protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "robot-assisted radical prostatectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer",
"Bleeding",
"Prostate Adenocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20122"
}
]
},
"descriptionModule": {
"briefSummary": "Nowadays robot-assisted radical prostatectomy (RARP) has become the standard surgical treatment for localised prostate cancer. The robotic approach has been proven superior to open retropubic prostatectomy (ORP) in terms of surgical-related morbidity: RARP has in fact been associated with significantly lower estimated blood loos (EBL), lower transfusion rate, less length of stay, shorter catheterization time, lower risk of Clavien-Dindo grade II and III complications, lower risk of vesicourethral anastomotic stricture and less post-operative pain. The optimal anatomical visualisation and the extraordinary maneuverability, along with the tamponade effect of the pneumoperitoneum, are surely to be deemed responsible of this statistically significant differences.However, to this day no study has ever investigated the prognostic significance of haematological parameters in terms of predicting perioperative bleeding risk in patients undergoing RARP.Therefore, the investigators conducted a retrospective non-interventional cohort study to gather evidence concerning the impact of anemia and thrombocytopenia on bleeding risk following this surgical procedure. Furthermore, the investigators evaluated associations between demographical, pathological and surgical factors and hemorrhagic complications.The investigators retrospectively evaluated all the patients that underwent robot-assisted radical prostatectomy in our Urology Unit from the 1st of January 2017 to the 31th of December 2020. The investigators collected demographic, clinical and pathological data from the medical records of these patients, with particular attention to other known risk-factors for RARP-associated bleeding (e.g.: volume of the prostate, body mass index, smoking status, nerve sparing technique).Complications were analyzed according to the Clavien- Dindo classification. Bleeding was assessed by considering both the hemoglobin (Hb) drop after surgery and the fluid intraoperatively collected in the suction canister, with all the due adjustments. Moreover, post-operative haemorrhagic complications were evaluated.The investigators included patients not younger than 18 years old, of which records of a pre-operative full blood count in the 30 days prior to the surgery along with a full blood count the day after were available.Criteria for exclusion were a history of congenital coagulopathies and/or congenital thrombocytopenia and patients that underwent salvage radical prostatectomy after radiation therapy.Statistics: EBL and operative time learning curve is studied. Clinical, pathological, intraoperative risk factors analysis for higher EBL is performed by linear regression modelling. Factors are evaluated independently and jointly. Association between each factor above and post-operative outcomes (i.e. post-op bleeding, need of transfusion and hematuria) is also assessed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 194,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "UROBLOOD01",
"briefTitle": "Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study",
"nctId": "NCT06299046",
"orgStudyIdInfo": {
"id": "3235",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Influence of hemoglobin value on haemorrhagic complications"
},
{
"measure": "Influence of hematocrit value on haemorrhagic complications"
},
{
"measure": "Influence of platelet count on haemorrhagic complications"
},
{
"measure": "Influence of blood group on haemorrhagic complications"
}
],
"secondaryOutcomes": [
{
"measure": "Identification of possibile demographic and surgical predictive factors of haemorrhagic complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hNPC01"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Ischemic Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Changsha",
"contacts": [
{
"email": null,
"name": "Dan Li",
"phone": "15074875481",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zhiquan Yang, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "XiangYa Hospital",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The principal aims of the clinical investigation involve assessing the safety profile and MTD of human forebrain neural progenitor cells (hNPC01) administered at escalated doses via single-dose intracerebral injection to subjects with stable chronic ischemic stroke."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke",
"nctId": "NCT06299033",
"orgStudyIdInfo": {
"id": "HPS-NP1-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Number of participants with motor function improvement as assessed by rating scales of Modified Rankin Scale (mRS) during 12 months of treatment"
},
{
"measure": "Number of participants with motor function improvement as assessed by rating scales of Fugl-Meyer Motor Scale (FMMS) during 12 months of treatment"
},
{
"measure": "Number of participants with motor function improvement as assessed by rating scales of NIH Stroke Scale (NIHSS) during 12 months of treatment"
},
{
"measure": "Number of participants with motor function improvement as assessed by rating scales of Barthel Index (BI) during 12 months of treatment"
}
],
"primaryOutcomes": [
{
"measure": "Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 12 months after intracerebral injection of hNPC01"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hopstem Biotechnology Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "intermittent fasting"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Adrenal Insufficiency",
"Intermittent Fasting"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency",
"nctId": "NCT06299020",
"orgStudyIdInfo": {
"id": "HLaRabta24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "hypoglycemia"
}
],
"secondaryOutcomes": [
{
"measure": "Dehydration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hopital La Rabta"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Upper Gastrointestinal Bleeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hat Yai",
"contacts": null,
"country": "Thailand",
"facility": "Hatyai Hospital",
"geoPoint": {
"lat": 7.00836,
"lon": 100.47668
},
"state": "Songkhla",
"status": null,
"zip": "90110"
}
]
},
"descriptionModule": {
"briefSummary": "BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 867,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AISE",
"briefTitle": "Awareness of Iron Status Evaluation in UGIB",
"nctId": "NCT06299007",
"orgStudyIdInfo": {
"id": "HYH EC 052-66-01",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Hatyai Hospital Education Center",
"id": "HYH EC 052-66-01",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "iron status measurement"
}
],
"secondaryOutcomes": [
{
"measure": "Iron deficiency anemia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hat Yai Medical Education Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Pulmonary Disease, Chronic Obstructive",
"Postural; Defect",
"Movement, Abnormal",
"Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Aynur Demirel",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06100"
},
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Aynur Demirel",
"phone": "+905545295057",
"phoneExt": "178",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "hidaye yamikan",
"phone": "+905349898724",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "hidaye yamikan",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "cansu akkus",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Hacettepe University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Determination of Body Awareness and the Functional Movement in Patients With COPD",
"nctId": "NCT06298994",
"orgStudyIdInfo": {
"id": "SBA 23/391",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of functional movement"
},
{
"measure": "Evaluation of Body Awareness"
}
],
"secondaryOutcomes": [
{
"measure": "Functional exercise capacity"
},
{
"measure": "Respiratory muscle strength"
},
{
"measure": "Respiratory muscle endurance"
},
{
"measure": "Pain Severity"
},
{
"measure": "Pain threshold"
},
{
"measure": "Posture"
},
{
"measure": "Daily living activities"
},
{
"measure": "Severity of disease"
},
{
"measure": "Dyspnea"
},
{
"measure": "Symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "noninvasive and investigational NuraLogix AMC-SDK"
}
]
},
"conditionsModule": {
"conditions": [
"Pulse Rate and Breathing Rate"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Louisville",
"contacts": [
{
"email": null,
"name": "Monica Rabanal",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Element Materials Technology",
"geoPoint": {
"lat": 39.97776,
"lon": -105.13193
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80027"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "81 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pulse Rate and Breathing Rate Accuracy",
"nctId": "NCT06298981",
"orgStudyIdInfo": {
"id": "2301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Breathing rate accuracy validation"
},
{
"measure": "Pulse rate accuracy validation"
}
],
"secondaryOutcomes": [
{
"measure": "Pulse rate simulation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Nuralogix Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab"
}
]
},
"conditionsModule": {
"conditions": [
"Intrahepatic Cholangiocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Mengya Zang",
"phone": "86-20-62787430",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Nanfang Hospital of Southern Medical University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 38,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma",
"nctId": "NCT06298968",
"orgStudyIdInfo": {
"id": "NFEC-2024-074",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "The disease control rate (DCR)"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "The median progression free survival time (mPFS)"
},
{
"measure": "The median overall survival time (mOS)"
},
{
"measure": "Number of participants with treatment-related adverse events as assessed by CTCAE v5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanfang Hospital, Southern Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OMS906 study drug"
}
]
},
"conditionsModule": {
"conditions": [
"Paroxysmal Nocturnal Hemoglobinuria"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aachen",
"contacts": null,
"country": "Germany",
"facility": "Omeros Investigational Site",
"geoPoint": {
"lat": 50.77664,
"lon": 6.08342
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Ulm",
"contacts": null,
"country": "Germany",
"facility": "Omeros Investigational Site",
"geoPoint": {
"lat": 48.39841,
"lon": 9.99155
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Lausanne",
"contacts": null,
"country": "Switzerland",
"facility": "Omeros Investigational Site",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kyiv",
"contacts": null,
"country": "Ukraine",
"facility": "Omeros Investigational Site",
"geoPoint": {
"lat": 50.45466,
"lon": 30.5238
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Leeds",
"contacts": null,
"country": "United Kingdom",
"facility": "Omeros Investigational Site",
"geoPoint": {
"lat": 53.79648,
"lon": -1.54785
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria",
"nctId": "NCT06298955",
"orgStudyIdInfo": {
"id": "OMS906-PNH-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients."
}
],
"secondaryOutcomes": [
{
"measure": "To assess efficacy measured by hemoglobin (Hgb)."
},
{
"measure": "To assess efficacy by transfusion requirements."
},
{
"measure": "To assess efficacy by measurement of lactate dehydrogenase (LDH)."
},
{
"measure": "To assess efficacy by measurement of reticulocyte count."
},
{
"measure": "To assess efficacy by measurement of clinical breakthrough hemolysis."
},
{
"measure": "To assess population PK Cmax of OMS906."
},
{
"measure": "To assess population PK AUC of OMS906."
},
{
"measure": "To assess population PK terminal half life of OMS906."
},
{
"measure": "To assess PD of OMS906"
},
{
"measure": "OMS906 anti-drug antibodies (ADA)."
},
{
"measure": "Assess the change in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Omeros Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "natural band"
},
{
"name": "silicone band"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity, Morbid"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy",
"nctId": "NCT06298942",
"orgStudyIdInfo": {
"id": "fac.med.24.9",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "total cost"
},
{
"measure": "food intolerance"
}
],
"secondaryOutcomes": [
{
"measure": "%EWL"
},
{
"measure": "complications rate"
},
{
"measure": "improvement of comorbidities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Minia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "medial rectus fenestration"
},
{
"name": "medial rectus recession"
}
]
},
"conditionsModule": {
"conditions": [
"Partially Accommodative Esotropia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tanta",
"contacts": [
{
"email": "[email protected]",
"name": "Heba M Shafeik, MD",
"phone": "+201227440829",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Tanta University",
"geoPoint": {
"lat": 30.78847,
"lon": 31.00192
},
"state": "Gharbeya",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration."
},
"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": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Medial Rectus Fenestration vs Recession for PAET",
"nctId": "NCT06298929",
"orgStudyIdInfo": {
"id": "36264PR427/11/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ocular alignment (measured in prism diopters)"
}
],
"secondaryOutcomes": [
{
"measure": "ocular motility"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Tanta University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "64Cu-LNTH-1363S"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Sarcoma",
"Esophageal Cancer",
"Gastric Cancer",
"Pancreatic Cancer",
"Colorectal Cancer",
"Sarcoma"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Part 1: Metastatic Sarcoma Part 2: Non-metastatic sarcoma or gastrointestinal tract (GIT) cancer (esophageal, gastric, pancreatic, colorectal cancer)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PHANTOM",
"briefTitle": "64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer",
"nctId": "NCT06298916",
"orgStudyIdInfo": {
"id": "FAPi-1301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory Part 1 and Part 2"
}
],
"primaryOutcomes": [
{
"measure": "Primary Part 1 Biodistribution of 64Cu-LNTH-1363S"
},
{
"measure": "Primary Part 1 - Optimal dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S"
},
{
"measure": "Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary Parts 1 and 2 Safety and Tolerability"
},
{
"measure": "Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma"
},
{
"measure": "Secondary Part 1 and Part 2 Cardiac Safety"
},
{
"measure": "Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Lantheus Medical Imaging"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hip Activation"
},
{
"name": "Hip activation + Single leg balance"
}
]
},
"conditionsModule": {
"conditions": [
"Control of Frontal Plane Biomechanics",
"Patellofemoral Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shreveport",
"contacts": null,
"country": "United States",
"facility": "LSUHSC-Shreveport",
"geoPoint": {
"lat": 32.52515,
"lon": -93.75018
},
"state": "Louisiana",
"status": null,
"zip": "71103"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The investigator who will analyze the data will be blinded",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test",
"nctId": "NCT06298903",
"orgStudyIdInfo": {
"id": "STUDY00002565",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Forward-Step-Down Test"
}
],
"secondaryOutcomes": [
{
"measure": "surface electromyography (sEMG) peak"
},
{
"measure": "surface electromyography (sEMG) mean"
},
{
"measure": "Unipedal Stance Test (UPST)"
},
{
"measure": "Dose-Response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Louisiana State University Health Sciences Center Shreveport"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Artificial tears (sodium hyaluronate 0.2%)"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Disease",
"Cataract",
"Ocular Surface Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kaunas",
"contacts": [
{
"email": "[email protected]",
"name": "Reda Zemaitiene",
"phone": "+ 370 37 327 201",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Lithuania",
"facility": "Lithuanian University of Health Sciences",
"geoPoint": {
"lat": 54.90272,
"lon": 23.90961
},
"state": null,
"status": "RECRUITING",
"zip": "LT-44307"
}
]
},
"descriptionModule": {
"briefSummary": "This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Pattern of Dry Eye Disease After Cataract Surgery",
"nctId": "NCT06298890",
"orgStudyIdInfo": {
"id": "SASKAT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of ocular surface changes following cataract surgery"
},
{
"measure": "Evaluation of the cornea morphology"
},
{
"measure": "Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears"
},
{
"measure": "Evaluation of tear osmolarity"
},
{
"measure": "Evaluation of tear cytokine levels"
},
{
"measure": "Assessment of central corneal sensitivity"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of potential pain biomarkers in patients' saliva"
},
{
"measure": "Dry Eye Questionnaire-5 (DEQ5) 5-item"
},
{
"measure": "Ocular surface disease index (OSDI)"
},
{
"measure": "Visual function (VFQ-25) questionnaire"
},
{
"measure": "Visual acuity evaluation (LogMAR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Santen Oy"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Lithuanian University of Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Frailty and Quality of Life evaluation"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": [
{
"email": "[email protected]",
"name": "Sahar Salehi, MD, Ass Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Daniel Hunde, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniel Hunde, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sahar Salehi, MD, Ass Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Karolinska University Hospital",
"geoPoint": {
"lat": 59.33258,
"lon": 18.0649
},
"state": "Solna",
"status": "RECRUITING",
"zip": "171 76"
},
{
"city": "Gothenburg",
"contacts": [
{
"email": "[email protected]",
"name": "Pernilla Dahm-Kähler, MD, Prof.",
"phone": "0313434216",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Pernilla Dahm-Kähler, MD, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Charlotte Palmqvist, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Sahlgrenska University Hospital and Sahlgrenska Academy",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "41685"
},
{
"city": "Linköping",
"contacts": [
{
"email": "[email protected]",
"name": "Madelene Wedin, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Madelene Wedin, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Linköping University Hospital",
"geoPoint": {
"lat": 58.41086,
"lon": 15.62157
},
"state": null,
"status": "RECRUITING",
"zip": "581 85"
},
{
"city": "Lund",
"contacts": [
{
"email": "[email protected]",
"name": "Mihaela Asp, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mihaela Asp, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Päivi Kannisto, MD, Ass Prof",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Skåne University Hospital",
"geoPoint": {
"lat": 55.70584,
"lon": 13.19321
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "22185"
}
]
},
"descriptionModule": {
"briefSummary": "Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are \\>75 years. Despite these circumstances guidelines on patient-selection are lacking.Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 450,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FOLERO",
"briefTitle": "Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer",
"nctId": "NCT06298877",
"orgStudyIdInfo": {
"id": "2023-04696-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall Survival"
}
],
"secondaryOutcomes": [
{
"measure": "1-year mortality"
},
{
"measure": "Health related quality of life (HRQoL) (QLQ-C30)"
},
{
"measure": "Health related quality of life (HRQoL) (QLQ-OV28)"
},
{
"measure": "Health related quality of life (HRQoL) (QLQ-ELD14)"
},
{
"measure": "Health related quality of life (HRQoL) (EQ-5D-5L)"
},
{
"measure": "Low anterior resection syndrome (LARS)"
},
{
"measure": "Postoperative complications"
},
{
"measure": "Readmissions"
},
{
"measure": "Length of hospital stay"
},
{
"measure": "Extent of surgery vs survival"
},
{
"measure": "Sarcopenia vs post-operative outcome"
},
{
"measure": "Standard regimen of adjuvant chemotherapy"
},
{
"measure": "Time interval to adjuvant chemotherapy"
},
{
"measure": "Total number of hospital days and readmissions within90 days after index surgery"
},
{
"measure": "Health economics"
},
{
"measure": "Recurrence or progression free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sahar Salehi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-03-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-03-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Internet-CBT"
},
{
"name": "Internet-CL"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Coronary Syndrome",
"Online CBT Targeting Cardiac Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": [
{
"email": null,
"name": "Josefin Särnholm, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Karolinska University Hospital",
"geoPoint": {
"lat": 59.33258,
"lon": 18.0649
},
"state": null,
"status": null,
"zip": "11635"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 260,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ACS-CBT",
"briefTitle": "Internet-based Behavioral Intervention Following ACS",
"nctId": "NCT06298864",
"orgStudyIdInfo": {
"id": "ASC-RCT 2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Adverse events"
},
{
"measure": "Adverse events"
},
{
"measure": "Adverse events"
},
{
"measure": "Adverse events"
},
{
"measure": "Accelerometer (Actigraf®)"
},
{
"measure": "Accelerometer (Actigraf®)"
},
{
"measure": "Swedish Prescribed Drug Register"
},
{
"measure": "Swedish Prescribed Drug Register"
},
{
"measure": "Swedish Prescribed Drug Register"
},
{
"measure": "Working Alliance Inventory"
},
{
"measure": "Treatment Credibility Scale"
},
{
"measure": "Client satisfaction Questionnaire"
},
{
"measure": "Follow-up questions on health changes"
},
{
"measure": "Follow-up questions on health changes"
},
{
"measure": "Follow-up questions on health changes"
},
{
"measure": "AFFS/SCL-4"
},
{
"measure": "MI-behavior Questionnaire"
},
{
"measure": "DOSE Non-Adherence questionnaire"
}
],
"primaryOutcomes": [
{
"measure": "Cardiac anxiety questionnaire modified for weekly assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Cardiac anxiety questionnaire"
},
{
"measure": "Cardiac anxiety questionnaire"
},
{
"measure": "HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment"
},
{
"measure": "HeartQoL Health-related Quality of Life Questionnaire"
},
{
"measure": "HeartQoL Health-related Quality of Life Questionnaire"
},
{
"measure": "Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment"
},
{
"measure": "Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)"
},
{
"measure": "Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)"
},
{
"measure": "University of Toronto Atrial fibrillation Severity Scale (AFSS)"
},
{
"measure": "University of Toronto Atrial fibrillation Severity Scale (AFSS)"
},
{
"measure": "University of Toronto Atrial fibrillation Severity Scale (AFSS)"
},
{
"measure": "Myocardial infarction behavior questionnaire"
},
{
"measure": "Myocardial infarction behavior questionnaire"
},
{
"measure": "Myocardial infarction behavior questionnaire"
},
{
"measure": "DOSE Non-Adherence questionnaire"
},
{
"measure": "DOSE Non-Adherence questionnaire"
},
{
"measure": "DOSE Non-Adherence questionnaire"
},
{
"measure": "Perceived stress scale 4-item"
},
{
"measure": "Perceived stress scale 4-item"
},
{
"measure": "Perceived stress scale 4-item"
},
{
"measure": "Short Fatigue questionnaire"
},
{
"measure": "Short Fatigue questionnaire"
},
{
"measure": "Short Fatigue questionnaire"
},
{
"measure": "Patient Health Questionnaire-9"
},
{
"measure": "Patient Health Questionnaire-9"
},
{
"measure": "Patient Health Questionnaire-9"
},
{
"measure": "Insomnia Severity Index"
},
{
"measure": "Insomnia Severity Index"
},
{
"measure": "Insomnia Severity Index"
},
{
"measure": "Perceived stress scale 4-item"
},
{
"measure": "The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity"
},
{
"measure": "The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity"
},
{
"measure": "The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity"
},
{
"measure": "Lifestyle factors: The national Board of health and Welfare questionnaire"
},
{
"measure": "Lifestyle factors: The national Board of health and Welfare questionnaire"
},
{
"measure": "Lifestyle factors: The national Board of health and Welfare questionnaire"
},
{
"measure": "Aversive cognition to medication"
},
{
"measure": "Adversive cognition to medication"
},
{
"measure": "Adversive cognition to medication"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Karolinska University Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neural Mobilization Group (NMG)"
},
{
"name": "Dynamic Stretching Group (DSG)"
},
{
"name": "Static Stretching Group (SSG)"
}
]
},
"conditionsModule": {
"conditions": [
"Sports Physical Therapy",
"Stretch",
"Stretch Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Medipol University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34820"
}
]
},
"descriptionModule": {
"briefSummary": "Neural mobilizations (NM) are defined as interventions that aim to directly or indirectly affect neural structures or surrounding tissue through manual techniques or exercise. Neural mobilizations have been studied in both patients and healthy populations. In the study, individuals in the amateur football team will be divided into three groups and will be given pre-training warm-up periods, including neural mobilization, dynamic and static stretching.After the warm-up period, its effect on flexibility and performance will be examined and compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Effects of Lower Body Quadrant Neural Mobilization and Stretching in Collegiate Football Players",
"nctId": "NCT06298851",
"orgStudyIdInfo": {
"id": "E-10840098-772.02-2026",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "One-Leg Forward Jump Test"
},
{
"measure": "T Test"
},
{
"measure": "BlazePod Reaction Time Determination Test"
}
],
"primaryOutcomes": [
{
"measure": "Straight Leg Raise Test"
}
],
"secondaryOutcomes": [
{
"measure": "Y Balance Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Medipol University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AURA10® Specimen PET/CT imager"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High-resolution Intra-operative PSMA PET-CT in Prostate Cancer",
"nctId": "NCT06298838",
"orgStudyIdInfo": {
"id": "XEOS study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard"
}
],
"secondaryOutcomes": [
{
"measure": "Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Acute Decompensated Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangdong",
"contacts": [
{
"email": "[email protected]",
"name": "Huan Ma, PhD",
"phone": "+86 15078755932",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Huan Ma",
"geoPoint": null,
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "S-ADHF",
"briefTitle": "S-ADHF：Sarcopenia in Patients With ADHF",
"nctId": "NCT06298825",
"orgStudyIdInfo": {
"id": "KY2024-148",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "The frequency and length of hospitalization of patient readmitted"
},
{
"measure": "Survival time from enrollment to death of deceased patients"
}
],
"primaryOutcomes": [
{
"measure": "All-cause mortality"
}
],
"secondaryOutcomes": [
{
"measure": "All-cause mortality"
},
{
"measure": "Cardiovascular mortality"
},
{
"measure": "All-cause hospitalisation"
},
{
"measure": "HF hospitalisation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangdong Provincial People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "REFLECT Scoliosis Correction System"
}
]
},
"conditionsModule": {
"conditions": [
"Idiopathic Scoliosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": null,
"name": "Jana Robinson",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Noelle Larson, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Patients treated with the REFLECT Scoliosis Correction System",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "REFLECT Scoliosis System Post Approval Study",
"nctId": "NCT06298812",
"orgStudyIdInfo": {
"id": "Protocol Rev 0 11July2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Probable Benefit"
},
{
"measure": "Primary Safety"
}
],
"secondaryOutcomes": [
{
"measure": "Curve progression"
},
{
"measure": "Device integrity"
},
{
"measure": "Composite endpoint analysis"
},
{
"measure": "Failure analysis"
},
{
"measure": "SRS score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Globus Medical Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DNA Sequencing and Analysis"
},
{
"name": "differential expression analysis with RNA-sequencing (RNA seq) experiments"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes",
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Haifa",
"contacts": [
{
"email": null,
"name": "Irit Hochberg, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Israel",
"facility": "Rambem medical center",
"geoPoint": {
"lat": 32.81841,
"lon": 34.9885
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:* Informed consent* Study eligibility (Inclusion / Exclusion criteria)* Collection of demographic data (age (date of birth), gender, ethnic origin)* General and T2DM medical history review (per subject file)* Concomitant medication review (at enrollment)* Physical attributes (Body Weight, Height, BMI)* Allocation to study cohort and study subgroup* Saliva and blood collection for genetic tests* Self-reported questionnaire for Ozempic (Semaglutide) experience"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The study population consists of two cohorts:A. Type 2 Diabetic participants cohort B. Healthy participants cohort",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "no masking",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GLP1 treatment",
"briefTitle": "GENETIC VARIABILITY TO GLP1 TREATMENT",
"nctId": "NCT06298799",
"orgStudyIdInfo": {
"id": "GEN-GE-001-IL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Genetic variants and miRNA expressions associated with side effects."
},
{
"measure": "Demographic parameters that affect GLP1 AG therapy."
}
],
"primaryOutcomes": [
{
"measure": "Genetic variants and miRNA expressions associated with changes in BMI."
}
],
"secondaryOutcomes": [
{
"measure": "Genetic variants and miRNA expressions associated with changes in A1c."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "GENGE"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Functional 6-minute mastication test"
}
]
},
"conditionsModule": {
"conditions": [
"Mastication Disorder",
"Fatigue",
"Temporomandibular Disorder",
"Orofacial Pain",
"Chewing Problem"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Manresa",
"contacts": [
{
"email": "[email protected]",
"name": "Jordi Padrós, Mr",
"phone": "613040826",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jordi Padros-Augé, PhDS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Arnau Cerdà-Ribó, PT",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Universitat de Manresa",
"geoPoint": {
"lat": 41.72815,
"lon": 1.82399
},
"state": "Barcelona",
"status": null,
"zip": "08242"
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Jordi Tomás-Aliberas, PhD",
"phone": "+34932541800",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Universitat Internacional de Catalunya",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": "08017"
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Cristian Justribó, Mr",
"phone": "+34672057031",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Cristian Justribó-Manion, PhDS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "José J Bara Casaus, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital QuirónSalud Sagrado Corazón",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": "08029"
},
{
"city": "Jaén",
"contacts": [
{
"email": "[email protected]",
"name": "Emilio López-Jiménez, PhD",
"phone": "665842389",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Clínicas Dr. Emilio López Jiménez",
"geoPoint": {
"lat": 37.76922,
"lon": -3.79028
},
"state": null,
"status": null,
"zip": "23280"
}
]
},
"descriptionModule": {
"briefSummary": "Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "F-6MMT",
"briefTitle": "Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).",
"nctId": "NCT06298786",
"orgStudyIdInfo": {
"id": "6MIMATE012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fatigue"
},
{
"measure": "Self-reported Pain"
}
],
"secondaryOutcomes": [
{
"measure": "Pain-related TMD diagnosis"
},
{
"measure": "Self-reported daily fatigue"
},
{
"measure": "Pain pressure threshold (PPT)"
},
{
"measure": "Taste of the gum"
},
{
"measure": "Difficulty in breaking the gum at the beginning of the F-6MMT"
},
{
"measure": "Preferred side when chewing during the F-6MMT"
},
{
"measure": "Kinesiofobia related to TMD"
},
{
"measure": "Health status"
},
{
"measure": "Comorbidities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hospital Universitari Sagrat Cor"
},
{
"name": "Universitat Internacional de Catalunya"
},
{
"name": "Clinicas Dr. Emilio López Jiménez"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundació Universitària del Bages"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spatial analysis of paraffin samples from solid tumors"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandro Sgambato",
"phone": "+390630154914",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alessandro Sgambato",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": null,
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROST",
"briefTitle": "Spatial Profile of Tumors",
"nctId": "NCT06298773",
"orgStudyIdInfo": {
"id": "6127",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Spatial analysis of cancer cells"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of clinical data"
},
{
"measure": "Identification of therapeutic targets"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Knee Massage With Black Cumin Oil Group:"
},
{
"name": "Foot Reflexology Group With Black Cumin Oil"
},
{
"name": "placebo group"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": null,
"country": "Turkey",
"facility": "Ercan Bakır",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": "Yakutiye",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In this study, black cumin extract oil was used in elderly individuals with Knee Osteoarthritis (OA). The effects of foot reflexology and knee massage on pain and fatigue symptoms. It is aimed to examine and research which of these two applications is more effective.The study, planned as a randomized controlled experimental study, included a total of 150 participants.The data consists of participants who receive outpatient treatment in the Physical Therapy and Rehabilitation Unit at a university hospital, are over 65 years old, and have no problems with their perception after the Mini Mental Test. After randomization, participants were divided into five groups, with 30 participants in each group. Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "After randomization, participants were divided into 30 participants in each group.were divided into five groups:Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. \"Patient Information Form\", \"Kellgren and Lawrence\", \"Pain Visual Analog Scale (A-VAS)\", \"Fatigue Severity Scale and Western Ontario and McMaster Universities Osteoarthritis Index \"WOMAC\" were applied to the participants. Participants in the application groups were administered once a week for 6 weeks. The session lasted 30 minutes. The control group was allowed to continue routine treatment and care without any intervention. Data were collected by applying questionnaires to the participants in the 1st and 6th weeks.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Reflexology and Knee Massage With Black Cumin Oil on Pain and Fatigue",
"nctId": "NCT06298760",
"orgStudyIdInfo": {
"id": "çörekotu refleksoloji",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Score"
}
],
"secondaryOutcomes": [
{
"measure": "fatigue severity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erzurum Technical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-04-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-02-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-06-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Selective cervical nerve root pulsed radiofrequency"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Etlik City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 45,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "pulsedrf",
"briefTitle": "Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain",
"nctId": "NCT06298747",
"orgStudyIdInfo": {
"id": "Cervical root PRF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS"
}
],
"secondaryOutcomes": [
{
"measure": "Neck Disability Index (NDI)"
},
{
"measure": "Douleur Neuropathique 4 Questions (DN4)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Diskapi Teaching and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise Program"
},
{
"name": "Diet Program"
}
]
},
"conditionsModule": {
"conditions": [
"Melanoma (Skin)",
"Skin Cancer",
"Advanced Melanoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.The names of the groups in this research study are:* High-Intensity Exercise (EX)* High-fiber Diet (DT)* Combined High-Intensity Exercise and High-Fiber Diet (COMB)* Attention Control (AC)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exercise and Diet Interventions During Immunotherapy in Melanoma Patients",
"nctId": "NCT06298734",
"orgStudyIdInfo": {
"id": "23-712",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Gut Microbiome Diversity"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Systemic Immune Function"
},
{
"measure": "Change in Cardiopulmonary Fitness"
},
{
"measure": "Change in Short Physical Performance Battery (SPPB)"
},
{
"measure": "Change in Percent Body Fat"
},
{
"measure": "Change in Lean mass"
},
{
"measure": "Change in Hip circumference"
},
{
"measure": "Change in Waist circumference"
},
{
"measure": "Change in Health-Related Quality of life (EORTC-QLQ C30)"
},
{
"measure": "Change in MDASI-Immunotherapy Questionnaire Score"
},
{
"measure": "Change in Anxiety (HADS)"
},
{
"measure": "Change in Depression (HADS)"
},
{
"measure": "Change in Sleep Quality (PSQI)"
},
{
"measure": "Proportion of Participants Completing the Exercise Intervention Sessions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "World Cancer Research Fund International"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dana-Farber Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Personalized outcome prediction tool + targeted interventions"
},
{
"name": "Standard of Care TKA"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis",
"Knee Arthropathy",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cleveland",
"contacts": [
{
"email": "[email protected]",
"name": "Shujaa T Khan, MD",
"phone": "419-965-8274",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Cleveland Clinic Foundation",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44195"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes",
"nctId": "NCT06298721",
"orgStudyIdInfo": {
"id": "23-885",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Satisfaction at 1 year"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "American Association of Hip and Knee Surgeons"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The Cleveland Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mevac-A vaccine"
},
{
"name": "Havrix 720 Junior"
}
]
},
"conditionsModule": {
"conditions": [
"HAV",
"Hepatitis A",
"Hep A",
"Vaccine-Preventable Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "18 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "HAV-RCT",
"briefTitle": "Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents",
"nctId": "NCT06298708",
"orgStudyIdInfo": {
"id": "PED-2566-0634",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anti-HAV immunoglobulin G (IgG) seroconversion rate"
}
],
"secondaryOutcomes": [
{
"measure": "Geometric mean concentration (GMC) of anti-HAV IgG level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Faculty of Medicine, Chiang Mai University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chiang Mai University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Individual Schema Therapy"
},
{
"name": "TAU"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A multicenter parallel group randomized controlled clinical intervention trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 172,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PaDoLA",
"briefTitle": "Schema Therapy for Treatment-resistant Anxiety Disorders",
"nctId": "NCT06298695",
"orgStudyIdInfo": {
"id": "2012939",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ZonMw",
"id": "10390022210010",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in the severity of anxiety symptoms"
},
{
"measure": "Health-related quality of life"
},
{
"measure": "Mental health quality of life"
},
{
"measure": "Health care utilization and productivity losses"
}
],
"secondaryOutcomes": [
{
"measure": "Remission from the primary anxiety disorder and from comorbid disorders"
},
{
"measure": "Screening for DSM-5 personality disorders"
},
{
"measure": "Assessment of DSM-5 personality disorders"
},
{
"measure": "Demographics"
},
{
"measure": "(Strength of) treatment preference"
},
{
"measure": "Assessment of childhood trauma"
},
{
"measure": "Assessment of autistic traits"
},
{
"measure": "Assessment of general mental health"
},
{
"measure": "Functioning and recovery in psychiatric patients"
},
{
"measure": "Early Maladaptive Schemas"
},
{
"measure": "Schema Modes"
},
{
"measure": "Positive and negative effects of psychotherapy"
},
{
"measure": "The level of satisfaction with the psychological treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ZonMw: The Netherlands Organisation for Health Research and Development"
},
{
"name": "ADF Stichting"
},
{
"name": "University of Amsterdam"
},
{
"name": "Maastricht University"
},
{
"name": "GGZ inGeest"
},
{
"name": "Pro Persona Mental Health Care Foundation"
},
{
"name": "Mondriaan"
},
{
"name": "GGNet"
},
{
"name": "GGZ Delfland"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Amsterdam UMC, location VUmc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Platelet Thrombus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Daniele Prati",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 175,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "EXOPLT",
"briefTitle": "Characterization of Exosomes Platelets-released",
"nctId": "NCT06298682",
"orgStudyIdInfo": {
"id": "CCM1421",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis"
},
{
"measure": "Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis"
}
],
"secondaryOutcomes": [
{
"measure": "Platelet exosome profile emerged by NTA and proteoma analysis will be related with the \"biographical\" and \"anthropometric\" data of the subjects."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centro Cardiologico Monzino"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biventricular Pacing"
},
{
"name": "Right Ventricular Pacing"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Indianapolis",
"contacts": null,
"country": "United States",
"facility": "Indiana University Health Methodist Hospital",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana",
"status": null,
"zip": "46202"
}
]
},
"descriptionModule": {
"briefSummary": "The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Biventricular Versus Right Ventricular Pacing",
"nctId": "NCT06298669",
"orgStudyIdInfo": {
"id": "10652",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6 Minute Walk Test Performance"
}
],
"secondaryOutcomes": [
{
"measure": "Serum NT-PRO-BNP"
},
{
"measure": "EQ-5D-3L"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indiana University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "SUSPENDED",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Acute-On-Chronic Liver Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Delhi",
"contacts": [
{
"email": "[email protected]",
"name": "Garvit Mundra, MD",
"phone": "01146300000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "India",
"facility": "Institute of Liver & Biliary Sciences (ILBS)",
"geoPoint": {
"lat": 28.63576,
"lon": 77.22445
},
"state": "Delhi",
"status": null,
"zip": "110070"
}
]
},
"descriptionModule": {
"briefSummary": "Clinically significant portal hypertension (CSPH) is defined as HVPG \\>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \\<12 mm Hg or reduction to \\>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - \"ACT - C ACLF study"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients",
"nctId": "NCT06298656",
"orgStudyIdInfo": {
"id": "ILBS-ACLF-17",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF"
}
],
"secondaryOutcomes": [
{
"measure": "Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days"
},
{
"measure": "Transplant-free survival rate at 90 days"
},
{
"measure": "Correlation with evolution of AARC score by 2 week"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institute of Liver and Biliary Sciences, India"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Red blood cell transfusion"
},
{
"name": "Red blood cell transfusion"
}
]
},
"conditionsModule": {
"conditions": [
"Lower-risk Myelodysplastic Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tokyo",
"contacts": null,
"country": "Japan",
"facility": "Mebix, Inc",
"geoPoint": {
"lat": 35.6895,
"lon": 139.69171
},
"state": "Minato-ku",
"status": null,
"zip": "107-0052"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan",
"nctId": "NCT06298643",
"orgStudyIdInfo": {
"id": "CA056-1094",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Participant age"
},
{
"measure": "Participant sex"
},
{
"measure": "Participant weight"
},
{
"measure": "Participant height"
},
{
"measure": "Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method"
},
{
"measure": "Participant Eastern Cooperative Oncology Group (ECOG) score"
},
{
"measure": "Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category"
},
{
"measure": "Percentage of ring sideroblasts present in participants"
},
{
"measure": "Percentage of bone marrow blasts present in participants"
},
{
"measure": "Histopathology results"
},
{
"measure": "Number of red-blood cell transfusions received by participants"
},
{
"measure": "Treatment prescribed by line of therapy"
},
{
"measure": "Duration of treatment by line of therapy"
},
{
"measure": "Time between date of diagnosis and treatment"
},
{
"measure": "Time between date of treatment initiation to treatment discontinuation"
},
{
"measure": "Time between date of diagnosis to date of first red-blood cell transfusion"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment"
},
{
"measure": "Mean hemoglobin change of participants during first-line of therapy"
},
{
"measure": "Number of transfusion dependant participants achieving re-blood cell transfusion independence for ≥12 weeks with associated concurrent mean hemoglobin increase of ≥1.5 g/dL during first-line of therapy"
},
{
"measure": "Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks"
},
{
"measure": "Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy"
},
{
"measure": "Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy"
},
{
"measure": "Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy"
},
{
"measure": "Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy"
},
{
"measure": "Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy"
},
{
"measure": "Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy"
},
{
"measure": "Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy"
},
{
"measure": "Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy"
},
{
"measure": "Number of participants diagnosed with Acute Myeloid Leukemia"
},
{
"measure": "Time to Acute Myeloid Leukemia diagnosis"
},
{
"measure": "Overall survival (OS) of participants"
},
{
"measure": "Number of red-blood cell transfusion days per participant"
},
{
"measure": "Number of red-blood cell units used per transfusion"
},
{
"measure": "Number of outpatient visits per month"
},
{
"measure": "Number of hospital admissions"
},
{
"measure": "Length of hospitalization"
},
{
"measure": "Reason for hospitalization"
},
{
"measure": "Number of emergency department visits"
},
{
"measure": "Number of Intensive care unit admissions (ICU)"
},
{
"measure": "Number of outpatient/inpatient medication claims"
},
{
"measure": "Supplemental medication use: Iron chelation use"
},
{
"measure": "Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF)"
},
{
"measure": "Number of hematology tests ordered"
},
{
"measure": "Medical costs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bristol-Myers Squibb"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
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"conditions": [
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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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"link": null,
"type": null
},
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"measure": "Incidence of hematologic malignancies"
},
{
"measure": "Frequency, grade, and relationship of SAEs"
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"name": "First Affiliated Hospital of Guangxi Medical University"
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"name": "Xiangya Hospital of Central South University"
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{
"name": "Chinese Academy of Medical Sciences"
},
{
"name": "Nanfang Hospital, Southern Medical University"
},
{
"name": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"
},
{
"name": "The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army"
},
{
"name": "Shenzhen Children 's Hospital"
}
],
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"name": "Bioray Laboratories"
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"date": "2038-10-15"
},
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},
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},
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"date": "2024-12-08"
},
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"date": "2024-03-07"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Diagnostic laparoscopy"
},
{
"name": "Full Blood Count (FBC)"
}
]
},
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"conditions": [
"Endometriosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banhā",
"contacts": null,
"country": "Egypt",
"facility": "Benha University",
"geoPoint": {
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"lon": 31.17858
},
"state": "Al Qalyobia",
"status": null,
"zip": "13511"
}
]
},
"descriptionModule": {
"briefSummary": "Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers ."
},
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},
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"type": "ACTUAL"
},
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"minimumAge": "25 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
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"nctId": "NCT06298617",
"orgStudyIdInfo": {
"id": "RC 27.1.2024",
"link": null,
"type": null
},
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},
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{
"measure": "Indices' ability to predict EM stage"
}
],
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},
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}
},
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},
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"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
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"interventions": [
{
"name": "EUS-guided standard fine needle biopsy"
},
{
"name": "EUS-guided motorized fine needle biopsy"
}
]
},
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"conditions": [
"Pancreas Disease",
"Liver Diseases"
]
},
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"locations": [
{
"city": "Guayaquil",
"contacts": [
{
"email": "[email protected]",
"name": "Carlos Robles-Medranda, MD FASGE",
"phone": "+593989158865",
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"role": "CONTACT"
},
{
"email": null,
"name": "Carlos Robles-Medranda, MD FASGE",
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"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Raquel Del Valle, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Maria Egas-Izquierdo, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jorge Baquerizo-Burgos, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Domenica Cunto, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Juan Alcivar-Vasquez, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Daniela Tabacelia, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Martha Arevalo-Mora, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Miguel Puga-Tejada, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Gustavo Rubio, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Hannah Pitanga-Lukashok, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
}
],
"country": "Ecuador",
"facility": "Instituto Ecuatoriano de Enfermedades Digestivas (IECED)",
"geoPoint": {
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"lon": -79.90795
},
"state": null,
"status": "RECRUITING",
"zip": "090505"
}
]
},
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"briefSummary": "Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy."
},
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]
},
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},
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"type": "ESTIMATED"
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"phases": [
"NA"
],
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},
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"maximumAge": "99 Years",
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Motorized Fine Needle Biopsy vs Standard Needles",
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"id": "IECED-12112023",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Time efficiency during tissue acquisition"
},
{
"measure": "Rate of liver specimen adequacy"
},
{
"measure": "Rate of adverse events associated with the procedure"
},
{
"measure": "Quality of cytologic sample"
}
],
"primaryOutcomes": [
{
"measure": "Endoscopic ultrasound fine needle biopsy sample quality"
},
{
"measure": "Diagnostic accuracy according to histological analysis"
}
],
"secondaryOutcomes": [
{
"measure": "Tissue blood contamination"
}
]
},
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"name": "Instituto Ecuatoriano de Enfermedades Digestivas"
}
},
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"date": "2024-12-09"
},
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},
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},
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"date": "2023-12-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
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"interventions": [
{
"name": "co2 laser"
}
]
},
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"conditions": [
"Atrophic Scar"
]
},
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"descriptionModule": {
"briefSummary": "There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6)"
},
"designModule": {
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Combination Therapy in Atrophic Scars",
"nctId": "NCT06298591",
"orgStudyIdInfo": {
"id": "atrophic scar treatment",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "change of dermal thickness in sonar and Vancouver scale"
}
],
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},
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"collaborators": null,
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"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
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"date": "2027-03-15"
},
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"date": "2024-03-07"
},
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"date": "2027-03-15"
},
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"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Acetabular Fracture"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.The secondary objective is to Improve quality of life and early prediction of the complications."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "ECOLOGIC_OR_COMMUNITY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 126,
"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial",
"nctId": "NCT06298578",
"orgStudyIdInfo": {
"id": "Mobile Based Application",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36)"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "efgartigimod"
}
]
},
"conditionsModule": {
"conditions": [
"Myasthenia Gravis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 680,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa",
"nctId": "NCT06298565",
"orgStudyIdInfo": {
"id": "ARGX-113-PASS-2208",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "argenx"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Efgartigimod IV"
},
{
"name": "Placebo IV"
}
]
},
"conditionsModule": {
"conditions": [
"Generalized Myasthenia Gravis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boca Raton",
"contacts": [
{
"email": "[email protected]",
"name": "Brian Costell, MD",
"phone": "857-350-4834",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "First Choice Neurology Boca Raton",
"geoPoint": {
"lat": 26.3669,
"lon": -80.13033
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33428"
}
]
},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod.Study will consist of:* Screening* Part A: participants will be randomized to receive either efgartigimod IV or placebo* Part B: participants completing part A will receive open-label efgartigimod IV"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
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]
},
"identificationModule": {
"acronym": "ADAPT SERON",
"briefTitle": "A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis",
"nctId": "NCT06298552",
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"id": "ARGX-113-2308",
"link": null,
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},
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{
"domain": "CTIS number",
"id": "2024-511796-15-00",
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}
]
},
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"primaryOutcomes": [
{
"measure": "Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline"
}
],
"secondaryOutcomes": [
{
"measure": "Quantitative myasthenia gravis (QMG) total score change from baseline"
},
{
"measure": "Proportion of participants who are both MG-ADL and QMG responders"
}
]
},
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"collaborators": null,
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"class": "INDUSTRY",
"name": "argenx"
}
},
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"completionDateStruct": {
"date": "2027-07-23"
},
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"date": "2024-04-23"
},
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"date": "2025-07-25"
},
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"date": "2024-04-16"
},
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"date": "2024-03-07"
}
}
} | false | null |
{
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"interventions": null
},
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"conditions": [
"Obesity"
]
},
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"locations": [
{
"city": "Piancavallo",
"contacts": null,
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"facility": "IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital",
"geoPoint": null,
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"status": null,
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}
]
},
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"briefSummary": "The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way."
},
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Ud_SA_OB",
"briefTitle": "Auditory Sensory Attenuation in Obesity",
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"id": "21C308",
"link": null,
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},
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},
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{
"measure": "point of subjective equality (PSE)"
}
],
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{
"measure": "cognitive empathy"
},
{
"measure": "interpersonal pleasure"
}
]
},
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"collaborators": [
{
"name": "University of Turin, Italy"
}
],
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"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
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"completionDateStruct": {
"date": "2024-12-31"
},
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},
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"date": "2024-12-31"
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"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
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"conditions": [
"Anorexia Nervosa"
]
},
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"locations": [
{
"city": "Piancavallo",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital",
"geoPoint": null,
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"status": null,
"zip": "28824"
}
]
},
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"briefSummary": "The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way."
},
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},
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"sex": "FEMALE",
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"ADULT",
"OLDER_ADULT"
]
},
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"acronym": "UdSA_AN",
"briefTitle": "Auditory Sensory Attenuation in Anorexia Nervosa",
"nctId": "NCT06298526",
"orgStudyIdInfo": {
"id": "21C307",
"link": null,
"type": null
},
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"measure": "point of subjective equality (PSE)"
}
],
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"measure": "cognitive empathy"
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{
"measure": "interpersonal pleasure"
}
]
},
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"class": "OTHER",
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}
},
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},
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},
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"date": "2024-02-29"
},
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"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cardiac rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Myocardial Infarction: Rehabilitation Phase"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Lia Crotti, MD PhD",
"phone": "39 0261911",
"phoneExt": "2903",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
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"lon": 9.18951
},
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"status": "RECRUITING",
"zip": "20149"
}
]
},
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"briefSummary": "Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine)."
},
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},
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"minimumAge": "25 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RIABILITOMICA",
"briefTitle": "Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI",
"nctId": "NCT06298513",
"orgStudyIdInfo": {
"id": "09C338",
"link": null,
"type": null
},
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},
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{
"measure": "Changes in purine after rehabilitation"
},
{
"measure": "Changes in histidine after rehabilitation"
},
{
"measure": "Changes in galactose after rehabilitation"
}
],
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},
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"class": "OTHER",
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}
},
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},
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},
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"date": "2025-04"
},
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"date": "2023-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
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"interventions": [
{
"name": "hernia repair surgery"
}
]
},
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"conditions": [
"Inguinal Hernia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santa Cruz De Tenerife",
"contacts": [
{
"email": null,
"name": "José Miguel Del Pino Monzón, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital San Juan de Dios",
"geoPoint": {
"lat": 28.46824,
"lon": -16.25462
},
"state": "Tenerife",
"status": null,
"zip": "38001"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified."
},
"designModule": {
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},
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"minimumAge": "18 Years",
"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HISTOLAP",
"briefTitle": "Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair",
"nctId": "NCT06298500",
"orgStudyIdInfo": {
"id": "AAG-O-H-2115",
"link": null,
"type": null
},
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},
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{
"measure": "Hernia recurrence rate"
}
],
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{
"measure": "Delayed tissue adhesive polymerization"
},
{
"measure": "Intraoperative bleeding requiring therapeutic measures"
},
{
"measure": "Organ injury"
},
{
"measure": "Hernia recurrence"
},
{
"measure": "Mesh migration"
},
{
"measure": "Adhesions"
},
{
"measure": "Erosion"
},
{
"measure": "Meshoma formation"
},
{
"measure": "Tack hernias"
},
{
"measure": "Surgical Site Infection (superficial, deep, intraabdominal)"
},
{
"measure": "Hematoma"
},
{
"measure": "Seroma"
},
{
"measure": "Hemorrhage"
},
{
"measure": "Orchitis"
},
{
"measure": "Other Adverse Event"
},
{
"measure": "Reintervention"
},
{
"measure": "Mesh repositioning or removal"
},
{
"measure": "Acute or chronic pain"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "B.Braun Surgical SA"
}
],
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"name": "Aesculap AG"
}
},
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"date": "2024-09"
},
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},
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"date": "2024-06"
},
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patient questionnaires"
}
]
},
"conditionsModule": {
"conditions": [
"COPD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pontoise",
"contacts": [
{
"email": "[email protected]",
"name": "Dr Bruno PHILIPPE",
"phone": "+33 1 30 75 47 75",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mme Anne-Charlotte TAUVERON",
"phone": "+33 6 75 08 36 60",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO",
"geoPoint": {
"lat": 49.05,
"lon": 2.1
},
"state": null,
"status": "RECRUITING",
"zip": "95300"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone."
},
"designModule": {
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"allocation": "NON_RANDOMIZED",
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MPSAT-ETP",
"briefTitle": "Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area",
"nctId": "NCT06298487",
"orgStudyIdInfo": {
"id": "CHRD 1023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care"
}
],
"secondaryOutcomes": [
{
"measure": "Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group)"
},
{
"measure": "Comparison of anxiety/depression levels in patients in the PTE group versus Control group"
},
{
"measure": "Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group"
},
{
"measure": "Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group"
},
{
"measure": "Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hôpital NOVO"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The BRAIN App"
}
]
},
"conditionsModule": {
"conditions": [
"Dementia",
"Alzheimer Disease",
"Vascular Dementia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Winchester",
"contacts": null,
"country": "United States",
"facility": "Hopeful Aging",
"geoPoint": {
"lat": 42.45232,
"lon": -71.137
},
"state": "Massachusetts",
"status": null,
"zip": "01890"
}
]
},
"descriptionModule": {
"briefSummary": "There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called \"Building Relationships using Artificial Intelligence and Nostalgia\" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A Cluster Randomized Trial (CRT) will be conducted with each LTC facility being considered a cluster. All PLWD at an Experimental facility will be invited to use the intervention twice per week for 3 months, while all PLWD at a Control facility will receive standard care/programming for 3 months. Individual random assignment is not feasible, due to the high likelihood of contamination in a study involving the facilitation of activities in a LTC environment. LTC Facilities Eight (8) LTC facilities will participate in the study-i.e., 4 NHs and 4 ALFs. Half of the sites will be randomly assigned to the Experimental Group and the other half to the Control Group. So, 2 NHs and 2 ALFs will be assigned to the Experimental Group, while 2 NHs and 2 ALFs will be assigned to the Control Group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The BRAIN App (Phase 2 SBIR)",
"nctId": "NCT06298474",
"orgStudyIdInfo": {
"id": "2R44AG071105-03",
"link": "https://reporter.nih.gov/quickSearch/2R44AG071105-03",
"type": "NIH"
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Menorah Park Engagement Scale (MPES)"
},
{
"measure": "Menorah Park Engagement Scale (MPES)"
},
{
"measure": "Engagement for Persons with Dementia Scale (EPWDS)"
},
{
"measure": "Engagement for Persons with Dementia Scale (EPWDS)"
}
],
"secondaryOutcomes": [
{
"measure": "Dementia Related Quality of Life (DEMQOL)"
},
{
"measure": "Dementia Related Quality of Life (DEMQOL)"
},
{
"measure": "Neuropsychiatric Inventory--Nursing Home (NPI-NH)"
},
{
"measure": "Neuropsychiatric Inventory--Nursing Home (NPI-NH)"
},
{
"measure": "Quality of Carer-Patient Relationship (QCPR)"
},
{
"measure": "Quality of Carer-Patient Relationship (QCPR)"
},
{
"measure": "Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE)"
},
{
"measure": "Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hopeful Aging"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "KleanLyte"
},
{
"name": "Bi-PegLyte"
}
]
},
"conditionsModule": {
"conditions": [
"Crohn Disease",
"Ulcerative Colitis"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 418,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.",
"nctId": "NCT06298461",
"orgStudyIdInfo": {
"id": "BowelPrep",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quality of bowel cleanliness"
},
{
"measure": "Quality of bowel cleanliness"
}
],
"secondaryOutcomes": [
{
"measure": "Volume of laxative intake"
},
{
"measure": "Endoscopic Outcomes"
},
{
"measure": "Endoscopic Outcomes"
},
{
"measure": "Endoscopic Outcomes"
},
{
"measure": "Endoscopic Outcomes"
},
{
"measure": "Patient experience data"
},
{
"measure": "Crohn's disease or ulcerative colitis flares after colonoscopy"
},
{
"measure": "Endoscopic Outcomes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canadian IBD Research Consortium (CIRC)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Manitoba"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "laboratory experiments before and after mepolizumab treatment"
}
]
},
"conditionsModule": {
"conditions": [
"EGPA - Eosinophilic Granulomatosis With Polyangiitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Groningen",
"contacts": [
{
"email": "[email protected]",
"name": "Abraham Rutgers, MD-PhD",
"phone": "+31503616161",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "UMC Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": "RECRUITING",
"zip": "9700RB"
}
]
},
"descriptionModule": {
"briefSummary": "Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "eGPA and Local Inflammation Within the Ear, Nose and Throat Area",
"nctId": "NCT06298448",
"orgStudyIdInfo": {
"id": "NL83176.042.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory evaluation of between group differences"
},
{
"measure": "Mepolizumab effect on outcome 2"
},
{
"measure": "s there a correlation between the disease activity, the quality of life and the microbiome and immune parameters?"
}
],
"primaryOutcomes": [
{
"measure": "The effect mepolizumab treatment has on the nasal microbiome profiles"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GlaxoSmithKline"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Center Groningen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intermittent Positive pressure ventilation"
}
]
},
"conditionsModule": {
"conditions": [
"Hypoxemia",
"Hypercapnia",
"Ventilator Associated Pneumonia",
"Complication of Anesthesia",
"Postoperative Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Groningen",
"contacts": [
{
"email": "[email protected]",
"name": "Rob Spanjersberg",
"phone": "+31503616161",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "UMCG",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": null,
"zip": "9700RB"
}
]
},
"descriptionModule": {
"briefSummary": "• Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.Main research question* To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes* Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.* Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 20000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OPTIMVSPRIME",
"briefTitle": "Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements",
"nctId": "NCT06298435",
"orgStudyIdInfo": {
"id": "17536",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SpO2/FiO2 ratio"
},
{
"measure": "SpO2"
},
{
"measure": "etCO2"
},
{
"measure": "Blood Pressure"
},
{
"measure": "Heart Rate"
},
{
"measure": "Positive end Expiratory Pressure"
},
{
"measure": "Plateau Pressure"
},
{
"measure": "Respiration rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Center Groningen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Generalised Melanin Pigmentation",
"Pulse Oximetry"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": [
{
"email": "[email protected]",
"name": "Pamela DeYoung",
"phone": "858-232-0343",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UCSD Health",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": "RECRUITING",
"zip": "92103"
}
]
},
"descriptionModule": {
"briefSummary": "Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "O2SATS",
"briefTitle": "Oxygen Saturations Across Tones of Skin",
"nctId": "NCT06298422",
"orgStudyIdInfo": {
"id": "806433",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference observed between SpO2 and SaO2."
},
{
"measure": "Melanin Index"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Diego"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CapScan collection capsule"
}
]
},
"conditionsModule": {
"conditions": [
"Small Intestinal Bacterial Overgrowth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mountain View",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Taufui",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Silicon Valley Gastroenterology",
"geoPoint": {
"lat": 37.38605,
"lon": -122.08385
},
"state": "California",
"status": "RECRUITING",
"zip": "94040"
}
]
},
"descriptionModule": {
"briefSummary": "We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®",
"nctId": "NCT06298409",
"orgStudyIdInfo": {
"id": "EB04",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sampling of gut microbiota"
},
{
"measure": "Sampling of gut metabolome"
}
],
"secondaryOutcomes": [
{
"measure": "Effect of rifaximin on gut microbiota"
},
{
"measure": "Effect of rifaximin on gut metabolome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Envivo Bio Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Program using default MAP"
},
{
"name": "Program using low-power 1 (LP1) MAP"
},
{
"name": "Program using low-power 2 (LP2) MAP"
},
{
"name": "Program using low-power 3 (LP3) MAP"
}
]
},
"conditionsModule": {
"conditions": [
"Hearing Loss, Sensorineural"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Macquarie Park",
"contacts": [
{
"email": "[email protected]",
"name": "Esti Nel",
"phone": "+61448495008",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Cochlear Macquarie",
"geoPoint": {
"lat": -33.7751,
"lon": 151.11272
},
"state": "New South Wales",
"status": null,
"zip": "2109"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "There is no masking in this study as all participants receive all MAPs (single group study model). The term \"single-blinded\" in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DUAL",
"briefTitle": "Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients",
"nctId": "NCT06298396",
"orgStudyIdInfo": {
"id": "CLTD5853",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting"
},
{
"measure": "Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise"
}
],
"secondaryOutcomes": [
{
"measure": "Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting"
},
{
"measure": "Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise"
},
{
"measure": "Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Avania"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Cochlear"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Trypsin, Bromelain and Rutoside"
},
{
"name": "Diclofenac Potassium"
},
{
"name": "Prednisolone Oral Tablet"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Symptomatic Irreversible Pulpitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain",
"nctId": "NCT06298383",
"orgStudyIdInfo": {
"id": "ERU1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Success of Anesthesia"
},
{
"measure": "Post-operative pain"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Egyptian Russian University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pericapsular nerve group block plus intrathecal bupivacaine"
},
{
"name": "Intrathecal bupivacaine and morphine"
},
{
"name": "Pericapsular nerve group block plus intrathecal bupivacaine and morphine"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Pain Management"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Bezmialem Vakif University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Fatih",
"status": "RECRUITING",
"zip": "34093"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "prospective, double-blind, randomized clinical trial",
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"measure": "Morphine consumption"
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"measure": "Postoperative pain scores"
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"measure": "The quality of recovery score"
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"name": "Immediate Start - Virtual Reality"
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{
"name": "Delayed Start - Virtual Reality"
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},
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"domain": "Kaul Pediatric Research Institute Pilot Grant",
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"measure": "Physical activity"
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"measure": "Minutes of gameplay"
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"measure": "Global Health"
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"measure": "Forced Expiratory Volume in the first second (FEV1)"
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"date": "2024-06-01"
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"date": "2024-03-07"
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}
} | false | null |
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"name": "Thiamine"
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"Congenital Heart Disease",
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"email": "[email protected]",
"name": "Putri Amelia",
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"briefSummary": "Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions."
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"ADULT"
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},
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"measure": "Correlation between transcatheter closure and left ventricular structure change after thiamine treatment"
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"measure": "Correlation between transcatheter closure and left ventricular function change after thiamine treatment"
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"measure": "Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment"
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{
"measure": "Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment"
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{
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{
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"name": "Ege Nur Atabey Gerlegiz",
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"name": "İrem Gül Doğan",
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"briefSummary": "The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial."
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"link": null,
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"measure": "Weekly defecation frequency"
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"measure": "Average weekly defecation time"
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"measure": "Average weekly frequency of laxative use"
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"measure": "The severity of constipation"
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{
"measure": "Gastrointestinal symptom level"
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{
"measure": "Constipation-related quality of life"
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{
"measure": "Patient perception of global change"
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"measure": "Abdominal muscle strength"
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{
"measure": "Functional exercise capacity"
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} | false | null |
{
"armsInterventionsModule": {
"interventions": [
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"name": "vodka"
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{
"name": "water"
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},
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"conditions": [
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"Liver Injury",
"Hepatic Steatosis"
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},
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{
"city": "Hangzhou",
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"country": "China",
"facility": "Zhejiang Chinese Medical University",
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"status": null,
"zip": "310053"
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"descriptionModule": {
"briefSummary": "The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are:1. if acute binge drink could alleviate liver injury and hepatic steatosis."
},
"designModule": {
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"phases": [
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"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MeABD",
"briefTitle": "Metabolic Changes in Healthy Subjects With Acute Binge Drink",
"nctId": "NCT06298318",
"orgStudyIdInfo": {
"id": "Acute Binge Drink",
"link": null,
"type": null
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"measure": "Hepatic fibrosis change"
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{
"measure": "hepatic function change"
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{
"measure": "hepatic injury change"
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{
"measure": "Lipid metabolism change"
},
{
"measure": "Laboratory markers of inflammation"
}
],
"secondaryOutcomes": [
{
"measure": "Fecal metabolites"
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{
"measure": "Ethanol concentration"
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{
"measure": "Acetaldehyde concentration"
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{
"measure": "hangover cognition assessment tools after drinking"
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"date": "2024-07-19"
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"startDateStruct": {
"date": "2024-04-18"
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"studyFirstPostDateStruct": {
"date": "2024-03-07"
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}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
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"name": "Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software"
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]
},
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"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele",
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"lon": 9.18951
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"status": null,
"zip": "20132"
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"briefSummary": "This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard."
},
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"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
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"OLDER_ADULT"
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},
"identificationModule": {
"acronym": "QUANTIB",
"briefTitle": "Artificial Intelligence & Prostate Cancer",
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"id": "QUANTIB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"measure": "To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI"
}
],
"secondaryOutcomes": [
{
"measure": "To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy"
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{
"measure": "To report time reduction in the diagnosis of suspicious PCa"
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]
},
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"date": "2023-10-10"
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"startDateStruct": {
"date": "2022-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Zero minis (range of protein substitutes in tablet form)"
}
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},
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"conditions": [
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"Tyrosinemia, Type II",
"Tyrosinemia, Type III",
"Alkaptonuria",
"Homocystine; Metabolic Disorder",
"MSUD (Maple Syrup Urine Disease)"
]
},
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"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years."
},
"designModule": {
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"eligibilityModule": {
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"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "ZeroMinisMR",
"briefTitle": "Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies",
"nctId": "NCT06298292",
"orgStudyIdInfo": {
"id": "ZerominisCT01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
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"measure": "Daily compliance"
}
],
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{
"measure": "Treatment-Emergent tolerability"
},
{
"measure": "Patient Acceptability"
},
{
"measure": "Metabolic control"
},
{
"measure": "Incidence of study product emergent events."
}
]
},
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"collaborators": [
{
"name": "Birmingham Women's and Children's NHS Foundation Trust"
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{
"name": "Great Ormond Street Hospital for Children NHS Foundation Trust"
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"name": "metaX Institut fuer Diatetik GmbH"
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"date": "2026-06-30"
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"startDateStruct": {
"date": "2024-04-01"
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"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tunneled Delivery"
},
{
"name": "Personalized Delivery"
},
{
"name": "Standard Resources"
},
{
"name": "Enhanced Social Learning Resources"
},
{
"name": "Transdiagnostic Self-Guided ICBT"
}
]
},
"conditionsModule": {
"conditions": [
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"Anxiety",
"Stress Disorders, Post-Traumatic"
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},
"contactsLocationsModule": {
"locations": [
{
"city": "Regina",
"contacts": [
{
"email": "[email protected]",
"name": "Heather D Hadjistavropoulos, PhD",
"phone": "306-585-5133",
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{
"email": "[email protected]",
"name": "Caeleigh A Landry, MSc",
"phone": "306-337-2473",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Heather D Hadjistavropoulos, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Department of Psychology, University of Regina",
"geoPoint": {
"lat": 50.45008,
"lon": -104.6178
},
"state": "Saskatchewan",
"status": null,
"zip": "S4S 0A2"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Participants cannot be blinded to condition because ICBT (like other psychotherapies) cannot be both provided to and concealed from a participant. However, the difference between the four conditions (i.e., presence or absence of social learning resources, tunneled versus personalized course navigation) will be concealed from all participants. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not applicable.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 164,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel",
"nctId": "NCT06298279",
"orgStudyIdInfo": {
"id": "2023-436",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Post-treatment Semi-structured interview"
}
],
"primaryOutcomes": [
{
"measure": "Generalized Anxiety Disorder 7-item (GAD-7)"
},
{
"measure": "Patient Health Questionnaire-9 (PHQ-9)"
},
{
"measure": "PTSD Checklist for the DSM-5 (PCL-5)"
},
{
"measure": "Engagement"
}
],
"secondaryOutcomes": [
{
"measure": "Work and Social Adjustment Scale (WSAS)"
},
{
"measure": "Brief Resilience Scale (BRS)"
},
{
"measure": "Healthcare Use Questionnaire"
},
{
"measure": "Case Story Questionnaire"
},
{
"measure": "Treatment Satisfaction Questionnaire"
},
{
"measure": "Digital Behavior Change Interventions Engagement Scale (DCBI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Government of Canada"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Regina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "infusion of GPRC5D-CD19 CAR T injection"
}
]
},
"conditionsModule": {
"conditions": [
"Relapsed or Refractory Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Qing Zhang",
"phone": "+862089169186",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Guangdong Second Provincial General Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510317"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma",
"nctId": "NCT06298266",
"orgStudyIdInfo": {
"id": "GD2H-XYK-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective Response Rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangdong Second Provincial General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Behavioral economics-enhanced SWAP implementation"
},
{
"name": "Basic SWAP implementation"
}
]
},
"conditionsModule": {
"conditions": [
"Food Insecurity",
"Implementation Science",
"Diet, Healthy",
"Behavioral Economics"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 3750,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BeWell",
"briefTitle": "Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2",
"nctId": "NCT06298253",
"orgStudyIdInfo": {
"id": "2024P000832",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pantry SWAP implementation"
},
{
"measure": "Percent items (by weight) ordered by pantry that are labeled green or red"
},
{
"measure": "Percent of pantry clients' selected food that is green or red"
},
{
"measure": "Client dietary quality score"
}
],
"secondaryOutcomes": [
{
"measure": "Skin carotenoid level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Massachusetts General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "nursing procedure for acute health problems of low complexity"
}
]
},
"conditionsModule": {
"conditions": [
"Nurse's Role",
"Disease, Acute"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mataró",
"contacts": null,
"country": "Spain",
"facility": "Mataró primary care emergency center",
"geoPoint": {
"lat": 41.54211,
"lon": 2.4445
},
"state": "Barcelona",
"status": null,
"zip": "08301"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Nurse Demand Management was born in 2009 out of the need to address the growth of spontaneous acute demand in primary care. But it is not until 2013 that guidelines for the exercise of nursing actions in demand management were established in Catalonia, Spain. Nurses trained specifically to solve acute and low complexity health problems generate a quality of care comparable to that provided by family medicine doctors. On the other hand, it is worth highlighting the need to rationalise medical resources in primary care centres, primary care emergency centres or points of continuous care (different emergency facilities in the territory in terms of size and services) in order to give priority to doctors being able to dedicate more time to medium or high complexity pathology. Although nurse demand management has been implemented in primary care teams for years, it is being carried out in different intensities according to the needs or priorities of each health territory.The promotion of the autonomous role of nursing through the implementation of nurse demand management in the urgent spontaneous demand of low complexity can be transcendent, both in the optimisation of health resources in primary care and in the management of the demand for care.Hypothesis: The implementation of nurse demand management is a factor of improvement in the efficiency and quality of care in the Primary Care Emergency Centre of the city of Mataró (Barcelona, Spain). Objectives: The main objective of this study was to determine whether the implementation of nurse demand management is a factor in improving efficiency and quality of care in the CUAP of Mataró. Methodology: Non-randomised controlled experimental intervention study. Application of a consensual guide with 5 reasons for health consultations where demand management nursing can be applied."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 312,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Implementation of Nursing Demand Management as a Factor for Improvement in a Primary Care Emergency Center.",
"nctId": "NCT06298240",
"orgStudyIdInfo": {
"id": "4R22/074",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Prescribed drugs"
},
{
"measure": "Processed labour disabilities"
},
{
"measure": "Diagnoses change"
}
],
"primaryOutcomes": [
{
"measure": "Waiting time and resolution of the visit"
},
{
"measure": "Number of reconsultations"
},
{
"measure": "patient experience"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-01-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Postoperative analgesia management with Paracerol® and IV PCA with Talinat®"
},
{
"name": "Erector spinae plane block"
},
{
"name": "Quadratus lumborum plane block"
}
]
},
"conditionsModule": {
"conditions": [
"Kidney Diseases",
"Kidney Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": null,
"name": "Ayşe İnce, Assist Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Istanbul Medipol University Mega Hospital Complex",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Bağcılar",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic nephrectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group ESPB = ESPB group, Group QLB = QLB group) including 30 patients each, before entering the operating room.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Outcomes assessor and participants will be blinded to the study",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy",
"nctId": "NCT06298227",
"orgStudyIdInfo": {
"id": "Medipol Hospital 1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively"
}
],
"secondaryOutcomes": [
{
"measure": "Pain scores (Numerical rating scale-NRS)"
},
{
"measure": "Need for rescue analgesia (meperidine)"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Medipol University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Her Health Program"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum",
"Pregnancy Related"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baton Rouge",
"contacts": null,
"country": "United States",
"facility": "Woman's Hospital",
"geoPoint": {
"lat": 30.45075,
"lon": -91.15455
},
"state": "Louisiana",
"status": null,
"zip": "70817"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.The main question\\[s\\] the study aims to answer are:* Can the Her Health program increase access to healthcare in the first year postpartum?* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?Participants will complete one research visit in which they will be enrolled and told which group they will be in- \"Her Health Program\" group or \"Usual Care\" group. If they are placed in the \"Her Health Program\" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Her Health",
"briefTitle": "Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester",
"nctId": "NCT06298214",
"orgStudyIdInfo": {
"id": "RP-23-019",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postpartum visit attendance"
}
],
"secondaryOutcomes": [
{
"measure": "Medical trust"
},
{
"measure": "Health literacy"
},
{
"measure": "Self-efficacy"
},
{
"measure": "Healthcare costs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Donaghue Medical Research Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Elizabeth F Sutton, PhD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-05",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 458232,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-02-02T12:19"
},
{
"date": "2023-12-06",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 188057,
"typeAbbrev": "ICF",
"uploadDate": "2024-02-02T12:21"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "E-Based Physical Exercise Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense",
"contacts": null,
"country": "Denmark",
"facility": "University of Southern Denmark",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": null,
"status": "ENROLLING_BY_INVITATION",
"zip": "5000"
},
{
"city": "Odense",
"contacts": [
{
"email": "[email protected]",
"name": "Nasrin Asgari, Professor",
"phone": "+4530700612",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ulrik Dalgas, Professor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "University of Southern Denmark",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
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"state": null,
"status": "RECRUITING",
"zip": "5230"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life.Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus.Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled trial (RCT) with prospective longitudinal follow up",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Due to the nature of the intervention, it is not feasible to blind participants or physiotherapists delivering the program. Nonetheless, to preserve the integrity of the trial, outcome assessors (researchers) will remain blinded to the allocation of treatments.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COMPACT",
"briefTitle": "E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity",
"nctId": "NCT06298201",
"orgStudyIdInfo": {
"id": "IMAGINE2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6-meters' walk test"
},
{
"measure": "\"no evidence of disease activity\" (NEDA-3) score"
}
],
"secondaryOutcomes": [
{
"measure": "Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA),"
},
{
"measure": "Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale"
},
{
"measure": "Neurofilament Light Chain (NfL) determination"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Risankizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Crohn Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risankizumab in Children With Crohn's Disease (RisaKids)",
"nctId": "NCT06298188",
"orgStudyIdInfo": {
"id": "RisaKids",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shaare Zedek Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Self management training"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Saglik Bilimleri Universitesi",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Pre-post test, randomized controlled study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions",
"nctId": "NCT06298175",
"orgStudyIdInfo": {
"id": "2021-157",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Self-Control Self-Management Scale (SCMS)"
}
],
"secondaryOutcomes": [
{
"measure": "Cognitive Emotion Regulation Questionnaire (CERQ)"
},
{
"measure": "The Occupational Balance Questionnaire (OBQ)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Saglik Bilimleri Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "2 years after RYGB, no intervention. MRI measurement. Observational."
}
]
},
"conditionsModule": {
"conditions": [
"Bariatric Surgery Candidate",
"Gastric Bypass",
"Obesity, Morbid",
"Pouch Emptying"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Arnhem",
"contacts": null,
"country": "Netherlands",
"facility": "Yonta Burgh",
"geoPoint": {
"lat": 51.98,
"lon": 5.91111
},
"state": null,
"status": null,
"zip": "6815 AD"
}
]
},
"descriptionModule": {
"briefSummary": "A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\\>35%) and bad responders (TWL\\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 10,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MRI pouch",
"briefTitle": "Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass",
"nctId": "NCT06298162",
"orgStudyIdInfo": {
"id": "2018-1279",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pouch emptying rate measured with MRI"
}
],
"secondaryOutcomes": [
{
"measure": "subjective ratings of fullness"
},
{
"measure": "subjective ratings of wellbeing"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rijnstate Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-07-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Turtle Island Tales"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity, Childhood",
"Obesity",
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bozeman",
"contacts": null,
"country": "United States",
"facility": "Montana State University",
"geoPoint": {
"lat": 45.67965,
"lon": -111.03856
},
"state": "Montana",
"status": null,
"zip": "59717"
}
]
},
"descriptionModule": {
"briefSummary": "Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"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": "Reach Through Equitable Implementation of Turtle Island Tales",
"nctId": "NCT06298149",
"orgStudyIdInfo": {
"id": "2023-650-EXEMPT",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1U54CA280812-01",
"link": "https://reporter.nih.gov/quickSearch/1U54CA280812-01",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "20-item Family Nutrition and Physical Activity Survey"
}
],
"secondaryOutcomes": [
{
"measure": "Food insecurity screener"
},
{
"measure": "Mental Health screening"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
},
{
"name": "University of Utah"
},
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Montana State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2028-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "mindfulness-based intervention"
},
{
"name": "child behavior management"
}
]
},
"conditionsModule": {
"conditions": [
"ADHD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Christine Wing Tung Yeung, MSsc",
"phone": "+85266279904",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Herman Hay Ming Lo",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 208,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MindADHD",
"briefTitle": "The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder",
"nctId": "NCT06298136",
"orgStudyIdInfo": {
"id": "15610923",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Child ADHD symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Parent depressive symptoms"
},
{
"measure": "Parent anxiety symptoms"
},
{
"measure": "Parent sleep quality"
},
{
"measure": "Parent well-being"
},
{
"measure": "Child executive functioning"
},
{
"measure": "Parental Stress"
},
{
"measure": "Expressed emotion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anti-PD-1 monoclonal antibody"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma",
"Adjuvant Immunotherapy",
"Checkpoint Inhibitor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": null,
"country": "China",
"facility": "Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430030"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 304,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling",
"nctId": "NCT06298123",
"orgStudyIdInfo": {
"id": "adjuvant-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Imaging data (enhanced CT and MRI） and histopathology data, if available."
}
],
"primaryOutcomes": [
{
"measure": "Recurrence-Free Survival (RFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chen Xiaoping"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Platelets Rich plasma of the same patient"
}
]
},
"conditionsModule": {
"conditions": [
"Wound Heal",
"Abdominal Wound",
"PRP"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy",
"nctId": "NCT06298110",
"orgStudyIdInfo": {
"id": "PRP in Abdominal hysterectomy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "changes in wound healing"
}
],
"secondaryOutcomes": [
{
"measure": "Vancouver scar scale changes"
},
{
"measure": "Visual Analog Scale changes"
},
{
"measure": "Hospital readmission"
},
{
"measure": "Infection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Helwan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Connectivity measures"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Venice",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS San Camillo Hospital",
"geoPoint": {
"lat": 45.43713,
"lon": 12.33265
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 170,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NEUROCONN",
"briefTitle": "Brain Connectivity Measured With High-density Electroencephalography",
"nctId": "NCT06298097",
"orgStudyIdInfo": {
"id": "2019.11",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "High-density electroencephalography measurements (work package 1, 2, and 3)"
},
{
"measure": "High-density electroencephalography measurements (work package 1, 2, and 3)"
},
{
"measure": "High-density electroencephalography measurements (work package 1, 2, and 3)"
},
{
"measure": "High-density electroencephalography measurements (work package 1, 2, and 3)"
},
{
"measure": "High-density electroencephalography measurements (work package 1, 2, and 3)"
},
{
"measure": "Magnetic Resonance Imaging measurement (work package 1, 2, and 3)"
},
{
"measure": "Magnetic Resonance Imaging measurement (work package 1, 2, and 3)"
},
{
"measure": "Magnetic Resonance Imaging measurement (work package 1, 2, and 3)"
},
{
"measure": "Magnetic Resonance Imaging measurement (work package 1, 2, and 3)"
},
{
"measure": "Magnetic Resonance Imaging measurement (work package 1, 2, and 3)"
}
],
"secondaryOutcomes": [
{
"measure": "Muscle strength measurement (work package 3)"
},
{
"measure": "Muscle strength measurement (work package 3)"
},
{
"measure": "Muscle strength measurement (work package 3)"
},
{
"measure": "Muscle strength measurement (work package 3)"
},
{
"measure": "Muscle strength measurement (work package 3)"
},
{
"measure": "Sensorimotor impairment measurement (work package 3)"
},
{
"measure": "Sensorimotor impairment measurement (work package 3)"
},
{
"measure": "Sensorimotor impairment measurement (work package 3)"
},
{
"measure": "Sensorimotor impairment measurement (work package 3)"
},
{
"measure": "Sensorimotor impairment measurement (work package 3)"
},
{
"measure": "Spasticity measurement (work package 3)"
},
{
"measure": "Spasticity measurement (work package 3)"
},
{
"measure": "Spasticity measurement (work package 3)"
},
{
"measure": "Spasticity measurement (work package 3)"
},
{
"measure": "Spasticity measurement (work package 3)"
},
{
"measure": "Funtional skills measurement (work package 3)."
},
{
"measure": "Funtional skills measurement (work package 3)."
},
{
"measure": "Funtional skills measurement (work package 3)."
},
{
"measure": "Funtional skills measurement (work package 3)."
},
{
"measure": "Funtional skills measurement (work package 3)."
},
{
"measure": "Activities of daily living measurement (work package 3)"
},
{
"measure": "Activities of daily living measurement (work package 3)"
},
{
"measure": "Activities of daily living measurement (work package 3)"
},
{
"measure": "Activities of daily living measurement (work package 3)"
},
{
"measure": "Activities of daily living measurement (work package 3)"
},
{
"measure": "Pain measurement (work package 3)"
},
{
"measure": "Pain measurement (work package 3)"
},
{
"measure": "Pain measurement (work package 3)"
},
{
"measure": "Pain measurement (work package 3)"
},
{
"measure": "Pain measurement (work package 3)"
},
{
"measure": "Cognitive performance measurements (work package 3)"
},
{
"measure": "Cognitive performance measurements (work package 3)"
},
{
"measure": "Cognitive performance measurements (work package 3)"
},
{
"measure": "Cognitive performance measurements (work package 3)"
},
{
"measure": "Cognitive performance measurements (work package 3)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Camillo, Venezia, Italy"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-06-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patritumab deruxtecan"
},
{
"name": "Olaparib"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer Metastatic",
"HER2-positive Metastatic Breast Cancer",
"HER2 Low Breast Carcinoma",
"Advanced Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Villejuif",
"contacts": [
{
"email": "[email protected]",
"name": "Barbara Pistilli",
"phone": "+33 (0)1 42 11 61 62",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Fernanda Mosele",
"phone": "+33 (0)1 42 11 61 43",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Gustave Roussy Institut",
"geoPoint": {
"lat": 48.7939,
"lon": 2.35992
},
"state": null,
"status": "RECRUITING",
"zip": "94805"
}
]
},
"descriptionModule": {
"briefSummary": "ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0).The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd.The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 152,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ICARUSBREAST02",
"briefTitle": "Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd",
"nctId": "NCT06298084",
"orgStudyIdInfo": {
"id": "2023-505925-15-00",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CSET number",
"id": "2023/3668",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "DLTs (dose-limiting toxicity) for part 1a and 1b"
},
{
"measure": "Frequency of safety event for part 1a and 1b"
},
{
"measure": "Severity of safety event for part 1a and 1b"
},
{
"measure": "Proportion of treatment modification due to AEs for part 1a and 1b"
},
{
"measure": "frequency of laboratory abnormalities for part 1a and 1b"
},
{
"measure": "Severity of laboratory abnormalities for part 1a and 1b"
},
{
"measure": "radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b"
},
{
"measure": "ORR for part 2"
},
{
"measure": "DOR for part 2"
},
{
"measure": "PFS for part 2"
},
{
"measure": "CBR for part 2"
}
],
"secondaryOutcomes": [
{
"measure": "ORR for part 1"
},
{
"measure": "DOR for part 1"
},
{
"measure": "PFS for part 1"
},
{
"measure": "CBR for part 1"
},
{
"measure": "PK analysis for part 1"
},
{
"measure": "ADA analysis for part 1"
},
{
"measure": "DLTs for part 2"
},
{
"measure": "Frequency of safety event for part 2"
},
{
"measure": "Severity of safety event for part 2"
},
{
"measure": "proportion of treatment modification event for part 2"
},
{
"measure": "frequency of laboratory abnormalities for part 2"
},
{
"measure": "Severity of laboratory abnormalities for part 2"
},
{
"measure": "radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 2"
},
{
"measure": "PK analysis for part 2"
},
{
"measure": "ADA analysis for part 2"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Daiichi Sankyo"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Gustave Roussy, Cancer Campus, Grand Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SIBP-R002"
},
{
"name": "SIBP-R002"
},
{
"name": "SIBP-R002"
},
{
"name": "Methotrexate"
}
]
},
"conditionsModule": {
"conditions": [
"Gout"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bengbu",
"contacts": [
{
"email": "[email protected]",
"name": "Huan Zhou, Master",
"phone": "86-13665527160",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Bengbu Medical College",
"geoPoint": {
"lat": 32.94083,
"lon": 117.36083
},
"state": "Anhui",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "According to the sequence from low-dose group to high-dose group, there are 12 participants in each group, totaling 36 participants.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.",
"nctId": "NCT06298071",
"orgStudyIdInfo": {
"id": "SIBP-R002-Ib",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "AE(Adverse Events)"
},
{
"measure": "SAE(Serious Adverse Events)"
},
{
"measure": "AUC(Area Under The Plasma Concentration Versus Time Curve)"
},
{
"measure": "Cmax(Peak Plasma Concentration)"
},
{
"measure": "Tmax(Peak Time)"
},
{
"measure": "T ½ (Terminal elimination half-life)"
},
{
"measure": "CL (Clearance Rate)"
},
{
"measure": "ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody)"
},
{
"measure": "NAb (Anti-PEG-uricase Neutralizing Antibody)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "First Affiliated Hospital Bengbu Medical College"
},
{
"name": "The First Affiliated Hospital of Henan University of Science and Technology"
},
{
"name": "Chengdu Fifth People's Hospital"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Shanghai Institute Of Biological Products"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SIBP-A13 formulation for injection"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This study is an open, multi-dose increasing single and multiple dose study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 144,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.",
"nctId": "NCT06298058",
"orgStudyIdInfo": {
"id": "SIBP-A13-I",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "AE (Adverse Events)"
},
{
"measure": "SAE (Serious Adverse Events)"
},
{
"measure": "AUC (Area Under The Plasma Concentration Versus Time Curve)"
},
{
"measure": "Cmax (Peak Plasma Concentration)"
},
{
"measure": "Tmax (Peak Time)"
},
{
"measure": "T ½ (Terminal elimination half-life)"
},
{
"measure": "CL (Clearance Rate)"
}
],
"secondaryOutcomes": [
{
"measure": "ORR (Objective Response Rate)"
},
{
"measure": "DCR (Disease control rate)"
},
{
"measure": "PFS (Progression-free survival)"
},
{
"measure": "OS (overall survival)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai Pulmonary Hospital, Shanghai, China"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Shanghai Institute Of Biological Products"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Stable Angina"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Braşov",
"contacts": [
{
"email": "[email protected]",
"name": "Zara Cornelia, Dr",
"phone": "+40723733774",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Romania",
"facility": "Thera Card Srl",
"geoPoint": {
"lat": 45.64861,
"lon": 25.60613
},
"state": null,
"status": "RECRUITING",
"zip": "500091"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy",
"nctId": "NCT06298045",
"orgStudyIdInfo": {
"id": "DIM-06790-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of angina symptoms via the summary score of SAQ-7"
}
],
"secondaryOutcomes": [
{
"measure": "CCS angina grading post-inclusion"
},
{
"measure": "Tolerance ( Adverse Events)"
},
{
"measure": "Tolerance ( Serious Adverse Events)"
},
{
"measure": "Adherence to the antianginal treatment combination under evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Servier Affaires Médicales"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Olamkicept Part A"
},
{
"name": "Olamkicept Part B"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Inflammatory Gastrointestinal Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": null,
"country": "Germany",
"facility": "Ferring Investigational Site",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons",
"nctId": "NCT06298032",
"orgStudyIdInfo": {
"id": "000414",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of treatment-emergent adverse events, including type, intensity, and causality"
},
{
"measure": "Change in vital signs from baseline to Day 36 after a single dose infusion"
},
{
"measure": "Change in vital signs from baseline to Day 64 after multiple dose infusions"
},
{
"measure": "Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion"
},
{
"measure": "Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions"
},
{
"measure": "Change in haematology from baseline to Day 36 after a single dose infusion"
},
{
"measure": "Change in haematology from baseline to Day 64 after multiple dose infusions"
},
{
"measure": "Change in clinical chemistry from baseline to Day 36 after a single dose infusion"
},
{
"measure": "Change in clinical chemistry from baseline to Day 64 after multiple dose infusions"
},
{
"measure": "Change in haemostasis parameters from baseline to Day 36 after a single dose infusion"
},
{
"measure": "Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions"
},
{
"measure": "Change in urinalysis parameters from baseline to Day 36 after a single dose infusion"
},
{
"measure": "Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions"
}
],
"secondaryOutcomes": [
{
"measure": "Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf)"
},
{
"measure": "Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)"
},
{
"measure": "Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi)"
},
{
"measure": "Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)"
},
{
"measure": "Single-dose PK of FE 999301: Time of maximum observed concentration (tmax)"
},
{
"measure": "Single-dose PK of FE 999301: Terminal half-life (t1/2)"
},
{
"measure": "Single-dose PK of FE 999301: Mean residence time (MRT)"
},
{
"measure": "Single-dose PK of FE 999301: Total clearance (CL)"
},
{
"measure": "Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)"
},
{
"measure": "Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ)"
},
{
"measure": "Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)"
},
{
"measure": "Multiple-dose PK of FE 999301: Observed accumulation index (Rac)"
},
{
"measure": "Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio)"
},
{
"measure": "Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)"
},
{
"measure": "Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax)"
},
{
"measure": "Multiple-dose PK of FE 999301: Terminal half-life (t½)"
},
{
"measure": "Multiple-dose PK of FE 999301: Mean residence time (MRT)"
},
{
"measure": "Multiple-dose PK of FE 999301: Total clearance (CL)"
},
{
"measure": "Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)"
},
{
"measure": "Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Ferring Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "KYV-101"
}
]
},
"conditionsModule": {
"conditions": [
"Dermatomyositis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stanford",
"contacts": null,
"country": "United States",
"facility": "Stanford University",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
},
"state": "California",
"status": null,
"zip": "94305"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called \"CD19\" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these \"re-engineered\" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will \"wipe out\" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.The main questions the study intends to answer are:* Understanding how well patients tolerate undergoing this therapy in terms of side effects;* Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs;"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Patients will be enrolled in a sequential manner with respect to the aggressiveness of the conditioning regimen used prior to receiving the CAR T infusion therapy. The first 3 patients will undergo standard conditioning--daily cyclophosphamide (IV, 300 mg/m2) and fludarabine (30 mg/m2) x 3 days. If this regimen is found to allow sufficient engraftment of the CAR T cells, participants will be enrolled in sequential groups (of 3-5) representing milder doses or alternative medications that overall represent gentler cytoreduction, which advancement to each sequential group contingent upon satisfactory number and function of infused CAR T cells.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "72 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis",
"nctId": "NCT06298019",
"orgStudyIdInfo": {
"id": "73464",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants experiencing adverse events"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2039-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Follow-up"
}
]
},
"conditionsModule": {
"conditions": [
"COVID-19"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Örebro",
"contacts": [
{
"email": "[email protected]",
"name": "Yvonne Freund-Levi, MD, PhD",
"phone": "+46 736841130",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zbigniew Dzialanski, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Department of Geriatrics, University Hospital Örebro",
"geoPoint": {
"lat": 59.27412,
"lon": 15.2066
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PASC24",
"briefTitle": "A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients",
"nctId": "NCT06298006",
"orgStudyIdInfo": {
"id": "275025",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore."
},
{
"measure": "Symptom improvement in depression"
},
{
"measure": "Self-reported symptom improvement in depression"
},
{
"measure": "Grade of self-reported mental fatigue"
},
{
"measure": "Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD)"
},
{
"measure": "Grade of self-reported stress"
},
{
"measure": "Grade of self-reported cognitive failures in everyday life"
}
],
"secondaryOutcomes": [
{
"measure": "Occurence of activity limitations and changes in health-related quality of life (QoL)"
},
{
"measure": "Grade of work incapacity/sick leave and time to return to work"
},
{
"measure": "Changes in body size"
},
{
"measure": "Waist size"
},
{
"measure": "Rate of peak expiratory flow (PEF)"
},
{
"measure": "Grade of physical exercise capacity"
},
{
"measure": "Concetration of Beta-Amyloid 42 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration."
},
{
"measure": "Beta Amyloid Ratio 42/40 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease"
},
{
"measure": "Concentration of neurogranin in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease"
},
{
"measure": "Concentration of Tau (P-Tau) protein in cerebrospinal fluid (CSF) as a CSF biomarker of cortikal damage/neurodegeneration"
},
{
"measure": "Concentration of phosphorylated Tau (P-Tau) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration/taupathy"
},
{
"measure": "Concentration of neurofilament light (NFL) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration"
},
{
"measure": "Concentration of neurofilament light (NFL) in plasma as a blood biomarker of neurodegeneration"
},
{
"measure": "Occurence of APOE4 allele as biomarker of genetic predisposition to Alzheimer's disease and susceptibility to more severe course of COVID-19 infection"
},
{
"measure": "Brain volumes and signal abnormalities in white and gray matter"
},
{
"measure": "Changes in functional and structural brain connectivity"
},
{
"measure": "Changes in gut microbiome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Örebro University, Sweden"
},
{
"name": "Karolinska Institutet"
},
{
"name": "Karolinska University Hospital"
},
{
"name": "Sahlgrenska University Hospital, Sweden"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Region Örebro County"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"PSC"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Miami",
"contacts": [
{
"email": "[email protected]",
"name": "Cynthia Levy, MD",
"phone": "306-243-4615",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Cynthia Levy, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Schiff Center for Liver Diseases / University of Miami",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33136"
}
]
},
"descriptionModule": {
"briefSummary": "Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "WIND-PSC",
"briefTitle": "Adult Patients With Primary Sclerosing Cholangitis",
"nctId": "NCT06297993",
"orgStudyIdInfo": {
"id": "WIND-PSC-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Develop interventional clinical trial external control using clinical and biomarker data."
}
],
"secondaryOutcomes": [
{
"measure": "Identify alternative endpoints to predict clinical benefit using large clinical and biomarker data."
},
{
"measure": "Changes in patient reported outcomes over time as assessed by Patient Reported Outcomes surveys."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Arbor Research Collaborative for Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Personalized modifications to treatment to address menstrual cycle effects on glycemia"
}
]
},
"conditionsModule": {
"conditions": [
"Type 1 Diabetes",
"Hypoglycemia",
"Hyperglycaemia Due to Type 1 Diabetes Mellitus",
"Menstruation Disturbances"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "JANET K SNELL-BERGEON, PhD",
"phone": "303-724-6762",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Catherine Chartier-Logan, MPH",
"phone": "3037247505",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sarit Polsky, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Cristy Geno, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Bryan Bergman, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Laura Pyle, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MERIT",
"briefTitle": "Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes",
"nctId": "NCT06297980",
"orgStudyIdInfo": {
"id": "23-1513",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glucose time in range"
},
{
"measure": "Glucose standard deviation"
}
],
"secondaryOutcomes": [
{
"measure": "Mean glucose (mg/dL) pre-exercise"
},
{
"measure": "Mean glucose (mg/dL) while exercising"
},
{
"measure": "Mean glucose (mg/dL) over 24 hours after exercise"
},
{
"measure": "Glucose standard deviation"
},
{
"measure": "Glucose standard deviation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Leona M. and Harry B. Helmsley Charitable Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Denver"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acetic Acid"
},
{
"name": "Prontosan"
}
]
},
"conditionsModule": {
"conditions": [
"Ulcer, Skin"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Marta De Vicente",
"phone": "+34 938931616",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Noemí Casaponsa",
"phone": "+34 938960025",
"phoneExt": "43197",
"role": "CONTACT"
},
{
"email": null,
"name": "Marta De Vicente",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Consorci Sanitari Alt'Pènedes i Garraf",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": "Cataluña",
"status": null,
"zip": "08810"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ECA-AA",
"briefTitle": "Acetic Acid 2% Solution for Skin Ulcers",
"nctId": "NCT06297967",
"orgStudyIdInfo": {
"id": "CSAPG-33",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants with ulcer healing at 4 weeks from the start of treatment."
},
{
"measure": "Percentage of participants with ulcer healing at 12 weeks from the start of treatment."
},
{
"measure": "Time (days) to ulcer healing from the start of treatment."
},
{
"measure": "Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 (\"Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds\" scale."
},
{
"measure": "Number of adverse reactions associated with the treatment, collected from the medical record."
},
{
"measure": "The healthcare expenditure associated with each branch of the study"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Consorci Sanitari de l'Alt Penedès i Garraf"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Metoclopramide"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Upper Gastrointestinal Bleeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Monterrey",
"contacts": [
{
"email": "[email protected]",
"name": "José Luis Herrera Elizondo, Physician",
"phone": "+528180182968",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "José Alberto González González, Physician",
"phone": "+528183668061",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Mexico",
"facility": "Hospital Universitario Dr. José Eleuterio González, UANL",
"geoPoint": {
"lat": 25.67507,
"lon": -100.31847
},
"state": "Nuevo León",
"status": "RECRUITING",
"zip": "64460"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "As it is double-blind, both physician and patient will not know the treatment they are receiving and it will only be revealed later at the end of the protocol. Following the previous folios, both the treatment and the placebo will be distributed in boxes by default by the research staff, delivering them to the personnel who will apply the drug or placebo, indicating the doses and frequencies of these when administered.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding",
"nctId": "NCT06297954",
"orgStudyIdInfo": {
"id": "GA22-00011",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding."
}
],
"secondaryOutcomes": [
{
"measure": "To determine whether the use of metoclopramide avoids repeating the endoscopic procedure."
},
{
"measure": "To determine whether the use of metoclopramide shortens the length of hospital stay."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Autonoma de Nuevo Leon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "REM-422"
}
]
},
"conditionsModule": {
"conditions": [
"Myelodysplastic Syndromes",
"Higher Risk Myelodysplastic Syndromes",
"Acute Myeloid Leukemia",
"Acute Myeloid Leukemia Refractory"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Duarte",
"contacts": [
{
"email": null,
"name": "Anthony S Stein, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "City of Hope",
"geoPoint": {
"lat": 34.13945,
"lon": -117.97729
},
"state": "California",
"status": null,
"zip": "91010"
},
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Eytan M Stein, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10065"
},
{
"city": "Houston",
"contacts": [
{
"email": null,
"name": "Courtney D DiNardo, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of REM-422 in Patients With AML or Higher Risk MDS",
"nctId": "NCT06297941",
"orgStudyIdInfo": {
"id": "REM-422-102",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Frequency and severity of Treatment Emergent Adverse Events (TEAEs)"
},
{
"measure": "Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)"
}
],
"secondaryOutcomes": [
{
"measure": "AML: Rate of Complete Response (remission) (CR)"
},
{
"measure": "AML: Rate of CR with partial hematologic recovery (CRh)"
},
{
"measure": "AML: Duration of CR"
},
{
"measure": "AML: Duration of CRh"
},
{
"measure": "AML: Overall response rate (ORR) (CR + CRh + CRi + PR) with incomplete hematologic recovery [CRi] + partial response [PR]) per modified IWG response criteria 2003 based on Investigator assessment"
},
{
"measure": "AML: Duration of response (DOR)"
},
{
"measure": "MDS: Rate of Compete Response (CR)"
},
{
"measure": "MDS: Duration of Complete Response (CR)"
},
{
"measure": "MDS: Overall Response Rate (ORR)"
},
{
"measure": "MDS: Duration of Response (DOR)"
},
{
"measure": "Determine pharmacokinetic profile (Cmax) of REM-422"
},
{
"measure": "Determine pharmacokinetic profile (Cmin) of REM-422"
},
{
"measure": "Determine pharmacokinetic profile (Tmax) of REM-422"
},
{
"measure": "Determine pharmacokinetic profile (AUC) of REM-422"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Remix Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "baratric surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Bariatric Surgery Candidate",
"Obesity, Morbid",
"Obesity, Metabolically Benign"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "David Benaiges Boix, PhD",
"phone": "0034932483902",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "David Benaiges, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Joan Pedro-Botet, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Albert Goday, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Carme Serra",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Elisenda Climent, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Helena Julià, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Miguel Olano, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Oscar Pozo, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital del Mar",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08003"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are:* Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery?* How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery?* What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery?Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 145,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity",
"nctId": "NCT06297928",
"orgStudyIdInfo": {
"id": "2023/11238/I",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of Metabolic Signatures Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Analysis Predicting Transition from Metabolically Unhealthy Obesity (MUO) to Metabolically Healthy Obesity (MHO) Status"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) between Patients with Persistent Metabolically Unhealthy Obesity (MUO) and Those Transitioning to Metabolically Healthy Obesity (MHO) Status"
},
{
"measure": "Comparison of Baseline Metabolomic Profile and Its Evolution Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) after Surgery between Patients with Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUO)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Parc de Salut Mar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketamine"
},
{
"name": "Lidocain"
}
]
},
"conditionsModule": {
"conditions": [
"Neuropathic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Hacettepe University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Cankaya",
"status": null,
"zip": "06360"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CROSSOVER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 102,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Infusion Treatments of Chronic Peripheral Neuropathic Pain",
"nctId": "NCT06297915",
"orgStudyIdInfo": {
"id": "2022/08-45",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neuropathic Pain Scale"
},
{
"measure": "Pain Rating Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of Life Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dose painting"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Cancer",
"Radiotherapy Side Effect"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority, multi-center phase II study, initiated at the Section for Head and Neck Cancer, Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after treatment. The expected inclusion period is three years, total study duration is six years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission computed tomography (FDG-PET/CT) prior to radiotherapy. In the experimental arm, we will escalate the dose to the hypermetabolic part of the tumor (maximum point dose 83.3 Gy), shown in pre-treatment FDG-PET images. Dose escalation will be applied to these regions during the first half of the fractionated treatment (17 of 34 fractions). The patients in both arms will receive concomitant nimorazole (hypoxic radiosensitizer) and concomitant cisplatin if indicated according to standard treatment. The main inclusion criterion is patients with human-papillomavirus (HPV)-unrelated head and neck cancer with poor prognosis.The RADPAINT-3 trial includes a translational sub-study where we aim to elucidate underlying mechanisms related to the radiotherapy effect, by investigating blood samples. Analysis of cytokines in repetitive blood samples may predict both tumor response and toxicity. The data derived from this sub-study, will be further explored using artificial intelligence.If RADPAINT-3 shows that there is no excess toxicity, we will continue the study after a new protocol has been approved. The new primary endpoint will be local control at 1 year after radiotherapy. Power analysis show that we will need in total 182 evaluable patients including the 100 patients from RADPAINT-3. The translational sub-study will then be extended to investigate genetic expression data from pre-therapy routine tumor biopsies and correlate this with the analysis of blood samples and tumor control."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RADPAINT-3",
"briefTitle": "RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3",
"nctId": "NCT06297902",
"orgStudyIdInfo": {
"id": "2023_31",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Cytokines"
}
],
"primaryOutcomes": [
{
"measure": "Late mucosal ulcer"
}
],
"secondaryOutcomes": [
{
"measure": "Early toxicity"
},
{
"measure": "Late toxicity"
},
{
"measure": "Odynophagia"
},
{
"measure": "Health-related quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Haukeland University Hospital"
},
{
"name": "St. Olavs Hospital"
},
{
"name": "Norwegian University of Life Sciences"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Oslo University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "core strength training 1-6weeks"
},
{
"name": "core strength training 7-12weeks"
}
]
},
"conditionsModule": {
"conditions": [
"Player"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lanzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Hucheng Ma, PHD",
"phone": "+8613909492013",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "WEI WEI, Senior Coach",
"phone": "+8618919171585",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ma Hucheng",
"geoPoint": {
"lat": 36.05701,
"lon": 103.83987
},
"state": "Gansu",
"status": "RECRUITING",
"zip": "730000"
}
]
},
"descriptionModule": {
"briefSummary": "Hockey, tracing its origins back to 2000 BC, has undergone substantial evolutionary transformations throughout the centuries. Initially known by various names, the game transitioned to its modern form approximately 50 years ago, when matches were conducted on grass fields with wooden sticks. In contemporary international hockey, there has been a notable shift towards artificial grass, cultivating a dynamic and fast-paced game that places heightened demands on individual skills, tactical acumen, and physical fitness. This evolution reflects a continuous adaptation, seamlessly blending tradition with cutting-edge equipment and hybrid playing grounds.Against this backdrop, modern-day hockey programs have metamorphosed into rigorous and demanding training regimes. Athletes engaged in these programs are required not only to demonstrate outstanding physical fitness but also exhibit a high level of proficiency in the nuanced skills essential for competitive play. As hockey continues its progressive trajectory, athletes partaking in these programs must meet elevated standards, underscoring the imperative integration of both exceptional fitness levels and precise skill execution.Despite the growing emphasis on the physical and skill dimensions of hockey, a literature review uncovered a dearth of research specifically focusing on core strength training for hockey players. While core strength training has demonstrated efficacy in improving physical fitness and skill performance among athletes in other team sports, its applicability to hockey players remains underexplored. Moreover, no studies have systematically examined the impact of core strength training on the two critical variables of physical fitness and skill performance in hockey players.To address this research gap, the present study sought to investigate the effects of core strength training on the physical fitness and skill performance of youth hockey players in Gansu Province, China. By doing so, this study not only contributes valuable insights to the existing body of literature but also furnishes theoretical support for the development of hockey sport programs. The findings are anticipated to inform targeted interventions aimed at enhancing athletes' physical fitness and skill performance, ultimately fostering the progression of hockey programs within the sporting landscape of China."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "In this experiment, the experimental group engaged in the core strength training segment of the intervention specifically devised for this study, whereas the control group underwent conventional strength training activities.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
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]
},
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"briefTitle": "Effect of Core Strength Training on the Physical Fitness and Skills of Youth Field Hockey Players in China",
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},
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},
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},
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},
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"date": "2024-02-15"
},
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}
}
} | false | null |
{
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"interventions": [
{
"name": "Storytelling"
},
{
"name": "Learn More (Active Comparator)"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
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"locations": [
{
"city": "Worcester",
"contacts": [
{
"email": "[email protected]",
"name": "Sarah Forrester, PhD",
"phone": "508-856-8338",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jeroan Allison, MD",
"phone": "5088568993",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Massachusetts Chan Medical School",
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},
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"status": "RECRUITING",
"zip": "01605"
}
]
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},
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"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"maskingDescription": "Participants will view either storytelling videos or learn more videos. They will not know which video they will get ahead of time nor will they know that they may get one or the other.",
"whoMasked": [
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]
},
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},
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},
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],
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"maximumAge": "105 Years",
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color",
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"link": null,
"type": null
},
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},
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"measure": "Change in Vaccine Hesitancy"
}
],
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}
]
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}
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}
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} | false | null |
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"name": "HEAD DOWN TILT -10° to -15°"
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]
},
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},
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"briefSummary": "The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°)."
},
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"maskingInfo": {
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"maskingDescription": "A blinded central imaging core lab, whose members will be unaware of the procedure assignments, will assess all imaging outcomes, including the primary efficacy outcome (collateral status, assessed during the pretreatment diagnostic angiographic series of mechanical thrombectomy)",
"whoMasked": [
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]
},
"identificationModule": {
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"briefTitle": "Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke",
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"id": "DOWN-SUITE",
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},
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},
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"measure": "Good collateral status"
}
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},
{
"measure": "Delay to thrombectomy"
},
{
"measure": "Vomiting"
},
{
"measure": "Early neurological deterioration"
},
{
"measure": "Symptomatic intracranial hemorrhage"
},
{
"measure": "Aspiration pneumonia"
},
{
"measure": "Neurological disability"
},
{
"measure": "Systolic blood pressure"
},
{
"measure": "Diastolic blood pressure"
},
{
"measure": "Oxygen saturation"
}
]
},
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{
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}
],
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{
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]
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"Dysglycemia",
"Perioperative Complication",
"Circulatory; Complications"
]
},
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"city": "Copenhagen",
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"name": "Eske K Aasvang, MD, DMSc",
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"name": "Christian S Meyhoff, MD, PhD",
"phone": null,
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}
],
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"zip": "2400"
},
{
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"name": "Henrik Palm, MD, DMSc",
"phone": null,
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],
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"name": "Lars N Jørgensen, MD, DMSc",
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]
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"briefSummary": "The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.The main questions it aims to answer are:• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days."
},
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},
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"link": null,
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],
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"measure": "Agreement between glucose"
}
],
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{
"measure": "Agreement between glucose readings when at low glucose levels"
},
{
"measure": "Agreement between glucose readings when at normal glucose levels"
},
{
"measure": "Agreement between glucose readings when at high glucose levels"
}
]
},
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"name": "Rigshospitalet, Denmark"
},
{
"name": "Steno Diabetes Center Copenhagen"
},
{
"name": "Zealand University Hospital"
}
],
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"name": "University Hospital Bispebjerg and Frederiksberg"
}
},
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},
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}
}
} | false | null |
{
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]
},
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"briefSummary": "The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are:* Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)?* Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient?Participants in this study will not be receiving treatments. The study will involve:Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs.Assessing whether it can help save money and resources in the lab and pharmacy."
},
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"minimumAge": "18 Years",
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]
},
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"acronym": "ADAPT-AST",
"briefTitle": "ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing)",
"nctId": "NCT06297837",
"orgStudyIdInfo": {
"id": "LHS0205",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
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"measure": "The number of antimicrobial susceptibility results that 'should' spur action by a clinician on"
}
],
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"measure": "The number of days until a result that 'should' spur action by a clinician"
},
{
"measure": "The number of antimicrobial susceptibility results that 'could' spur action by a clinician on"
},
{
"measure": "The number of days until a result that 'could' spur action by a clinician"
},
{
"measure": "The projected health economic cost per specimen, including laboratory (e.g., consumable cost) and patient (e.g., drug toxicity, clinical failure) measures."
}
]
},
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"leadSponsor": {
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},
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"startDateStruct": {
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}
}
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{
"armsInterventionsModule": {
"interventions": [
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"name": "ERGT-A"
}
]
},
"conditionsModule": {
"conditions": [
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"Emotion Regulation",
"Adolescent - Emotional Problem"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": [
{
"email": "[email protected]",
"name": "Dimitar Krastev, MSc",
"phone": "+46735269516",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "MaiBritt Giacobini, PhD",
"phone": "+46709736662",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Prima Barn och Vuxenpsykiatri Handen och Järva",
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"lon": 18.0649
},
"state": "Spånga",
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"zip": "16374"
}
]
},
"descriptionModule": {
"briefSummary": "Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents."
},
"designModule": {
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},
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},
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],
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"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "ERGT-A",
"briefTitle": "Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm",
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"id": "2023-04909-01",
"link": null,
"type": null
},
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},
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"measure": "Feasibility measure, recruitment rate"
},
{
"measure": "Feasibility measures, proportion included"
},
{
"measure": "Feasibility measures, compliance"
},
{
"measure": "Feasibility measures, attrition"
},
{
"measure": "Feasibility measures, client satisfaction"
},
{
"measure": "Feasibility measures, negative effects of treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Preliminary effect, self harm frequency EOT"
},
{
"measure": "Preliminary effect, self harm frequency 1MFU"
},
{
"measure": "Preliminary effect, emotion dysregulation EOT"
},
{
"measure": "Preliminary effect, emotion dysregulation 1MFU"
}
]
},
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"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
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"date": "2025-06-30"
},
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"date": "2024-03-07"
},
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"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2023-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Trilaciclib Injection"
},
{
"name": "Paclitaxel"
},
{
"name": "Carboplatin"
}
]
},
"conditionsModule": {
"conditions": [
"Non-Small Cell Lung Cancer",
"Breast Cancer",
"Endometrial Cancer",
"Cervical Cancer",
"Head And Neck Squamous Cell Carcinomas"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": null,
"country": "China",
"facility": "Medical Oncology,Sun Yat-sen University Cancer Center",
"geoPoint": {
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"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510060"
}
]
},
"descriptionModule": {
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},
"designModule": {
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},
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},
"enrollmentInfo": {
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},
"phases": [
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Myeloprotection With Trilaciclib in Pan-cancer Population",
"nctId": "NCT06297811",
"orgStudyIdInfo": {
"id": "SMA PT 001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Occurrence of grade 3/4 neutropenia within 6 cycles"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Telerehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Drive",
"Musculoskeletal Diseases",
"Postural; Defect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sakarya",
"contacts": [
{
"email": "[email protected]",
"name": "Nurgul SEN, Master's degree",
"phone": "05344527440",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ceyhun TURKMEN, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Sakarya University of Applied Sciences",
"geoPoint": null,
"state": null,
"status": null,
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "30 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers",
"nctId": "NCT06297798",
"orgStudyIdInfo": {
"id": "SakaryaAppliedSciencesUPNS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MUSCLE SKELETAL SYSTEM ASSESSMENT"
}
],
"secondaryOutcomes": [
{
"measure": "Posture Measures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sakarya Applied Sciences University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gut-directed hypnotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"IBS - Irritable Bowel Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gothenburg",
"contacts": [
{
"email": "[email protected]",
"name": "Jenny Lövdahl",
"phone": "0313428107",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Mag-Tarmlab, Sahlgrenska University Hospital",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "RECRUITING",
"zip": "41345"
},
{
"city": "Gothenburg",
"contacts": null,
"country": "Sweden",
"facility": "Sahlgrenska University Hospital",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "RECRUITING",
"zip": "41345"
}
]
},
"descriptionModule": {
"briefSummary": "Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"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": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)",
"nctId": "NCT06297785",
"orgStudyIdInfo": {
"id": "2022-03997-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in gastrointestinal symptom severity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sahlgrenska University Hospital, Sweden"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Decitabine"
},
{
"name": "Fludarabine Injection"
},
{
"name": "Busulfan Injection"
}
]
},
"conditionsModule": {
"conditions": [
"AML, Adult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaoxia Hu",
"phone": "862164370045",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ruijin Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": "200025"
}
]
},
"descriptionModule": {
"briefSummary": "A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR",
"nctId": "NCT06297772",
"orgStudyIdInfo": {
"id": "RJBMT-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "disease-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "incidence of relapse rate"
},
{
"measure": "Non-recurrent mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ruijin Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Dementia"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale",
"nctId": "NCT06297759",
"orgStudyIdInfo": {
"id": "ATADEK-2023/16",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sense of Competence in Dementia Care Staff (SCIDS) Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Caring Behaviors Inventory-24"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Acibadem University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Yeditepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-07"
}
}
} | false | null |
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