone Cancer Center",
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"lon": -89.40123
},
"state": "Wisconsin",
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"zip": "53792"
}
]
},
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"briefSummary": "This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months."
},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
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"ADULT",
"OLDER_ADULT"
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},
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"acronym": null,
"briefTitle": "Outcomes and Cosmesis With Whole Breast Irradiation and Boost",
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"id": "2023-1724",
"link": null,
"type": null
},
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{
"domain": "UW Madison",
"id": "Protocol Version 2/5/2024",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "A533300",
"link": null,
"type": "OTHER"
},
{
"domain": "UWCCC OnCore ID",
"id": "UW23114",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Harvard Breast Cosmesis Scale Score"
}
],
"secondaryOutcomes": [
{
"measure": "Change in BREAST-Q Score"
},
{
"measure": "Incidence of Acute Toxicities"
},
{
"measure": "Incidence of Late Toxicities"
},
{
"measure": "Ipsilateral Breast Tumor Recurrence-Free Survival"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "University of Wisconsin, Madison"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "INBRX-106"
},
{
"name": "Pembrolizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Squamous Cell Carcinoma (HNSCC)"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20."
},
"designModule": {
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"allocation": "RANDOMIZED",
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"INVESTIGATOR"
]
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 410,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC",
"nctId": "NCT06295731",
"orgStudyIdInfo": {
"id": "INBRX106-01-201",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "2024-511323-34",
"id": "EU CT",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Phase 2: Objective Response Rate (ORR)"
},
{
"measure": "Phase 3: Progression-Free Survival (PFS)"
},
{
"measure": "Phase 3: Overall Survival (OS)"
}
],
"secondaryOutcomes": [
{
"measure": "Phase 3: Objective Response Rate (ORR)"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Clinical Benefit Rate (CBR)"
},
{
"measure": "Phase 3: Time to Chemotherapy (TTCtx)"
},
{
"measure": "Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference"
},
{
"measure": "TTCD in physical functioning (PF)"
},
{
"measure": "TTCD in role functioning (RF)"
},
{
"measure": "TTCD in Global Health Status/quality of life (GHS/QoL)"
},
{
"measure": "Incidence and severity of Adverse Events (AEs)"
},
{
"measure": "Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Inhibrx, Inc."
}
},
"statusModule": {
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"date": "2029-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Duchenne Muscular Dystrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "İstanbul University - Cerrahpaşa",
"geoPoint": {
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"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34758"
}
]
},
"descriptionModule": {
"briefSummary": "Thanks to tele-assessment methods, it may be possible to evaluate DMD patients without traveling to clinical centers. In recent years, the applicability of remote assessment methods in DMD patients, as in many populations, is being investigated. However, studies have generally focused on a single evaluation parameter such as physical function, a special evaluation method or a special evaluation tool. The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable. If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable, the travel burden on patients and caregivers can be eased, patients\\' stress and anxiety related to travel can be reduced, caregivers can save time and energy and provide patients with the best possible treatment."
},
"designModule": {
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "5 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study",
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"orgStudyIdInfo": {
"id": "2023/51",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Timed Performance Tests"
},
{
"measure": "Brooke Upper Extremity Functional Classification (BUEFS)"
},
{
"measure": "Vignos Lower Extremity Functional Classification (VAEFS)"
},
{
"measure": "PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "OTHER",
"name": "Sahra Şirvan"
}
},
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"date": "2024-05-10"
},
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"date": "2024-03-06"
},
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"primaryCompletionDateStruct": {
"date": "2024-03-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hip-Hop Dance"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Loma Linda",
"contacts": [
{
"email": "[email protected]",
"name": "Julie Kugel, OTD",
"phone": "909-558-4628",
"phoneExt": "47473",
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Loma Linda University Health",
"geoPoint": {
"lat": 34.04835,
"lon": -117.26115
},
"state": "California",
"status": "RECRUITING",
"zip": "92350"
}
]
},
"descriptionModule": {
"briefSummary": "This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD."
},
"designModule": {
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"interventionModelDescription": null,
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"whoMasked": null
},
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"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
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},
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},
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{
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},
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},
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},
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},
{
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},
{
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},
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{
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{
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{
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},
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},
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},
{
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"lon": 120.16142
},
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"status": "RECRUITING",
"zip": "310016"
},
{
"city": "Hangzhou",
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"facility": "the First Peoples Hospital of Xiaoshan District Hangzhou",
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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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"status": "RECRUITING",
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},
{
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"facility": "The first affiliated hospital of Ningbo university",
"geoPoint": {
"lat": 29.87819,
"lon": 121.54945
},
"state": "Zhejiang",
"status": "RECRUITING",
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},
{
"city": "Ningbo",
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"facility": "Ningbo medical center lihuili hospital",
"geoPoint": {
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"lon": 121.54945
},
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{
"city": "Shaoxing",
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"facility": "Shaoxing Second Hospital",
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"lon": 120.57864
},
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"zip": "312000"
},
{
"city": "Beijing",
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"country": "China",
"facility": "Beijing Anzhen Hospital, Capital Medical University",
"geoPoint": {
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"lon": 116.39723
},
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"status": "RECRUITING",
"zip": "100029"
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{
"city": "Shanghai",
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"country": "China",
"facility": "Tongji Hospital of Tongji University",
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"lon": 121.45806
},
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"status": "RECRUITING",
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}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice."
},
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},
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"count": 7000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "150 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease",
"nctId": "NCT06295679",
"orgStudyIdInfo": {
"id": "20180442",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First"
}
],
"secondaryOutcomes": [
{
"measure": "Time to CV Death, MI, or Stroke, Whichever Occurs First"
},
{
"measure": "Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline"
},
{
"measure": "Percent Change in LDL-C From Baseline"
},
{
"measure": "Number of Participants Who Experienced Adverse Events"
},
{
"measure": "Number of Participants Who Experienced Adverse Drug Reactions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Amgen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Periodontitis",
"Gingival Crevicular Fluid",
"Interleukin 1-beta",
"Bactericidal Permeability Protein"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Antalya",
"contacts": null,
"country": "Turkey",
"facility": "Akdeniz Üniversitesi Diş Hekimliği Fakültesi",
"geoPoint": {
"lat": 36.90812,
"lon": 30.69556
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta",
"nctId": "NCT06295666",
"orgStudyIdInfo": {
"id": "26.12.2018/901",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Akdeniz University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-01-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-11-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Implant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tanta",
"contacts": [
{
"email": "[email protected]",
"name": "Faten a Seddiq, Faculty Dean",
"phone": "3335631",
"phoneExt": "+20",
"role": "CONTACT"
},
{
"email": null,
"name": "ahmed a abdelsayed",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Faculity of Dentistry Tanta University",
"geoPoint": {
"lat": 30.78847,
"lon": 31.00192
},
"state": "Elgarbia",
"status": null,
"zip": "6620012"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 26,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement",
"nctId": "NCT06295653",
"orgStudyIdInfo": {
"id": "7-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "measure changes in periimplant mucosal thickness"
}
],
"secondaryOutcomes": [
{
"measure": "mid-buccal keratinized mucosal width"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tanta University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-03-03",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 472866,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-03T10:57"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral glucose tolerance test with double-tracer dilution and intranasal insulin spray"
},
{
"name": "Oral glucose tolerance test with double-tracer dilution and intranasal placebo spray"
}
]
},
"conditionsModule": {
"conditions": [
"Glucose Metabolism Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ulm",
"contacts": [
{
"email": "[email protected]",
"name": "Julia Hummel, Phd",
"phone": "+4973150044744",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rebecca Spies, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Universityhospital Ulm",
"geoPoint": {
"lat": 48.39841,
"lon": 9.99155
},
"state": null,
"status": "RECRUITING",
"zip": "89081"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized, controlled, cross-over design for men. Randomized, controlled, 2x2 factorial cross-over design for women taking the menstrual cycle phase into account.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "BrainInsPPM",
"briefTitle": "Relative Contribution of Brain Insulin Action for Postprandial Metabolism",
"nctId": "NCT06295640",
"orgStudyIdInfo": {
"id": "300/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Endogenous glucose production"
},
{
"measure": "Rate of glucose disappearance"
}
],
"secondaryOutcomes": [
{
"measure": "Proglucagon cleavage products"
},
{
"measure": "Glucose tolerance"
},
{
"measure": "Whole-body insulin sensitivity"
},
{
"measure": "Insulin secretion"
},
{
"measure": "Post-absorptive energy expenditure"
},
{
"measure": "Sex differences"
},
{
"measure": "Menstrual cycle effects"
},
{
"measure": "Autonomic nervous system activity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Ulm"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "There were no interventions in retrospective analysis"
}
]
},
"conditionsModule": {
"conditions": [
"Catheter-associated Urinary Tract Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Canton",
"contacts": null,
"country": "China",
"facility": "Sun Yat-Sen Memorial Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510030"
}
]
},
"descriptionModule": {
"briefSummary": "To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 291,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies",
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"id": "SYSKY-2024-115-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "How many patients in the infected group and how many patients in the non-infected group had bladder irrigation"
},
{
"measure": "How many patients in the infected group and how many patients in the non-infected group were given enema"
},
{
"measure": "How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively"
},
{
"measure": "How many patients in the infected group and the non-infected group had co-diabetes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"
}
},
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"completionDateStruct": {
"date": "2024-01-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
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"primaryCompletionDateStruct": {
"date": "2023-09-30"
},
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"date": "2023-01-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ARC-IM System implantation"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": [
{
"email": null,
"name": "Jocelyne Dr Bloch, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "Centre Hospitalier Universitaire Vaudois (CHUV)",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": "Vaud",
"status": "RECRUITING",
"zip": "1011"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease."
},
"designModule": {
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},
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},
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"sex": "ALL",
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SPARKL",
"briefTitle": "Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease",
"nctId": "NCT06295614",
"orgStudyIdInfo": {
"id": "SPARKL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "Nerve conduction studies (NCS)"
},
{
"measure": "Somato-sensory evoked potential (SSEP)"
},
{
"measure": "Cortical signal recording"
},
{
"measure": "Kinematic analysis in different therapeutic conditions"
},
{
"measure": "Muscle analysis in different therapeutic conditions"
}
],
"primaryOutcomes": [
{
"measure": "Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system."
}
],
"secondaryOutcomes": [
{
"measure": "10-meter walk test"
},
{
"measure": "6-minute walk test"
},
{
"measure": "Timed up and Go and its cognitive version"
},
{
"measure": "Freezing of gait circuit"
},
{
"measure": "Kinematic analysis"
},
{
"measure": "Muscle analysis"
},
{
"measure": "Mini Balance Evaluation Systems Test (mini-BESTest)"
},
{
"measure": "Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III"
},
{
"measure": "King's Parkinson's disease Pain Scale (KPPS)"
},
{
"measure": "The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV."
},
{
"measure": "Parkinson's Disease Questionnaire-39 (PDQ-39)"
},
{
"measure": "Activities specific Balance Confidence Questionnaire (ABC-Q)"
},
{
"measure": "The Freezing of Gait Questionnaire (FOG-Q)"
},
{
"measure": "Home-use kinematic monitoring"
},
{
"measure": "Daily falls tracking"
},
{
"measure": "Satisfaction questionnaire"
},
{
"measure": "User Evaluation of Satisfaction with technology (QUEST 2.0)"
},
{
"measure": "System Usability Scale (SUS)"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Ecole Polytechnique Fédérale de Lausanne"
}
},
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"date": "2029-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
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"date": "2029-04-01"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Traditional rehabilitation"
},
{
"name": "Action observation therapy and motor imagery"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": null
},
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"briefSummary": "This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life."
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},
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},
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},
"phases": [
"NA"
],
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},
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"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis",
"nctId": "NCT06295601",
"orgStudyIdInfo": {
"id": "2024/5591",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Berg Balance Scale"
},
{
"measure": "Berg Balance Scale"
},
{
"measure": "Muscle strength and functional mobility"
},
{
"measure": "Muscle strength and functional mobility"
}
],
"secondaryOutcomes": [
{
"measure": "Fatigue Severity Scale"
},
{
"measure": "Fatigue Severity Scale"
},
{
"measure": "Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire"
},
{
"measure": "Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Inonu University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
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"date": "2025-02-15"
},
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"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fucoidan extracted from F. Vesiculosus"
},
{
"name": "Fucoidan extracted from U. Pinnatifida"
}
]
},
"conditionsModule": {
"conditions": [
"Fatigue",
"Inflammation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": null,
"country": "United States",
"facility": "University of Rochester Medical Center",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York",
"status": null,
"zip": "14642"
}
]
},
"descriptionModule": {
"briefSummary": "To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer",
"nctId": "NCT06295588",
"orgStudyIdInfo": {
"id": "STUDY00009135",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "T32CA102618",
"link": "https://reporter.nih.gov/quickSearch/T32CA102618",
"type": "NIH"
}
]
},
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"primaryOutcomes": [
{
"measure": "percentage of participants who are randomized to the study out of all participants approached"
},
{
"measure": "percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention"
},
{
"measure": "percentage of participants who take at least 80% of the fucoidan pills during the study"
}
],
"secondaryOutcomes": [
{
"measure": "mean change in Brief Fatigue Inventory"
},
{
"measure": "mean change in plasma viscosity in blood"
},
{
"measure": "mean change in erythrocyte sedimentation rate in blood"
},
{
"measure": "mean change in thyroid stimulating hormone in blood"
},
{
"measure": "mean change in C-reactive protein in blood"
},
{
"measure": "mean change in leptin in blood"
},
{
"measure": "mean change in D Dimer in blood"
},
{
"measure": "mean change in TNF alpha in blood"
},
{
"measure": "mean change in neopterin in blood"
},
{
"measure": "mean change in lactase dehydrogenase in blood"
},
{
"measure": "mean change in procalcitonin in blood"
},
{
"measure": "mean change in frailty using a modified Fried's Frailty questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Rochester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "probiotics containing Bifidobacterium infantis and Lactobacillus"
},
{
"name": "placebos containing lactose"
}
]
},
"conditionsModule": {
"conditions": [
"Congenital Heart Disease",
"Intestinal Disease",
"Dysbiosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "Children's Hospital of Nanjing Medical University",
"geoPoint": {
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"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": "210093"
}
]
},
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"briefSummary": "A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora."
},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
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]
},
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},
"enrollmentInfo": {
"count": 80,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "1 Year",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
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"acronym": null,
"briefTitle": "Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass",
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"id": "ZZhang",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "incidence of morbidity"
},
{
"measure": "gastrointestinal functional recovery indicators"
},
{
"measure": "biomarkers"
},
{
"measure": "microbiome"
}
],
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},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanjing Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Atomoxetine 80mg combined with oxybutynin 5mg"
},
{
"name": "Venlafaxine 37.5mg"
},
{
"name": "Atomoxetine 80mg combined with trazodone 100mg"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea of Adult"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea",
"nctId": "NCT06295562",
"orgStudyIdInfo": {
"id": "CMUH112-REC3-201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "Sleep quality"
},
{
"measure": "Waking sleepiness"
}
],
"primaryOutcomes": [
{
"measure": "Physiological parameter"
}
],
"secondaryOutcomes": [
{
"measure": "Endotypic traits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "China Medical University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LUCAR-G39P cells product"
}
]
},
"conditionsModule": {
"conditions": [
"Relapsed and Refractory B-cell Non-Hodgkin Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjin",
"contacts": [
{
"email": "[email protected]",
"name": "Huayuan Zhu, PhD，MD",
"phone": "86 25 68306034",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yeqin Sha, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital",
"geoPoint": null,
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210029"
}
]
},
"descriptionModule": {
"briefSummary": "A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 33,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma",
"nctId": "NCT06295549",
"orgStudyIdInfo": {
"id": "LB2304-0001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence, severity and type of TEAEs"
},
{
"measure": "Pharmacokinetics in peripheral blood"
},
{
"measure": "Pharmacokinetics in bone marrow"
},
{
"measure": "The recommended Phase II dose (RP2D) for this cell therapy"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Response Rate (ORR)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Time to Response (TTR)"
},
{
"measure": "Duration of Response (DoR)"
},
{
"measure": "Immunogenicity assessment of LUCAR-G39P cells"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Nanjing Legend Biotech Co."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Comparator device, Closed-field autorefractometer"
}
]
},
"conditionsModule": {
"conditions": [
"Ametropia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 115,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "13 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children",
"nctId": "NCT06295536",
"orgStudyIdInfo": {
"id": "WS10363",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective refractive error"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Essilor International"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Water Spray"
},
{
"name": "Control"
}
]
},
"conditionsModule": {
"conditions": [
"COPD",
"Aging",
"Hyperthermia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": null,
"name": "Whitley Atkins, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Courtney Kirby, BS RN",
"phone": "214-345-6502",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Craig Crandall, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Texas Health Presbyterian Hospital Dallas",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75231"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Heat Waves and the Elderly With COPD",
"nctId": "NCT06295523",
"orgStudyIdInfo": {
"id": "STU_2019_1759_COPD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Core body temperature"
},
{
"measure": "Forced expiratory volume (FEV1)"
},
{
"measure": "Forced vital capacity (FVC)"
},
{
"measure": "FEV1/FVC ratio"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "American Heart Association"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Texas Southwestern Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No interventions."
}
]
},
"conditionsModule": {
"conditions": [
"Diet Habit",
"Endometrial Polyp",
"Women"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Observational Study of the Association Between Food Intake and Endometrial Polyps",
"nctId": "NCT06295510",
"orgStudyIdInfo": {
"id": "CDUTCM20240223",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hormonal dietary intake"
},
{
"measure": "Comparison of daily living habits"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "qinxiu zhang"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lung-SIGHT"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Molly SC LI, MBBS, MRCP",
"phone": "3505 2166",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Department of Clinical Oncology, Prince of Wales Hospital",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Lung Cancer Screening by Artificial Intelligence Device",
"nctId": "NCT06295497",
"orgStudyIdInfo": {
"id": "LC-SHIELD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population"
}
],
"secondaryOutcomes": [
{
"measure": "Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment"
},
{
"measure": "Rate of invasive workup and incidence of associated complications."
},
{
"measure": "Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT"
},
{
"measure": "Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value"
},
{
"measure": "To determine the quality adjusted life years (QALYs) gained through screening"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Alternating traditional CPAP, NIPPV, and high CPAP"
}
]
},
"conditionsModule": {
"conditions": [
"Preterm Birth",
"Premature Lungs",
"Respiratory Distress Syndrome in Premature Infant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Maher Shahroor, MD",
"phone": "(416) 480-6100",
"phoneExt": "687939",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Sunnybrook Health Sciences Center",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "M4N 3M5"
}
]
},
"descriptionModule": {
"briefSummary": "Background:In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. We will continue to record the Edi signals during the 3 methods.Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, your baby will be put back to the originally prescribed breathing support.Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Months",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants",
"nctId": "NCT06295484",
"orgStudyIdInfo": {
"id": "5136",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O)."
}
],
"secondaryOutcomes": [
{
"measure": "1. Neural respiratory rate per minute"
},
{
"measure": "2. Edi peak measured in MicroVoltage"
},
{
"measure": "3. The difference in transcutaneous pCO2 in mmHg"
},
{
"measure": "4. The difference in oxygen requirements in percent (i.e, 21%)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sunnybrook Health Sciences Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-08-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DFG Laser"
},
{
"name": "CO2 Laser"
},
{
"name": "Optical coherence tomography (OCT)"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Alicia Van Cott, MSN",
"phone": "617-726-4454",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Abigail Carlson, BS",
"phone": "617-726-4454",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "MGH Clinical Unit for Research Trials & Outcomes in Skin",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02114"
}
]
},
"descriptionModule": {
"briefSummary": "This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime."
},
"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": 23,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser",
"nctId": "NCT06295471",
"orgStudyIdInfo": {
"id": "2024P000112",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale (VAS) pain score"
},
{
"measure": "Wound healing time"
}
],
"secondaryOutcomes": [
{
"measure": "Vessel density via OCT imaging"
},
{
"measure": "Vessel length via OCT imaging"
},
{
"measure": "Vessel thickness via OCT imaging"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Massachusetts General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GammaSense Stimulation System"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Gait Disorders, Neurologic",
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Atlanta",
"contacts": null,
"country": "United States",
"facility": "Emory Movement Disorders Center",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia",
"status": null,
"zip": "30329"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG.Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being \"glued\" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence.FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Flicker w FOG",
"briefTitle": "Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait",
"nctId": "NCT06295458",
"orgStudyIdInfo": {
"id": "STUDY00006945",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change in the effects of driving gamma on cerebrospinal fluid (CSF) amyloid levels in patients with PD-FOG"
},
{
"measure": "Change in the effects of driving gamma on cerebrospinal fluid (CSF) inflammatory markers levels in patients with PD-FOG"
}
],
"primaryOutcomes": [
{
"measure": "Number of participants with Adverse events"
},
{
"measure": "Number of participants compliant with the study procedures"
}
],
"secondaryOutcomes": [
{
"measure": "Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD"
},
{
"measure": "Change in the freezing of gait severity in participants with PD."
},
{
"measure": "Change in subjective changes in FOG."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Parkinson's Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Emory University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "care cardio-pulmonary ultrasound"
},
{
"name": "treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management"
}
]
},
"conditionsModule": {
"conditions": [
"Shock"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Al-Azhar University hospitals",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 108,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit",
"nctId": "NCT06295445",
"orgStudyIdInfo": {
"id": "Cardiopulmonary Ultrasound",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality rate"
},
{
"measure": "Number of mortalities"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Egymedicalpedia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DZD9008+AZD4205"
}
]
},
"conditionsModule": {
"conditions": [
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Zhen Wang",
"phone": "020-83827812",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Guangdong Provincial People'S Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510000"
}
]
},
"descriptionModule": {
"briefSummary": "DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)",
"nctId": "NCT06295432",
"orgStudyIdInfo": {
"id": "DZ2022E0001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Dizal Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "dual task"
},
{
"name": "single task"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers.Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:* Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.* Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.* In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.* The Body Control Measurement Scale will be applied for body evaluation purposes.As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy",
"nctId": "NCT06295419",
"orgStudyIdInfo": {
"id": "Igdir182",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Abilhand Kids"
},
{
"measure": "cognitive task (single task)"
},
{
"measure": "motor performance of manual skills (writing a paragraph) (single task)"
},
{
"measure": "motor performance of manual skills (single task)"
},
{
"measure": "motor performance of manual skills (dual task)"
},
{
"measure": "motor performance of manual skills (writing a paragraph) (dual task)"
},
{
"measure": "The Body Control Measurement Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Igdir University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neuropsychological assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity, Childhood",
"Obesity, Adolescent"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Piancavallo",
"contacts": [
{
"email": "[email protected]",
"name": "Federica Scarpina, PhD",
"phone": "+39032351",
"phoneExt": "4003",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe",
"geoPoint": null,
"state": "VCO",
"status": "RECRUITING",
"zip": "28824"
}
]
},
"descriptionModule": {
"briefSummary": "There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "11 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "Lettura_evOB",
"briefTitle": "Reading Ability in Childhood Obesity",
"nctId": "NCT06295406",
"orgStudyIdInfo": {
"id": "21C310",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Raw score at the neuropsychological assessment"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Sepsis",
"Acute Kidney Injury Due to Sepsis",
"Acute Kidney Injury (Nontraumatic)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Hyde Park",
"contacts": [
{
"email": "[email protected]",
"name": "Grace Fisler, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Shannon A Moriarty",
"phone": "631-834-0984",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Cohen Children's Medical Center",
"geoPoint": {
"lat": 40.7351,
"lon": -73.68791
},
"state": "New York",
"status": "RECRUITING",
"zip": "11004"
}
]
},
"descriptionModule": {
"briefSummary": "Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 74,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "RISK",
"briefTitle": "Renin Angiotensin Aldosterone System In Septic Kids",
"nctId": "NCT06295393",
"orgStudyIdInfo": {
"id": "20-0229-CCMC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in serum renin in sepsis"
}
],
"secondaryOutcomes": [
{
"measure": "Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury"
},
{
"measure": "Septic induced kidney injury will be associated with alterations in renal blood flow"
},
{
"measure": "Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients"
},
{
"measure": "Changes in the components of the RAAS over the first three days in sepsis"
},
{
"measure": "Changes in renal blood flow on Ultrasound in Sepsis"
},
{
"measure": "Renal blood flow and RAAS in sepsis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Northwell Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-24"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual environment practiced on the Caren"
},
{
"name": "Conventional physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Lower Limb Amputation Knee",
"Injuries",
"Biomechanical Lesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Messina",
"contacts": [
{
"email": "[email protected]",
"name": "Rocco Salvatore Calabrò, MD",
"phone": "09060128179",
"phoneExt": "+39",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Centro Neurolesi",
"geoPoint": {
"lat": 38.19394,
"lon": 15.55256
},
"state": "Sicily",
"status": null,
"zip": "98124"
}
]
},
"descriptionModule": {
"briefSummary": "Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees",
"nctId": "NCT06295380",
"orgStudyIdInfo": {
"id": "CarenAmp",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Kinematic data"
},
{
"measure": "Kinetic data"
},
{
"measure": "Electromyography"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Centro Neurolesi \"Bonino-Pulejo\""
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Best Practice"
},
{
"name": "Financial Navigation"
},
{
"name": "Interview"
},
{
"name": "Survey Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Malignant Solid Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fort Smith",
"contacts": [
{
"email": null,
"name": "Site Public Contact",
"phone": "800-378-9373",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mercy Hospital Fort Smith",
"geoPoint": {
"lat": 35.38592,
"lon": -94.39855
},
"state": "Arkansas",
"status": "RECRUITING",
"zip": "72903"
},
{
"city": "Little Rock",
"contacts": [
{
"email": "[email protected]",
"name": "Site Public Contact",
"phone": "501-906-4199",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "CARTI Cancer Center",
"geoPoint": {
"lat": 34.74648,
"lon": -92.28959
},
"state": "Arkansas",
"status": "RECRUITING",
"zip": "72205"
},
{
"city": "Alton",
"contacts": [
{
"email": null,
"name": "Site Public Contact",
"phone": "618-463-5623",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Saint Anthony's Health",
"geoPoint": {
"lat": 38.8906,
"lon": -90.18428
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "62002"
},
{
"city": "Centralia",
"contacts": [
{
"email": "[email protected]",
"name": "Site Public Contact",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Saint Mary's Hospital",
"geoPoint": {
"lat": 38.52505,
"lon": -89.1334
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "62801"
},
{
"city": "Mount Vernon",
"contacts": [
{
"email": null,
"name": "Site Public Contact",
"phone": "618-242-4600",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Good Samaritan Regional Health Center",
"geoPoint": {
"lat": 38.31727,
"lon": -88.90312
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "62864"
},
{
"city": "Garden City",
"contacts": [
{
"email": "[email protected]",
"name": "Site Public Contact",
"phone": "913-948-5588",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Central Care Cancer Center - Garden City",
"geoPoint": {
"lat": 37.97169,
"lon": -100.87266
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "67846"
},
{
"city": "Great Bend",
"contacts": [
{
"email": "[email protected]",
"name": "Site Public Contact",
"phone": "913-948-5588",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Central Care Cancer Center - Great Bend",
"geoPoint": {
"lat": 38.36446,
"lon": -98.76481
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "67530"
},
{
"city": "Ballwin",
"contacts": [
{
"email": null,
"name": "Site Public Contact",
"phone": "314-251-7058",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Saint Louis Cancer and Breast Institute-Ballwin",
"geoPoint": {
"lat": 38.59505,
"lon": -90.54623
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "63011"
},
{
"city": "Bolivar",
"contacts": [
{
"email": "[email protected]",
"name": "Site Public Contact",
"phone": "913-948-5588",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Central Care Cancer Center - Bolivar",
"geoPoint": {
"lat": 37.61448,
"lon": -93.41047
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "65613"
},
{
"city": "Branson",
"contacts": [
{
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"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Genesis Healthcare System Cancer Care Center",
"geoPoint": {
"lat": 39.94035,
"lon": -82.01319
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43701"
},
{
"city": "Oklahoma City",
"contacts": [
{
"email": null,
"name": "Site Public Contact",
"phone": "405-752-3402",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jay W. Carlson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mercy Hospital Oklahoma City",
"geoPoint": {
"lat": 35.46756,
"lon": -97.51643
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "73120"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 760,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)",
"nctId": "NCT06295367",
"orgStudyIdInfo": {
"id": "EAQ222CD",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2023-09944",
"link": null,
"type": "REGISTRY"
},
{
"domain": "ECOG-ACRIN Cancer Research Group",
"id": "EAQ222CD",
"link": null,
"type": "OTHER"
},
{
"domain": "DCP",
"id": "ECOG-ACRIN-EAQ222CD",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "EAQ222CD",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "R01CA272680",
"link": "https://reporter.nih.gov/quickSearch/R01CA272680",
"type": "NIH"
},
{
"domain": null,
"id": "UG1CA189828",
"link": "https://reporter.nih.gov/quickSearch/UG1CA189828",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Out of pocket cost (OOPC) accuracy"
},
{
"measure": "Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population."
},
{
"measure": "Patient reported satisfaction with intervention"
},
{
"measure": "Receipt of financial navigation via internal practice or external resources"
},
{
"measure": "Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care"
},
{
"measure": "longitudinal changes in cost-related cancer care non-adherence"
},
{
"measure": "longitudinal changes in cost-related cancer care material hardship"
},
{
"measure": "longitudinal changes in cost-related cancer care financial worry"
},
{
"measure": "longitudinal changes in cost-related cancer care quality of life"
},
{
"measure": "longitudinal changes in cost-related cancer care satisfaction with care"
}
],
"primaryOutcomes": [
{
"measure": "Cost-related cancer care non-adherence"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of Material Financial Hardship"
},
{
"measure": "Patient-reported financial worry"
},
{
"measure": "Patient-reported Quality of life - mental and physical health"
},
{
"measure": "Patient-reported satisfaction with care at 12 months"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "NETWORK",
"name": "ECOG-ACRIN Cancer Research Group"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention, we just study 'aging'"
}
]
},
"conditionsModule": {
"conditions": [
"Aging",
"Aging Well",
"Immuno Aging"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Background:Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.Study design:A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "EVIA-NL",
"briefTitle": "Early Variations in Immune Aging",
"nctId": "NCT06295354",
"orgStudyIdInfo": {
"id": "2024-17062",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Immunological function"
},
{
"measure": "Immunological Aging Score"
},
{
"measure": "Biological Aging Score"
},
{
"measure": "Metagenomics"
},
{
"measure": "Genetics and epigenetics"
},
{
"measure": "Clinical events"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Radboud University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Recombinant human growth hormone (only for children with growth hormone deficiency)"
}
]
},
"conditionsModule": {
"conditions": [
"Short Stature",
"Short; Stature, Psychosocial"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandro Sartorio, MD",
"phone": "+390261911",
"phoneExt": "2426",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20145"
}
]
},
"descriptionModule": {
"briefSummary": "The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PSICOSHORT",
"briefTitle": "Short Stature and Psychological Well-being",
"nctId": "NCT06295341",
"orgStudyIdInfo": {
"id": "01C312",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Psychological well-being through the Psychological Well-Being Scales (PWB)"
},
{
"measure": "Psychological distress through the Depression Anxiety Stress Scale (DASS-21)"
},
{
"measure": "Quality of life through the Quality of Life in Short Stature Youth (QoLISSY),"
},
{
"measure": "Skills and problems through the Strengths and Difficulties Questionnaire (SDQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Behavioral problems through the Child Behaviour Checklist for Children (CBCL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Terbinafine"
},
{
"name": "Placebo"
},
{
"name": "Tenofovir"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Hepatitis b"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amsterdam",
"contacts": [
{
"email": "[email protected]",
"name": "M.W. Peters, RN",
"phone": "+31207320393",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "D.J. van Doorn, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Amsterdam UMC",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": "Noord-Holland",
"status": "RECRUITING",
"zip": "1105AZ"
}
]
},
"descriptionModule": {
"briefSummary": "Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB).Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group.Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial.Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir \\> 6 months (group B, n=16).Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B).Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg \\>0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA \\>0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4).Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase 1b study with two parallel treatment arms and placebo controls.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Double blind",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "HepBTer",
"briefTitle": "From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients",
"nctId": "NCT06295328",
"orgStudyIdInfo": {
"id": "NL 72439.018.19",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in level of serum HBsAG"
},
{
"measure": "Change in serum HBV DNA"
}
],
"secondaryOutcomes": [
{
"measure": "Safety of terbinafine"
},
{
"measure": "Tolerability of terbinafine"
},
{
"measure": "Serum levels of HBsAG"
},
{
"measure": "Serum levels of HBV DNA"
},
{
"measure": "Serum levels of HBV RNA"
},
{
"measure": "Serum levels of HBcrAg"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Prader-Willi Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oggebbio",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandro Sartorio, MD",
"phone": "+390261911",
"phoneExt": "2426",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano IRCCS, site Piancavallo",
"geoPoint": {
"lat": 45.99088,
"lon": 8.64663
},
"state": "Verbania",
"status": "RECRUITING",
"zip": "28824"
}
]
},
"descriptionModule": {
"briefSummary": "The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PROPSICOPWS",
"briefTitle": "Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome",
"nctId": "NCT06295315",
"orgStudyIdInfo": {
"id": "01C310",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Psychological well-being through the Psychological General Well-Being Index (PGWBI)"
},
{
"measure": "Perception of life quality through the 36-Item Short Form Survey (SF-36)"
},
{
"measure": "Mental distress through the Symptom Checklist-90-R (SCL-90-R)"
}
],
"secondaryOutcomes": [
{
"measure": "Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21)"
},
{
"measure": "Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version)."
},
{
"measure": "Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HWH486"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Spontaneous Urticaria"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": [
{
"email": null,
"name": "Bioethics Committee of West China Hospital",
"phone": "+86 28 8512 3237",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "West China Hospital,Sichuan University",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated."
},
"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": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria",
"nctId": "NCT06295302",
"orgStudyIdInfo": {
"id": "RFCU-IIa-202308",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Hive Severity Score (HSS) over a 7-day period (HSS7)"
},
{
"measure": "Change in Itch Severity Score (ISS) over a 7-day period (ISS7)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hubei Biological Medicine Industrial Technology Institute Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hybrid Closed-loop Insulin Delivery System"
},
{
"name": "Insulin pump"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Xuefeng Yu",
"phone": "02783662883",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": "RECRUITING",
"zip": "430030"
}
]
},
"descriptionModule": {
"briefSummary": "Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial",
"nctId": "NCT06295289",
"orgStudyIdInfo": {
"id": "ZRKY-2023-04",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "postoperative infection"
}
],
"primaryOutcomes": [
{
"measure": "TIR"
}
],
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{
"measure": "TAR"
},
{
"measure": "TBR"
},
{
"measure": "MBG"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Huazhong University of Science and Technology"
}
},
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"date": "2024-12-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-04"
},
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"startDateStruct": {
"date": "2023-10-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "teletherapy-guided exercise programme"
},
{
"name": "Waiting list/control intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain",
"Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Osnabrück",
"contacts": [
{
"email": "[email protected]",
"name": "Roland Simon, BScPTc",
"phone": "05068932755",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Diakonie Pflege Schule",
"geoPoint": {
"lat": 52.27264,
"lon": 8.0498
},
"state": "Niedersachsen",
"status": "RECRUITING",
"zip": "49078"
}
]
},
"descriptionModule": {
"briefSummary": "Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale"
},
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"maskingDescription": "Allocation concealment:The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality.",
"whoMasked": null
},
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},
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},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Teletherapy-supported Training on Nursing Students",
"nctId": "NCT06295276",
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"id": "HSOsnabruck",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Neck Disability Index (NDI)"
},
{
"measure": "Oswestry Disability Index (ODI)"
},
{
"measure": "NRS Numeric rating scale for pain"
}
],
"secondaryOutcomes": [
{
"measure": "Short-Form: SF 36-Quality of life"
},
{
"measure": "Global rating scale"
}
]
},
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"leadSponsor": {
"class": "OTHER",
"name": "Hochschule Osnabruck"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
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"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease",
"Alzheimer Disease",
"Nervous System Diseases",
"Geriatric Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jinan",
"contacts": [
{
"email": "[email protected]",
"name": "Wenjing Jiang",
"phone": "18560082210",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Qilu Hospital of Shandong University",
"geoPoint": {
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"lon": 116.99722
},
"state": "Shandong",
"status": "RECRUITING",
"zip": "250012"
}
]
},
"descriptionModule": {
"briefSummary": "1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease.(2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease.(3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders.(4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients."
},
"designModule": {
"designInfo": {
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},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases",
"nctId": "NCT06295263",
"orgStudyIdInfo": {
"id": "KYLL-202203-028-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Handwriting"
},
{
"measure": "gait"
},
{
"measure": "speech"
},
{
"measure": "eye movements"
},
{
"measure": "biological samples (blood, urine, stool, saliva, etc.)"
},
{
"measure": "images"
},
{
"measure": "EEG"
},
{
"measure": "other relevant markers"
}
],
"secondaryOutcomes": null
},
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"collaborators": [
{
"name": "Shandong University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Qilu Hospital of Shandong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manualized Group Based Psychotherapy"
},
{
"name": "Poverty Alleviation"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Economic Vulnerability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dhaka",
"contacts": [
{
"email": "[email protected]",
"name": "Fahmida Tofail, MBBS, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Bangladesh",
"facility": "International Centre for Diarrhoeal Disease Research",
"geoPoint": {
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"lon": 90.40744
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\\[s\\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months."
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"maskingDescription": "Interventionists and outcome assessors will not be informed regarding the study design and research question.",
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 660,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression",
"nctId": "NCT06295250",
"orgStudyIdInfo": {
"id": "STUDY00001114",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "7R01MH127577",
"link": "https://reporter.nih.gov/quickSearch/7R01MH127577",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Implementation Outcomes--Adoption"
},
{
"measure": "Implementation Outcomes--Feasibility"
},
{
"measure": "Implementation outcomes--fidelity"
}
],
"primaryOutcomes": [
{
"measure": "Change in Depressive symptoms at 24 Months"
},
{
"measure": "Change in Depressive symptoms at intermediate timepoints"
},
{
"measure": "24 Month Relapse"
}
],
"secondaryOutcomes": [
{
"measure": "Economic vulnerability"
},
{
"measure": "Anxiety"
},
{
"measure": "Function"
},
{
"measure": "European Quality of Life Five Dimensions Five Level scale"
},
{
"measure": "Tension Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "International Centre for Diarrhoeal Disease Research, Bangladesh"
},
{
"name": "Georgetown University"
},
{
"name": "National Institute of Mental Health (NIMH)"
},
{
"name": "Albert Einstein College of Medicine"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Massachusetts, Worcester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intellisync+"
}
]
},
"conditionsModule": {
"conditions": [
"Mechanical Ventilation Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Miguel Sanchez-Garcia, MD",
"phone": "+34658762739",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Paloma Gonzalez-Arenas, MD",
"phone": "+34 670 57 66 45",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "David Janeiro Lumbreras, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fernando Suarez-Sipmann, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "José Antonio Sánchez-Giralt, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Clinico San Carlos",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "RECRUITING",
"zip": "28040"
}
]
},
"descriptionModule": {
"briefSummary": "Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Two 2-hour periods: 1) \"off mode\" consisting of a control period with optimized ventilator parameters and 2) \"on mode\" with an active automated detection and adjustment for asynchronies. The starting first period is randomized.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Anonymized evaluation",
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "i-Sync",
"briefTitle": "Automatic Adjustment for Asynchronies During Mechanical Ventilation",
"nctId": "NCT06295237",
"orgStudyIdInfo": {
"id": "i-Sync",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Duration of asyncronies"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fundación de Investigación Biomédica - Hospital Universitario de La Princesa"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hospital San Carlos, Madrid"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
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"conditions": [
"Regional Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kocaeli",
"contacts": [
{
"email": "[email protected]",
"name": "Hadi Ufuk Yörükoğlu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Kocaeli Universty",
"geoPoint": {
"lat": 39.62497,
"lon": 27.51145
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure."
},
"designModule": {
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Retrospective Evaluation of Effect of Anterior Iliac Block",
"nctId": "NCT06295224",
"orgStudyIdInfo": {
"id": "GOKAEK-2024/02.19",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Morphine consumption"
}
],
"secondaryOutcomes": [
{
"measure": "NRS score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kocaeli University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-10"
},
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"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "observational"
}
]
},
"conditionsModule": {
"conditions": [
"Hodgkin Lymphoma"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 32,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "HL_PR/R-B",
"briefTitle": "Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.",
"nctId": "NCT06295211",
"orgStudyIdInfo": {
"id": "FEDII_HL_PR/R-Bv-Bs",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "Progression overall survival"
},
{
"measure": "Response to treatment"
},
{
"measure": "Incidence of treatment emergent adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Federico II University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Single lep drop jump test"
}
]
},
"conditionsModule": {
"conditions": [
"Ankle Sprains",
"Ankle Injuries",
"Kinesiophobia",
"Jumping From Height"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Besiktas",
"contacts": [
{
"email": "[email protected]",
"name": "Pelin Pişirici, PT, PhD",
"phone": "05055016076",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ozlem Feyzioglu, PT, PhD",
"phone": "05353529794",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Bahcesehir University",
"geoPoint": null,
"state": "Istanbul",
"status": "RECRUITING",
"zip": "34353"
}
]
},
"descriptionModule": {
"briefSummary": "Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants with lateral ankle sprains will be randomized to the Mulligan and Maithland groups, and their evaluations and treatments will be completed.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "After evaluations, the groups determined as a result of randomization via a website were placed in opaque envelopes. The participant is randomized to one of the Mulligan or Maitland groups by selecting an envelope.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain",
"nctId": "NCT06295198",
"orgStudyIdInfo": {
"id": "OPMM-Ankle Instability",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Single-leg drop jump test"
}
],
"secondaryOutcomes": [
{
"measure": "Weight-bearing lunge test"
},
{
"measure": "Tampa kinesiophobia scale"
},
{
"measure": "Fear Avoidance Belief Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bahçeşehir University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "application MARO"
},
{
"name": "Sham application"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Mental Health Issue"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care",
"nctId": "NCT06295185",
"orgStudyIdInfo": {
"id": "AJOUIRB-IV-2024-097",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in network on the Standard Name Generator Approach scale"
},
{
"measure": "Change in depression symptoms severity on the Patient Health Questionnaire-9"
}
],
"secondaryOutcomes": [
{
"measure": "Change in social capital on the Social Capital Scale"
},
{
"measure": "Change in perceived workload on the Perceived Workload Scale"
},
{
"measure": "Change in job self-efficacy on the Job Self-Efficacy Scale"
},
{
"measure": "Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale"
},
{
"measure": "Change in work orientation toward his or her job on the Work Orientation Scale"
},
{
"measure": "Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees"
},
{
"measure": "Change in firm performance on the Company weekly sales records"
},
{
"measure": "Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities"
},
{
"measure": "Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire"
},
{
"measure": "Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale"
},
{
"measure": "Change in perceived stress level on the Perceived Stress Scale"
},
{
"measure": "Change in social functioning on Social Adaptation Self Rating Scale"
},
{
"measure": "Change in positive psychological capital on Korean version of Positive Psychological Capital Scale"
},
{
"measure": "Change in Organizational Companionship on Organizational Culture Inventory"
},
{
"measure": "Change in individual's social network on Lubben Social Network Scale-18"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ajou University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lafullen15"
},
{
"name": "Lafullen"
}
]
},
"conditionsModule": {
"conditions": [
"Nasolabial Folds"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 73,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement",
"nctId": "NCT06295172",
"orgStudyIdInfo": {
"id": "LF15_NLF_301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Samyang Biopharmaceuticals Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nivolumab"
},
{
"name": "Nivolumab + Relatlimab"
},
{
"name": "Ipilimumab"
}
]
},
"conditionsModule": {
"conditions": [
"Melanoma Stage III",
"Melanoma Stage IV",
"Advanced Melanoma",
"Melanoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Justin Martin",
"phone": "813-745-7544",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ahmad Tarhini, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Moffitt Cancer Center",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33612"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma",
"nctId": "NCT06295159",
"orgStudyIdInfo": {
"id": "MCC-22574",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pathologic Major Response (pMR)"
}
],
"secondaryOutcomes": [
{
"measure": "Preoperative Radiologic Response Rate"
},
{
"measure": "Complete Pathologic Response Rate (pCR)"
},
{
"measure": "Partial Pathologic Response Rate (pPR)"
},
{
"measure": "Non-Response Pathologic Response Rate (pNR)"
},
{
"measure": "Progression Free Survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "H. Lee Moffitt Cancer Center and Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-06"
}
}
} | false | null |
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