protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Insight Scale"
},
{
"name": "Semi-directional interviews"
},
{
"name": "routine care"
},
{
"name": "session of mutual assistance with a mediator psychologist"
}
]
},
"conditionsModule": {
"conditions": [
"Psychotic Episode"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Neuilly-sur-Marne",
"contacts": [
{
"email": "[email protected]",
"name": "Rusheenthira Thavaseelan",
"phone": "0143093232",
"phoneExt": "033",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Dominique Januel",
"phone": "0143093232",
"phoneExt": "033",
"role": "CONTACT"
},
{
"email": null,
"name": "Dominique Januel, Pr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ilona Arcomano, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "Etablissement Public de Santé de Ville-Evrard",
"geoPoint": {
"lat": 48.85373,
"lon": 2.54903
},
"state": null,
"status": "RECRUITING",
"zip": "93330"
}
]
},
"descriptionModule": {
"briefSummary": "Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A control group and a intervention group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "DIPEM",
"briefTitle": "Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode",
"nctId": "NCT06263933",
"orgStudyIdInfo": {
"id": "2023-A01804-41",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The level of the increasing of The INSIGHT scale"
}
],
"secondaryOutcomes": [
{
"measure": "The increase of Recovery Scale"
},
{
"measure": "The semi-structured interview"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre hospitalier de Ville-Evrard, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Late Onset Epilepsy",
"Stroke",
"Dementia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Preston",
"contacts": [
{
"email": "[email protected]",
"name": "Kina Bennett",
"phone": "(+44) 01772 522031",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Research Access",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jasmine Wall",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Lancashire Teaching Hospitals NHS",
"geoPoint": {
"lat": 53.76282,
"lon": -2.70452
},
"state": "Lancashire",
"status": "RECRUITING",
"zip": "PR2 9HT"
}
]
},
"descriptionModule": {
"briefSummary": "We don't know a great deal about why some people develop seizures in adulthood, but some researchers think that it might tell us something about the brain. A small number of people with first seizure in adulthood go on to experience problems like stroke or dementia later in life. However, stroke and dementia are common diseases, so we don't know whether there is a real association between these conditions. When people develop their first seizure in adult life, this is sometimes called Late-Onset Epilepsy. Through the NeuroFrailty study, we will observe 'brain health' over the years following the onset of a seizure, and I hope that it might give us more information about people with these kinds of seizures.The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. At this time, we will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses which might tell us whether there are differences compared to people without seizures. For some people, we will also look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.Over the following years, we will look at how things change: for example whether there are changes in memory, new diagnoses, medication changes and how lifestyle has changed. Because there is so little research in this area, it is very difficult to predict what might happen. For example, some people can experience worse memory because of medication side effects; on the other hand, good seizure control following a diagnosis can sometimes lead to improved memory. Over years, it may become clear that some diseases are more likely in people with late-onset epilepsy than in people without such a diagnosis. You will receive a yearly newsletter to keep you updated on everything we learn about late-onset epilepsy.Purpose and BackgroundMost of the time, we do not know why an adult develops epilepsy. Some researchers think there may be a connection between epilepsy which starts in adulthood, and increased risk of stroke or dementia in the future. However, there is very little research or evidence in this area, so we cannot say whether this is true.What does taking part involve?This study is an observational study, which means that the management of participants' seizure disorder will not be affected if they choose to take part in this study. The purpose of this study is to watch participants over the course of several years, to find out more about seizures which start in adulthood.Participants can choose the level of involvement that is right for them.1. LOW involvement. A researcher will check hospital and General Practice (GP records) once or twice per year, for the LIMITED AND SPECIFIC purpose of checking: medications, any new diagnoses, investigations associated with stroke risk (such as cholesterol, blood pressure, heart trace) and any brain scans that have been performed. I will not have access to more detailed information, such as conversations between a participant and their GP.2. HIGH involvement. This involves being contacted by telephone once per year for 15-30 minutes to ask questions assessing memory and enquiring about lifestyle, such as exercise, smoking and alcohol use.3. VERY HIGH involvement. These participants will be contacted for a longer telephone conversation 30-45 minutes once per year about their experience of how epilepsy has affected home life, work and medications.If someone decides in the future that they don't want to be involved, they can withdraw from the study. However, once the study is completely finished, the information will be completely anonymous, which means that I won't be able to find individual's information in order to delete it.Glossary Seizure disorder = any disorder which involved having experienced at least one seizure. First seizure and epilepsy both can be classed as a form of seizure disorder.Neurofrailty = A condition whereby a person is at risk of stroke or dementia."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 360,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neurofrailty: A Study of Late-onset Epilepsy and Its Associations",
"nctId": "NCT06263920",
"orgStudyIdInfo": {
"id": "288703",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?"
},
{
"measure": "Quality of Life - how of chronic illness is mediated"
}
],
"secondaryOutcomes": [
{
"measure": "What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?"
},
{
"measure": "Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Lancashire Teaching Hospitals NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stellate gangalion block"
}
]
},
"conditionsModule": {
"conditions": [
"Mastectomy",
"Pain, Acute",
"Pain, Chronic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Complications after mastectomy include chronic pain and depression."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SGB",
"briefTitle": "Stellate Ganglion Block for Prevention of Post Mastectomy Depression",
"nctId": "NCT06263907",
"orgStudyIdInfo": {
"id": "stellate ganglion block",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "incidence of postmastectomy depression"
}
],
"secondaryOutcomes": [
{
"measure": "incidence of postmastectomy depression"
},
{
"measure": "the need for postoperative antidepressant"
},
{
"measure": "acute postoperative pain at the incision site (breast and the axilla)"
},
{
"measure": "chronic postmastectomy pain at the incision site"
},
{
"measure": "incidence of nausea and vomiting"
},
{
"measure": "Functional pain in the ipsilateral shoulder"
},
{
"measure": "Any complications related to stellate ganglion injection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental group"
}
]
},
"conditionsModule": {
"conditions": [
"Labor Pain",
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Ayşen Özgür",
"phone": "+905393806296",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Başakşehir Çam and Sakura City Hospital",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G\\*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "One experimental group and one conventional (control) group",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "In order to reduce selection bias in determining the experimental and control groups, a computer-assisted randomization program (https://www.randomizer.org) will be used for pregnant women who meet the inclusion criteria.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Alexander Technique on Labor Pain and Anxiety",
"nctId": "NCT06263894",
"orgStudyIdInfo": {
"id": "MarmaraU-Ebe-ZDY-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Decreasing labor pain"
},
{
"measure": "Decreasing anxiety"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Scientific and Technological Research Council of Turkey"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Marmara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Raphamin"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Community-acquired Pneumonia",
"Pneumonia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Arkhangelsk",
"contacts": [
{
"email": null,
"name": "Vadim Arkhipovsky, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Vadim Arkhipovsky, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency",
"geoPoint": {
"lat": 64.5401,
"lon": 40.5433
},
"state": null,
"status": "RECRUITING",
"zip": "163000"
},
{
"city": "Chelyabinsk",
"contacts": null,
"country": "Russian Federation",
"facility": "Regional Clinical Hospital # 3",
"geoPoint": {
"lat": 55.15402,
"lon": 61.42915
},
"state": null,
"status": "WITHDRAWN",
"zip": "454018"
},
{
"city": "Ivanovo",
"contacts": [
{
"email": null,
"name": "Svetlana Ushakova, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Svetlana Ushakova, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Ivanovo Clinical Hospital named after Kuvayevs",
"geoPoint": {
"lat": 56.99719,
"lon": 40.97139
},
"state": null,
"status": "RECRUITING",
"zip": "153025"
},
{
"city": "Kaliningrad",
"contacts": [
{
"email": null,
"name": "Vladimir Rafalsky, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Vladimir Rafalsky, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Central City Clinical Hospital",
"geoPoint": {
"lat": 54.70649,
"lon": 20.51095
},
"state": null,
"status": "RECRUITING",
"zip": "236005"
},
{
"city": "Kazan",
"contacts": [
{
"email": null,
"name": "Irina Kravchenko, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Irina Kravchenko, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Kazan State Medical University/Department of Infectious Diseases",
"geoPoint": {
"lat": 55.78874,
"lon": 49.12214
},
"state": null,
"status": "RECRUITING",
"zip": "420012"
},
{
"city": "Krasnodar",
"contacts": [
{
"email": null,
"name": "Marina Avdeeva, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marina Avdeeva, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology",
"geoPoint": {
"lat": 45.04484,
"lon": 38.97603
},
"state": null,
"status": "RECRUITING",
"zip": "350063"
},
{
"city": "Lomonosov",
"contacts": [
{
"email": null,
"name": "Svetlana Mosolova, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Svetlana Mosolova, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Lomonosov Interdistrict Hospital named after. I.N. Yudchenko",
"geoPoint": {
"lat": 59.90612,
"lon": 29.77253
},
"state": null,
"status": "RECRUITING",
"zip": "188531"
},
{
"city": "Moscow",
"contacts": [
{
"email": null,
"name": "Antonina Ploskireva, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Antonina Ploskireva, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Central Research Institute of Epidemiology",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": null,
"status": "RECRUITING",
"zip": "111123"
},
{
"city": "Moscow",
"contacts": [
{
"email": null,
"name": "Svetlana Erofeeva, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Svetlana Erofeeva, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": null,
"status": "RECRUITING",
"zip": "129110"
},
{
"city": "Nizhny Novgorod",
"contacts": [
{
"email": null,
"name": "Vladimir Nosov, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Vladimir Nosov, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko",
"geoPoint": {
"lat": 56.32867,
"lon": 44.00205
},
"state": null,
"status": "RECRUITING",
"zip": "603093"
},
{
"city": "Nizhny Novgorod",
"contacts": [
{
"email": null,
"name": "Natalya Eremina, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Natalya Eremina, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "LLC \"Persona group of companies\"",
"geoPoint": {
"lat": 56.32867,
"lon": 44.00205
},
"state": null,
"status": "RECRUITING",
"zip": "603155"
},
{
"city": "Perm",
"contacts": [
{
"email": null,
"name": "Svetlana Teplykh, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Svetlana Teplykh, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "LLC \"Professor's clinic\"",
"geoPoint": {
"lat": 58.01046,
"lon": 56.25017
},
"state": null,
"status": "RECRUITING",
"zip": "614070"
},
{
"city": "Pyatigorsk",
"contacts": [
{
"email": null,
"name": "Daria Saenko, MD",
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"contacts": [
{
"email": "[email protected]",
"name": "Isabelle GUEMAS, MD",
"phone": "02 40 53 88 91",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Isabelle GUEMAS, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 47.28333,
"lon": -2.2
},
"state": "Pays De La Loire",
"status": null,
"zip": "44600"
},
{
"city": "Trélazé",
"contacts": [
{
"email": "[email protected]",
"name": "Julie CHEIGNON, MD",
"phone": "02 41 79 08 09",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Julie CHEIGNON, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 47.44565,
"lon": -0.4654
},
"state": "Pays De La Loire",
"status": null,
"zip": "49800"
},
{
"city": "Aix-en-Provence",
"contacts": [
{
"email": "[email protected]",
"name": "Céline CASTAINGS-CARLIOZ, MD",
"phone": "06 20 70 02 99",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Céline CASTAINGS-CARLIOZ, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 43.5283,
"lon": 5.44973
},
"state": "Provence-Alpes-Côte d'Azur",
"status": null,
"zip": "13090"
},
{
"city": "Marseille",
"contacts": [
{
"email": "[email protected]",
"name": "Hélène Bellon, MD",
"phone": "04 86 97 40 13",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Hélène Bellon, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": "Provence-Alpes-Côte d'Azur",
"status": null,
"zip": "13008"
},
{
"city": "Nice",
"contacts": [
{
"email": "[email protected]",
"name": "Frédérique GASTAUD, MD",
"phone": "04 93 13 85 17",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Frédérique GASTAUD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 43.70313,
"lon": 7.26608
},
"state": "Provence-Alpes-Côte d'Azur",
"status": null,
"zip": "06000"
},
{
"city": "Marseille",
"contacts": [
{
"email": "[email protected]",
"name": "Catherine BRUE FABRE",
"phone": "04 91 49 29 35",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Catherine BRUE FABRE, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": "Provence-Alpes-Côte-d'Azur",
"status": null,
"zip": "13012"
},
{
"city": "Bron",
"contacts": [
{
"email": "[email protected]",
"name": "Emilie Doye, MD",
"phone": "0472118890",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Emilie Doye, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hôpital Femme Mère Enfant, Hospices civils de Lyon",
"geoPoint": {
"lat": 45.73333,
"lon": 4.91667
},
"state": null,
"status": null,
"zip": "69677"
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Capucine VIGNON SAVOYE, MD",
"phone": "09 80 46 71 19",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Capucine VIGNON SAVOYE, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Île-De-France",
"status": null,
"zip": "75010"
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Isabelle FLECHTNER, MD",
"phone": "01 43 55 17 17",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Isabelle FLECHTNER, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Île-De-France",
"status": null,
"zip": "75011"
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Maxime GERARD, MD",
"phone": "06 37 63 83 07",
"phoneExt": "33",
"role": "CONTACT"
},
{
"email": null,
"name": "Maxime GERARD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Pediatric practice",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Île-De-France",
"status": null,
"zip": "75017"
}
]
},
"descriptionModule": {
"briefSummary": "The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3360,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PAPPEL",
"briefTitle": "First Observatory of Precocious Puberty.",
"nctId": "NCT06263868",
"orgStudyIdInfo": {
"id": "69HCL23_1090",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID-RCB",
"id": "2023-A02313-42",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of recruited patients with at least 80% of the main data collected"
},
{
"measure": "Missing data rate"
},
{
"measure": "At least 75% of patients included"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospices Civils de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CURE"
}
]
},
"conditionsModule": {
"conditions": [
"Large Language Model"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": null,
"country": "United States",
"facility": "Mayo Clinic",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes."
},
"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": 1015,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients",
"nctId": "NCT06263855",
"orgStudyIdInfo": {
"id": "24-000352",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of patient accrual"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "modified Elamrousy approach for socket shield technique"
},
{
"name": "conventional socket shield"
},
{
"name": "combined socket shild with xenograft"
}
]
},
"conditionsModule": {
"conditions": [
"Implant Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kafr Ash Shaykh",
"contacts": [
{
"email": "[email protected]",
"name": "walid elamrousy, phd",
"phone": "+201005724781",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "mostafa fayed, bachelor",
"phone": "+201063376252",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Walid Elamrousy",
"geoPoint": {
"lat": 31.11174,
"lon": 30.93991
},
"state": null,
"status": "RECRUITING",
"zip": "76130"
}
]
},
"descriptionModule": {
"briefSummary": "The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "neither participant nor the outcome assessor know the group distribution",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 63,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Elamrousy Novel Approach of Socket Shield Technique",
"nctId": "NCT06263842",
"orgStudyIdInfo": {
"id": "KFSIRB200-132",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Stability Quotient of dental implant (SQDI)"
},
{
"measure": "pink esthetic score (PES)"
},
{
"measure": "Midfacial Mucosal Alterations"
}
],
"secondaryOutcomes": [
{
"measure": "facial marginal bone level (FMBL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kafrelsheikh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Use of Tappt App"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatitis C"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.* The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "HCV Tappt Adherence Study",
"nctId": "NCT06263829",
"orgStudyIdInfo": {
"id": "2023-1580",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Medication adherence"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Synchronyx"
},
{
"name": "American Society of Health-System Pharmacists"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental group: Patients will be treated with carvedilol."
},
{
"name": "Control group: Patients will receive a placebo."
}
]
},
"conditionsModule": {
"conditions": [
"Asymptomatic Cirrhosis",
"Clinically Significant Portal Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amiens",
"contacts": [
{
"email": "[email protected]",
"name": "NGUYEN KHAC Eric, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Amiens Picardie",
"geoPoint": {
"lat": 49.9,
"lon": 2.3
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Angers",
"contacts": [
{
"email": "[email protected]",
"name": "OBERTI FREDERIC",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Angers",
"geoPoint": {
"lat": 47.46667,
"lon": -0.55
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Assistance Publique Hôpitaux De Paris",
"contacts": [
{
"email": "[email protected]",
"name": "RAUTOU PIERRE EMMANUEL, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Beaujon",
"geoPoint": null,
"state": null,
"status": null,
"zip": null
},
{
"city": "Besançon",
"contacts": [
{
"email": "[email protected]",
"name": "WEIL DELPHINE, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Jean Minjoz",
"geoPoint": {
"lat": 47.24878,
"lon": 6.01815
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Bordeaux",
"contacts": [
{
"email": "[email protected]",
"name": "DE LEDINGHEN VICTOR, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Haut Lévêque",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Caen",
"contacts": [
{
"email": "[email protected]",
"name": "OLLIVIER-HOURMAND Isabelle, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Caen",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": null
},
{
"city": "CH Intercommunal De Créteil",
"contacts": [
{
"email": "[email protected]",
"name": "ROSA ISABELLE, dR",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CH intercommunal de Créteil",
"geoPoint": null,
"state": null,
"status": null,
"zip": null
},
{
"city": "Clermont Ferrand",
"contacts": [
{
"email": "[email protected]",
"name": "ABERGEL ARMAND, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Clermont Ferrand",
"geoPoint": {
"lat": 45.77966,
"lon": 3.08628
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Créteil",
"contacts": [
{
"email": "[email protected]",
"name": "LEROY Vincent, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Henri Mondor",
"geoPoint": {
"lat": 48.78333,
"lon": 2.46667
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Dijon",
"contacts": [
{
"email": "[email protected]",
"name": "MINELLO Anne, Dr",
"phone": null,
"phoneExt": null,
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}
],
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"name": "HILLERET Marie-Noelle, Dr",
"phone": null,
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"role": "CONTACT"
}
],
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},
{
"city": "La Roche-sur-Yon",
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"email": "[email protected]",
"name": "LAGIN Ludovic, Dr",
"phone": null,
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"role": "CONTACT"
}
],
"country": "France",
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}
],
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"facility": "Hôpital Huriez",
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"name": "LEBOSSE FANNY, Dr",
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}
],
"country": "France",
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}
],
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{
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}
],
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}
],
"country": "France",
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"name": "THABUT DOMINIQUE, Dr",
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}
],
"country": "France",
"facility": "CHU Pitié-Salpêtrière",
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{
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{
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"name": "OZENNE Violaine, Dr",
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}
],
"country": "France",
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},
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},
{
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"email": "[email protected]",
"name": "BERNARD CHABERT Brigitte, Dr",
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}
],
"country": "France",
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{
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}
],
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{
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{
"email": "[email protected]",
"name": "TRIPON Simona, Dr",
"phone": null,
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"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpitaux Universitaires de Strasbourg",
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{
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{
"email": "[email protected]",
"name": "BUREAU Christophe, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Toulouse",
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"state": null,
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},
{
"city": "Villejuif",
"contacts": [
{
"email": "[email protected]",
"name": "KOUNIS Ilias, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "Hôpital Paul Brousse",
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"state": null,
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}
]
},
"descriptionModule": {
"briefSummary": "Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study will be a national multicentric, phase III, superiority double-blinded randomized controlled trial with two parallel arms: carvedilol versus placebo. The primary end-point will be assessed by the local investigator (hepatologist), blinded of the randomization arm",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 290,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARVECIR",
"briefTitle": "Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial",
"nctId": "NCT06263816",
"orgStudyIdInfo": {
"id": "CARVECIR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Centre Hospitalier Universitaire Amiens Picardie"
},
{
"name": "Centre Hospitalier Universitaire Angers"
},
{
"name": "Assistance Publique Hopitaux Paris BEAUJON"
},
{
"name": "Centre Hospitalier Universitaire Caen"
},
{
"name": "Centre Hospitalier intercommunal de Créteil"
},
{
"name": "Hospices Civils de Lyon"
},
{
"name": "Centre Hospitalier Universitaire Grenoble"
},
{
"name": "Centre Hospitalier Universitaire Haut Lévêque"
},
{
"name": "Centre Hospitalier Régional Universitaire Lille"
},
{
"name": "Centre Hospitalier Universitaire Jean Minjoz"
},
{
"name": "Assistance Publique Hopitaux Paris AVICENNE"
},
{
"name": "Centre Hospitalier Universitaire Clermont Ferrand"
},
{
"name": "Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE"
},
{
"name": "Centre Hospitalier Universitaire Pontchaillou"
},
{
"name": "Assistance Publique Hopitaux Paris ST ANTOINE"
},
{
"name": "Assistance Publique Hopitaux Paris PAUL BROUSSE"
},
{
"name": "University Hospital, Montpellier"
},
{
"name": "Assistance Publique Hopitaux Paris HENRI MONDOR"
},
{
"name": "Centre Hospitaliser Départemental de Vendée"
},
{
"name": "Nantes University Hospital"
},
{
"name": "Centre Hospitalier Universitaire Dijon"
},
{
"name": "CHU de Reims"
},
{
"name": "Hôpitaux Universitaires de Strasbourg"
},
{
"name": "University Hospital, Toulouse"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Tours"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Music listening, classic physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Chronic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karatay",
"contacts": [
{
"email": "[email protected]",
"name": "Mustafa S Torlak",
"phone": "+905373660138",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Mustafa Savaş Torlak",
"geoPoint": {
"lat": 37.86726,
"lon": 32.52863
},
"state": "Eyalet/Yerleşke",
"status": "RECRUITING",
"zip": "42000"
}
]
},
"descriptionModule": {
"briefSummary": "The effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "single",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Listening to Music on Chronic Low Back Pain",
"nctId": "NCT06263803",
"orgStudyIdInfo": {
"id": "Karataymusic",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Beck anxiety inventory"
},
{
"measure": "Visual Analogue Scale"
},
{
"measure": "Short From-36"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "KTO Karatay University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intubating laryngeal mask"
},
{
"name": "Direct laryngoscopy"
}
]
},
"conditionsModule": {
"conditions": [
"Neonatal Disease",
"Intubation; Difficult or Failed"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial",
"nctId": "NCT06263790",
"orgStudyIdInfo": {
"id": "NEOUNIPD1(2024)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Success at the first attempt"
}
],
"secondaryOutcomes": [
{
"measure": "Time of device positioning"
},
{
"measure": "Participant's opinion on difficulty of the procedure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Padova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nurses training program on early detection of disability"
}
]
},
"conditionsModule": {
"conditions": [
"Developmental Disability",
"Development Delay",
"Motor Delay",
"Down Syndrome",
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banī Suwayf",
"contacts": null,
"country": "Egypt",
"facility": "Tayseer Saber Abdeldayem",
"geoPoint": {
"lat": 29.07441,
"lon": 31.09785
},
"state": "Beni-Suef",
"status": null,
"zip": "62521"
}
]
},
"descriptionModule": {
"briefSummary": "The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Early Detection of Children With Developmental Disabilities in Assiut Governorate",
"nctId": "NCT06263777",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004142",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire of Screening and referral knowledge"
},
{
"measure": "Questionnaire of Disability Perception"
},
{
"measure": "questionnaire about Monitoring Practices"
},
{
"measure": "Follow up"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beni-Suef University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Listening to Qur'an Recital"
}
]
},
"conditionsModule": {
"conditions": [
"Quality of Life"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta",
"contacts": [
{
"email": "[email protected]",
"name": "Alvina Widhani, PhD",
"phone": "+6281905910034",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Karina Wijayanti, MD",
"phone": "+6285226207270",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": null,
"status": "RECRUITING",
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients",
"nctId": "NCT06263764",
"orgStudyIdInfo": {
"id": "23-11-1954",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in Quality of Life Pre and Post Intervention"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Product prescription program- NutriConnect Credit"
},
{
"name": "Product prescription program- NutriConnect Delivery"
}
]
},
"conditionsModule": {
"conditions": [
"Food Insecurity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint Louis",
"contacts": [
{
"email": "[email protected]",
"name": "Jing Li, MD, DrPH, MS",
"phone": "314-273-9386",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Adam Hively, MPH",
"phone": "6142021540",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Barnes Jewish Hospital",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "63110"
}
]
},
"descriptionModule": {
"briefSummary": "The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers \"prescribe\" fruits and vegetables (F\\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "240 patients will be randomized to three arms: \"usual care,\" NutriConnect Credit, and NutriConnect Delivery with equivalent monetary value to credit. The interventions will last 6 months.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Due to the open study design, the NutriConnect team will not be able to have either patient or research coordinator/Schnucks intervention delivers blinded on group assignment. However, the assignment will be hidden from research faculty, the study biostatistician, and study analyst.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NutriConnect",
"briefTitle": "Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost",
"nctId": "NCT06263751",
"orgStudyIdInfo": {
"id": "202401096",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "American Heart Association",
"id": "24FIM1268045",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Self-reported health status"
}
],
"primaryOutcomes": [
{
"measure": "change in F&V intake"
}
],
"secondaryOutcomes": [
{
"measure": "Household food insecurity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Schnuck Markets, Inc."
},
{
"name": "BJC HealthCare"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Washington University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Whole Body Hyperthermia"
},
{
"name": "Cold Water Plunge"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Mood Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Edwards",
"contacts": [
{
"email": "[email protected]",
"name": "Study Coordinator",
"phone": "970-445-2489",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Barry Sandler, DO",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Vail Health Behavioral Health Innovation Center",
"geoPoint": {
"lat": 39.64499,
"lon": -106.5942
},
"state": "Colorado",
"status": null,
"zip": "81632"
}
]
},
"descriptionModule": {
"briefSummary": "This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The randomization list will be prepared by an unblinded study statistician and administered by study personnel with no other involvement in study activities. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 112,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CHILL'D",
"briefTitle": "Cold and Heat Investigation to Lower Levels of Depression",
"nctId": "NCT06263738",
"orgStudyIdInfo": {
"id": "2024-248",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Montgomery-Åsberg Depression Rating Scale (MADRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Warwick Edinburgh Mental Well-Being Scale (WEMWBS)"
},
{
"measure": "Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety"
},
{
"measure": "Sheehan Disability Scale (SDS)"
},
{
"measure": "Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Steadman Philippon Research Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Vail Health Behavioral Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Restricted dietary protein"
},
{
"name": "Habitual diet"
}
]
},
"conditionsModule": {
"conditions": [
"Diet, Healthy, Body Weight"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": null,
"country": "Denmark",
"facility": "University of Copenhagen",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": "2100"
}
]
},
"descriptionModule": {
"briefSummary": "Prolonged dietary protein restriction has been shown to increase energy expenditure in mice simultaneously with an increase in plasma FGF21 levels. In overfeeding studies, a protein-restricted diet reduces weight gain in both mice and humans compared with normal and high-protein diets. Further, in energy balance studies, when lean men are provided with a protein-restricted diet for five weeks, an increase in energy intake was necessary to obtain their body weight. However, whether the effect of a protein-restricted diet is the same when consumed by overweight to obese men has divergent results in both mice and humans."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "25 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PR",
"briefTitle": "Protein Restriction (PR) for Weight Loss",
"nctId": "NCT06263725",
"orgStudyIdInfo": {
"id": "ALyster",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Body weight"
}
],
"secondaryOutcomes": [
{
"measure": "FGF21"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Copenhagen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Attempted Suicide Short Intervention Program (ASSIP)"
},
{
"name": "Standard of care plus resource interview group (STAR)"
}
]
},
"conditionsModule": {
"conditions": [
"Inhibitory Control",
"Self Efficacy",
"Suicide Ideation",
"Suicide, Attempted",
"Locus of Control",
"Process Factors",
"Movement Synchrony"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bern",
"contacts": [
{
"email": "[email protected]",
"name": "Anja C Gysin-Maillart, Ph.D.",
"phone": "0041 31 632 88 11",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anja C Gysin-Maillart, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "University Hospital of Psychiatry and Psychotherapy, University of Bern",
"geoPoint": {
"lat": 46.94809,
"lon": 7.44744
},
"state": null,
"status": "RECRUITING",
"zip": "3008"
}
]
},
"descriptionModule": {
"briefSummary": "The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 156,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NePsyAssip HT",
"briefTitle": "Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2",
"nctId": "NCT06263712",
"orgStudyIdInfo": {
"id": "2021-02504 (Project 2)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility"
},
{
"measure": "Sociodemographic data"
},
{
"measure": "Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders"
},
{
"measure": "Depressive symptoms"
},
{
"measure": "Loneliness"
},
{
"measure": "Therapeutic Alliance"
},
{
"measure": "Therapeutic change"
},
{
"measure": "Therapeutic outcomes"
},
{
"measure": "Adherence and Competence"
},
{
"measure": "Physiologically Experienced Emotional Distress and Arousal"
},
{
"measure": "Ecological Momentary Assesment"
},
{
"measure": "Attention and Concentration Abilities"
},
{
"measure": "Dissociative Experience"
},
{
"measure": "Motivational Incongruence"
},
{
"measure": "Motivational Goals"
},
{
"measure": "Suicide-Related Coping"
}
],
"primaryOutcomes": [
{
"measure": "Differences in Inhibitory Control"
},
{
"measure": "Differences in Inhibitory Control"
},
{
"measure": "Differences in Inhibitory Control"
}
],
"secondaryOutcomes": [
{
"measure": "Movement analyses"
},
{
"measure": "Selective Attention and Interference Control"
},
{
"measure": "General Sense of Self-Efficacy"
},
{
"measure": "Locus of control"
},
{
"measure": "Psychological Pain"
},
{
"measure": "Suicidal ideation and behavior"
},
{
"measure": "Suicidal ideation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Bern"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ROM measurement of the MCP and PIP joints in digits 4 and 5"
}
]
},
"conditionsModule": {
"conditions": [
"Dupuytren's Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leuven",
"contacts": [
{
"email": "[email protected]",
"name": "Ilse Degreef, Prof. Dr.",
"phone": "+32 16 33 88 43",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anna Tarasiuk",
"phone": "+32 16 33 88 18",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ilse Degreef, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Universitaire Ziekenhuizen KU Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": "Vlaams-Brabant",
"status": "RECRUITING",
"zip": "3000"
}
]
},
"descriptionModule": {
"briefSummary": "Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 59,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Goniometry",
"briefTitle": "Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease",
"nctId": "NCT06263699",
"orgStudyIdInfo": {
"id": "S68225",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Active Extension Deficits (AED)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pasteurised yoghurt"
},
{
"name": "Fresh yoghurt"
},
{
"name": "Sterilised yoghurt"
}
]
},
"conditionsModule": {
"conditions": [
"Immune System",
"Innate Inflammatory Response"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 125,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "YASI-03",
"briefTitle": "Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults",
"nctId": "NCT06263686",
"orgStudyIdInfo": {
"id": "DAN056",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "T-cells"
},
{
"measure": "IFN-gamma induction"
},
{
"measure": "IgG"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Danone Institute International"
},
{
"name": "University of Seville"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Valladolid"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2016-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2016-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sitagliptin"
},
{
"name": "Dapagliflozin"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Lewy Body Dementia",
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jacksonville",
"contacts": [
{
"email": "[email protected]",
"name": "Zoe A Parrales, BS",
"phone": "904-953-3381",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Mayo Clinic Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32224"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Anti-Diabetic Medications to Fight PD and LBD",
"nctId": "NCT06263673",
"orgStudyIdInfo": {
"id": "23-008183",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)"
},
{
"measure": "Change in Mini Mental State Examination"
}
],
"secondaryOutcomes": [
{
"measure": "Glucose"
},
{
"measure": "Supine blood pressure"
},
{
"measure": "Standing blood pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Keto-like supplement"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tulsa",
"contacts": [
{
"email": "[email protected]",
"name": "Teresa Victor, PhD",
"phone": "918-502-5108",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Colleen McCallum",
"phone": "918-502-5180",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Laureate Institute for Brain Research",
"geoPoint": {
"lat": 36.15398,
"lon": -95.99277
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "74136"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression",
"nctId": "NCT06263660",
"orgStudyIdInfo": {
"id": "2022-007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "BOLD response during Monetary Incentive Delay Task"
}
],
"secondaryOutcomes": [
{
"measure": "BOLD response during Adjective Task"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Laureate Institute for Brain Research, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Houston-HVIP treatment"
},
{
"name": "Enhanced Case Management"
}
]
},
"conditionsModule": {
"conditions": [
"Firearm Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Sandra McKay, MD",
"phone": "713-500-5666",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Alexander Testa, PhD",
"phone": "(210) 276-9000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Texas Health Science Center at Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants will be partially blinded in that they will know some information about the intervention but will not be exposed to the details of the intervention or the intervention manual.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area",
"nctId": "NCT06263647",
"orgStudyIdInfo": {
"id": "HSC-MS-23-0904",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "UG3NR021232",
"link": "https://reporter.nih.gov/quickSearch/UG3NR021232",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury"
},
{
"measure": "Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument"
}
],
"secondaryOutcomes": [
{
"measure": "Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5)"
},
{
"measure": "Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ)"
},
{
"measure": "Change in general health as assessed by the 12-item Short Form Health Survey (SF-12)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Nursing Research (NINR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas Health Science Center, Houston"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hand exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Psoriatic Arthritis",
"Hand Rheumatism"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Antalya",
"contacts": [
{
"email": "[email protected]",
"name": "Ayse Ayan, MD",
"phone": "+90 242 249 44 00",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Akdeniz University",
"geoPoint": {
"lat": 36.90812,
"lon": 30.69556
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hand Exercises in Psoriatic Arthritis",
"nctId": "NCT06263634",
"orgStudyIdInfo": {
"id": "2022-206",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Psoriatic Arthritis Disease Activity Score (DAPSA)"
},
{
"measure": "Hand grip strength measurement"
},
{
"measure": "Hand fine grip strength measurement:"
}
],
"secondaryOutcomes": [
{
"measure": "Nine-Hole Peg Test"
},
{
"measure": "Duruöz Hand Index"
},
{
"measure": "Michigan Hand Outcome Questionnaire (MHQ)"
},
{
"measure": "Hand Functional Index (HFI)"
},
{
"measure": "Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Akdeniz University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention \"Standard\""
}
]
},
"conditionsModule": {
"conditions": [
"Food Selection",
"Obesity",
"Weight Gain",
"Food Preferences"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Courtyard Cafe",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
},
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Elements Cafe",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called \"standard\" instead of \"small\"?Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the \"Standard\" portion label for the smaller size (Intervention) or the \"Small\" portion label for the smaller size (Control). The larger portion was labeled \"Large.\" Daily lunch transaction data will be provided by the cafes.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Changing Portion Size Descriptions in a Cafeteria",
"nctId": "NCT06263621",
"orgStudyIdInfo": {
"id": "855090",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Average kcal per entree sold"
}
],
"secondaryOutcomes": [
{
"measure": "Number of entrée units purchased"
},
{
"measure": "Total kcal per transaction"
},
{
"measure": "Weekly gross sales"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Restaurant Associates"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "(Cardio)Respiratory polygraphy (NOX T3s)"
},
{
"name": "Polysomnography"
},
{
"name": "Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)"
},
{
"name": "Fitbit smartwatch"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation",
"Obstructive Sleep Apnea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Edegem",
"contacts": [
{
"email": "[email protected]",
"name": "Lien Desteghe, MSc PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "University Hospital of Antwerp",
"geoPoint": {
"lat": 51.15662,
"lon": 4.44504
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hasselt",
"contacts": [
{
"email": "[email protected]",
"name": "Lien Desteghe, MSc PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Jessa Hospital",
"geoPoint": {
"lat": 50.93106,
"lon": 5.33781
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 209,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STAROSA",
"briefTitle": "Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation",
"nctId": "NCT06263608",
"orgStudyIdInfo": {
"id": "BUN B3002023000204",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "User-friendliness of the NOX T3s polygraphy device"
},
{
"measure": "User-friendliness of the Fitbit-based FibriCheck monitoring"
},
{
"measure": "Uptake rate of the advice to patients to undergo a polysomnography examination"
},
{
"measure": "Protocol adherence to smartphone heart rhythm measurements"
},
{
"measure": "The quality of the FibriCheck measurements"
},
{
"measure": "Number of technical issues"
}
],
"primaryOutcomes": [
{
"measure": "AF burden before and after CPAP treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Obstructive sleep apnea severity agreement between polygraphy and polysomnography"
},
{
"measure": "False positive rate of polygraphy"
},
{
"measure": "Total sleep apnea burden"
},
{
"measure": "CPAP/BiPAP/ASV compliance"
},
{
"measure": "Sleep score"
},
{
"measure": "Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ)"
},
{
"measure": "Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ)"
},
{
"measure": "Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS)"
},
{
"measure": "Polygraphy negative patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jessa Hospital"
},
{
"name": "Hasselt University"
},
{
"name": "Universiteit Antwerpen"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Antwerp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "gastric antral sonography"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Aspiration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Calgary",
"contacts": [
{
"email": "[email protected]",
"name": "Joanna J Moser, MD, PhD",
"phone": "403-956-3883",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "South Health Campus",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": "Alberta",
"status": null,
"zip": "T3M 1M4"
}
]
},
"descriptionModule": {
"briefSummary": "Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Semaglutide and Preoperative Residual Gastric Volumes",
"nctId": "NCT06263595",
"orgStudyIdInfo": {
"id": "REB23-1754",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants presenting with a full stomach"
}
],
"secondaryOutcomes": [
{
"measure": "Number of occurrences requiring change in anesthetic management plan"
},
{
"measure": "Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume"
},
{
"measure": "Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Alberta Health services"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Calgary"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
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"date": "2024-03-01"
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"studyFirstPostDateStruct": {
"date": "2024-02-16"
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}
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{
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"name": "Artesunate pessary"
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{
"name": "blood draws for pharmacokinetics of the study drug"
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"conditions": [
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"Cervix Intraepithelial Neoplasia Grade 3",
"Cervix; Intraepithelial Neoplasia, Grade I",
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},
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{
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},
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"type": null
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},
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"measure": "To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin"
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],
"secondaryOutcomes": [
{
"measure": "To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS)"
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{
"measure": "To determine the maximum concentration of Artesunate (AS)"
},
{
"measure": "To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax)"
},
{
"measure": "To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days"
},
{
"measure": "To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA"
},
{
"measure": "To determine the half-life (t1/2) of Artesunate (AS)"
},
{
"measure": "To determine the half-life (t1/2) of dihydroartemisinin (DHA)"
},
{
"measure": "To determine the apparent clearance (CL/F) of Artesunate (AS)"
},
{
"measure": "To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA)"
},
{
"measure": "To determine the volume of distribution (V/F) of Artesunate (AS)"
},
{
"measure": "To determine the volume of distribution (V/F) of dihydroartemisinin (DHA)"
},
{
"measure": "Type, frequency, severity, and duration of adverse events"
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]
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"date": "2024-06"
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}
} | false | null |
{
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"name": "Total hip arthroplasty"
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"conditions": [
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},
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"id": "SDB 2023-002",
"link": null,
"type": null
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"measure": "Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline"
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"measure": "Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline"
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"name": "Pelvic floor exercises"
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{
"name": "Transcutaneous posterior tibial nerve stimulation"
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"name": "Sham stimulation"
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"measure": "Post-void residue (PVR)"
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{
"measure": "Bladder diary"
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{
"measure": "International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)"
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"date": "2024-01-17"
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}
} | false | null |
{
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"name": "Sacituzumab govitecan"
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"Human Epidermal Growth Factor 2 Low Breast Cancer"
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"email": "[email protected]",
"name": "Aditya Bardia, M.D.",
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{
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"name": "Reshma L Mahtani, D.O.",
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{
"email": "[email protected]",
"name": "Krystal Fernandez",
"phone": "(786) 596-2000",
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"role": "CONTACT"
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],
"country": "United States",
"facility": "Miami Cancer Institute at Baptist Health, Inc.",
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"zip": "33176"
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{
"city": "Atlanta",
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"name": "Kevin Kalinsky, M.D., M.S.",
"phone": "404-778-0519",
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"role": "CONTACT"
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],
"country": "United States",
"facility": "Winship Cancer Institute at Emory University",
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"zip": "30322"
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},
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"acronym": "SERIES",
"briefTitle": "Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC",
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"measure": "Overall response rate (ORR)"
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{
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{
"measure": "Duration of response (DOR)"
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{
"measure": "Global Quality of Life"
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{
"measure": "Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)"
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"measure": "Laboratory and Vital Sign Abnormalities"
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{
"measure": "Growth Factor Support"
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{
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],
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"facility": "University Hospital Olomouc",
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{
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"name": "Heidi Mocikova, M.D., Ph.D.",
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{
"email": "[email protected]",
"name": "Katerina Klaskova, Ing.",
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"facility": "University Hospital Kralovske Vinohrady",
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{
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"name": "Jan Koren, M.D.",
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"descriptionModule": {
"briefSummary": "Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \\<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy."
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},
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"type": null
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{
"measure": "Quantitative analysis of ctDNA level during the first-line chemotherapy"
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{
"measure": "Identification of tumor specific mutation profiles at relapse of classical HL"
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"measure": "In vitro functional characterization of identified DNA variants and/or mutations"
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{
"name": "General University Hospital, Prague"
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{
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{
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{
"name": "University Hospital, Motol"
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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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"state": "Torino",
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},
{
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],
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],
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{
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}
],
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},
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"name": "Alberto Migliore",
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}
],
"country": "Italy",
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{
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}
],
"country": "Italy",
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},
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}
],
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Senese",
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},
{
"city": "Verona",
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"email": null,
"name": "Luca Dalle Carbonare",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale Policlinico \"G.B. Rossi\" Borgo Roma",
"geoPoint": {
"lat": 45.4299,
"lon": 10.98444
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"state": null,
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"zip": "37134"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.The main questions it aims to answer are:* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA"
},
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"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": "Randomization list will be performed with Proc Plan procedure by SAS ® Software (release 9.4 or later) software using the block randomization method with block size of 4.Subjects eligible at Baseline will be randomly allocated to receive 2, 5, 10 /2ml or placebo according to the balanced randomization list.",
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},
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"studyType": "INTERVENTIONAL"
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"id": "SPA-S-899-01-21",
"link": null,
"type": null
},
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"domain": null,
"id": "2021-003124-33",
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"type": "EUDRACT_NUMBER"
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]
},
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"otherOutcomes": [
{
"measure": "SAE Reporting"
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{
"measure": "AE Reporting"
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{
"measure": "Clinical signs of intolerance Recording"
}
],
"primaryOutcomes": [
{
"measure": "Efficacy: VAS Reduction"
}
],
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"measure": "VAS mean changes"
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{
"measure": "VAS mean changes observed 120 minutes after IA"
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{
"measure": "Lequesne Algofunctional Index mean changes"
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{
"measure": "WOMAC mean changes"
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{
"measure": "Range of motion mean changes"
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{
"measure": "Paracetamol consumption"
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]
},
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"name": "Pharmaceutical Development and Services"
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],
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"date": "2025-10"
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"date": "2023-10-12"
},
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"date": "2024-02-16"
}
}
} | false | null |
{
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"name": "at correcting malocclusions or restoring the integrity of the dentition"
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{
"name": "comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system."
}
]
},
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]
},
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"locations": [
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"email": "[email protected]",
"name": "Tatiana A Gatilova",
"phone": "952939919",
"phoneExt": "+7",
"role": "CONTACT"
},
{
"email": null,
"name": "Anastasia V Semivolova",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Russian Federation",
"facility": "Nmsi Dentmaster",
"geoPoint": {
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"lon": 82.9346
},
"state": "Novosibirsk Region",
"status": null,
"zip": "630090"
}
]
},
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"briefSummary": "In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.The endpoints will be :Primary endpoint:• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.Secondary endpoints:* Change in pain intensity measured by visual analog scale (VAS).* Improvement of functional indicators of the temporomandibular joint, including range of motion.* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months."
},
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"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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},
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"phases": [
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},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
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"acronym": null,
"briefTitle": "The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.",
"nctId": "NCT06263504",
"orgStudyIdInfo": {
"id": "DM001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
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{
"measure": "Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition."
}
],
"secondaryOutcomes": [
{
"measure": "Change in pain intensity measured by visual analog scale (VAS)."
},
{
"measure": "Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion."
},
{
"measure": "Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "NMSI DENTMASTER"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-15"
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"date": "2024-03-10"
},
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"date": "2024-02-16"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Rituximab"
},
{
"name": "Pirtobrutinib"
}
]
},
"conditionsModule": {
"conditions": [
"Mantle Cell Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
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"email": "[email protected]",
"name": "Preetesh Jain, MBBS, MD, DM, PhD",
"phone": "(713) 563-8786",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Preetesh Jain, MBBS, MD, DM, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL."
},
"designModule": {
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"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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},
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},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients",
"nctId": "NCT06263491",
"orgStudyIdInfo": {
"id": "2023-0413",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-01325",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
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"date": "2025-03-01"
},
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"startDateStruct": {
"date": "2024-08-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "INCA034176"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Graft-versus-host-disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease",
"nctId": "NCT06263478",
"orgStudyIdInfo": {
"id": "INCA34176-358",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall Response Rate in the First 6 Cycles"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score"
},
{
"measure": "Overall Response Rate"
},
{
"measure": "Duration of Response"
},
{
"measure": "Organ-specific Response Rate"
},
{
"measure": "Percent reduction in average daily dose (or equivalent) of corticosteroids"
},
{
"measure": "Proportion of participants who discontinue corticosteroid use"
},
{
"measure": "Number of participants with Treatment-emergent Adverse Events (TEAEs)"
},
{
"measure": "Change from baseline in Karnofsky/Lansky performance status"
},
{
"measure": "Axatilimab pharmacokinetic (PK) in Plasma"
},
{
"measure": "Number of Participants with Anti-Drug Antibody (ADA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Incyte Biosciences Japan GK"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lactobacillus cispatus"
},
{
"name": "placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Bacterial Vaginosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zhuhai",
"contacts": [
{
"email": null,
"name": "Jingya WU, Doctor",
"phone": "+8615902057821",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhuhai People'S Hospital",
"geoPoint": {
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"lon": 113.56778
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "519050"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR"
]
},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis",
"nctId": "NCT06263465",
"orgStudyIdInfo": {
"id": "CALM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "BV recurrence rate"
}
],
"secondaryOutcomes": [
{
"measure": "vaginal secretions 16s rRNA gene sequencing"
},
{
"measure": "BV recurrence rate"
}
]
},
"sponsorCollaboratorsModule": {
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{
"name": "ZhuHai Hospital"
}
],
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"name": "Zhujiang Hospital"
}
},
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"date": "2025-12-31"
},
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"date": "2024-03-13"
},
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"date": "2025-07-01"
},
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"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Propranolol"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Keely A Muscatell, PhD",
"phone": "916-495-7661",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jessica R Cohen, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Kristen A Lindquist, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Samantha E Meltzer-Brody, MD, MPH",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Social Neuroscience and Health Laboratory",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": null,
"zip": "27514"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Beta-Blocker Influences on Inflammatory and Neural Responses to Stress",
"nctId": "NCT06263452",
"orgStudyIdInfo": {
"id": "23-2768",
"link": null,
"type": null
},
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{
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"id": "1R01HL157422-01",
"link": "https://reporter.nih.gov/quickSearch/1R01HL157422-01",
"type": "NIH"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress"
},
{
"measure": "Change in levels of inflammatory gene expression in response to social stress"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
},
{
"name": "University of California, Los Angeles"
},
{
"name": "Dartmouth College"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-03"
},
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Throat/buccal swab sample"
}
]
},
"conditionsModule": {
"conditions": [
"Hand, Foot and Mouth Disease",
"Herpangina",
"Enterovirus Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Clermont-Ferrand",
"contacts": [
{
"email": "[email protected]",
"name": "Lise Laclautre",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Audrey Mirand",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU de Clermont-Ferrand",
"geoPoint": {
"lat": 45.77966,
"lon": 3.08628
},
"state": null,
"status": "RECRUITING",
"zip": "63000"
}
]
},
"descriptionModule": {
"briefSummary": "The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PMB",
"briefTitle": "Surveillance of HFMD in Pediatric Outpatients",
"nctId": "NCT06263439",
"orgStudyIdInfo": {
"id": "RNI 2023 MIRAND",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A00585-40",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of different types of Enteroviruses"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Clermont-Ferrand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-20"
},
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"startDateStruct": {
"date": "2023-06-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HIV D+/R+"
},
{
"name": "HIV D-/R+"
}
]
},
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"conditions": [
"Hiv"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
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{
"email": "[email protected]",
"name": "Shikha Mehta, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shikha Mehta, MD",
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}
],
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},
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},
{
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"contacts": [
{
"email": "[email protected]",
"name": "Joanna Schaenman, MD, PhD",
"phone": null,
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"role": "CONTACT"
},
{
"email": null,
"name": "Joanna Schaenman, MD, PhD",
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}
],
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},
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},
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{
"email": "[email protected]",
"name": "Saima Aslam, MBBS",
"phone": null,
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},
{
"email": null,
"name": "Saima Aslam, MBBS",
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}
],
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},
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},
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{
"email": "[email protected]",
"name": "Garrett Roll, MD",
"phone": null,
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},
{
"email": null,
"name": "Garrett Roll, MD",
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}
],
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},
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},
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"email": "[email protected]",
"name": "Maricar Malinis, MD",
"phone": null,
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},
{
"email": null,
"name": "Maricar Malinis, MD",
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}
],
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"facility": "Yale School of Medicine",
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},
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},
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{
"email": "[email protected]",
"name": "Carlos Santos, MD",
"phone": null,
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},
{
"email": null,
"name": "Carlos Santos, MD",
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}
],
"country": "United States",
"facility": "Rush University Medical Center",
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},
"state": "Illinois",
"status": null,
"zip": "60612"
},
{
"city": "New Orleans",
"contacts": [
{
"email": "[email protected]",
"name": "Jonathan Hand, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jonathan Hand, MD",
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}
],
"country": "United States",
"facility": "Ochsner Clinic Foundation",
"geoPoint": {
"lat": 29.95465,
"lon": -90.07507
},
"state": "Louisiana",
"status": null,
"zip": "70121"
},
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Christine Durand, MD",
"phone": null,
"phoneExt": null,
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},
{
"email": null,
"name": "Christine Durand, MD",
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}
],
"country": "United States",
"facility": "Johns Hopkins University",
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},
"state": "Maryland",
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},
{
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"contacts": [
{
"email": "[email protected]",
"name": "Nahel Elias, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nahel Elias, MD",
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],
"country": "United States",
"facility": "Massachusetts General Hospital",
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},
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},
{
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"contacts": [
{
"email": "[email protected]",
"name": "Sapna Mehta, MD",
"phone": null,
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},
{
"email": null,
"name": "Sapna Mehta, MD",
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}
],
"country": "United States",
"facility": "New York University",
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},
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"zip": "10016"
},
{
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"contacts": [
{
"email": "[email protected]",
"name": "Sander Florman, MD",
"phone": null,
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},
{
"email": null,
"name": "Sander Florman, MD",
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}
],
"country": "United States",
"facility": "Icahn School of Medicine at Mt. Sinai",
"geoPoint": {
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},
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"status": null,
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},
{
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"contacts": [
{
"email": null,
"name": "Marcus Pereira, MD",
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{
"email": null,
"name": "Marcus Pereira, MD",
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],
"country": "United States",
"facility": "Columbia University",
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},
"state": "New York",
"status": null,
"zip": "10032"
},
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Catherine Small, MD",
"phone": null,
"phoneExt": null,
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},
{
"email": null,
"name": "Catherine Small, MD",
"phone": null,
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}
],
"country": "United States",
"facility": "Weill Cornell Medical Center",
"geoPoint": {
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"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10065"
},
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Ghady Haidar, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ghady Haidar, MD",
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}
],
"country": "United States",
"facility": "University of Pittsburgh Medical Center",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15213"
}
]
},
"descriptionModule": {
"briefSummary": "This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)",
"nctId": "NCT06263426",
"orgStudyIdInfo": {
"id": "IRB00387066",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "U01AI177211",
"link": "https://reporter.nih.gov/quickSearch/U01AI177211",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cumulative incidence of death and allograft rejection."
}
],
"secondaryOutcomes": [
{
"measure": "Participant survival"
},
{
"measure": "Graft survival"
},
{
"measure": "Type and severity of graft rejection"
},
{
"measure": "Time to first rejection"
},
{
"measure": "Rate of rejection events over time"
},
{
"measure": "Graft function over time measured by eGFR trajectory"
},
{
"measure": "Incidence of HIV viremia post-transplant"
},
{
"measure": "Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant"
},
{
"measure": "Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant"
},
{
"measure": "Incidence of surgical and vascular transplant complications post-transplant"
},
{
"measure": "Incidence and causes of chronic kidney disease post-transplant"
},
{
"measure": "Incidence of post-transplant malignancies"
},
{
"measure": "Incidence of de novo donor specific antibody (DSA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Allergy and Infectious Diseases (NIAID)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Acne",
"Acne Vulgaris",
"Alopecia, Androgenetic",
"Pigmented Lesions",
"Pigmented Skin Lesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Miguel Sánchez-Viera, PhD",
"phone": "+34 915740990",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Miguel Sánchez-Viera, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Concetta Alessandro, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Alejandra Capote, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Pablo López-Andina, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Allison Marie Bell-Smythe Sorg, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Alejandra Vallejos, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Isabel del Campo, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Juliana Machado, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Raúl Lucas-Escobar, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Beatriz Torres",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Alfonso Medela, MsC",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Taig Mac Carthy, MsC",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "IDEI Hospital",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "RECRUITING",
"zip": "28009"
}
]
},
"descriptionModule": {
"briefSummary": "Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload.Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician.In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts.Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination.The secondary objectives focus on measuring the diagnostic performance of Legit.Health:Demonstrate that Legit.Health enhances healthcare professionals\\' ability to detect malignant or suspicious pigmented lesions.Demonstrate that Legit.Health improves healthcare professionals\\' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia.Demonstrate that Legit.Health improves healthcare professionals\\' ability and precision in measuring the degree of involvement in patients with acne.Additionally, the study aims to assess the utility of this tool:Automate the triage/initial assessment process in patients presenting with pigmented lesions.Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological).Evaluate Legit.Health\\'s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings.Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series.Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report.The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day.Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IDEI_2023",
"briefTitle": "Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions",
"nctId": "NCT06263413",
"orgStudyIdInfo": {
"id": "24.12.2266-GHM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Concordance between the physician's diagnosis and that of the tool."
},
{
"measure": "Agreement of detected malignancy between the dermatologist and Legit.Health tool"
}
],
"secondaryOutcomes": [
{
"measure": "Acne severity"
},
{
"measure": "Severity of alopecia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto de Dermatología Integral (IDEI)"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "AI Labs Group S.L"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "psychoeducation and follow-up study"
}
]
},
"conditionsModule": {
"conditions": [
"Psychoeducation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aydın",
"contacts": [
{
"email": "[email protected]",
"name": "şerife öztaban, MsC",
"phone": "+905557130105",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Filiz ADANA, Phd",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing",
"geoPoint": {
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}
]
},
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},
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"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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},
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"type": "ESTIMATED"
},
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"NA"
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},
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"minimumAge": "18 Years",
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"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"link": null,
"type": null
},
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},
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{
"measure": "to patients before training"
},
{
"measure": "pre-training caregivers"
}
],
"secondaryOutcomes": [
{
"measure": "after training"
},
{
"measure": "after training"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Aydin Adnan Menderes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
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"conditions": [
"AML, Adult"
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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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},
"descriptionModule": {
"briefSummary": "Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 230,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VENAZA",
"briefTitle": "Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine",
"nctId": "NCT06263387",
"orgStudyIdInfo": {
"id": "FILObsLAM_VENAZA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort"
},
{
"measure": "characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort"
},
{
"measure": "characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort"
}
],
"secondaryOutcomes": [
{
"measure": "characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life"
},
{
"measure": "describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Acute Leukemia French Association"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "French Innovative Leukemia Organisation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Motor imagery of the jaw"
},
{
"name": "Control task (Sudoku or Crossword puzzle)"
}
]
},
"conditionsModule": {
"conditions": [
"Maxillofacial Abnormalities"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Guillaume Nainani",
"phone": "0478011908",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet Bataille",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69003"
},
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Caroline Alvarado-Faysse",
"phone": "0437410332",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet de kinésithérapie Saint Alexandre",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69005"
},
{
"city": "Saint-Genis-Laval",
"contacts": [
{
"email": "[email protected]",
"name": "Sébastien Matéo",
"phone": "0478865066",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Henry Gabrielle",
"geoPoint": {
"lat": 45.69558,
"lon": 4.7934
},
"state": null,
"status": null,
"zip": "69230"
}
]
},
"descriptionModule": {
"briefSummary": "Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \\[watching a non-emotional content film or filling out a crossword or Sudoku grid\\] to maxillofacial physiotherapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Multi-centric randomized controlled trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "A randomization list will be centrally generated by an independent methodologist for each center and integrated into the electronic case report form. The physiotherapist will disclose the allocation to the participant during the inclusion visit, following clear, transparent, and appropriate information, and obtaining the participant's consent to participate in the study. This disclosure occurs after all measurements have been completed. The inclusion visit is scheduled 30 days ± 8 before the surgery.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MAXIMAND",
"briefTitle": "Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery",
"nctId": "NCT06263374",
"orgStudyIdInfo": {
"id": "69HCL21_0355",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximal mouth opening measured in millimeters using a caliper"
}
],
"secondaryOutcomes": [
{
"measure": "Active maximum mouth opening in millimeter using a vernier caliper"
},
{
"measure": "Active jaw range of motion (ROM) other than maximal opening"
},
{
"measure": "Maxillofacial pain"
},
{
"measure": "Body weight mass (kilograms)"
},
{
"measure": "Orthodontic associated treatment"
},
{
"measure": "Compliance with physiotherapy and intervention"
},
{
"measure": "Orofacial function"
},
{
"measure": "Maxillofacial quality of life"
},
{
"measure": "Level of achievement of the goals set by the patient before surgery"
},
{
"measure": "Motor imagery capability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospices Civils de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MRI imaging"
},
{
"name": "Cerebral biopsy"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Laura Sincinelli",
"phone": "003926435568",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS San Raffaele Scientific Institute",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.",
"nctId": "NCT06263361",
"orgStudyIdInfo": {
"id": "NCH02-2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MRI imaging"
},
{
"measure": "MRI imaging"
},
{
"measure": "MRI imaging"
},
{
"measure": "MRI imaging"
},
{
"measure": "Define immunopathological features"
}
],
"secondaryOutcomes": [
{
"measure": "Accuracy of fluoresceine guided stereotactic biopsy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dorzagliatin tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Type2diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Wenying Yang, MD,PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "China-Japan Friendship Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100029"
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Bo Zhang, MD,PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "China-Japan Friendship Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100029"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes",
"nctId": "NCT06263348",
"orgStudyIdInfo": {
"id": "HMM0601",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidences of ADRs and SAEs"
}
],
"secondaryOutcomes": [
{
"measure": "Blood glucose indicators"
},
{
"measure": "Response rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd."
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hua Medicine Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindfulness Based Stress Reduction Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Psychological Distress",
"Suicidal Ideation",
"Non-Suicidal Self Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": null,
"country": "Pakistan",
"facility": "Fatima Jinnah Women University",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": null,
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "MBI for Psychological Distress, SI and NSSI Among Young Adults",
"nctId": "NCT06263335",
"orgStudyIdInfo": {
"id": "Fatima Jinnah Women University",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Psychological Distress"
},
{
"measure": "Suicidal Ideation"
},
{
"measure": "Non-Suicidal Self-Injury (NSSI)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fatima Jinnah Women University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-05-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-05-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Actionable remotely generated health data"
},
{
"name": "Non-Actionable remotely generated health data"
}
]
},
"conditionsModule": {
"conditions": [
"Peripheral Arterial Disease",
"Chronic Limb-Threatening Ischemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gainesville",
"contacts": [
{
"email": "[email protected]",
"name": "Institute_of_Aging",
"phone": "352-273-5919",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "HOBI_Department",
"phone": "352.627.9467",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Institute of Aging",
"geoPoint": {
"lat": 29.65163,
"lon": -82.32483
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32611"
}
]
},
"descriptionModule": {
"briefSummary": "In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ROAMM-EHR",
"briefTitle": "The ROAMM-EHR Study",
"nctId": "NCT06263322",
"orgStudyIdInfo": {
"id": "IRB202200419",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R21AG073769",
"link": "https://reporter.nih.gov/quickSearch/R21AG073769",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6-min walk distance"
}
],
"secondaryOutcomes": [
{
"measure": "self-reported quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Aging (NIA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Femoral neck shortening measurement"
}
]
},
"conditionsModule": {
"conditions": [
"Femoral Neck Fractures",
"Femoral Neck Shortening"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İstanbul",
"contacts": null,
"country": "Turkey",
"facility": "University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34093"
}
]
},
"descriptionModule": {
"briefSummary": "OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.METHODS:Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 10,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis",
"nctId": "NCT06263309",
"orgStudyIdInfo": {
"id": "Femoralneckfracture",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Harris Hip score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Self Management Education"
}
]
},
"conditionsModule": {
"conditions": [
"Burns",
"Self Efficacy",
"Burn Second Degree",
"Burns Third Degree",
"Quality of Life",
"Adherence, Treatment",
"Burn Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Siu Kwong LIU, ANC",
"phone": "852 22557610",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "LIU Siu Kwong",
"geoPoint": {
"lat": 22.39407,
"lon": 114.13737
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general populationThere is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:1. Higher level of health-related quality of life,2. Higher level of self-efficacy3. Higher level of score in Burn Rehabilitation Knowledge4. Lower pain level, as measured by Numeric Pain Rating Scale; and5. Lower level of itchinessThe desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive \"Rehabilitation Booklet for Burn Patients\" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Pilot Randomized Controlled Trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Only subject will be single blinded to the intervention provided",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare",
"nctId": "NCT06263296",
"orgStudyIdInfo": {
"id": "UW 24-055",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Percentage in the Burn related out-patient clinic attendance"
}
],
"primaryOutcomes": [
{
"measure": "Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12"
},
{
"measure": "Change from Baseline in the Generic Quality of life at Week 4 & Week 12"
},
{
"measure": "Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline in the Self efficacy at Week 4 & Week 12"
},
{
"measure": "Change from Baseline in the Itchiness of life at Week 4 & Week 12"
},
{
"measure": "Change from Baseline in the Pain level at Week 4 & Week 12"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Queen Mary Hospital, Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "session of Kine-Yoga"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Cancer",
"Brachytherapy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.Moreover, educational requirements are high in women treated to gynecological cancer.Meeting these needs helps to improve quality of life, pain management and drug use.Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Control Group: Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed) Experimental Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "KYOCOL",
"briefTitle": "Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer",
"nctId": "NCT06263283",
"orgStudyIdInfo": {
"id": "PROICM 2023-04 KYO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer."
}
],
"secondaryOutcomes": [
{
"measure": "assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention"
},
{
"measure": "Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy."
},
{
"measure": "Evaluation of the evolution of fatigue during uterovaginal brachytherapy"
},
{
"measure": "assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy"
},
{
"measure": "Description of the use of anxiolytics by group (experimental vs control)"
},
{
"measure": "Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut du Cancer de Montpellier - Val d'Aurelle"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CYT-108, a recombinant protease inhibitor"
},
{
"name": "Phosphate Buffered Saline (PBS)"
}
]
},
"conditionsModule": {
"conditions": [
"Osteoarthritis, Knee",
"Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Camberwell",
"contacts": [
{
"email": "[email protected]",
"name": "Stuart Game, MD",
"phone": "+61 3 9509 6166",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Emeritus Research",
"geoPoint": {
"lat": -37.84205,
"lon": 145.0694
},
"state": "Victoria",
"status": null,
"zip": "3124"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify \"disease modification\" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomisation to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183; Weeks 1, 4, 8, 12, 16, and 26 weeks post-first dose respectively).",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "This study is double-blind, placebo-controlled. Neither the investigator, care providers, patients, nor study sponsor have knowledge of the interventions assigned to each participant.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee",
"nctId": "NCT06263270",
"orgStudyIdInfo": {
"id": "12-2023-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Concentration of Cartilage Degradation Fragments in Blood Plasma"
}
],
"primaryOutcomes": [
{
"measure": "Adverse Events"
},
{
"measure": "Blood Pressure"
},
{
"measure": "Heart Rate"
},
{
"measure": "Respiratory Rate"
},
{
"measure": "Body Temperature"
},
{
"measure": "Titer of Human Anti-Drug Antibody"
}
],
"secondaryOutcomes": [
{
"measure": "Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities)"
},
{
"measure": "Time of Onset"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Southern Star Research Pty Ltd."
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Cytonics Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mandala Art Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety",
"Transplant;Failure,Kidney",
"Transplant Complication"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.Mandala art therapy is known as an effective method that supports the mental health, physical functioning, and social and emotional well-being of individuals with health issues. Mandalas can contribute to comfort by promoting inner peace, focusing attention, and encouraging creative expression. This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients. To achieve this goal, a mixed-methods study using a randomized controlled and nested experimental design is planned.The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients. This information may guide healthcare professionals in enhancing kidney transplant recipients' psychological and emotional well-being, reducing stress, and promoting higher levels of comfort through mandala art therapy.H0a: There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients.H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "For the intervention group, the first measurement (afternoon of the day before surgery) will include State-Trait Anxiety Inventory and General Comfort Questionaire, the second measurement (Postoperative Day 5 - discharge day) will include State Anxiety Inventory and General Comfort Questionaire. The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows: Session 1 on Postoperative Day 5 - discharge day (after the scales), Session 2 on 1st Control (1 week after surgery), Session 3 on 2nd Control (2 weeks after surgery), and the third measurement at 3rd Control (1 month after surgery). For the Control Group, the third measurement (1 month after surgery) will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire. This stage aims to conduct a randomized controlled study.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Blinding In this study, blinding of participants and the statistician is planned. Blinding of the researcher implementing the intervention will not be possible. Since participants will not know to which group they are assigned, participant blinding is considered feasible. Data related to the scales (post-test) will be coded as 'A' and 'B' without indicating whether they belong to the intervention or control group. The coded data will be analyzed by a statistician, without knowledge of group allocation. After the statistical analyses are completed, the coding for the intervention and control groups will be revealed. This blinding technique is intended to minimize statistical bias.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"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 Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients",
"nctId": "NCT06263257",
"orgStudyIdInfo": {
"id": "2023-631",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reduction in anxiety levels"
},
{
"measure": "Increasing comfort level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Busra Nur Temur"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ziltivekimab"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Atherosclerosis",
"Inflammation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized, double blind, placebo-controlled trial",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "After informed consent has been obtained, patients will be randomized via computer randomization to either 15 mg ziltivekimab (n=20) or placebo (n=20). On the eCRFs or other documents subjects will be identified by subject ID and randomization number only.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SPIDER",
"briefTitle": "Specifying the Anti-inflammatory Effects of Ziltivekimab",
"nctId": "NCT06263244",
"orgStudyIdInfo": {
"id": "NL83403.018.22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "TBRmax coronary arteries"
},
{
"measure": "monocyte activation marker protein expression"
}
],
"secondaryOutcomes": [
{
"measure": "delta PCAT"
},
{
"measure": "Correlation delta TBRmax and CCTA derived plaque characteristics"
},
{
"measure": "delta SUVmax bone marrow"
},
{
"measure": "delta TBRmax ascending aorta"
},
{
"measure": "changes monocyte phenotype"
},
{
"measure": "changes in hsCRP"
},
{
"measure": "changes plasma cytokine and chemokine levels (pg/mL)"
},
{
"measure": "changes plasma cytokine and chemokine levels (ng/mL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "INT230-6"
},
{
"name": "Eribulin"
},
{
"name": "Trabectedin"
},
{
"name": "Pazopanib"
}
]
},
"conditionsModule": {
"conditions": [
"Sarcoma,Soft Tissue"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 333,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "INVINCIBLE-3",
"briefTitle": "A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)",
"nctId": "NCT06263231",
"orgStudyIdInfo": {
"id": "IT-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall Survival (OS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma"
},
{
"measure": "Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Premier Research Group plc"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Intensity Therapeutics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"CMV Infection",
"CMV Viremia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "São Paulo",
"contacts": null,
"country": "Brazil",
"facility": "Hospital do Rim",
"geoPoint": {
"lat": -23.5475,
"lon": -46.63611
},
"state": null,
"status": null,
"zip": "04038-002"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil",
"nctId": "NCT06263218",
"orgStudyIdInfo": {
"id": "CCR-2023-200344",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of infection, CMV disease, and tissue invasive disease."
}
],
"secondaryOutcomes": [
{
"measure": "Incidence recurrent CMV infection/disease"
},
{
"measure": "Incidence of refractory CMV infection/disease"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospital do Rim e Hipertensão"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Dressing of Surgical Wound"
},
{
"name": "Regular Dressing Change of Surgical Wound"
}
]
},
"conditionsModule": {
"conditions": [
"Gastrointestinal Tumors",
"Surgical Wound Infection",
"Pain, Postoperative"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Dazhi Xu, MD,PHD",
"phone": "021-64175590",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "2000000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 816,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Dressing",
"briefTitle": "Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques",
"nctId": "NCT06263205",
"orgStudyIdInfo": {
"id": "Dressing",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of Postoperative Wound Healing Complications"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Pain Levels"
},
{
"measure": "Medical Costs Associated with Wound Care"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai Changzheng Hospital"
},
{
"name": "Changhai Hospital"
},
{
"name": "Shanghai East Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intrauterine insemination"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility, Female",
"Anti-Mullerian Hormone Deficiency"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Fertty International",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": "08010"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \\> and \\< 1.1 ng/mL."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 342,
"type": "ACTUAL"
},
"phases": null,
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"briefSummary": "Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 63,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery",
"nctId": "NCT06263101",
"orgStudyIdInfo": {
"id": "ChaoyangHospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1"
}
],
"secondaryOutcomes": [
{
"measure": "Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3"
},
{
"measure": "Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 1"
},
{
"measure": "Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 3"
},
{
"measure": "Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1."
},
{
"measure": "Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Chaoyang Hospital of China Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-01-08",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 182027,
"typeAbbrev": "Prot",
"uploadDate": "2024-02-12T01:53"
},
{
"date": "2024-01-08",
"filename": "SAP_001.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 154895,
"typeAbbrev": "SAP",
"uploadDate": "2024-02-12T01:52"
},
{
"date": "2024-01-08",
"filename": "ICF_002.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 277845,
"typeAbbrev": "ICF",
"uploadDate": "2024-02-12T01:37"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EQUITY GI"
}
]
},
"conditionsModule": {
"conditions": [
"Gastrointestinal Cancer",
"Colon Cancer",
"Rectal Cancer",
"Anal Cancer",
"Esophageal Cancer",
"Stomach Cancer",
"Appendix Cancer",
"Pancreas Cancer",
"Liver Cancer",
"Neuroendocrine Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cleveland",
"contacts": [
{
"email": "[email protected]",
"name": "Sakti Chakrabarti, MD",
"phone": "216-844-3951",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": null,
"zip": "44106"
}
]
},
"descriptionModule": {
"briefSummary": "This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).This study has 3 components as follows-1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single arm study to address the existing disparities faced by Black participants with gastrointestinal (GI) cancer in accessing crucial biomarker testing, receiving evidence-based care, and participating in clinical trials.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"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": "EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.",
"nctId": "NCT06263088",
"orgStudyIdInfo": {
"id": "CASE15223",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biomarker testing rate of Black participants diagnosed with GI cancer"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical trial enrollment rate among black participants diagnosed with GI cancer"
},
{
"measure": "Change in Health literacy test among black participants diagnosed with GI cancer"
},
{
"measure": "Change in Health literacy score among black participants diagnosed with GI cancer"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Case Comprehensive Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intraoperative monitoring"
}
]
},
"conditionsModule": {
"conditions": [
"Craniosynostoses",
"Hypovolemia",
"Hemorrhage",
"Hemodynamic Instability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Luigia Scudeller, MD",
"phone": "051 2141402",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Barbara Lotito, MD",
"phone": "051 2141296",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": null,
"name": "Lorena Pasini, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fabio Caramelli, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Rosario Ruga, Student",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Andrea La Placa, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS AOU of Bologna Policlinico Sant'Orsola",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": "BO",
"status": "RECRUITING",
"zip": "40138"
}
]
},
"descriptionModule": {
"briefSummary": "Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Months",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "CRASY-PRAM",
"briefTitle": "Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)",
"nctId": "NCT06263075",
"orgStudyIdInfo": {
"id": "717/2023/Oss/AOUBo",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "SirER (Emilia-Romagna Research Information System) platform",
"id": "6822",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hemodynamic events occurring during surgery"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of changes in volemic status"
},
{
"measure": "Evaluation of changes in volemic status"
},
{
"measure": "Evaluation of changes in systemic vascular resistance"
},
{
"measure": "Evaluation of changes in cardiac function"
},
{
"measure": "Evaluation of changes in cardiac function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Azienda Ospedaliero-Universitaria di Bologna"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Awareness-Based Coping with Fear of Cancer Programme"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer Fear",
"Cervical Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alanya",
"contacts": [
{
"email": "[email protected]",
"name": "fatma ozlem uner, MSc",
"phone": "+905062972749",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Alanya Alaaddin Keykubat University",
"geoPoint": {
"lat": 36.54375,
"lon": 31.99982
},
"state": null,
"status": "RECRUITING",
"zip": "7400"
}
]
},
"descriptionModule": {
"briefSummary": "Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study",
"nctId": "NCT06263062",
"orgStudyIdInfo": {
"id": "women undergoing colposcopy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Cancer Worry Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Philadelphia Mindfulness Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Alanya Alaaddin Keykubat University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "transurethral resection of prostate"
}
]
},
"conditionsModule": {
"conditions": [
"Benign Prostatic Hyperplasia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Ain shams university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 106,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Is Ejaculation Preservation TURis the Natural Evolution of the \"Gold Standard\".",
"nctId": "NCT06263049",
"orgStudyIdInfo": {
"id": "ejaculation post TURP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "post operative antegrade ejaculation"
}
],
"secondaryOutcomes": [
{
"measure": "post operative urine continence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Men"
},
{
"name": "Women"
}
]
},
"conditionsModule": {
"conditions": [
"Laryngeal Dimensions in Males and Females"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 102,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Morphometric Examination of the Larynx",
"nctId": "NCT06263036",
"orgStudyIdInfo": {
"id": "Bilgen S",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To measure laryngeal dimensions in cadavers"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Acibadem University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2013-06-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2013-06-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sub-Normothermic Machine Preservation and Assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Organ Preservation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Miami",
"contacts": [
{
"email": null,
"name": "Giselle Guerra, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Giselle Guerra, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Miami Transplant Institute, University of Miami Miller School of Medicine",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"zip": "33136"
},
{
"city": "Indianapolis",
"contacts": [
{
"email": null,
"name": "William Goggins, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "William Goggins, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Indiana University Health",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana",
"status": "RECRUITING",
"zip": "46202"
},
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Matthew Holzner, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew Holzner, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Mount Sinai Hospital",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10029"
},
{
"city": "Madison",
"contacts": [
{
"email": null,
"name": "Jacqueline Garonzik Wang, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jacqueline Garonzik Wang, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Wisconsin School of Medicine and Public Health",
"geoPoint": {
"lat": 43.07305,
"lon": -89.40123
},
"state": "Wisconsin",
"status": "NOT_YET_RECRUITING",
"zip": "53792"
}
]
},
"descriptionModule": {
"briefSummary": "This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OPTIMAL",
"briefTitle": "A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation",
"nctId": "NCT06263023",
"orgStudyIdInfo": {
"id": "34L-CP-02-009",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Transplant Allocation Success"
}
],
"secondaryOutcomes": [
{
"measure": "7-Day Delayed Graft Function (DGF)"
},
{
"measure": "Graft Survival"
},
{
"measure": "Patient Survival"
},
{
"measure": "Serum Creatinine (sCr)"
},
{
"measure": "eGFR"
},
{
"measure": "Long term data collection- Graft Survival"
},
{
"measure": "Long term data collection- Patient Survival"
},
{
"measure": "Long term data collection- Serum Creatinine"
},
{
"measure": "Long term data collection- eGFR"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Indiana University Health"
},
{
"name": "University of Miami"
},
{
"name": "MOUNT SINAI HOSPITAL"
},
{
"name": "University of Wisconsin, Madison"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "34 Lives, PBC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Allopregnanolone"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tucson",
"contacts": [
{
"email": "[email protected]",
"name": "Dakota Darby",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Arizona Clinical & Translational Science Research Center",
"geoPoint": {
"lat": 32.22174,
"lon": -110.92648
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85721"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:1. Is a large-scale clinical trial testing how well it works in patients with PD feasible?2. Is allopregnanolone safe and well-tolerated in patients with PD.3. Can we see any signals of changes in imaging and clinical scales?Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and \"Open-label\" means the study is not blinded so both the participant and investigators know the assigned treatment."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Allo-PD",
"briefTitle": "Allopregnanolone as a Regenerative Treatment for Parkinson's Disease",
"nctId": "NCT06263010",
"orgStudyIdInfo": {
"id": "CIBS-2023-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Dopamine transporter (DaT) SPECT imaging"
},
{
"measure": "MRI: Regional brain volumes"
},
{
"measure": "MRI: Fractional Anisotropy"
},
{
"measure": "MRI: Quantitative anisotropy"
},
{
"measure": "MRI: Functional connectivity"
},
{
"measure": "Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part I (non-motor EDL)"
},
{
"measure": "Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part II (motor EDL)"
},
{
"measure": "Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part III (motor examination)"
},
{
"measure": "Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part IV (motor complications)"
},
{
"measure": "Mean rate of change in the Unified Dyskinesia Rating Scale (UDysRS) total score"
},
{
"measure": "Change from baseline in Montreal Cognitive Assessment (MoCA) score"
},
{
"measure": "Change from baseline in Parkinson's disease Questionnaire (PDQ-39)."
},
{
"measure": "Change from baseline in Hamilton Depression Rating Scale (HAM-D)"
},
{
"measure": "Cambridge Cognition's Paired Associates Learning (PAL) Test"
},
{
"measure": "Cambridge Cognition's Motor Screening Task (MOT)"
},
{
"measure": "Cambridge Cognition's One Touch Stockings of Cambridge (OTS)"
}
],
"primaryOutcomes": [
{
"measure": "Study completion"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse Events"
},
{
"measure": "Infusion Reactions"
},
{
"measure": "Pharmacokinetics: Peak Plasma Concentration (Cmax)"
},
{
"measure": "Pharmacokinetics: Time of peak concentration (tmax)"
},
{
"measure": "Pharmacokinetics: Half-life (t1/2)"
},
{
"measure": "Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Roberta Brinton"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pilates"
},
{
"name": "Pilates and Kinesiotape"
}
]
},
"conditionsModule": {
"conditions": [
"Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mersin",
"contacts": [
{
"email": null,
"name": "Ali Mutlu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ali MUTLU",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Tarsus University",
"geoPoint": {
"lat": 36.79526,
"lon": 34.61792
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "One group will receive only pilates training. Other group participants will receive kinesiobant application in addition to pilates training.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The researcher who will do the pilates training and taping and the other researcher who will do the pre-test and post-test are blinded.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Pilates and Taping in Office Workers With Neck Pain",
"nctId": "NCT06262997",
"orgStudyIdInfo": {
"id": "TU-FTR-AMUTLU-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neck Disability Index"
}
],
"secondaryOutcomes": [
{
"measure": "Pain PressureThreshold"
},
{
"measure": "Muscle Strength"
},
{
"measure": "Range of Motion"
},
{
"measure": "Prone Bridge Test"
},
{
"measure": "Sits Up Test:"
},
{
"measure": "Postural Habits and Awareness Scale"
},
{
"measure": "Short Form 36"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tarsus University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Therapeutic Play"
}
]
},
"conditionsModule": {
"conditions": [
"Behavior, Coping"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Maltepe University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Therapeutic Play Before Nasopharyngeal Swabbing in Children",
"nctId": "NCT06262984",
"orgStudyIdInfo": {
"id": "2023/21-754",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Children's emotional manifestation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Maltepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Percutaneous coronary intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease",
"Left Main Coronary Artery Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Medipol University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3620,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital",
"nctId": "NCT06262971",
"orgStudyIdInfo": {
"id": "PCI-LM-Registry-2018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI"
}
],
"secondaryOutcomes": [
{
"measure": "Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)"
},
{
"measure": "Procedure-Related Complications Within 30 Days of PCI"
},
{
"measure": "Health-Related Quality of Life (HRQoL) Scores One Year After PCI"
},
{
"measure": "Rate of stent thrombosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medipol University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ASSIST"
},
{
"name": "Treatment as usual"
}
]
},
"conditionsModule": {
"conditions": [
"Alcoholism",
"Substance Abuse",
"Alcohol Dependence",
"Alcohol-Related Disorders",
"Substance Use Disorders",
"Adolescent Behavior",
"Adolescent Problem Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuopio",
"contacts": [
{
"email": "[email protected]",
"name": "Sanna Voutilainen, Res. nurse",
"phone": "+358447175351",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Finland",
"facility": "Kuopio University Hospital",
"geoPoint": {
"lat": 62.89238,
"lon": 27.67703
},
"state": null,
"status": "RECRUITING",
"zip": "70110"
}
]
},
"descriptionModule": {
"briefSummary": "ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "19 Years",
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "REAL-SMART",
"briefTitle": "Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent",
"nctId": "NCT06262958",
"orgStudyIdInfo": {
"id": "KUH5703459",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Decreased consumption of alcohol, tobacco or substances"
}
],
"secondaryOutcomes": [
{
"measure": "BDI scores"
},
{
"measure": "GAD scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kuopio University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-08-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagnoses"
},
{
"name": "traditional osteotomies"
},
{
"name": "platelet rich fibrin"
},
{
"name": "Antibiotics, Penicillin"
},
{
"name": "low laser therapy, bicure laser"
},
{
"name": "Analgesic"
}
]
},
"conditionsModule": {
"conditions": [
"Impacted Third Molar Tooth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nicosia",
"contacts": null,
"country": "Cyprus",
"facility": "Near East University",
"geoPoint": {
"lat": 35.17531,
"lon": 33.3642
},
"state": "Lefkosa",
"status": null,
"zip": "99138"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery.",
"nctId": "NCT06262945",
"orgStudyIdInfo": {
"id": "YDU/2024/120-1808",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual analogue scale (VAS)"
},
{
"measure": "Visual analogue scale (VAS)"
},
{
"measure": "Visual analogue scale (VAS)"
},
{
"measure": "Visual analogue scale (VAS)"
},
{
"measure": "Trismus"
},
{
"measure": "Trismus"
},
{
"measure": "Trismus"
},
{
"measure": "Trismus"
},
{
"measure": "Swelling"
},
{
"measure": "Swelling"
},
{
"measure": "Swelling"
},
{
"measure": "Swelling"
}
],
"secondaryOutcomes": [
{
"measure": "the number of analgesic tablets"
},
{
"measure": "the number of analgesic tablets"
},
{
"measure": "the number of analgesic tablets"
},
{
"measure": "the number of analgesic tablets"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beste Erismen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Amiodarone"
}
]
},
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"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen* Repeated dosing regimen* Standard dosing regimen"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response",
"nctId": "NCT06262932",
"orgStudyIdInfo": {
"id": "RADS regimen",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Heart rate"
}
],
"secondaryOutcomes": [
{
"measure": "Normal sinus rhythm at 24 hours"
},
{
"measure": "Heart rate"
},
{
"measure": "Major adverse cardiovascular events"
},
{
"measure": "Phlebitis"
},
{
"measure": "Changed in heart rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Police General Hospital, Thailand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tafinlar/Mekinist"
}
]
},
"conditionsModule": {
"conditions": [
"BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kobe",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 34.6913,
"lon": 135.183
},
"state": "Hyogo",
"status": "RECRUITING",
"zip": "650-0011"
},
{
"city": "Akita",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 39.71667,
"lon": 140.10826
},
"state": null,
"status": "RECRUITING",
"zip": "010-8543"
},
{
"city": "Osaka",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
},
"state": null,
"status": "RECRUITING",
"zip": "534-0021"
},
{
"city": "Osaka",
"contacts": null,
"country": "Japan",
"facility": "Novartis Investigative Site",
"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
},
"state": null,
"status": "RECRUITING",
"zip": "550-0015"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Special Drug Use-results Surveillance of Tafinlar/Mekinist",
"nctId": "NCT06262919",
"orgStudyIdInfo": {
"id": "CDRB436I1401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "[Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation"
},
{
"measure": "[Adult patients] overall response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "[Pediatric patients] Incidence proportion of ORR"
},
{
"measure": "[Pediatric and adult patients] Incidence proportion of PFS"
},
{
"measure": "[Pediatric patients] Number of patients with changes in height and body weight and sexual maturation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novartis Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
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"contactsLocationsModule": null,
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"identificationModule": {
"acronym": null,
"briefTitle": "[Trial of device that is not approved or cleared by the U.S. FDA]",
"nctId": "NCT06262906",
"orgStudyIdInfo": {
"id": "BA-VCAP-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Shoulder arthroscopy blocks"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Arthroscopy Blocks",
"Dexamethasone"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assiut",
"contacts": [
{
"email": null,
"name": "Assiut University",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Assiut University",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy",
"nctId": "NCT06262893",
"orgStudyIdInfo": {
"id": "Shoulder nerve blocks",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative analgesia by visual analog scale (VAS)."
}
],
"secondaryOutcomes": [
{
"measure": "Diaphragmatic excursion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "plant derived phenolics"
},
{
"name": "Microcrystaline cellulose (MCC)"
}
]
},
"conditionsModule": {
"conditions": [
"Intestinal Permeability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Addison",
"contacts": [
{
"email": null,
"name": "Chad Cook",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Biofortis",
"geoPoint": {
"lat": 41.9317,
"lon": -87.98896
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60101"
}
]
},
"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 on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"masking": "TRIPLE",
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"CARE_PROVIDER",
"INVESTIGATOR"
]
},
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},
"enrollmentInfo": {
"count": 126,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "69 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dietary Supplementation on Gastrointestinal Barrier Function",
"nctId": "NCT06262880",
"orgStudyIdInfo": {
"id": "BIO-2305",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "0-2 h urine 13C Mannitol excretion"
}
],
"secondaryOutcomes": [
{
"measure": "2 to 8 h urine 13C Mannitol"
},
{
"measure": "0 to 2 h urine LMR"
},
{
"measure": "2 to 8 h urine LMR"
},
{
"measure": "Blood Biomarkers"
},
{
"measure": "Blood Biomarkers"
},
{
"measure": "Blood Biomarkers"
},
{
"measure": "Fecal Biomarkers"
},
{
"measure": "Fecal Biomarkers"
},
{
"measure": "Inflammatory Biomarkers (Blood)"
},
{
"measure": "Inflammatory Biomarkers (Blood)"
},
{
"measure": "Inflammatory Biomarkers (Blood)"
},
{
"measure": "Inflammatory Biomarkers (Blood)"
},
{
"measure": "7-day recall of gastrointestinal symptoms"
},
{
"measure": "7-day recall of gastrointestinal symptoms"
},
{
"measure": "Stool frequency"
},
{
"measure": "Stool consistency"
},
{
"measure": "Body Weight"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Brightseed"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ready. Set. Food! Stage 1 Mix ins"
}
]
},
"conditionsModule": {
"conditions": [
"Food Allergy in Infants"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!.This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician.The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Months",
"minimumAge": "2 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "EASE",
"briefTitle": "Early Allergen System Experience",
"nctId": "NCT06262867",
"orgStudyIdInfo": {
"id": "ReadySetFood",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut"
},
{
"measure": "The total allergy-related healthcare costs"
},
{
"measure": "The proportion of participants with food allergy to cow's milk, egg, or peanut"
},
{
"measure": "The proportion of participants with a suspected food allergy"
}
],
"primaryOutcomes": [
{
"measure": "The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period"
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut"
},
{
"measure": "Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut"
},
{
"measure": "Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ObvioHealth"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Prollergy dba Ready Set Food"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Calcium-sulphate granules with tobramicina+vancomicina"
}
]
},
"conditionsModule": {
"conditions": [
"Diabete Mellitus",
"Foot Ulcer",
"Osteomyelitis - Foot",
"Surgical Procedure, Unspecified"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Granules of calcium sulphate with and without antibiotics are identical and undistinguishable.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BIG D-FOOT",
"briefTitle": "Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study",
"nctId": "NCT06262854",
"orgStudyIdInfo": {
"id": "AOU Careggi Firenze",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis."
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of healed patients"
},
{
"measure": "Proportion of osteomyelitis recurrence"
},
{
"measure": "Proportion of post-surgical tissue infection"
},
{
"measure": "Proportion of wound recurrence"
},
{
"measure": "Proportion of patients undergoing major amputation"
},
{
"measure": "Proportion of patients undergoing new surgical intervention"
},
{
"measure": "Ulcer time-to-healing"
},
{
"measure": "Osteomyelitis time-to-recurrence"
},
{
"measure": "Any serious adverse events"
},
{
"measure": "Any non serious adverse events"
},
{
"measure": "Proportion of post-surgical dehiscence"
},
{
"measure": "Direct medical costs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Ospedaliero-Universitaria Careggi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Piezosurgery"
},
{
"name": "Conventional burs"
}
]
},
"conditionsModule": {
"conditions": [
"Impacted Third Molar Tooth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara University Faculty of Dentistry",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Çankaya",
"status": null,
"zip": "06510"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments",
"nctId": "NCT06262841",
"orgStudyIdInfo": {
"id": "Murat Kaan Erdem",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Oral Health-related Quality of Life"
}
],
"secondaryOutcomes": [
{
"measure": "Change in pain"
},
{
"measure": "Change in Mouth opening"
},
{
"measure": "Operation time"
},
{
"measure": "Change in facial swelling"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"CVD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Sze Ling Celine Chui, PhD",
"phone": "(852) 3917 6629",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "School of Nursing, The University of Hong Kong",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HEARTWISE",
"briefTitle": "HEARTWISE - P-CARDIAC for Chinese: Population-based Study",
"nctId": "NCT06262828",
"orgStudyIdInfo": {
"id": "UW 24-064",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The relationship between P-CARDIAC risk score and heart disease related symptoms"
},
{
"measure": "P-CARDIAC risk thresholds determination"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-10-31",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 294821,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-01-31T01:00"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nasogastric tube placement"
},
{
"name": "Clinical Frailty Scale"
}
]
},
"conditionsModule": {
"conditions": [
"Small Bowel Obstruction",
"Frailty",
"Nasogastric Tube"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Göteborg",
"contacts": [
{
"email": null,
"name": "Nina Bardhi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Sahlgrenska Universitetssjukhuset",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Göteborg",
"contacts": [
{
"email": null,
"name": "Mathias Jerkfelt, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Östra sjukhuset",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Lund",
"contacts": null,
"country": "Sweden",
"facility": "Skånes Universitetssjukhus",
"geoPoint": {
"lat": 55.70584,
"lon": 13.19321
},
"state": null,
"status": "ACTIVE_NOT_RECRUITING",
"zip": null
},
{
"city": "Malmö",
"contacts": null,
"country": "Sweden",
"facility": "Skånes Universitetssjukhus",
"geoPoint": {
"lat": 55.60587,
"lon": 13.00073
},
"state": null,
"status": "ACTIVE_NOT_RECRUITING",
"zip": null
},
{
"city": "Motala",
"contacts": [
{
"email": "[email protected]",
"name": "Jens Wretborn, PhD",
"phone": "+46101033000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Lasarett i Motala",
"geoPoint": {
"lat": 58.53706,
"lon": 15.03649
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Norrköping",
"contacts": [
{
"email": null,
"name": "Sigrid Wallden, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Vrinnevisjukhuset",
"geoPoint": {
"lat": 58.59419,
"lon": 16.1826
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Sundsvall",
"contacts": [
{
"email": null,
"name": "Robert Schytzer, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Sundsvalls sjukhus",
"geoPoint": {
"lat": 62.39129,
"lon": 17.3063
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Linköping",
"contacts": [
{
"email": "[email protected]",
"name": "Jens Wretborn, PhD",
"phone": "+46101033000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Alaa Hussein, MD",
"phone": "+46101033000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Akutmottagningen US Östergötland",
"geoPoint": {
"lat": 58.41086,
"lon": 15.62157
},
"state": "Östergötland",
"status": "RECRUITING",
"zip": "58185"
}
]
},
"descriptionModule": {
"briefSummary": "Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NGTUBE-OBS",
"briefTitle": "The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction",
"nctId": "NCT06262815",
"orgStudyIdInfo": {
"id": "2023-06806-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain at Emergency Department discharge"
}
],
"secondaryOutcomes": [
{
"measure": "Nausea at Emergency Department discharge"
},
{
"measure": "Hospital Length of Stay"
},
{
"measure": "Mortality"
},
{
"measure": "Admission for Small bowel obstruction"
},
{
"measure": "Emergency Surgery"
},
{
"measure": "Emergency Department Length of Stay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Linkoeping University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Daniel Wilhelms"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Active decompression"
}
]
},
"conditionsModule": {
"conditions": [
"Odontogenic Cysts"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "DEVICE_FEASIBILITY",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression",
"nctId": "NCT06262802",
"orgStudyIdInfo": {
"id": "123123",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Volume change"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Radwa Hydar Ragab"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "\"Return-to-work after cancer\" consultation"
}
]
},
"conditionsModule": {
"conditions": [
"Leukemia",
"Lymphoma",
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Angers",
"contacts": [
{
"email": "[email protected]",
"name": "PAILLASSA Jérome, MD",
"phone": "02.41.35.45.24",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Angers University hospital",
"geoPoint": {
"lat": 47.46667,
"lon": -0.55
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Brest",
"contacts": [
{
"email": "[email protected]",
"name": "Marie-Anne Couturier, MD",
"phone": "02.98.22.30.37",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Brest University Hospital, Morvan Site",
"geoPoint": {
"lat": 48.3903,
"lon": -4.48628
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Caen",
"contacts": [
{
"email": "[email protected]",
"name": "Ghandi Laurent DAMAJ, MD",
"phone": "02.31.27.21.40",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Caen University hospital",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Rennes",
"contacts": [
{
"email": "[email protected]",
"name": "Roch HOUOT, MD",
"phone": "02.99.28.42.91",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Rennes University Hospital, Pontchaillou site",
"geoPoint": {
"lat": 48.11198,
"lon": -1.67429
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Rouen",
"contacts": [
{
"email": "[email protected]",
"name": "Stéphane LEPRETRE, MD",
"phone": "02.32.08.22.23",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Henri Becquerel",
"geoPoint": {
"lat": 49.44313,
"lon": 1.09932
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Rouen",
"contacts": [
{
"email": "[email protected]",
"name": "Laetitia ROLLIN, MD",
"phone": "02.32.88.82.69",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Rouen University Hospital",
"geoPoint": {
"lat": 49.44313,
"lon": 1.09932
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Tours",
"contacts": [
{
"email": "[email protected]",
"name": "Emmanuel GYAN",
"phone": "02.47.47.38.11",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Tours University Hospital, Bretonneau Site",
"geoPoint": {
"lat": 47.38333,
"lon": 0.68333
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their \"pre-cancer life\" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of \"return-to-work self-efficacy\" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 264,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "RAT-HEMATO",
"briefTitle": "RAT-HEMATO : Return to Work After Malignant Hemopathy",
"nctId": "NCT06262789",
"orgStudyIdInfo": {
"id": "49RC23_0011",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Return-to-work rate at 1 year (percentage)"
}
],
"secondaryOutcomes": [
{
"measure": "Cumulative incidence of return-to-work at 1 year"
},
{
"measure": "Change or not of the professional situation in the 2 arms"
},
{
"measure": "Factors influencing return to work"
},
{
"measure": "Quality of life (SF-12 score) evolution"
},
{
"measure": "Anxiety and depression (HAD scale) evolution"
},
{
"measure": "Return-to-work self-efficacy (RTW-SE-11 scale) evolution"
},
{
"measure": "Self-assessment of the benefit of the \"return-to-work after cancer\" consultation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "University Hospital, Angers"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Recombinant zoster vaccine adjuvanted (SHINGRIX)"
}
]
},
"conditionsModule": {
"conditions": [
"Immunosuppression",
"Vaccine Response Impaired"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SIR ZOSTER",
"briefTitle": "Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients",
"nctId": "NCT06262776",
"orgStudyIdInfo": {
"id": "SIRZOSTER1.01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Incidence of shingles"
},
{
"measure": "Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
},
{
"measure": "Tolerability of vaccination regimen as assessed by EQ-5D"
}
],
"primaryOutcomes": [
{
"measure": "Functional T cell memory"
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of virus specific T cells"
},
{
"measure": "Magnitude of antibody response"
},
{
"measure": "Concentration of post-vaccination circulating cytokines"
},
{
"measure": "Frequency of polyfunctional T cells"
},
{
"measure": "Magnitude of vaccine-induced cross-protective antiviral responses"
},
{
"measure": "Frequency of virus-specific T stem cell memory compared to baseline"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Health and Medical Research Council, Australia"
},
{
"name": "University of Adelaide"
},
{
"name": "Royal Prince Alfred Hospital, Sydney, Australia"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Central Adelaide Local Health Network Incorporated"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Laser Therapy"
},
{
"name": "Traditional exercises"
},
{
"name": "Placebo laser"
}
]
},
"conditionsModule": {
"conditions": [
"Sacroiliac Joint Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kafr Ash Shaykh",
"contacts": null,
"country": "Egypt",
"facility": "Kafr Al-Sheikh University",
"geoPoint": {
"lat": 31.11174,
"lon": 30.93991
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Effect of high intensity laser on sacroiliac joint pain"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Girls",
"briefTitle": "High-intensity Laser Therapy for Sacroiliac Joint Pain",
"nctId": "NCT06262763",
"orgStudyIdInfo": {
"id": "HILT for SIJP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Functional disability"
}
],
"primaryOutcomes": [
{
"measure": "Pain intensity"
}
],
"secondaryOutcomes": [
{
"measure": "Pressure pain threshold"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kafrelsheikh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-04-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Splanchnic Vein Thrombosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": [
{
"email": null,
"name": "Valerio De Stefano",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rossella Talerico",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Silvia Betti",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Francesco Santopaolo",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "UOC Servizio e DH Ematologia",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 170,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SAPIENT",
"briefTitle": "Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study",
"nctId": "NCT06262750",
"orgStudyIdInfo": {
"id": "00375/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidenze of bleedings events"
},
{
"measure": "Incidence of venous and arterial thromboembolic events"
},
{
"measure": "Rate of progress /stable /regressive"
},
{
"measure": "incidence of liver related events"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Macular Degeneration",
"Diabetic Macular Edema",
"Retinal Vein Occlusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Clermont-Ferrand",
"contacts": null,
"country": "France",
"facility": "CHU de Clermont-Ferrand",
"geoPoint": {
"lat": 45.77966,
"lon": 3.08628
},
"state": null,
"status": "RECRUITING",
"zip": "63000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PISO",
"briefTitle": "Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol",
"nctId": "NCT06262737",
"orgStudyIdInfo": {
"id": "RBHP 2023 CHIAMBARETTA",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A01121-44",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "OSDI"
}
],
"secondaryOutcomes": [
{
"measure": "OSDI"
},
{
"measure": "HM"
},
{
"measure": "AM"
},
{
"measure": "NIBUT 1"
},
{
"measure": "NIBUT 2"
},
{
"measure": "Interferometry"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Clermont-Ferrand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Breast auto-augmentation"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Ptosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Medicine, Ain Shams University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": "Abbasia",
"status": null,
"zip": "11591"
}
]
},
"descriptionModule": {
"briefSummary": "Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "All patients were subjected to the same intervention.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Breast Reshaping Following Massive Weight Loss",
"nctId": "NCT06262724",
"orgStudyIdInfo": {
"id": "Perforator Flaps",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measurement of breast volume by sono-mammography"
}
],
"secondaryOutcomes": [
{
"measure": "Sternal notch to nipple distance"
},
{
"measure": "Nipple to inframammary fold distance"
},
{
"measure": "Measure of nipple-to-nipple distance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin C"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Norwich",
"contacts": null,
"country": "United Kingdom",
"facility": "University of East Anglia",
"geoPoint": {
"lat": 52.62783,
"lon": 1.29834
},
"state": "Norfolk",
"status": null,
"zip": "NR4 7TJ"
}
]
},
"descriptionModule": {
"briefSummary": "As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Crossover Assignment",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Double blind masking",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "FEMALE",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VICS",
"briefTitle": "Effects of Vitamin C on Skeletal Muscle",
"nctId": "NCT06262711",
"orgStudyIdInfo": {
"id": "321917",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups."
}
],
"secondaryOutcomes": [
{
"measure": "Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups."
},
{
"measure": "Difference in knee extension strength between vitamin C and placebo groups."
},
{
"measure": "Difference in hand grip strength between vitamin C and placebo groups."
},
{
"measure": "Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups."
},
{
"measure": "Difference in plasma vitamin C between vitamin C and placebo groups."
},
{
"measure": "Difference in serum hs-CRP between vitamin C and placebo groups."
},
{
"measure": "Difference in serum IL-6 between vitamin C and placebo groups."
},
{
"measure": "Difference in serum TNF-α between vitamin C and placebo groups."
},
{
"measure": "Difference in plasma P1NP between vitamin C and placebo groups."
},
{
"measure": "Difference in plasma CTX between vitamin C and placebo groups."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Norfolk and Norwich University Hospitals NHS Foundation Trust"
},
{
"name": "The Quadram Institute Clinical Research Facility"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of East Anglia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experiment group"
},
{
"name": "Pre-post test"
}
]
},
"conditionsModule": {
"conditions": [
"Nursing",
"Evidence-Based Nursing"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kars",
"contacts": [
{
"email": "[email protected]",
"name": "Gönül GÖKÇAY, Asist. Prof.",
"phone": "05447915549",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Kafkas University Faculty of Health Sciences",
"geoPoint": {
"lat": 40.59825,
"lon": 43.08548
},
"state": null,
"status": null,
"zip": "36500"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.Research hypotheses:Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The experimental group will receive six weeks of HBM-based training.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants were assigned to groups using the \"simple randomization method\". Participants were not informed of which group they were in. Automated computer-based randomization resulted in the implementation of the experiment with the scheduling scenario and confidential allocation of participants to one of the four intervention branches. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or a control condition. In addition, researchers coding and analyzing data will be blind to randomization and interventions.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HBM",
"briefTitle": "The Effect of HBM-Based Education on Nursing Students",
"nctId": "NCT06262698",
"orgStudyIdInfo": {
"id": "81825902.903/148",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The TCM Attitude Scale (CACMAS) The GETAT Attitude Scale (CACMAS): The scale, developed by McFadden et al. (2010), consists of 27 items rated on a 7-point Likert scale. Its Turkish validity and reliability were established by Köse et al. (2018)."
},
{
"measure": "The Medication Health Belief Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kafkas University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines"
},
{
"name": "Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines"
},
{
"name": "Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines"
},
{
"name": "Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines"
},
{
"name": "Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines"
},
{
"name": "Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines"
},
{
"name": "Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines"
},
{
"name": "Standard of Care (SoC) dosing of atorvastatin"
},
{
"name": "Standard of Care (SoC) dosing of simvastatin"
},
{
"name": "Standard of Care (SoC) dosing of pitavastatin"
},
{
"name": "Standard of Care (SoC) dosing of rosuvastatin"
},
{
"name": "Standard of Care (SoC) dosing of prasavastatin"
},
{
"name": "Standard of Care (SoC) dosing of lovastatin"
},
{
"name": "Standard of Care (SoC) dosing of fluvastatin"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Dyslipidemias",
"Statin Adverse Reaction",
"Pharmacogenic Myopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": null,
"name": "Stefan Mark Stewart Balbás, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital La Paz",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": "Comunidad De Madrid",
"status": null,
"zip": "28046"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Subjects will remain blinded to arm assigned because pharmacogenetic phenotype and statin/dose-guidance will only be exclusively accesible to the attending physician",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 216,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PREVESTATGx",
"briefTitle": "Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins",
"nctId": "NCT06262685",
"orgStudyIdInfo": {
"id": "2023-509418-12-00",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification"
},
{
"measure": "Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest"
},
{
"measure": "Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm"
},
{
"measure": "SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme"
}
],
"primaryOutcomes": [
{
"measure": "Incidence of clinically relevant statin-associated musculoskeletal events"
}
],
"secondaryOutcomes": [
{
"measure": "Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate"
},
{
"measure": "Baseline change in statin therapy prescription"
},
{
"measure": "Cost of a statin preemptive pharmacogenetic prescription scheme"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto de Salud Carlos III"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Instituto de Investigación Hospital Universitario La Paz"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Evaluation form"
}
]
},
"conditionsModule": {
"conditions": [
"Health Behavior",
"Sleep",
"Body Weight"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kirklareli",
"contacts": null,
"country": "Turkey",
"facility": "Kirklareli University",
"geoPoint": {
"lat": 41.73508,
"lon": 27.22521
},
"state": "Kayalı",
"status": null,
"zip": "39000"
}
]
},
"descriptionModule": {
"briefSummary": "The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 236,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process",
"nctId": "NCT06262672",
"orgStudyIdInfo": {
"id": "PR0319R01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Health Promotion Life-Style Profile (HPLP-II)"
},
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "Anthropometric Measurements"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kırklareli University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-11-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Doppler Ultrasonography Assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Arteriovenous Fistula"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Merkez",
"contacts": [
{
"email": "[email protected]",
"name": "Kudret Atakan Tekin",
"phone": "05424912184",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Kudret Atakan Tekin",
"geoPoint": null,
"state": "Çorum",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula",
"nctId": "NCT06262659",
"orgStudyIdInfo": {
"id": "2023-142",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "intraoperative Arteriovenous Fistula Flow Measurement"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kudret Atakan Tekin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Focused Acceptance and Commitment Therapy"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder",
"Attention Deficit Hyperactivity Disorder",
"Specific Learning Disorder",
"Communication Disorders",
"Motor Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Pui Tik YAU",
"phone": "(852) 3943-9915",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "The Chinese University of Hong Kong",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations.",
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 253,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Video-conferencing FACT for Young Children With Special Needs",
"nctId": "NCT06262646",
"orgStudyIdInfo": {
"id": "NTEC-2023-677",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parenting stress"
}
],
"secondaryOutcomes": [
{
"measure": "Parental depressive symptoms"
},
{
"measure": "Parental anxiety symptoms"
},
{
"measure": "Parental Psychological Flexibility"
},
{
"measure": "ACT Core Process Utilization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hong Kong Christian Service"
},
{
"name": "Hong Kong Federation of Youth Groups"
},
{
"name": "Hong Kong Young Women's Christian Association"
},
{
"name": "Yang Memorial Methodist Social Service"
},
{
"name": "Hong Kong Sheng Kung Hui Welfare Council"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-16"
}
}
} | false | null |
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