protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin B12 Level"
}
]
},
"conditionsModule": {
"conditions": [
"Vitamin D Deficiency",
"B12 Deficiency Vitamin",
"Lipedema"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Gulcan Ozturk",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34752"
}
]
},
"descriptionModule": {
"briefSummary": "Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 200,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema",
"nctId": "NCT06338059",
"orgStudyIdInfo": {
"id": "Gulcanozturkchatipchousein",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Vitamin B12 Level"
},
{
"measure": "25 OH Vitamin D Level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fatih Sultan Mehmet Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Corthellus Shiitake(Mushroom) Extract"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Naples",
"contacts": null,
"country": "Italy",
"facility": "RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II",
"geoPoint": {
"lat": 40.85216,
"lon": 14.26811
},
"state": null,
"status": null,
"zip": "80131"
}
]
},
"descriptionModule": {
"briefSummary": "This double-blind placebo-controlled study intends to confirm skin adaptogen and sebum balance efficacy of the investigational active ingredient NC65 - Vita D-Light, transmitted at 0.5% w/w in a topical cosmetic formulation, on a panel of healthy human subjects.The study is performed by RD Cosmetics - University of Naples Federico II, from October to June 2024. The study involves female and male subjects, scheduled for eligibility screening at the study site. A total of 40 subjects were enrolled, and randomly divided into 2 groups: 20 subjects received the active treatment (cosmetic formulation with 0.5 %w/w NC65 - Vita D-Light) and 20 subjects the placebo one.The cosmetic effectiveness of the products was instrumentally detected, using innovative, non-invasive and worldwide recognized devices for skin analysis, like:* Corneometer CM 825 (C+K electronic GmbH) detects water's content of the stratum corneum.* Tewameter® TM Hex (C+K electronic GmbH) detects the trans-epidermal water loss (TEWL).* Sebumeter SM 815 accurately and reproducibly measures the level of sebum on the skin surface.* Visia VISIA® (Canfield Scientific, Inc.) for skin surface assessment.The monitored skin features parameters will be check after 1 hour (T1h) for the adaptogen test, and after 7, 14 and 28 days (T7 -T14-T28), for the detox test. Panelists will complete the self-assessment questionnaire at the end of the study period (T28)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "2 parallel arm, double blind, randomized, placebo-controlled",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "neither the patient nor the investigator knows who is getting which treatment.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Shitake",
"briefTitle": "In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY",
"nctId": "NCT06338046",
"orgStudyIdInfo": {
"id": "EAShi23M01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Soothing Test"
}
],
"secondaryOutcomes": [
{
"measure": "Detox and adaptogen Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ritamaria Di Lorenzo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Heart Failure With Preserved Ejection Fraction and Visceral Fat"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": null,
"country": "China",
"facility": "The First Affiliated Hospital of Chongqing Medical University",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 298,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction",
"nctId": "NCT06338033",
"orgStudyIdInfo": {
"id": "2024-03-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Composite endpoints of all-cause mortality and rehospitalization for heart failure"
}
],
"primaryOutcomes": [
{
"measure": "All-cause mortality"
}
],
"secondaryOutcomes": [
{
"measure": "Rehospitalization for heart failure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chongqing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-08-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-09-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adaptive variable-resistance training"
},
{
"name": "Standard physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Lymphoblastic Leukemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Al Kharj",
"contacts": null,
"country": "Saudi Arabia",
"facility": "Ragab K. Elnaggar",
"geoPoint": {
"lat": 24.15541,
"lon": 47.33457
},
"state": "Riyadh",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A prospective, dual-arm, randomized controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 62,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia",
"nctId": "NCT06338020",
"orgStudyIdInfo": {
"id": "RHPT/0022/0042",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Thigh muscle thickness"
},
{
"measure": "Muscle strength"
}
],
"secondaryOutcomes": [
{
"measure": "Fatigue"
},
{
"measure": "Six-minute walk test"
},
{
"measure": "4x10 meter Shuttle Run test"
},
{
"measure": "Timed up and down stairs test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hand Dynamometer"
},
{
"name": "Pulmonary Function Test"
},
{
"name": "Modified Frailty Index"
}
]
},
"conditionsModule": {
"conditions": [
"Complication,Postoperative",
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Gülay ÜLGER, specialist",
"phone": "05059532122",
"phoneExt": "+9",
"role": "CONTACT"
},
{
"email": null,
"name": "Onur KÜÇÜK, specialist",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Ankara Atatürk Sanatorium Training and Research Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Keçiören",
"status": null,
"zip": "06290"
}
]
},
"descriptionModule": {
"briefSummary": "The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes",
"nctId": "NCT06338007",
"orgStudyIdInfo": {
"id": "2012-KAEK-15/2702",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complication"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Atatürk Chest Diseases and Chest Surgery Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Memantine Hydrochloride"
}
]
},
"conditionsModule": {
"conditions": [
"Treatment of Posttraumatic Cognitive Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assiut",
"contacts": [
{
"email": "[email protected]",
"name": "Sherifa A Hamed, M.D.",
"phone": "+201115324560",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sherifa A Hamed, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Assiut University, Faculty of Medicine, Hospital of Neurology, Psychiatry and Neurosurgery",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": "RECRUITING",
"zip": "71516"
}
]
},
"descriptionModule": {
"briefSummary": "Posttraumatic consequences are common causes of disability and long-term morbidity. They include cognitive dysfunction, seizures, headache, dizziness, fatigue, sensory deficits, neurodegeneration and psychiatric disorders (e.g. posttraumatic stress disorder, depression, anxiety, etc). Diffuse axonal injury and disruption of normal neuronal function are the most common and important pathologic features of traumatic primary closed head injury. depression, anxiety, etc). Excitotoxicity and apoptosis caused by activation of N-methyl-D-aspartate (NMDA) glutamate receptors, are two main suggested mechanisms of traumatic neuronal cell death and posttraumtic neurologic adverse consequences. Experimental and clinical studies have demonstrated that memantine hydrochloride, NMDA-type glutamate receptor antagonist, could have beneficial effect in treatment of posttraumatic cognitive dysfunction. Memantine may contribute to cognitive improvements in TBI by decreasing the synaptic 'noise' resulting from excessive NMDA receptor activation, inhibition of β-amyloid mediated toxicity and readjustment of the balance between inhibition and excitation on neuronal networks in the central nervous system (CNS)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "parallel assignment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury",
"nctId": "NCT06337994",
"orgStudyIdInfo": {
"id": "AUH-Neurol-TBI_2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The severity of traumatic brain injury (TBI)"
},
{
"measure": "The symptoms of depression"
},
{
"measure": "The symptoms of anxiety"
},
{
"measure": "The cognitive function"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of life"
},
{
"measure": "The cognitive function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "(AJU-S56 5% and placebo)"
},
{
"name": "AJU-S56 5%"
},
{
"name": "Placebo(Vehicle)"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "AJU Pharm Co., Ltd.",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease."
},
"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": 99,
"type": "ACTUAL"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients",
"nctId": "NCT06337981",
"orgStudyIdInfo": {
"id": "21DE20901",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total corneal staining score (TCSS)"
}
],
"secondaryOutcomes": [
{
"measure": "LGCSS"
},
{
"measure": "TFBUT"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GL Pharm Tech Corporation"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "AJU Pharm Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-11-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-06-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Circum-psoas Block"
},
{
"name": "Sham block"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Pain",
"Opioid Use"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CPB for Arthroscopic Hip Surgery",
"nctId": "NCT06337968",
"orgStudyIdInfo": {
"id": "Circum-Psoas Block LN",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pain severity at 6 hours postoperatively"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative opioid consumption"
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "neurologic evaluation"
},
{
"measure": "Patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Second Hospital of Shandong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cytomegalovirus Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pavia",
"contacts": null,
"country": "Italy",
"facility": "Fondazione IRCCS Policlinico San Matteo",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": "PV",
"status": null,
"zip": "27100"
}
]
},
"descriptionModule": {
"briefSummary": "The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 204,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non Primary HCMV Infection: Natural History and Immune Response",
"nctId": "NCT06337955",
"orgStudyIdInfo": {
"id": "20170007596",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Potential use of saliva swabs for antibody determination."
}
],
"primaryOutcomes": [
{
"measure": "HCMV non-primary infection (reinfection or reactivation)."
}
],
"secondaryOutcomes": [
{
"measure": "HCMV-specific humoral and cell-mediated immune response during non-primary infection."
},
{
"measure": "Maternal behaviours and occurrence of non-primary infection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Università degli Studi di Pavia"
},
{
"name": "Merck Sharp & Dohme LLC"
},
{
"name": "Fondazione Regionale per la Ricerca Biomedica (FRRB) - Regione Lombardia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Foundation IRCCS San Matteo Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-06-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bladder Transplantation"
},
{
"name": "Combined Kidney and Bladder Transplantation"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Disease",
"Bladder, Neurogenic",
"Bladder Cancer",
"Kidney Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Magdalena Mendez-Smith",
"phone": "310-267-7727",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nima Nassiri, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UCLA",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90095"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are:* Is human bladder transplantation feasible and safe?* How will the new bladder function in terms of storage and emptying?Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 5,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study",
"nctId": "NCT06337942",
"orgStudyIdInfo": {
"id": "23-001621",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Demonstrating the technical success of bladder or combined kidney-bladder transplantation"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of adverse events after bladder or combined kidney-bladder transplantation"
},
{
"measure": "Incidence of immune rejection after bladder or combined kidney-bladder transplantation"
},
{
"measure": "Evaluate the functionality of the transplanted bladder"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Los Angeles"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CAPOEIRA TRAINING"
},
{
"name": "CONTROL GROUP"
}
]
},
"conditionsModule": {
"conditions": [
"Training",
"Mental Health",
"Physical Fitness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Petrolina",
"contacts": null,
"country": "Brazil",
"facility": "UNIVASF",
"geoPoint": {
"lat": -9.39861,
"lon": -40.50083
},
"state": "Pernambuco",
"status": null,
"zip": "56300000"
}
]
},
"descriptionModule": {
"briefSummary": "Regular physical activity (PA) promotes benefits for both physical and mental health. Among the numerous PA\\'s with a collective nature that can add to the existing recommendations, combat sports training interventions are viable alternatives since they integrate benefits in different aspects for health. In this way, capoeira can be a strategy for the prescription of exercise, aiming to serve participants collectively and maintaining the adherence of this practitioner to the intervention. However, little is known about this issue. So, the aim of the present study is to verify the effect of 12 weeks of capoeira training on the physical performance and psychological aspects of previously physically inactive adults."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "59 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Capoeira on the Physical and Psychological Performance of Adults",
"nctId": "NCT06337929",
"orgStudyIdInfo": {
"id": "Ethics Approval: n. 6.683.936",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline in aerobic fitness (maximal oxygen uptake and anaerobic threshold) at week 12"
},
{
"measure": "Change from baseline in anaerobic fitness (Peak, average and minimum power in the Wingate test) at week 12"
},
{
"measure": "Change from baseline in muscle strength (Horizontal Leg Press) at week 12"
},
{
"measure": "Change from baseline in muscle power (Vertical Jump Tests from Squat Jump and Counter Movement Jump) on force platform at week 12"
},
{
"measure": "Change from baseline in balance (Center of Pressure) on force platform at week 12"
},
{
"measure": "Change from baseline in motor coordination (Test of Gross Motor Development) at week 12"
},
{
"measure": "Change from baseline in Emotional Intelligence to sport (Likert-type scales with 26 items) at week 12"
},
{
"measure": "Change from baseline in Motivation for Sport II (Likert-type scales with 18 items) at week 12"
},
{
"measure": "Change from baseline in Quality of life measuring by Questionnaire of Word Health Organization (WHOQOL-bref) at week 12"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidade Federal do vale do São Francisco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cervical Stabilization Exercise"
},
{
"name": "Cervical Standard Exercise Group"
}
]
},
"conditionsModule": {
"conditions": [
"Neck Pain",
"Chronic Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zonguldak",
"contacts": null,
"country": "Turkey",
"facility": "Zonguldak Bülent Ecevit University",
"geoPoint": {
"lat": 41.45139,
"lon": 31.79305
},
"state": null,
"status": null,
"zip": "67100"
}
]
},
"descriptionModule": {
"briefSummary": "Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, \\<6 weeks; subacute, ≤3 months; chronic, \\>3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain",
"nctId": "NCT06337916",
"orgStudyIdInfo": {
"id": "2021/16-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "assessment of cervical joint position sense"
}
],
"secondaryOutcomes": [
{
"measure": "assessment of cervical range of motion"
},
{
"measure": "assessment of neck disability"
},
{
"measure": "assessment of pain"
},
{
"measure": "assessment of life quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Zonguldak Bulent Ecevit University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Şenay Özdolap"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-11-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Self-compassion intervention (the Mindful Self-Compassion course)"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis",
"Self-Compassion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": null,
"name": "Robert Simpson, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Unity Health Toronto",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study",
"nctId": "NCT06337903",
"orgStudyIdInfo": {
"id": "Self-compassion for PwMS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recruitment"
},
{
"measure": "Retention"
},
{
"measure": "Adherence"
},
{
"measure": "Follow-up rates"
}
],
"secondaryOutcomes": [
{
"measure": "Stress"
},
{
"measure": "Anxiety"
},
{
"measure": "Depression"
},
{
"measure": "Self-compassion"
},
{
"measure": "Emotion Regulation"
},
{
"measure": "Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)"
},
{
"measure": "Participant Experiences and Perspectives"
},
{
"measure": "Adjustment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Robert Simpson"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Zero contrast FEVAR"
}
]
},
"conditionsModule": {
"conditions": [
"Aortic Aneurysm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Enrico Gallitto, MD, PhD",
"phone": "+390512143288",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "University of Bologna",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": "Emilia Romagna",
"status": "RECRUITING",
"zip": "40138"
}
]
},
"descriptionModule": {
"briefSummary": "Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results.Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up. One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).Automated carbon dioxide (CO2) angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.In adjunct, hybrid room and fusion imaging (FI) technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time.In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms.The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR.",
"nctId": "NCT06337890",
"orgStudyIdInfo": {
"id": "FEZECO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of technical success"
},
{
"measure": "Reintervention and mortality"
},
{
"measure": "Number of participants with perioperative renal function worsening"
},
{
"measure": "Rate of TVVs instability"
},
{
"measure": "Rate of survival"
},
{
"measure": "Rate of reintervention"
},
{
"measure": "Number of participants with renal function worsening"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Bologna"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Depth of sedation monitoring"
}
]
},
"conditionsModule": {
"conditions": [
"Sedation Complication",
"Acute Respiratory Distress Syndrome Due to COVID-19",
"Anesthesia Awareness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İ̇zmi̇r",
"contacts": null,
"country": "Turkey",
"facility": "Aykut Saritaş",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": null,
"status": null,
"zip": "35640"
}
]
},
"descriptionModule": {
"briefSummary": "\"In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used.\""
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 52,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis",
"nctId": "NCT06337877",
"orgStudyIdInfo": {
"id": "pEEG ARDS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To determine the sedation levels of patients during paralysis"
},
{
"measure": "The prevalence of inadequate or excessive sedation,"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tepecik Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PreKUnil® LNAA Medical Food for PKU"
}
]
},
"conditionsModule": {
"conditions": [
"Brain Diseases",
"Brain Diseases, Metabolic",
"Brain Diseases, Metabolic, Inborn",
"Genetic Diseases, Inborn",
"Metabolism, Inborn Errors",
"Amino Acid Metabolism, Inborn Errors",
"Metabolic Disease",
"Phenylketonurias"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Olivia Welle Fjellbirkeland, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Copenhagen University Hospital, Rigshospitalet",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This research investigates the effectiveness and safety of large neutral amino acid (LNAA) supplementation in patients with classical phenylketonuria (PKU). Advanced brain imaging techniques alongside comprehensive neuropsychological and functional assessments will be employed. Short-term and long-term follow-up of participants will be conducted."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "To fully assess the effectiveness of LNAA, the following trials will be conducted:1. A crossover study comparing LNAA supplementation to no treatment2. A crossover study comparing LNAA supplementation to the Phe-free PKU diet3. Open-label extension study to assess the long-term safety and efficacy of LNAA supplementation4. Healthy control group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating the Efficacy and Safety of Large Neutral Amino Acids in the Treatment of Classical Phenylketonuria",
"nctId": "NCT06337864",
"orgStudyIdInfo": {
"id": "H-24017055",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Fasting plasma amino acids, dried blood spots (finger-prick method)"
},
{
"measure": "Brain perfusion measures"
},
{
"measure": "Adherence to dietary treatment"
},
{
"measure": "Brain Magnetic Resonance Imaging (MRI)"
},
{
"measure": "Wechsler Adult Intelligence Scale (WAIS) - IV"
}
],
"primaryOutcomes": [
{
"measure": "Dynamic positron emission tomography (PET) imaging with the fluorine-18-labeled tracer [18F]-(E)-N-(3-iodoprop-2-enyl)-2β-carbofluoroethoxy-3β-(4'-methyl phenyl)nortropane ([18F]FE-PE2I)"
},
{
"measure": "Computerized neuropsychological testing (responses over study iPad)"
}
],
"secondaryOutcomes": [
{
"measure": "Behaviour Rating Inventory of Executive Function - Adult version (BRIEF-A)"
},
{
"measure": "Behaviour Rating Inventory of Executive Function - Second edition (BRIEF-2)"
},
{
"measure": "Adult attention deficit hyperactivity disorder (ADHD) Self-Report Scale (ASRS v1.1)"
},
{
"measure": "Adolescent ADHD Self-Report Scale"
},
{
"measure": "PKU-QOL Questionnaire Adolescent or Adult version"
},
{
"measure": "Symptom Checklist-90-Revised (SCL-90-R)"
},
{
"measure": "Behavior Assessment System for Children, Third Edition (BASC-3)"
},
{
"measure": "Neuropsychological testing of flexibility and verbal fluency"
},
{
"measure": "Urine peripheral biomarkers of neurotransmitters"
},
{
"measure": "Incidence and severity of treatment-emergent adverse events (TEAEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Simultaneous burr hole craniostomy"
},
{
"name": "Consecutive burr hole craniostomy"
}
]
},
"conditionsModule": {
"conditions": [
"Subdural Hematoma, Chronic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Izmir",
"contacts": null,
"country": "Turkey",
"facility": "Izmir Ataturk Training and Research Hospital",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": null,
"status": null,
"zip": "35360"
}
]
},
"descriptionModule": {
"briefSummary": "Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDHExclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgeryRandomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "a prospective randomized controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 43,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma",
"nctId": "NCT06337851",
"orgStudyIdInfo": {
"id": "AtaturkTRH2003/9",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Primary Outcome: Mortality"
},
{
"measure": "The Primary Outcome: Early Postoperative Success Rate (Redo Surgery)"
}
],
"secondaryOutcomes": [
{
"measure": "The secondary outcome: Follow-up assessment (Age)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Sex)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Trauma-Relation)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Concomitant Pathologies)"
},
{
"measure": "The secondary outcome: Follow-up assessment (The Glasgow Coma Scale)"
},
{
"measure": "The secondary outcome: Follow-up assessment (The Markwalder Grading Scale)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Neurological Examination - Motor)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift)"
},
{
"measure": "The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2011-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2010-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2003-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Desmopressin Injectable Solution"
},
{
"name": "Tranexamic Acid Injectable Product"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Kidney Diseases",
"Acute Kidney Injury",
"Bleeding",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Study drugs will be sourced locally and will be prepared by appropriately qualified center personnel who are independent of the study team to ensure blinding is maintained.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BRACKETS",
"briefTitle": "Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial",
"nctId": "NCT06337838",
"orgStudyIdInfo": {
"id": "2024.BRACKETS-Pilot",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of recruitment"
},
{
"measure": "Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial"
},
{
"measure": "Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial"
},
{
"measure": "Completion of 30-day follow-up"
}
],
"secondaryOutcomes": [
{
"measure": "Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS)"
},
{
"measure": "Reoperation for reasons of bleeding"
},
{
"measure": "Blood (red blood cells or whole blood) transfused"
},
{
"measure": "Blood (red blood cells or whole blood) transfused"
},
{
"measure": "Any blood transfusion (red blood cells or whole blood)"
},
{
"measure": "Any blood transfusion (red blood cells or whole blood)"
},
{
"measure": "Lowest measured hemoglobin concentration"
},
{
"measure": "Most recent hemoglobin concentration"
},
{
"measure": "Death"
},
{
"measure": "Major arterial and venous thrombosis"
},
{
"measure": "Myocardial Injury after Noncardiac Surgery (MINS)"
},
{
"measure": "Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction"
},
{
"measure": "MINS that is an isolated ischemic troponin elevation"
},
{
"measure": "Stroke"
},
{
"measure": "Non-hemorrhagic stroke"
},
{
"measure": "Hemorrhagic stroke"
},
{
"measure": "Peripheral arterial thrombosis"
},
{
"measure": "Thrombosis of arteriovenous fistula or graft"
},
{
"measure": "Symptomatic proximal venous thromboembolism"
},
{
"measure": "Symptomatic pulmonary embolism"
},
{
"measure": "Symptomatic proximal leg or arm deep venous thrombosis (DVT)"
},
{
"measure": "Non-fatal cardiac arrest"
},
{
"measure": "Coronary revascularization procedure"
},
{
"measure": "Clinically important atrial fibrillation or flutter"
},
{
"measure": "Acute heart failure"
},
{
"measure": "Acute kidney injury (for patients not receiving dialysis before surgery)"
},
{
"measure": "New start of dialysis"
},
{
"measure": "Seizure"
},
{
"measure": "Clinically significant intraoperative hypotension"
},
{
"measure": "Clinically significant postoperative hypotension"
},
{
"measure": "Sepsis"
},
{
"measure": "Duration of surgery"
},
{
"measure": "Receipt of platelets"
},
{
"measure": "Receipt of fibrinogen"
},
{
"measure": "Receipt of fresh frozen plasma"
},
{
"measure": "Receipt of cryoprecipitate"
},
{
"measure": "Receipt of recombinant Factor VIIa"
},
{
"measure": "Receipt of prothrombin complex concentrate"
},
{
"measure": "Prescribed erythropoiesis stimulating agent"
},
{
"measure": "Severe hyponatremia"
},
{
"measure": "Duration of hospital stay after surgery"
},
{
"measure": "Duration of critical care stay after surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Population Health Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Activity Tracker (Fitbit)"
},
{
"name": "HbA1C"
},
{
"name": "The PROMPT Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Hyperparathyroidism",
"Multinodular Goiter"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cleveland",
"contacts": null,
"country": "United States",
"facility": "The Cleveland Clinic Foundation",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": null,
"zip": "44195"
}
]
},
"descriptionModule": {
"briefSummary": "Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated."
},
"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": "Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism",
"nctId": "NCT06337825",
"orgStudyIdInfo": {
"id": "22-727",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in resting heart rate over time among study participants as monitored by fitness tracker"
},
{
"measure": "Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker"
},
{
"measure": "Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker"
},
{
"measure": "Change in steps over time among study participants as monitored by fitness tracker"
},
{
"measure": "Change in total active minutes over time among study participants as monitored by fitness tracker"
},
{
"measure": "Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker"
},
{
"measure": "Change in glucose levels (HbA1C)"
},
{
"measure": "Correlation of Quality of Life surveys with the PROMPT survey"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Cleveland Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-07-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Potato Starch"
}
]
},
"conditionsModule": {
"conditions": [
"Type2diabetes",
"Heart Failure With Preserved Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ann Arbor",
"contacts": [
{
"email": "[email protected]",
"name": "Hayley Billingsley, PhD",
"phone": "734-726-0308",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Scott Hummel, MD, MS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Michigan",
"geoPoint": {
"lat": 42.27756,
"lon": -83.74088
},
"state": "Michigan",
"status": null,
"zip": "48109"
}
]
},
"descriptionModule": {
"briefSummary": "The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)",
"nctId": "NCT06337812",
"orgStudyIdInfo": {
"id": "HUM00240473",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool"
},
{
"measure": "Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma"
},
{
"measure": "Changes in propionate levels - stool"
},
{
"measure": "Changes in propionate levels- plasma"
},
{
"measure": "Changes in acetate levels- stool"
},
{
"measure": "Changes in acetate levels- plasma"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Michigan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Research Pharmacist"
}
]
},
"conditionsModule": {
"conditions": [
"Preeclampsia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.Participants will:Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Use of Allied-health Professionals to Improve Treatment of Disease",
"nctId": "NCT06337799",
"orgStudyIdInfo": {
"id": "202210411",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Subjects at Risk for Hypertension"
},
{
"measure": "Number of Subjects Exposed to a Screening Clinic"
},
{
"measure": "Number of Subjects Screened at a Screening Clinic"
},
{
"measure": "Number of Subjects Followed-Up by the Research Pharmacist"
},
{
"measure": "Number of Subjects Diagnosed with Hypertension"
},
{
"measure": "Number of Subjects Treated for Hypertension, if Diagnosed"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Iowa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2026-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital app RB4.1"
},
{
"name": "Control arm"
}
]
},
"conditionsModule": {
"conditions": [
"Rheumatoid Arthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Frederiksberg",
"contacts": [
{
"email": "[email protected]",
"name": "Tanja Schjødt Jørgensen",
"phone": "+4538164173",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Lars Erik Kristensen",
"phone": "+4538164157",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "The Parker Institute, Bispebjerg and Frederiksberg Hospital",
"geoPoint": {
"lat": 55.67938,
"lon": 12.53463
},
"state": "Copenhagen F",
"status": null,
"zip": "2000"
}
]
},
"descriptionModule": {
"briefSummary": "Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population (1). RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability.There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease.The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual.The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The trial is an open-label matched register controlled clinical trial with two parallel groups (intervention and matched controls from the DANBIO register).The number of study participants is 40 in the intervention arm and up to 120 in the matched control arm.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "74 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis",
"nctId": "NCT06337786",
"orgStudyIdInfo": {
"id": "MSK-2023-TSJ1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Medication Adherence"
},
{
"measure": "Better alignment between patient and health care professionals"
}
],
"primaryOutcomes": [
{
"measure": "Primary Outcome"
}
],
"secondaryOutcomes": [
{
"measure": "Disease-activity Score28 using C-reactive protein (DAS28-CRP)"
},
{
"measure": "Self-Efficacy"
},
{
"measure": "Pain and Fatigue"
},
{
"measure": "Health related quality of life"
},
{
"measure": "Physical function/activity"
},
{
"measure": "Well-Being"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eurostars"
},
{
"name": "DAMAN"
},
{
"name": "Medical University of Vienna"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Henning Bliddal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "8-weeks's on-line precision nursing education program"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is aimed to demonstrate the long-term effectiveness of 8-week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors",
"nctId": "NCT06337773",
"orgStudyIdInfo": {
"id": "B-BR-112-036",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The depression symptoms on young colorectal cancer survivors"
}
],
"secondaryOutcomes": [
{
"measure": "Dispositional mindfulness status on young colorectal cancer survivors"
},
{
"measure": "General quality of life on young colorectal cancer survivors"
},
{
"measure": "Colorectal specific quality of life on young colorectal cancer survivors"
},
{
"measure": "Cancer threat appraisal on young colorectal cancer survivors"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fooyin University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Neuroendocrine Neoplasm",
"Adenocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Lorenzo Gervaso, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chiara Alessandra Cella, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Luca Mazzarella, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "European Institute of Oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition \"adolescent and young adults (AYA)\" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "39 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "YOUNGSTER",
"briefTitle": "YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.",
"nctId": "NCT06337760",
"orgStudyIdInfo": {
"id": "IEO 1669",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numbers of partecipants with genetic alterations"
}
],
"secondaryOutcomes": [
{
"measure": "Number of partecipants with survival outcomes"
},
{
"measure": "Number of partecipants toxicities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional technique"
},
{
"name": "Experimental technique"
}
]
},
"conditionsModule": {
"conditions": [
"Aging"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montreal",
"contacts": [
{
"email": "[email protected]",
"name": "Andreas Nikolis, MD",
"phone": "514-488-0163",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Erevna Innovations Inc",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "H3R 3A1"
}
]
},
"descriptionModule": {
"briefSummary": "The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "A prospective, randomized-controlled trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline",
"nctId": "NCT06337747",
"orgStudyIdInfo": {
"id": "04-2023-PLLA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To access the efficacy of the tradition and experimental technique"
}
],
"secondaryOutcomes": [
{
"measure": "To access the safety of the tradition and experimental technique"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erevna Innovations Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AI-Driven Lifestyle Coaching Program"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "La Jolla",
"contacts": null,
"country": "United States",
"facility": "University of California, San Diego",
"geoPoint": {
"lat": 32.84727,
"lon": -117.2742
},
"state": "California",
"status": null,
"zip": "92093"
}
]
},
"descriptionModule": {
"briefSummary": "This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 141,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension",
"nctId": "NCT06337734",
"orgStudyIdInfo": {
"id": "2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Average change in systolic blood pressure (SBP) from baseline to 12 weeks"
},
{
"measure": "Average change in diastolic blood pressure (DBP) from baseline to 12 weeks"
},
{
"measure": "Average change in SBP from baseline to 24 weeks"
},
{
"measure": "Average change in DBP from baseline to 24 weeks"
},
{
"measure": "Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks"
},
{
"measure": "Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks"
},
{
"measure": "Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks"
},
{
"measure": "Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Average weekly percentage of active participants measuring their BP"
},
{
"measure": "Average weekly percentage of active participants syncing their wearable"
},
{
"measure": "Average weekly percentage of active participants answering the mobile app questionnaire"
},
{
"measure": "Number of manual clinician outreaches based on the escalation rules set for the study"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Diego"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Use Disorder",
"Alcohol; Harmful Use"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Riverside",
"contacts": null,
"country": "United States",
"facility": "UC Riverside",
"geoPoint": {
"lat": 33.95335,
"lon": -117.39616
},
"state": "California",
"status": null,
"zip": "91784"
}
]
},
"descriptionModule": {
"briefSummary": "This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Will conduct a randomized controlled trial of the SPEAR intervention vs. control group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults",
"nctId": "NCT06337721",
"orgStudyIdInfo": {
"id": "R01AA030786",
"link": "https://reporter.nih.gov/quickSearch/R01AA030786",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Heavy Episodic Drinking (HED) Days"
}
],
"secondaryOutcomes": [
{
"measure": "Alcohol Consumption"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Riverside"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Smart Walk"
},
{
"name": "Fitbit"
}
]
},
"conditionsModule": {
"conditions": [
"Physical Activity",
"Exercise",
"Heart Diseases",
"Diabetes Mellitus",
"Physical Inactivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phoenix",
"contacts": [
{
"email": "[email protected]",
"name": "Carina Platte, PhD",
"phone": "602-543-2213",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rodney Joseph, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Arizona State University",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85004"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "24 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women",
"nctId": "NCT06337708",
"orgStudyIdInfo": {
"id": "STUDY00017286",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01HL168170",
"link": "https://reporter.nih.gov/quickSearch/R01HL168170",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Treatment acceptance"
},
{
"measure": "Protocol Adherence"
},
{
"measure": "Program costs"
},
{
"measure": "Participant costs"
},
{
"measure": "Cost-effectiveness"
},
{
"measure": "Objectively-measured home neighborhood characteristics"
},
{
"measure": "Subjectively-measured Neighborhood environment walkability"
},
{
"measure": "Race-related Stress"
},
{
"measure": "Perceived Structural Racism"
}
],
"primaryOutcomes": [
{
"measure": "Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months"
},
{
"measure": "Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months"
}
],
"secondaryOutcomes": [
{
"measure": "Change in cardiorespiratory fitness from baseline to 4- and 12-months"
},
{
"measure": "Change in aortic pulse wave velocity from baseline to 4- and 12-months"
},
{
"measure": "Change in body weight from baseline to 4- and 12-months."
},
{
"measure": "Change in body mass index from baseline to 4- and 12-months"
},
{
"measure": "Change in waste circumference from baseline to 4- and 12-months"
},
{
"measure": "Change in blood pressure (mmHG) from baseline to 4- and 12-months"
},
{
"measure": "Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months"
},
{
"measure": "Change in interleukin 6 (IL-6) from baseline to 4- and 12-months"
},
{
"measure": "Change in interleukin 10 (IL-10) from baseline to 4- and 12-months"
},
{
"measure": "Change in interleukin 15 (IL-15) from baseline to 4- and 12-months"
},
{
"measure": "Change in fasting blood glucose glucose from baseline to 4- and 12-months"
},
{
"measure": "Change in serum insulin from baseline to 4- and 12-months"
},
{
"measure": "Change in serum lipids (mg/DL) from baseline to 4- and 12-months"
},
{
"measure": "Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months"
},
{
"measure": "Change in exercise self-efficacy from baseline to 4- and 12-months"
},
{
"measure": "Change in self-regulation for physical activity from baseline to 4- and 12-months"
},
{
"measure": "Change in social support for physical activity from baseline to 4- and 12-months"
},
{
"measure": "Change in outcome expectations for physical activity from baseline to 4- and 12-months"
},
{
"measure": "Change in behavioral capability for physical activity from baseline to 4- and 12-months"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Arizona State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vedolizumab"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer",
"Cancer Metastatic"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A Randomized, Double-Blinded, Placebo Controlled Trial",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 298,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer",
"nctId": "NCT06337695",
"orgStudyIdInfo": {
"id": "HREBA.CC-23-0271",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of patients with histologically confirmed colitis-free survival at 6 months"
},
{
"measure": "Proportion of patients with severe diarrhea or colitis at 6 months"
},
{
"measure": "Hazard Ratio of patients with diarrhea or colitis after 6 months"
},
{
"measure": "Total average dose of checkpoint inhibitor therapy received within 6 and 12 months"
},
{
"measure": "Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs)"
},
{
"measure": "Proportion of participants who require permanent ICI discontinuation due to irAEs"
},
{
"measure": "Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis"
},
{
"measure": "Total average prednisone equivalent dose of rescue corticosteroids required"
},
{
"measure": "Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365"
},
{
"measure": "Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365"
},
{
"measure": "Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline"
},
{
"measure": "Overall survival (measured as death) at +180 and Day +365 compared to baseline"
},
{
"measure": "Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176"
},
{
"measure": "Proportion of participants experiencing any adverse events (AEs)"
},
{
"measure": "Proportion of participants experiencing serious AEs"
},
{
"measure": "Proportion of participants experiencing other irAEs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Calgary"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Aging",
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bradford",
"contacts": null,
"country": "United Kingdom",
"facility": "Academic Unit for Ageing and Stroke Research",
"geoPoint": {
"lat": 53.79391,
"lon": -1.75206
},
"state": "West Yorkshire",
"status": null,
"zip": "BD9 6RJ"
}
]
},
"descriptionModule": {
"briefSummary": "The UK care home population is projected to increase significantly over the coming decades. A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication. This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure. Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life. The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population. It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 3000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BPITCH",
"briefTitle": "Blood Pressure Management in the Care Home Population",
"nctId": "NCT06337682",
"orgStudyIdInfo": {
"id": "CB_CY_P09_23_11",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "change in systolic pressure following care home admission"
}
],
"primaryOutcomes": [
{
"measure": "Frequency of blood pressure measurements"
},
{
"measure": "change in antihypertensive medication"
},
{
"measure": "Injurious falls"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of hypertension"
},
{
"measure": "Antihypertensive medication"
},
{
"measure": "Blood pressure treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bradford Teaching Hospitals NHS Foundation Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Leeds"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2020-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Muscular Dystrophy, Duchenne"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Stefano C Previtali, MD",
"phone": "00390226433036",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Dept. of Neurology, IRCCS Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "To characterize the clinical phenotype and possible predictive/prognostic factors of patients with Duchenne muscular dystrophy (DMD) due to duplication of exon 2 (Dup2). Specifically, we aim 1) to describe the progression of motor, respiratory and cardiac function; 2) to enquire if the phenotypic spectrum of Dup2 is milder than classic DMD, 3) to perform whole genome sequencing (WGS) to characterize DNA breakpoints to correlate with the phenotype; 4) to collect material for future proteomic/transcriptomic studies.Background/Rationale DMD is caused by mutations in the DMD gene and in 11% of cases is due to duplications. The most promising therapeutic approaches include mutation-specific therapies. Notably, there is increasing evidence that specific groups of mutations may underlie different disease trajectories compared to the \"average\" DMD population. It is thus mandatory to have more information on genotype-phenotype correlations and patterns of progression related to different genotypes.Dup2 is the most common DMD duplication and the only one for which a AAV-mediated exon skipping study is ongoing. Despite most case series and databases ascribe Dup2 to severe phenotype, our preliminary findings sustain that these patients have collectively a milder progression of the disease and in 1/3 of cases a significantly milder phenotype. Moreover, our attempts to reveal mechanism involved in attenuating the phenotype would confute the hypothesis of alternative spicing transcripts as previously described for DMD with deletion of exon 2.Research design and methods Clinical information regarding a cohort of 26 Italian Dup2 patients will be collected. Differences in time to loss of ambulation compared to a DMD control group will be achieved. Finally, we will retrieve DNA for correlative WGS studies.Anticipated output We expect that Dup2 patients present a milder DMD phenotype , which might be predicted by genomic studies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 26,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DMDDup2",
"briefTitle": "Characterization of DupEx2 Duchenne Muscular Dystrophy",
"nctId": "NCT06337669",
"orgStudyIdInfo": {
"id": "OSRSCP-GUP21006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Age at loss of ambulation"
}
],
"secondaryOutcomes": [
{
"measure": "Time test for motor function"
},
{
"measure": "Respiratory function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Galileo WBV"
}
]
},
"conditionsModule": {
"conditions": [
"Liver Cirrhosis"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "* Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia* Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"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": "VITAL",
"briefTitle": "Vibration Training Approach in Liver Cirrhosis",
"nctId": "NCT06337656",
"orgStudyIdInfo": {
"id": "VITAL_0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the Effectiveness on muscle strength"
},
{
"measure": "Evaluation of the Effectiveness on muscle strength"
},
{
"measure": "Evaluation of the Effectiveness on muscle strength"
},
{
"measure": "Evaluation of the Effectiveness on muscle strength"
},
{
"measure": "Evaluation of the Effectiveness on muscle mass"
},
{
"measure": "Evaluation of the Effectiveness on muscle thickness"
},
{
"measure": "Evaluation of the Effectiveness on mobility, in particular the risk of falling"
},
{
"measure": "Evaluation of the Effectiveness on physical function"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of Safety of the Training Method"
},
{
"measure": "Health-Related Quality of Life"
},
{
"measure": "Health-Related Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital of Cologne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MVX01"
},
{
"name": "MVX01 Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Pneumococcal Vaccine"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Savannah",
"contacts": null,
"country": "United States",
"facility": "Velocity (Meridian) Clinical Research",
"geoPoint": {
"lat": 32.08354,
"lon": -81.09983
},
"state": "Georgia",
"status": null,
"zip": "31406"
},
{
"city": "Knoxville",
"contacts": null,
"country": "United States",
"facility": "Alliance for Multispecialty Research (AMR)",
"geoPoint": {
"lat": 35.96064,
"lon": -83.92074
},
"state": "Tennessee",
"status": null,
"zip": "37909"
}
]
},
"descriptionModule": {
"briefSummary": "The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Cohort 1 is open-label. Cohorts 2-5 include two open-label sentinel participants each and the remainder of the participants are randomized and double-blind to either MVX01 or MVX01 Placebo (Participant \\& Site).",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine",
"nctId": "NCT06337643",
"orgStudyIdInfo": {
"id": "MVX01-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of immediate reactogenicity adverse events"
},
{
"measure": "Incidence of solicited reactogenicity events"
},
{
"measure": "Incidence of adverse events (AEs)"
},
{
"measure": "Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI)"
},
{
"measure": "Changes in safety laboratory results compared to baseline"
},
{
"measure": "Changes in vital signs compared to baseline"
},
{
"measure": "Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Matrivax Research and Development Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PLX038 + Tuvusertib"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "François-Clément BIDARD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "François-Clément BIDARD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Institut Curie",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75005"
},
{
"city": "Saint-Cloud",
"contacts": [
{
"email": "[email protected]",
"name": "François-Clément BIDARD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "François-Clément BIDARD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Institut Curie",
"geoPoint": {
"lat": 48.84598,
"lon": 2.20289
},
"state": null,
"status": null,
"zip": "92210"
}
]
},
"descriptionModule": {
"briefSummary": "Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 92,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "POP-ART",
"briefTitle": "A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors",
"nctId": "NCT06337630",
"orgStudyIdInfo": {
"id": "IC 2022-10",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose escalation step : Dose limiting toxicities (DLTs)"
},
{
"measure": "Expansion cohorts : Best tumor response"
},
{
"measure": "Expansion cohorts : Serious Adverse Events (SAEs)"
},
{
"measure": "Expansion cohorts : Adverse Events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib"
},
{
"measure": "Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib"
},
{
"measure": "Dose escalation step : objective response rate (ORR)"
},
{
"measure": "Dose escalation step : Time to response (TTR)"
},
{
"measure": "Dose escalation step : Duration of Response (DoR)"
},
{
"measure": "Dose escalation step : Progression free survival (PFS)"
},
{
"measure": "Expansion cohorts : Time to response (TTR)"
},
{
"measure": "Expansion cohorts : Duration of Response (DoR)"
},
{
"measure": "Expansion cohorts : Progression free survival (PFS)"
},
{
"measure": "Expansion cohorts : Overall Survival (OS)"
},
{
"measure": "Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups"
},
{
"measure": "Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib"
},
{
"measure": "Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib"
},
{
"measure": "Exploratory endpoints"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ProLynx LLC"
},
{
"name": "Merck Sharp & Dohme LLC"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Institut Curie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"BRAF V600 Mutation Positive Melanoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Novartis",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": "201203"
}
]
},
"descriptionModule": {
"briefSummary": "This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record."
},
"designModule": {
"designInfo": {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
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"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 90,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma",
"nctId": "NCT06337617",
"orgStudyIdInfo": {
"id": "CDRB436B2407",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Real-world overall response rate (rwORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Mean Age"
},
{
"measure": "Percentage of patients per sex"
},
{
"measure": "Number of years of disease history at treatment initiation since initial melanoma diagnosis"
},
{
"measure": "Number and percentage of patients per anatomic sites of origin"
},
{
"measure": "Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis"
},
{
"measure": "Number and percentage of patients per tumor stage"
},
{
"measure": "Number and percentage of patients with occurrence of tumor metastasis"
},
{
"measure": "Number and percentage of patients per metastatic location"
},
{
"measure": "Number and percentage of patients per metastases"
},
{
"measure": "Lactate dehydrogenase (LDH) levels"
},
{
"measure": "Eastern Cooperative Oncology Group (ECOG) performance status"
},
{
"measure": "Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment"
},
{
"measure": "Number and percentage of patients per type of surgery"
},
{
"measure": "Number and percentage of patients per name of surgery"
},
{
"measure": "Number and percentage of patients per surgical and medical procedure"
},
{
"measure": "Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment"
},
{
"measure": "Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent"
},
{
"measure": "Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting"
},
{
"measure": "Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment"
},
{
"measure": "Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type"
},
{
"measure": "Number and percentage of patients per reason for immunotherapy discontinuation"
},
{
"measure": "Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response"
},
{
"measure": "Number and percentage of patients per prior anti-neoplastic drug for melanoma"
},
{
"measure": "Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment"
},
{
"measure": "Number and percentage of patients with prior radiotherapy for melanoma per treatment intent"
},
{
"measure": "Number and percentage of patients with prior radiotherapy for melanoma per treatment setting"
},
{
"measure": "Number and percentage of patients per radiation site"
},
{
"measure": "Mean total dosage for all radiotherapy"
},
{
"measure": "Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response"
},
{
"measure": "Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment"
},
{
"measure": "Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent"
},
{
"measure": "Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting"
},
{
"measure": "Number and percentage of patients per type of D+T treatment change"
},
{
"measure": "Number and percentage of patients per reason for D+T treatment change"
},
{
"measure": "Mean duration of D+T, if not ongoing to end of study follow-up"
},
{
"measure": "rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS)"
},
{
"measure": "Real-world disease control rate (rwDCR) of D+T (FAS)"
},
{
"measure": "Real-world duration of response (rwDOR) of dabrafenib plus trametinib"
},
{
"measure": "Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS)"
},
{
"measure": "Real-world overall survival (rwOS) since D+T initiation (FAS)"
},
{
"measure": "Time to treatment discontinuation (FAS)"
},
{
"measure": "Number and percentage of patients with adverse events of special interest (AESIs) (FAS)"
},
{
"measure": "Number and percentage of patients with serious adverse events (SAEs) (FAS)"
},
{
"measure": "rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use"
},
{
"measure": "rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use"
},
{
"measure": "rwOS since D+T initiation (MMS), by immunotherapy use"
},
{
"measure": "rwOS since D+T initiation (NMS), by immunotherapy use"
},
{
"measure": "Number and percentage of patients with systemic anti-neoplastic treatment after D+T"
},
{
"measure": "Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment"
},
{
"measure": "Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up"
},
{
"measure": "Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type"
},
{
"measure": "Number and percentage of patients per reason for immunotherapy discontinuation"
},
{
"measure": "Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response"
},
{
"measure": "Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment"
},
{
"measure": "Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication"
},
{
"measure": "Number and percentage of patients per concomitant medication"
},
{
"measure": "Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS)"
},
{
"measure": "Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novartis Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TNP-2092 capsules"
},
{
"name": "TNP-2092 capsules placebo"
},
{
"name": "Rabeprazole sodium enteric-coated tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Helicobacter Pylori Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Changchun",
"contacts": null,
"country": "China",
"facility": "The First Hospital of Jilin University",
"geoPoint": {
"lat": 43.88,
"lon": 125.32278
},
"state": "Jilin",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets",
"nctId": "NCT06337604",
"orgStudyIdInfo": {
"id": "TNP-2092-04",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)"
},
{
"measure": "Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)"
},
{
"measure": "Maximum Observed Plasma Concentration (Cmax) of TNP-2092"
},
{
"measure": "Percentage of Participants With Adverse Events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "TenNor Therapeutics Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2017-11-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2017-11-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VI-RADS"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ancona",
"contacts": null,
"country": "Italy",
"facility": "AOU Hospital",
"geoPoint": {
"lat": 43.5942,
"lon": 13.50337
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Ancona",
"contacts": null,
"country": "Italy",
"facility": "IRCCS INRCA Hospital",
"geoPoint": {
"lat": 43.5942,
"lon": 13.50337
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Jesi",
"contacts": null,
"country": "Italy",
"facility": "Carlo Urbani Hospital",
"geoPoint": {
"lat": 43.52142,
"lon": 13.24368
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VI-RADS",
"briefTitle": "Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location",
"nctId": "NCT06337591",
"orgStudyIdInfo": {
"id": "INRCA_003_2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Nazionale di Ricovero e Cura per Anziani"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Telephone-based neuropsychological assessment - ALS"
},
{
"name": "Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD"
},
{
"name": "Telephone-based and in-person cognitive screening - NIs"
}
]
},
"conditionsModule": {
"conditions": [
"Amyotrophic Lateral Sclerosis",
"Alzheimer's Disease",
"Lewy Body Dementia",
"Frontotemporal Degeneration",
"Cerebrovascular Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Barbara Poletti, Ph.D.",
"phone": "+390261911",
"phoneExt": "2609",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20149"
}
]
},
"descriptionModule": {
"briefSummary": "1. Background Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture). The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the \"paper-and-pencil\" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.2. Aims The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used \"paper-and-pencil\" screeners ) and the TICS.3. MethodsThe study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 280,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TBCS",
"briefTitle": "Advances in Telephone-based Cognitive Screening Procedures",
"nctId": "NCT06337578",
"orgStudyIdInfo": {
"id": "23C308",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ALS Cognitive Behavioral Screen-Phone Version in ALS patients"
},
{
"measure": "Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients"
},
{
"measure": "Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients"
},
{
"measure": "Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients"
},
{
"measure": "Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients"
},
{
"measure": "Mini-Mental State Examination in NI"
},
{
"measure": "Montreal Cognitive Assessment in NI"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Drusgs for IBD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Javier P. Gisbert, PhD, MD",
"phone": "913093911",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "María G Donday, PhD",
"phone": "913093911",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Universitario de La Princesa",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": "28006"
}
]
},
"descriptionModule": {
"briefSummary": "This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes",
"nctId": "NCT06337565",
"orgStudyIdInfo": {
"id": "GIS-DUMBO 2-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess the safety of new drugs (non-anti-TNF biologics and targeted small molecules) used for IBD treatment both for pregnancy and in offspring, mainly focused on the risk of serious infections (from birth and in the first 4 years of life)."
}
],
"secondaryOutcomes": [
{
"measure": "To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD."
},
{
"measure": "To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life."
},
{
"measure": "To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different new drugs to treat IBD with that of children who were not exposed to these agents."
},
{
"measure": "To compare the prevalence of malformations in children exposed to new drugs to treat IBD in utero with that of children who were not exposed to these agents."
},
{
"measure": "To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fundación de Investigación Biomédica - Hospital Universitario de La Princesa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "FEED-FF"
},
{
"name": "Standard of Care (SUC)"
}
]
},
"conditionsModule": {
"conditions": [
"Rectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Stephanie Hogue",
"phone": "813-745-1891",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Doratha (Armen) Byrd, MPH, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Sylvia Crowder, PhD, RDN, LDN",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Moffitt Cancer Center",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33612"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiotherapy (CRT)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Clincial response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention.",
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)",
"nctId": "NCT06337552",
"orgStudyIdInfo": {
"id": "MCC-22709",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effects of the FEED-FF diet on clinical response to chemoradiation"
},
{
"measure": "Effects of FEED-FF diet on the gut microbiome"
},
{
"measure": "Effects of FEED-FF diet on local immune-related biomarkers"
},
{
"measure": "Effects of FEED-FF diet on quality of life"
},
{
"measure": "Efficacy of the FEED-FF intervention"
},
{
"measure": "Feasibility of the FEED-FF intervention"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "H. Lee Moffitt Cancer Center and Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SSRI"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Inflammation",
"Antidepressants",
"Immunity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Badalona",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitari Germans Trias i Pujol",
"geoPoint": {
"lat": 41.45004,
"lon": 2.24741
},
"state": "Catalonia",
"status": null,
"zip": "08916"
}
]
},
"descriptionModule": {
"briefSummary": "Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs).Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group.Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LYMPHODEP",
"briefTitle": "Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants",
"nctId": "NCT06337539",
"orgStudyIdInfo": {
"id": "PI-23-185",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment Response"
}
],
"secondaryOutcomes": [
{
"measure": "Lymphocyte subpopulations"
},
{
"measure": "Biochemical variables"
},
{
"measure": "Single-cell CITEseq"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Germans Trias i Pujol Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Apple Watch v8"
}
]
},
"conditionsModule": {
"conditions": [
"Complex Regional Pain Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stanford",
"contacts": null,
"country": "United States",
"facility": "Pediatric Pain Clinic",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
},
"state": "California",
"status": null,
"zip": "94305"
}
]
},
"descriptionModule": {
"briefSummary": "objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS)",
"nctId": "NCT06337526",
"orgStudyIdInfo": {
"id": "IRB-71503",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline in pain score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Medeloop.ai"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rehabilitation intervention"
},
{
"name": "Usual care"
}
]
},
"conditionsModule": {
"conditions": [
"Axial Spondyloarthritis",
"Back Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "In the rehabilitation feasibility study: pre-post design. In the rehabilitation RCT, participants are allocated to either the intervention or control group with standard care.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Blinding of the the health care professionals and patients is not possible in the rehabilitation intervention. The person analysing the data will be blinded to the group allocation.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "48 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "SPINCODE",
"briefTitle": "Spondyloarthritis Inception Cohort of Southern Denmark",
"nctId": "NCT06337513",
"orgStudyIdInfo": {
"id": "S-20230055",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Patient global assessment"
},
{
"measure": "Acceptable state"
},
{
"measure": "Mental state"
}
],
"primaryOutcomes": [
{
"measure": "Clinicians diagnosis of axSpA"
},
{
"measure": "Health related quality of life"
}
],
"secondaryOutcomes": [
{
"measure": "axSpA disease activity"
},
{
"measure": "axSpA disease mobility"
},
{
"measure": "axSpA patient-reported physical function"
},
{
"measure": "Inflammatory back pain (IBP) symptoms"
},
{
"measure": "Physical examination I"
},
{
"measure": "Physical examination II"
},
{
"measure": "Symptomatic SpA features I"
},
{
"measure": "Symptomatic SpA features II"
},
{
"measure": "Symptomatic SpA features III"
},
{
"measure": "Symptomatic SpA features IV"
},
{
"measure": "Symptomatic SpA features V"
},
{
"measure": "Symptomatic SpA features VI"
},
{
"measure": "Physicians global assessment of disease activity"
},
{
"measure": "Magnetic resonance imaging of sacroiliac joints (SIJ) and spine"
},
{
"measure": "low dose computed tomography of SIJ and spine"
},
{
"measure": "dual energy computed tomography of SIJ"
},
{
"measure": "radiography SIJ"
},
{
"measure": "Work"
},
{
"measure": "Fatigue"
},
{
"measure": "Physical activity"
},
{
"measure": "Sleep"
},
{
"measure": "Self-efficacy"
},
{
"measure": "Objective physical function"
},
{
"measure": "Aerobic capacity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Danish Center for Expertise in Rheumatology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neurophysiological measure (EEG)"
},
{
"name": "Survey"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteers",
"Behavior and Behavior Mechanisms"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the \"hybrid\" task and the \"virtual\" task will be evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LABLife",
"briefTitle": "Validation of a Making Decision Hybrid (Ecologic and Virtual) Task",
"nctId": "NCT06337500",
"orgStudyIdInfo": {
"id": "2023/764",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Validation of the homemade \"Lab-Life\" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Besancon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "QoL questionnaires"
},
{
"name": "Qualitative Interview (for one part of nurses only)"
},
{
"name": "ORIC questionnaire"
},
{
"name": "Professionals satisfaction survey"
},
{
"name": "Patients satisfaction survey"
}
]
},
"conditionsModule": {
"conditions": [
"Oncology"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Besançon",
"contacts": [
{
"email": "[email protected]",
"name": "Magalie Pagnot, Nurse",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Besançon",
"geoPoint": {
"lat": 47.24878,
"lon": 6.01815
},
"state": null,
"status": null,
"zip": "25000"
},
{
"city": "Vesoul",
"contacts": [
{
"email": null,
"name": "Cathy Pothier, Nurse",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Groupement Hospitalier de Haute-Saône",
"geoPoint": {
"lat": 47.63333,
"lon": 6.16667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the value of the nurse's use of the Quality of Life (QoL) scores of the European Organisation for Research and Treatment of Cancer \\[EORTC\\] Quality of Life Questionnaire \\[QLQ\\] C30 as an aid in identifying the needs for supportive oncological care at the start of care, in patients followed up for locally advanced or metastatic cancer starting systemic antineoplastic treatment. The main questions it aims to answer are as follows:* Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained* The nurse's assessment of the relevance of the information provided by the QOL scores.During the Care Support Stage (CSS), the nurse will assess the patient's situation during the interview and will fill in directly on an electronic form the Oncological Support Care proposed to the patient, making up the Personalised Pre-QoL Oncological Support Care Plan (PPSOS pre-QoL). The nurse will then give the patient the tablet to fill in the QoL questionnaire. She will then look at the results of the QoL questionnaire and the alerts in the event of deterioration, and will reassess the PPSOS using a new computerised PPSOS post-QoL form. The nurse will assess the relevance of the information provided by the QoL scores concerning the urgency of care, the need to go into certain subjects in greater depth, the identification of problems not addressed before or the discussion of sensitive subjects not addressed before. The nurse will give the patient the tablet to fill in a satisfaction questionnaire. In an attempt to control the biases inherent in an assessment carried out by a single healthcare professional, the clinical records of the patients included will be presented to a group of professionals who will also propose a PPSOS, known as Experts. The group will be made up of a nurse, a medical oncologist and at least two healthcare professionals and professionals in a similar field (dietician, psychologist, APA teacher, social worker, etc.). This group will analyse all the patient files included in the two study centres at dedicated meetings. In order to characterise patient care following the CSS, the oncological support care performed, unscheduled hospitalisations, emergency room visits and calls to the on-call medical team will be collected for the two months following the CSS."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients, nurses and health professionals and professionals assimilated to the health are recruited in 3 different groups but no comparison will be made between them. Recruitment of patients will be stopped once 79 analyzable patients will be enrolled.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 93,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SOS-DETEQT",
"briefTitle": "Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients",
"nctId": "NCT06337487",
"orgStudyIdInfo": {
"id": "2022/716",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change between pre and post QoL Questionnaires"
},
{
"measure": "The nurse's assessement of the relevance of the information provided by each patients's QoL scores"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Direction Générale de l'Offre de Soins"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Besancon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "anti-CD19 CAR NK cells (KN5501)"
}
]
},
"conditionsModule": {
"conditions": [
"Thrombocytopenia Alloimmune"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\\^9 cells, 13.5×10\\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 9,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia",
"nctId": "NCT06337474",
"orgStudyIdInfo": {
"id": "[2023]YLJSA089",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Dose Limiting Toxicity (DLTs)"
},
{
"measure": "Treatment Emergent Adverse Events (TEAEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate of subjects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Rui Therapeutics Co., Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Changzhou No.2 People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Chronic Coronary Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Chiara Centenaro",
"phone": "0258002031",
"phoneExt": "+39",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Centro Cardiologico Monzino",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20131"
}
]
},
"descriptionModule": {
"briefSummary": "Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \\[Computational method for simulating myocardial blood flow in stress conditions\\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CONCERTO",
"briefTitle": "Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography",
"nctId": "NCT06337461",
"orgStudyIdInfo": {
"id": "CCM1930",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Development of a computational model to predict MBF avoiding CT stress protocol"
}
],
"secondaryOutcomes": [
{
"measure": "Improvement of CAD risk assesment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari"
},
{
"name": "Politecnico di Milano"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centro Cardiologico Monzino"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blue LED"
}
]
},
"conditionsModule": {
"conditions": [
"Vulvodynia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salvador",
"contacts": [
{
"email": "[email protected]",
"name": "Patricia Lordelo, post doc",
"phone": "+5571988592400",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Brazil",
"facility": "Centro de Atenção ao assoalho pélvico",
"geoPoint": {
"lat": -12.97111,
"lon": -38.51083
},
"state": "Bahia",
"status": "RECRUITING",
"zip": "40290000"
}
]
},
"descriptionModule": {
"briefSummary": "Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked \"What is your perception of improvement\" and \"What is your level of satisfaction with the treatment?\". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW/cm2 and dose 5J/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Light Emitting Diode in the Treatment of Vulvodynia",
"nctId": "NCT06337448",
"orgStudyIdInfo": {
"id": "74090923.9.0000.5544",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale."
},
{
"measure": "Tolerability of participants to the treatment assessed by Likert Scale."
},
{
"measure": "Evaluate the clinical response assessed by the Visual Analogue Scale."
},
{
"measure": "Evaluate the clinical response assessed by a questionnaire."
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI)."
},
{
"measure": "Evaluate the sexual function of women with vulvodynia by Sexual Quotient - Female Version (SQ-FV)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centro de Atenção ao Assoalho Pélvico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "multi-looped wire"
}
]
},
"conditionsModule": {
"conditions": [
"Crowding of Anterior Mandibular Teeth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "faculty of dentistry Cairo university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding",
"nctId": "NCT06337435",
"orgStudyIdInfo": {
"id": "8223",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The improvement of lower incisors irregularity using Little Irregularity Index."
}
],
"secondaryOutcomes": [
{
"measure": "The stability of lower incisor positioning after ending treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Celecoxib 200 mg capsule"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bioequivalence Study of Generic Celecoxib 200 mg Capsules",
"nctId": "NCT06337422",
"orgStudyIdInfo": {
"id": "BE21-023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bioequivalence based on Cmax period"
},
{
"measure": "Bioequivalence based on AUC parameters"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "International Bio service"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Generic empagliflozin 25 mg film-coated tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers",
"nctId": "NCT06337409",
"orgStudyIdInfo": {
"id": "BE24-004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bioequivalence based on Cmax period"
}
],
"secondaryOutcomes": [
{
"measure": "Bioequivalence based on AUC parameters"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "International Bio service"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "WGS and transcriptome analysis"
}
]
},
"conditionsModule": {
"conditions": [
"Neurodevelopmental Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bosisio Parini",
"contacts": null,
"country": "Italy",
"facility": "Scientific Institute IRCCS Eugenio Medea",
"geoPoint": {
"lat": 45.80075,
"lon": 9.29
},
"state": "LC",
"status": null,
"zip": "23842"
}
]
},
"descriptionModule": {
"briefSummary": "to bridge the gap between the molecular structure of CNV and the effect on the phenotype, considering NDDs as complex diseases, as they are a consequence of the imbalance in several dosage-sensitive genes, we might try to approach them through different --omics investigations (genomics, epigenomics, transcriptomics) according to the emerging field of network medicine. This holistic can provide valuable insight into understanding peculiar molecular mechanisms and unsuspected molecular interactions that contribute to the pathogenesis of the condition and possibly pave the way for uncovering new drug strategies that even if they do not heal the patient may improve his performance and the social interaction"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Omic Approaches to Neurodevelopmental Disabilities",
"nctId": "NCT06337396",
"orgStudyIdInfo": {
"id": "1001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of likely pathogenic structural variants"
},
{
"measure": "Number of patients for whom a genotype-phenotype correlation is found"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Angelman Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Conegliano",
"contacts": [
{
"email": "[email protected]",
"name": "Martina Baggio",
"phone": "+39 340 802 1282",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "I.R.C.C.S. \"E.Medea\"",
"geoPoint": {
"lat": 45.88805,
"lon": 12.30201
},
"state": "Treviso",
"status": "RECRUITING",
"zip": "31015"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational cross-sectional study is to establish the prevalence of autism spectrum disorder in children and adolescents with Angelman syndrome. The main questions it aims to answer are:* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.* which clinical variables differentiate parenting styles and levels of perceived stress.Data from neuropsychological, speech therapy and physiotherapeutic assessments are collected during regular clinical follow-ups, regarding: cognitive development (\"Bayely Scales of Infant Development-III\", Cognitive Scale) and adaptive behaviour; Autism and Autism Spectrum Disorder (\"Autism Diagnostic Observational Schedule-2\"); parental stress and parenting styles; social-communicative skills; motor development."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of the Prevalence of Autistic Traits in Angelman Syndrome",
"nctId": "NCT06337383",
"orgStudyIdInfo": {
"id": "12.2021 ANGELMAN",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total score of the Autism Diagnostic Observation Schedule -2 (ADOS-2), Module 1,"
}
],
"secondaryOutcomes": [
{
"measure": "Age-equivalent score at the Cognitive Scale of the Bayley Scales of Infant Development - 3rd version (Bayley-III)"
},
{
"measure": "Total Stress score at the Parent Stress Index - 4th edition (PSI-4) questionnaire"
},
{
"measure": "Global score at the Aberrant Behaviour Checklist (ABC)"
},
{
"measure": "Total Raw score at the Social Communication Questionnaire - Current version(SCQ)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Chronic Disease Self Management Program"
},
{
"name": "Conventional Care Group"
}
]
},
"conditionsModule": {
"conditions": [
"Arthritis, Rheumatoid"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bogotá",
"contacts": [
{
"email": "[email protected]",
"name": "Klaus Mieth Alviar, Dr.",
"phone": "601 6030303",
"phoneExt": "5402",
"role": "CONTACT"
}
],
"country": "Colombia",
"facility": "Fundación Santa Fe de Bogotá",
"geoPoint": {
"lat": 4.60971,
"lon": -74.08175
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the QOLRA-II; self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "CDSMP is a group-based chronic disease self-management education intervention comprised of 2.5-hour sessions, including time for a break and snack. The maximum number of participants per session ranges from 12 to 16. In total the program consists of 6 sessions that take place once a week for a total duration of 6 weeks. The development of each of the sessions is standardized and scripted; two group leaders previously trained by a Master Trainer, who in turn was trained to train leaders with Stanford University, guide the sessions. In the case of the present study, the main researcher and a nursing professional with experience in health education will receive the training from a Master Trainer of the program. Participants receive the book \"Taking Control of Your Health\" at the beginning of the program.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "In order to guarantee the objectivity and impartiality of the research team, randomization will be accompanied by blinding. A single-blind trial is proposed in which the participants during the conduct of the study will be unaware of their assignment to the experimental or control groups; likewise, the research assistants who perform the pre and post measurement will be unaware of their assignment to the groups; there will be specific assistants for the pre measurement and specific assistants for the post measurement with each group. Candidates will be invited to participate in the study, explaining to them that it is a randomized study in which they may be assigned to a specific intervention group, that their assignment will only be random, that neither the research team nor the treating health team will be able to interfere with their assignment and that this will be revealed to them once the study is completed.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 55,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Self-management Nursing Intervention for Women With Rheumatoid Arthritis",
"nctId": "NCT06337370",
"orgStudyIdInfo": {
"id": "61284",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Self-management behaviors"
}
],
"secondaryOutcomes": [
{
"measure": "Perceived Self-efficacy,"
},
{
"measure": "Health-related quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Nacional de Colombia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Progressive Resistance Training"
}
]
},
"conditionsModule": {
"conditions": [
"Sarcopenia",
"Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hanoi",
"contacts": [
{
"email": "[email protected]",
"name": "Huyen TT Vu, PhD",
"phone": "+84913531579",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Vietnam",
"facility": "National Geriatric Hospital",
"geoPoint": {
"lat": 21.0245,
"lon": 105.84117
},
"state": null,
"status": null,
"zip": "100000"
}
]
},
"descriptionModule": {
"briefSummary": "A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia",
"nctId": "NCT06337357",
"orgStudyIdInfo": {
"id": "NatGerHos-Sarcopenia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physical performance 1 - Handgrip strength"
},
{
"measure": "Physical performance 2 - Gait speed"
},
{
"measure": "Physical performance 3 - Short Physical Performance Battery (SPPB)"
},
{
"measure": "Muscle mass"
}
],
"secondaryOutcomes": [
{
"measure": "Nutritional status"
},
{
"measure": "Health-related Quality of Life"
},
{
"measure": "Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "National Geriatric Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-01-23",
"filename": "ICF_000.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 212556,
"typeAbbrev": "ICF",
"uploadDate": "2024-03-22T11:34"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Baduanjin"
},
{
"name": "Exercise"
},
{
"name": "Video Viewing"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hung Hom",
"contacts": [
{
"email": null,
"name": "Yvonne Han, PhD",
"phone": "+852 2766 7578",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "The Hong Kong Polytechnic University",
"geoPoint": {
"lat": 22.30715,
"lon": 114.18532
},
"state": "Kowloon",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning , and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neurophysiological Effects of Mind-body Exercise in Healthy Adults",
"nctId": "NCT06337344",
"orgStudyIdInfo": {
"id": "HSEARS20230213007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in cognitive function as assessed by verbal fluency task (VFT)"
},
{
"measure": "Hemodynamic changes as assessed by fNIRS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Venetoclax"
},
{
"name": "Decitabine"
},
{
"name": "Fludarabine"
},
{
"name": "Busulfan"
},
{
"name": "Total Body Irradiation"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Myeloid Leukemia",
"Myelodysplastic Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Atlanta",
"contacts": null,
"country": "United States",
"facility": "Caitlin Guzowski",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia",
"status": null,
"zip": "30342"
}
]
},
"descriptionModule": {
"briefSummary": "Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 23,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant",
"nctId": "NCT06337331",
"orgStudyIdInfo": {
"id": "NSH 1401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant"
}
],
"secondaryOutcomes": [
{
"measure": "Number of patients alive at one-year post transplant"
},
{
"measure": "Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures"
},
{
"measure": "Number of patients who died one year post-transplant not related to recurrence of disease"
},
{
"measure": "Number of patients who fully engrafted (blood counts fully recovered) by conducting chimerism studies at 30-, 60-, 90-, 180-, and 365-days post transplant"
},
{
"measure": "Number of patients who developed acute graft-versus-host disease by recording signs and symptoms of acute GVHD according to MAGIC standards at one-year post-transplant"
},
{
"measure": "Number of patients who developed chronic graft-versus-host disease by recording signs and symptoms of chronic GVHD according to NIH standards at one-year post-transplant"
},
{
"measure": "Number of patients who are alive at one-year post transplant who also did not develop GVHD"
},
{
"measure": "Number of patients with treatment-related adverse events to venetoclax as assessed by CTCAE v5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Northside Hospital, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biospecimen Collection"
},
{
"name": "Computed Tomography"
},
{
"name": "Mosunetuzumab"
},
{
"name": "Positron Emission Tomography"
},
{
"name": "Rituximab"
},
{
"name": "Rituximab and Hyaluronidase Human"
}
]
},
"conditionsModule": {
"conditions": [
"Classic Follicular Lymphoma",
"Follicular Lymphoma With Unusual Cytological Features"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"masking": "NONE",
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"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma",
"nctId": "NCT06337318",
"orgStudyIdInfo": {
"id": "NCI-2024-02361",
"link": null,
"type": null
},
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{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-02361",
"link": null,
"type": "REGISTRY"
},
{
"domain": "SWOG",
"id": "S2308",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "S2308",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "U10CA180888",
"link": "https://reporter.nih.gov/quickSearch/U10CA180888",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "3-year milestone progression free survival (PFS)"
},
{
"measure": "PFS"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Overall response rate"
},
{
"measure": "Event free survival (EFS)"
},
{
"measure": "Incidence of adverse events"
},
{
"measure": "Restricted chance of longer PFS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2032-03-31"
},
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"startDateStruct": {
"date": "2024-08-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Bladder Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kansas City",
"contacts": null,
"country": "United States",
"facility": "University of Kansas Medical Center",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas",
"status": null,
"zip": "66160"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"maskingInfo": null,
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},
"enrollmentInfo": {
"count": 74,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer",
"nctId": "NCT06337305",
"orgStudyIdInfo": {
"id": "STUDY00146138",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25)."
},
{
"measure": "Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys)."
},
{
"measure": "Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29."
}
],
"secondaryOutcomes": [
{
"measure": "Identification of clinical and demographic factors in bladder cancer patients"
},
{
"measure": "Demographics"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Kansas Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-08-19"
},
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"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-08-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-08-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Incisional Negative Pressure Wound Therapy (NPWT)"
}
]
},
"conditionsModule": {
"conditions": [
"Fracture of Tibia",
"Wound Heal",
"Infected Wound",
"Wound Complication",
"Wound Dehiscence"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \\>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 352,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "iVAC",
"briefTitle": "Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial",
"nctId": "NCT06337292",
"orgStudyIdInfo": {
"id": "IRB00440042",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complication composite outcome"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Major Extremity Trauma Research Consortium"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-09-30"
},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Gastric Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": null,
"country": "China",
"facility": "Fujian Medical University Union Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": null,
"zip": "350000"
}
]
},
"descriptionModule": {
"briefSummary": "The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions."
},
"designModule": {
"designInfo": {
"allocation": null,
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},
"enrollmentInfo": {
"count": 3820,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk",
"nctId": "NCT06337279",
"orgStudyIdInfo": {
"id": "FMUUH-0322",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "5-year OS"
},
{
"measure": "5-year DFS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fujian Medical University Union Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fujian Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-20"
},
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"date": "2024-03-29"
},
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"primaryCompletionDateStruct": {
"date": "2023-08-20"
},
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"startDateStruct": {
"date": "2022-12-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Gastric Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": null,
"country": "China",
"facility": "Fujian Medical University Union Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": null,
"zip": "350000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC)."
},
"designModule": {
"designInfo": {
"allocation": null,
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},
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"count": 3622,
"type": "ACTUAL"
},
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma",
"nctId": "NCT06337266",
"orgStudyIdInfo": {
"id": "2024KY246",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "5-year OS"
},
{
"measure": "5-year DFS"
}
],
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},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fujian Medical University Union Hospital"
}
],
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"class": "OTHER",
"name": "Fujian Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-19"
},
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"date": "2024-03-29"
},
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"date": "2023-08-20"
},
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"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sulfadoxine/pyrimethamine plus amodiaquine"
}
]
},
"conditionsModule": {
"conditions": [
"Malaria,Falciparum",
"Chemoprevention"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from one of the 3 manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements: Tridem Pharma, S Kant Healthcare Ltd, or MacLeods Pharmaceuticals Ltd.Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged three to \\<12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged three to \\<12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "59 Months",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique",
"nctId": "NCT06337253",
"orgStudyIdInfo": {
"id": "MOZ202401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Chemoprevention failure"
}
],
"secondaryOutcomes": [
{
"measure": "Uncomplicated malaria within 28 days"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Malaria Consortium"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pelvic floor on COPD patients"
},
{
"name": "Pilates exercises on COPD patients"
}
]
},
"conditionsModule": {
"conditions": [
"Urinary Incontinence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Donia El masry, doctorate",
"phone": "01005587119",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Physical Therapy",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease",
"nctId": "NCT06337240",
"orgStudyIdInfo": {
"id": "pelvic floor exercise",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Urinary incontinence (1 Hour and 24- Hour pad test)"
},
{
"measure": "Incontinence severity index:"
}
],
"secondaryOutcomes": [
{
"measure": "Urinary incontinence quality of life questionnaire (I-QOL)"
},
{
"measure": "Cough symptoms score"
},
{
"measure": "Cough symptoms questionnaire"
},
{
"measure": "The COPD Assessment Tool (CAT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "lncRNA signature analyses"
}
]
},
"conditionsModule": {
"conditions": [
"Atherosclerosis and Calcific Aortic Stenosis With and Without Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Naples",
"contacts": [
{
"email": "[email protected]",
"name": "Monica Franzese, PhD",
"phone": "+393334041413",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Irccs Synlab Sdn",
"geoPoint": {
"lat": 40.85216,
"lon": 14.26811
},
"state": null,
"status": "RECRUITING",
"zip": "80143"
}
]
},
"descriptionModule": {
"briefSummary": "The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Potential Role of Sirtuins as Epigenetic Biomarkers of the Patient With Atherosclerosis or Calcific Aortic Stenosis",
"nctId": "NCT06337227",
"orgStudyIdInfo": {
"id": "2/22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis"
}
],
"secondaryOutcomes": [
{
"measure": "To evaluate the experimental results achieved in the clinical-diagnostic context"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Federico II University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS SYNLAB SDN"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Neoplasm, Breast",
"Patient Participation",
"Mental Health Issue"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": [
{
"email": "[email protected],[email protected]",
"name": "Yu-Hsuan Tai, MD",
"phone": "+886918130891",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Taipei City Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": "RECRUITING",
"zip": "10845"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to evaluate the impact of the \"Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy\" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:Can the \"Traditional Chinese Medicine Therapy Program\" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?Participants will:Engage in the \"Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy\" provided by the Taiwan Compassionate Cancer Care Association.Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy",
"nctId": "NCT06337214",
"orgStudyIdInfo": {
"id": "TCHIRB-11301014-E",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire: Constitution in Chinese Medicine Questionnaire"
},
{
"measure": "Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)"
},
{
"measure": "Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)"
}
],
"secondaryOutcomes": [
{
"measure": "Additional questions regarding the \"Traditional Chinese Medicine Program for Reinforcing Vital Energy\""
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Taipei City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Test of the application Min Memoria"
}
]
},
"conditionsModule": {
"conditions": [
"Cognitive Impairment",
"Dementia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karlskrona",
"contacts": [
{
"email": "[email protected]",
"name": "Johan Sanmartin Berglund, MD, PhD",
"phone": "+46455385471",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Peter Anderberg, PhD",
"phone": "+46455385436",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Blekinge Institute of Technology",
"geoPoint": {
"lat": 56.16156,
"lon": 15.58661
},
"state": "Blekinge",
"status": "RECRUITING",
"zip": "37179"
}
]
},
"descriptionModule": {
"briefSummary": "Person-centred care can be supported when healthcare professionals access and actively use the information recorded in a life story. Active use of the life story can create security for a person with dementia and their carers. The written life story describes the person and their life experiences, which can define the person's identity. National guidelines for care and nursing in dementia and Blekinge's regional guidelines emphasise the importance of care and nursing for people with dementia, which should be given with a person-centred approach, where the life story becomes a tool for healthcare professionals. Research shows that a life story can be designed in several ways. For example, in book form, as a brochure, collage, memory box or electronically. The life story is also intended as a tool for healthcare professionals to create security and facilitate communication with the individual. As more and more older adults are using computers and tablets as assistive devices, and it is also becoming more common for healthcare professionals to use, for example, tablets as assistive devices in nursing care, the life story could be shared in digital form as an application and become a living document.Overall aim: To test an application for the life story with the intention of supporting person-centred care for older adults with dementia and to test whether the application can replace the written completion document. Study I: Exploring the research area of the life story in digital form. Study II: Focus group interviews with healthcare professionals. Study III: Test the application, Min Memoria. Study IV: Observations on the use of the application."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Digital Life Story to Support Person-centred Care for Older Adults With Dementia Perspectives",
"nctId": "NCT06337201",
"orgStudyIdInfo": {
"id": "BTH-6.1.1-0138-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Healthcare professionals' experiences using a written life story in the daily care of older adults with dementia"
},
{
"measure": "Data on the use of a digital life story tool."
},
{
"measure": "Observation when using a digital life story"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Blekinge Institute of Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental AAC"
},
{
"name": "Generic AAC"
}
]
},
"conditionsModule": {
"conditions": [
"Communication Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adaptive and Individualized AAC Phase II",
"nctId": "NCT06337188",
"orgStudyIdInfo": {
"id": "AAC PhII",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)"
},
{
"measure": "Information Transfer Rate"
},
{
"measure": "National Aeronautics and Space Administration (NASA) Task Load Index"
}
],
"secondaryOutcomes": [
{
"measure": "Character-to-character Movement Time"
},
{
"measure": "Path Efficiency"
},
{
"measure": "Frequency of Selecting Word Completion Options"
},
{
"measure": "Number of Written Disfluencies"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Nebraska"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Altec Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Alteplase"
},
{
"name": "Alteplase"
}
]
},
"conditionsModule": {
"conditions": [
"Ischemic Stroke",
"Alteplase Adverse Reaction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kafr Ash Shaykh",
"contacts": [
{
"email": "[email protected]",
"name": "mohamed G. Zeinhom, MD",
"phone": "2001009606828",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "sherihan R ahmed, MD",
"phone": "2001007481842",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Kafr Elsheikh University Hospital",
"geoPoint": {
"lat": 31.11174,
"lon": 30.93991
},
"state": null,
"status": "RECRUITING",
"zip": "33155"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study consisted of two distinct groups. The first group comprised 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction",
"nctId": "NCT06337175",
"orgStudyIdInfo": {
"id": "000000230988",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "predictors of the hemorrhagic infarction type 1"
}
],
"secondaryOutcomes": [
{
"measure": "predictors of the hemorrhagic infarction type 2"
},
{
"measure": "predictors of the parenchymal hematoma type 1"
},
{
"measure": "predictors of the parenchymal hematoma type 2"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kafrelsheikh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "INCB099280"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Walsh",
"phone": "215-615-5858",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Abramson Cancer Center at University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HCC",
"briefTitle": "Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)",
"nctId": "NCT06337162",
"orgStudyIdInfo": {
"id": "UPCC 20223",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "University of Pennsylvania IRB",
"id": "IRB#855195",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy"
}
],
"secondaryOutcomes": [
{
"measure": "Acute Cellular Rejection of Liver Transplant Within 3 Months"
},
{
"measure": "Acute Cellular Rejection of Liver Transplant Within 1 Year"
},
{
"measure": "Toxicity Rates by Category and Grade"
},
{
"measure": "Proportion of Patients Downstaged"
},
{
"measure": "Pathologic Complete Response Rate"
},
{
"measure": "Recurrence-Free Survival at 1 Year After Transplant"
},
{
"measure": "Overall Survival at 1 Year After Transplant"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Incyte Corporation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Abramson Cancer Center at Penn Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task)"
}
]
},
"conditionsModule": {
"conditions": [
"Ondine Syndrome",
"Congenital Central Hypoventilation Syndrome (CCHS)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Christophe DELCLAUX, MD, PhD",
"phone": "+331 40 03 41 90",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Benjamin DUDOIGNON, MD",
"phone": "+331 40 03 41 90",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Robert Debre Hospital",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": "RECRUITING",
"zip": "75019"
}
]
},
"descriptionModule": {
"briefSummary": "Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that alters oxygen delivery to the brain. CCHS patients are at risk for broad neurocognitive deficits. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks. The purpose of this study is to assess the relationship between breathing pattern and attention in CCHS children"
},
"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": "16 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "OndineCo",
"briefTitle": "Relationship Between Breathing and Attention in Children With Ondine Syndrome",
"nctId": "NCT06337149",
"orgStudyIdInfo": {
"id": "APHP230348",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IDRCB ANSM",
"id": "IDRCB: 2023-A00006-39",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Wechsler scale"
},
{
"measure": "Nepsy II test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Automated Computer Analysis",
"Neonatal Motor Pattern"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Garches",
"contacts": null,
"country": "France",
"facility": "Department of paediatric neurological care and intentive care unity (PICU), Raymond Poincaré hospital - APHP",
"geoPoint": {
"lat": 48.84226,
"lon": 2.18232
},
"state": null,
"status": null,
"zip": "92380"
}
]
},
"descriptionModule": {
"briefSummary": "This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ..."
},
"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": "15 Days",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "AIMOTHERNeo",
"briefTitle": "neonAtal motoR paTtErn autoMatIc analySis",
"nctId": "NCT06337136",
"orgStudyIdInfo": {
"id": "2022-A01837-36",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "comparison of the computer score with the clinical examination"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of the evolution of neurological examination and posture based on the day of life for each patient and each group of patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Device: Physica TT TIbial Plate and Physica Porous KR"
},
{
"name": "Device: Physica TT TIbial Plate and Physica Porous PS"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Arthropathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Forte Dei Marmi",
"contacts": [
{
"email": null,
"name": "Alessandro Tripodo",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alessandro Tripodo",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Casa di Cura San Camillo Hopital",
"geoPoint": {
"lat": 43.96388,
"lon": 10.17478
},
"state": "Lucca",
"status": null,
"zip": "55042"
},
{
"city": "Torre Pedrera",
"contacts": [
{
"email": null,
"name": "Marco Fravisini",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marco Fravisini",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale Privato Accreditato Sol et Salus",
"geoPoint": {
"lat": 44.10694,
"lon": 12.51274
},
"state": "Rimini",
"status": null,
"zip": "47922"
},
{
"city": "Messina",
"contacts": [
{
"email": null,
"name": "Marcello La Bruna",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marcello La Bruna",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Casa di Cura Carmona",
"geoPoint": {
"lat": 38.19394,
"lon": 15.55256
},
"state": null,
"status": null,
"zip": "98100"
},
{
"city": "Perugia",
"contacts": null,
"country": "Italy",
"facility": "Istituto Clinico Porta Sole",
"geoPoint": {
"lat": 43.1122,
"lon": 12.38878
},
"state": null,
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 130,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physica TT Tibial Plate Follow up Study",
"nctId": "NCT06337123",
"orgStudyIdInfo": {
"id": "K-38",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of Knee Society Score (KSS) equal or greater than \"Good\" (score ≥ 70) 2 years after surgery"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in Range of Motion over time up to 2 years after surgery"
},
{
"measure": "Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery."
},
{
"measure": "Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery."
},
{
"measure": "Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery."
},
{
"measure": "Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery"
},
{
"measure": "Survival rate (Kaplan-Meier) at 2 years after surgery"
},
{
"measure": "Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Limacorporate S.p.a"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lu AF28996"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Participants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Holbeck",
"contacts": null,
"country": "United Kingdom",
"facility": "Fortrea Clinical Research Unit Ltd",
"geoPoint": {
"lat": 53.25,
"lon": -1.18333
},
"state": "Leeds",
"status": null,
"zip": "LS11 9EH"
}
]
},
"descriptionModule": {
"briefSummary": "The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "35 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men",
"nctId": "NCT06337110",
"orgStudyIdInfo": {
"id": "20436A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)"
},
{
"measure": "AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity"
},
{
"measure": "Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material"
},
{
"measure": "Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material"
},
{
"measure": "T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material"
},
{
"measure": "AUC0-infinity of Lu AF28996"
},
{
"measure": "Cmax of Lu AF28996"
},
{
"measure": "Tmax of Lu AF28996"
},
{
"measure": "T½ of Lu AF28996"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "H. Lundbeck A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Troponin surveillance"
},
{
"name": "Standard of care"
}
]
},
"conditionsModule": {
"conditions": [
"Immune Checkpoint Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Nicolas Palaskas, MD",
"phone": "713-606-3957",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nicolas Palaskas, 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": "RECRUITING",
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 880,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy",
"nctId": "NCT06337097",
"orgStudyIdInfo": {
"id": "2023-1021",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-02687",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumor, Adult",
"Bladder Cancer",
"Urothelial Carcinoma",
"Triple-negative Breast Cancer",
"Lung Cancer",
"Colorectal Cancer",
"Gastric Cancer",
"Ovarian Cancer",
"Pancreatic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "North Melbourne",
"contacts": [
{
"email": null,
"name": "Referral Coordinator",
"phone": "03 9454 5800",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Melbourne Theranostic Innovation Centre (MTIC)",
"geoPoint": {
"lat": -37.80132,
"lon": 144.95822
},
"state": "Victoria",
"status": "RECRUITING",
"zip": "3051"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.The amount of radioactivity injected will range between 37-74 MBq (±10%)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors",
"nctId": "NCT06337084",
"orgStudyIdInfo": {
"id": "MNPR-101-D001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "assess tumor uptake to background and tumor uptake to liver ratios of product"
}
],
"primaryOutcomes": [
{
"measure": "assess dosimetry and biodistribution of product"
},
{
"measure": "assess tumor Standard Uptake Values (SUV) of product"
}
],
"secondaryOutcomes": [
{
"measure": "assess pharmacokinetics (PK) levels of product"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Monopar Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ACYW135 Meningococcal Polysaccharide Conjugate Vaccine"
},
{
"name": "ACYW135 Meningococcal Polysaccharide Vaccine"
}
]
},
"conditionsModule": {
"conditions": [
"Meningococcal Meningitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kunming",
"contacts": [
{
"email": "[email protected]",
"name": "ZHENG Yan",
"phone": "+8687163627796",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Yunnan Center For Disease Control and Prevention",
"geoPoint": {
"lat": 25.03889,
"lon": 102.71833
},
"state": "Yunnan",
"status": null,
"zip": "650022"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1200,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine",
"nctId": "NCT06337071",
"orgStudyIdInfo": {
"id": "AM2023MCV4Ⅱ",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Immunogenicity 1"
},
{
"measure": "Immunogenicity 2"
},
{
"measure": "Immunogenicity 3"
},
{
"measure": "Safety 1"
}
],
"secondaryOutcomes": [
{
"measure": "Immunogenicity 4"
},
{
"measure": "Immunogenicity 5"
},
{
"measure": "Immunogenicity 6"
},
{
"measure": "Immunogenicity 7"
},
{
"measure": "Immunogenicity 8"
},
{
"measure": "Immune persistence 1"
},
{
"measure": "Immune persistence 2"
},
{
"measure": "Safety 2"
},
{
"measure": "Safety 3"
},
{
"measure": "Safety 4"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Aimei Vacin BioPharm (Zhejiang) Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental group (motivational interview)"
}
]
},
"conditionsModule": {
"conditions": [
"Sexual Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kahramanmaraş",
"contacts": null,
"country": "Turkey",
"facility": "Kahramanmaras Sutçu Imam University",
"geoPoint": {
"lat": 37.5847,
"lon": 36.92641
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 164,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period",
"nctId": "NCT06337058",
"orgStudyIdInfo": {
"id": "KSUHULYAKAMALAK001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F)"
},
{
"measure": "Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F)"
},
{
"measure": "Sexual Quality of Life-Female Questionnaire (SQOL-F)"
},
{
"measure": "Sexual Quality of Life-Female Questionnaire (SQOL-F)"
},
{
"measure": "Sexual Self-Efficacy Scale (SSES)"
},
{
"measure": "Sexual Self-Efficacy Scale (SSES)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hülya KAMALAK"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Complex prevention and rehabilitation intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation",
"Prevention",
"Rehabilitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense",
"contacts": null,
"country": "Denmark",
"facility": "Department of Cardiology, Odense University Hospital",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": "Region Of Southern Denmark",
"status": null,
"zip": "5000"
},
{
"city": "Svendborg",
"contacts": null,
"country": "Denmark",
"facility": "Health Center, Municipality Svendborg",
"geoPoint": {
"lat": 55.05982,
"lon": 10.60677
},
"state": "Region Of Southern Denmark",
"status": null,
"zip": "5700"
}
]
},
"descriptionModule": {
"briefSummary": "Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.There were the following four secondary objectives:1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.2. To explore the participant's needs and preferences of the interventions.3. To explore changes in HRQoL, anxiety and depression.4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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],
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"name": "Department of Cardiology, Odense University Hospital, Odense, Denmark."
},
{
"name": "Health Center, Municipality of Svendborg, Svendborg, Denmark."
},
{
"name": "Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark."
},
{
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}
}
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{
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{
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{
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{
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],
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}
],
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}
],
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],
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{
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],
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],
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],
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{
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"name": "Paolo Pedrazzoli",
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],
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},
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},
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"OLDER_ADULT"
]
},
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"briefTitle": "The Italian Registry of Malnutrition in Oncology",
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"link": null,
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},
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}
],
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},
{
"measure": "Treatment toxicity"
}
]
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],
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}
},
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},
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},
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},
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"date": "2024-03-29"
}
}
} | false | null |
{
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]
},
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},
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"locations": [
{
"city": "Samsun",
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{
"email": "[email protected]",
"name": "OZGUR KOMURCU, 1",
"phone": "90 505 5273180",
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"role": "CONTACT"
},
{
"email": null,
"name": "Hatice SELCUK KUSDERCİ",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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]
},
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"briefSummary": "There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs, which are increasingly used especially in short surgical procedures.The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data."
},
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"stdAges": [
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]
},
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"id": "SÜKAEK 2023/14/1",
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"type": null
},
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}
},
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"date": "2024-04-15"
},
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"startDateStruct": {
"date": "2023-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
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{
"name": "herbal compound"
},
{
"name": "Celecoxib"
}
]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "Tongde Hospital",
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"lon": 120.16142
},
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]
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},
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},
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},
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"type": "ACTUAL"
},
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],
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},
"eligibilityModule": {
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"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP",
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"id": "liuxianguiji",
"link": null,
"type": null
},
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{
"measure": "the adverse reactions of digestive or other system"
}
],
"primaryOutcomes": [
{
"measure": "Visual Analogue Scale"
},
{
"measure": "Oswestry disability index"
},
{
"measure": "Japanese Orthopaedic Association Scores"
}
],
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},
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"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang Provincial Tongde Hospital"
}
},
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},
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},
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"date": "2023-06-16"
},
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"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Increasing Inclusionary Practices in Faith Communities"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Crystal Slanzi, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Temple Univeristy",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19121"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this intervention study is to test a behavioral intervention to increase inclusionary practices toward individuals with serious mental illness in faith communities. The main questions it aims to answer are:1. To determine if the behavior-based intervention leads to an increase in inclusionary practices (e.g., conducting outreach with mental health agencies).2. To determine if the behavior-based intervention is effective in increasing inclusive practices by members and leaders of faith communities.3. To determine if the intervention leads to a greater understand of mental illness and a decrease in stigmatizing beliefs by congregation members.4. To determine if the intervention results in individuals with serious mental illness and their family members reporting less discrimination and increased inclusion.Congregations will be asked to create an inclusion committee that will then work on developing systems and changing congregational practices to become more inclusive. All congregation members will be invited to a half-day training that will provide information on mental illness and inclusion, and will provide tips and strategies when they encounter situations or behaviors that are less familiar to them. All congregation members will be given the opportunity to participate in a survey about congregational practices."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 700,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Creating Welcoming Faith Communities for People With Serious Mental Illnesses",
"nctId": "NCT06336980",
"orgStudyIdInfo": {
"id": "31021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Inclusionary practices"
},
{
"measure": "Indicators of Welcome"
},
{
"measure": "Mental Health Knowledge Questionnaire"
},
{
"measure": "Social Distance Scale"
},
{
"measure": "Community Attitudes Toward the Mentally Ill"
},
{
"measure": "Reported and Intended Behavior Scale"
},
{
"measure": "Sense of Belonging Scale"
}
],
"secondaryOutcomes": [
{
"measure": "University of California Los Angeles Loneliness Scale"
},
{
"measure": "Lerman Quality of Life Interview"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Disability, Independent Living, and Rehabilitation Research"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Temple University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GUIDE"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Wellness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": null,
"country": "United States",
"facility": "University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19146"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Testing a Wellness App for First Responders, Military Personnel and Veterans",
"nctId": "NCT06336967",
"orgStudyIdInfo": {
"id": "855282",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Feasibility of Intervention Measure (FIM)"
},
{
"measure": "Acceptability of Intervention Measure (AIM)"
},
{
"measure": "Intervention Appropriateness Measure (IAM)"
},
{
"measure": "System Usability Scale (SUS)"
}
],
"primaryOutcomes": [
{
"measure": "PERMA-Profiler Overall Wellbeing Score"
},
{
"measure": "Patient Health Questionnaire for depression symptoms (PHQ-8)"
},
{
"measure": "Generalized Anxiety Disorder (GAD-7)"
},
{
"measure": "WHO Well-being Index (WHO-5)"
},
{
"measure": "Personal Wellbeing Score (PWS)"
},
{
"measure": "Difficulties in Emotion Regulation Scale Short Form (DERS-SF)"
}
],
"secondaryOutcomes": [
{
"measure": "Positive Emotion (Positive emotion subscale of the PERMA-Profiler)"
},
{
"measure": "Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler)"
},
{
"measure": "Social Connectedness (Number of posts/comments in the app)"
},
{
"measure": "Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler)"
},
{
"measure": "Personal Growth (Total GUIDE lessons and courses completed)"
},
{
"measure": "Utrecht Work Engagement Scale (UWES-17)"
},
{
"measure": "Maslach Burnout Inventory (MBI)"
},
{
"measure": "Job Retention (Employment status)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Nlyten Corp"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adibelimab"
}
]
},
"conditionsModule": {
"conditions": [
"Non Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure",
"nctId": "NCT06336954",
"orgStudyIdInfo": {
"id": "MA-NSCLC-#-037",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival time (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate"
},
{
"measure": "Duration of Response"
},
{
"measure": "Overall Survival"
},
{
"measure": "Treatment-Related Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Affiliated Hospital of Xi'an Jiaotong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pisa",
"contacts": [
{
"email": "[email protected]",
"name": "Rossana Izzetti, DS, PhD",
"phone": "+39050993037",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Università di Pisa",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null,
"status": "RECRUITING",
"zip": "56126"
}
]
},
"descriptionModule": {
"briefSummary": "Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HOUSTON",
"briefTitle": "\"Ultra-High Frequency intraOral UltraSonography of the TONgue\" (HOUSTON)",
"nctId": "NCT06336941",
"orgStudyIdInfo": {
"id": "32822",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Depth of invasion"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pisa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-06-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Bomi Choi",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anastasia Martynova, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Keck Medicine of USC Koreatown",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90020"
},
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Kimberly Arieli, RN",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anastasia Martynova, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Los Angeles General Medical Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90033"
},
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Kimberly Arieli, RN",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anastasia Martynova, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "USC / Norris Comprehensive Cancer Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90033"
},
{
"city": "Newport Beach",
"contacts": [
{
"email": "[email protected]",
"name": "Kristy Massopust",
"phone": "949-474-5733",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anastasia Martynova, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "USC Norris Oncology/Hematology-Newport Beach",
"geoPoint": {
"lat": 33.61891,
"lon": -117.92895
},
"state": "California",
"status": null,
"zip": "92663"
}
]
},
"descriptionModule": {
"briefSummary": "This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 490,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis",
"nctId": "NCT06336928",
"orgStudyIdInfo": {
"id": "1B-23-6",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01332",
"link": null,
"type": "REGISTRY"
},
{
"domain": "USC / Norris Comprehensive Cancer Center",
"id": "1B-23-6",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "P30CA014089",
"link": "https://reporter.nih.gov/quickSearch/P30CA014089",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess the sensitivity and specificity of LBx as a screening method for breast cancer"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern California"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physician-Nurse Dyad Rounding"
}
]
},
"conditionsModule": {
"conditions": [
"Wellness, Psychological"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Colette N Ndjom, MS",
"phone": "410-947-4681",
"phoneExt": "74681",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Loretta W Bedell, MPH",
"phone": "214-947-4680",
"phoneExt": "74680",
"role": "CONTACT"
},
{
"email": null,
"name": "Lauren Hoffman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Clinical Research Institute at Methodist Health System",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75203"
},
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Colette N Ndjom, MS",
"phone": "214-947-4681",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Loretta W Bedell, MPH",
"phone": "217-947-4680",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lauren Hoffman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Methodist Dallas Medical Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "NOT_YET_RECRUITING",
"zip": "75203"
}
]
},
"descriptionModule": {
"briefSummary": "The project will be implemented on one unit at a time until the co-rounding process has been implemented on each Medical-Surgical unit. This study will involve the geo-localized hospitalist on the designated unit and the nursing staff involved in clinical patient care"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physician-Nurse Dyad Rounding: A Collaborative Approach to Improve Unit-Level Metrics",
"nctId": "NCT06336915",
"orgStudyIdInfo": {
"id": "121.NUR.2022.D",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in percentage of discharged patients before 1400 (Mon-Fri) after project implementation compared to before implementation"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in Top Box Patient Satisfaction Scores and Doctor Domain"
},
{
"measure": "Difference in LOS of private hospitalist patients after project implementation compared to before implementation"
},
{
"measure": "Difference in collaboration and build positive relationships scores after project implementation compared to before implementation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Methodist Health System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Balstilimab"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Botensilimab"
},
{
"name": "Computed Tomography"
},
{
"name": "Dietary Intervention"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Vitamin C"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Colorectal Adenocarcinoma",
"Stage IV Colorectal Cancer AJCC v8"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Charlean Ketchens, RN",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rabia Rehman",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Diana Hanna, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Los Angeles General Medical Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90033"
},
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Charlean Ketchens, RN",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rabia Rehman",
"phone": "323-865-0451",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Diana Hanna, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "USC / Norris Comprehensive Cancer Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90033"
}
]
},
"descriptionModule": {
"briefSummary": "This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer",
"nctId": "NCT06336902",
"orgStudyIdInfo": {
"id": "3C-23-11",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01368",
"link": null,
"type": "REGISTRY"
},
{
"domain": "USC / Norris Comprehensive Cancer Center",
"id": "3C-23-11",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "P30CA014089",
"link": "https://reporter.nih.gov/quickSearch/P30CA014089",
"type": "NIH"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Proportion of patients who adhere to the fast mimicking diet"
},
{
"measure": "Incidence of adverse events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall response rate (ORR)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Overall survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern California"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-04-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pelvic Angioembolization"
}
]
},
"conditionsModule": {
"conditions": [
"Pelvic Hemorrhage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Burris, MD",
"phone": "214-947-1280",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Methodist Dallas Medical Center",
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"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75201"
}
]
},
"descriptionModule": {
"briefSummary": "The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
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},
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"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used)",
"nctId": "NCT06336889",
"orgStudyIdInfo": {
"id": "092.TRA.2018.D",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality outcome"
},
{
"measure": "transfusion requirements"
},
{
"measure": "thromboembolic events"
}
],
"secondaryOutcomes": [
{
"measure": "Patient demographics(age, sex)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Methodist Health System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-10-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Survey"
}
]
},
"conditionsModule": {
"conditions": [
"Undefined"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Richardson",
"contacts": [
{
"email": "[email protected]",
"name": "Maxine Adegbola, RN",
"phone": "214-876-9767",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Maxine Adegbola, RN",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "David Irvan, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Terri Daugherty, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Joanna Bender, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Tabitha Moore, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sharon Blackerby, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Katherine Hartdegen, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Melissa Miller, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Shannon Jackson, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Obed Thomas, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Methodist Richardson Medical Center",
"geoPoint": {
"lat": 32.94818,
"lon": -96.72972
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75082"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Perceived Coping, Meaning, and Joy at Work",
"nctId": "NCT06336876",
"orgStudyIdInfo": {
"id": "080.EDU.2019.R",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Workplace Incivil Behavior"
},
{
"measure": "Meaning, Joy in Work"
},
{
"measure": "Occupational Coping Self-Efficacy"
},
{
"measure": "Demographic"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Methodist Health System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Allosure and TruGraf"
},
{
"name": "Immunosuppression Taper"
}
]
},
"conditionsModule": {
"conditions": [
"Kidney Transplant Immunosuppression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": null,
"name": "David Wojciechowski, DO",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Texas Southwestern Medical Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75390"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: \"Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients.\""
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression",
"nctId": "NCT06336863",
"orgStudyIdInfo": {
"id": "STU-2023-1151",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of acute kidney graft rejection"
},
{
"measure": "Incidence of facilitation to Belatacept monotherapy"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Survival after Immunosuppression Wean"
},
{
"measure": "Kidney Graft Failure after Immunosuppression Wean"
},
{
"measure": "Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean"
},
{
"measure": "Incidence of Proteinuria after Immunosuppression Wean"
},
{
"measure": "Incidence of de-novo donor specific antibodies (dnDSA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Texas Southwestern Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-03-06",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 293395,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-28T09:25"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement"
}
]
},
"conditionsModule": {
"conditions": [
"Liver Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": null,
"name": "Prashant Kedia, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Methodist Dallas Medical Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75203"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement",
"nctId": "NCT06336850",
"orgStudyIdInfo": {
"id": "069.GID.2020.D",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Portal Pressure Gradient Measurements from Hepatic and Portal Veins"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension"
},
{
"measure": "Clinical significance between portal pressure gradient measurement and portal hypertension"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Methodist Health System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-12-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Nurse's Role",
"Leukemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İzmir",
"contacts": [
{
"email": "[email protected]",
"name": "Seda ARDAHAN SEVGILI, PhD",
"phone": "00905544318390",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Figen YARDIMCI, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ege University",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": null,
"status": "RECRUITING",
"zip": "35100"
}
]
},
"descriptionModule": {
"briefSummary": "Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study",
"nctId": "NCT06336837",
"orgStudyIdInfo": {
"id": "24-3T/48",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "blood culture contamination rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ege University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid"
},
{
"name": "IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline"
}
]
},
"conditionsModule": {
"conditions": [
"Staphylococcus Aureus Bacteremia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Johor Bahru",
"contacts": [
{
"email": "[email protected]",
"name": "Wei Xuan Tuang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Malaysia",
"facility": "Hospital Sultanah Aminah",
"geoPoint": {
"lat": 1.4655,
"lon": 103.7578
},
"state": "Johor",
"status": null,
"zip": "80100"
},
{
"city": "Alor Setar",
"contacts": [
{
"email": "[email protected]",
"name": "Sharifah Baizura Syed Alwi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Malaysia",
"facility": "Hospital Sultanah Bahiyah",
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"lat": 6.12104,
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],
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{
"email": "[email protected]",
"name": "Steven Lim",
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}
],
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"email": "[email protected]",
"name": "Suraya Hanim Abdullah Hashim",
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"role": "CONTACT"
}
],
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"state": "Selangor",
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{
"email": "[email protected]",
"name": "Kah Chuan Lim",
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"phoneExt": null,
"role": "CONTACT"
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],
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"email": "[email protected]",
"name": "Azureen Azmel",
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"role": "CONTACT"
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],
"country": "Malaysia",
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"lat": 3.03333,
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},
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{
"city": "Selayang Baru Utara",
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{
"email": "[email protected]",
"name": "Anuradha P. Radhakrisnan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "Hospital Selayang",
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"lat": 3.2549,
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},
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{
"city": "Melaka",
"contacts": [
{
"email": "[email protected]",
"name": "Wee Fu Gan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Malaysia",
"facility": "Hospital Melaka",
"geoPoint": {
"lat": 2.196,
"lon": 102.2405
},
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]
},
"descriptionModule": {
"briefSummary": "The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 290,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EVOS",
"briefTitle": "Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia",
"nctId": "NCT06336824",
"orgStudyIdInfo": {
"id": "EVOS 1.2 dated 25/10/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of SAB-relapse"
}
],
"secondaryOutcomes": [
{
"measure": "Number of days of hospitalization"
},
{
"measure": "Rate of all-cause mortality"
},
{
"measure": "Rate of complications related to IV therapy"
},
{
"measure": "Rate of Clostridium difficile diarrhoea"
},
{
"measure": "Rate of adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Clinical Research Centre, Malaysia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-10-25",
"filename": "Prot_SAP_001.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 749936,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-28T09:13"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "passive virtual reality distraction"
},
{
"name": "active virtual reality distraction"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Acute",
"Child, Only",
"Anxiety and Fear"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İzmir",
"contacts": null,
"country": "Turkey",
"facility": "Gülçin Özalp Gerçeker",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": null,
"status": null,
"zip": "35100"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Before blood collection, the \"Emotional Appreance Scale for Children\" was evaluated by a non-researcher nurse. Pediatric patients between the ages of 6 and 12, from whom blood would be collected, were distributed to groups according to the randomization scheme.",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "activeVR",
"briefTitle": "Virtual Reality Distraction During Phlebotomy in Children",
"nctId": "NCT06336811",
"orgStudyIdInfo": {
"id": "DEU active-pasive VR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "procedure related pain"
},
{
"measure": "anxiety"
},
{
"measure": "fear"
},
{
"measure": "emotional apperance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dokuz Eylul University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pioglitazone 30mg"
},
{
"name": "Placebo"
},
{
"name": "Labs"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Hypertension",
"Pulmonary Hypertension Due to Lung Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bioenergetic Effect of Pioglitazone in CLD-PH",
"nctId": "NCT06336798",
"orgStudyIdInfo": {
"id": "STUDY00005871",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "K23HL166775",
"link": "https://reporter.nih.gov/quickSearch/K23HL166775",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Mitochondrial metabolism parameters: Spare respiratory capacity"
},
{
"measure": "Change in Mitochondrial metabolism parameters: Maximal respiration"
},
{
"measure": "Change in Mitochondrial metabolism parameters: Basal respiration"
}
],
"secondaryOutcomes": [
{
"measure": "Number of hypoglycemia incidences"
},
{
"measure": "Number of participants with leg edema"
},
{
"measure": "Change in BNP levels"
},
{
"measure": "Change in Six minute walk distance (6MWT)"
},
{
"measure": "Change in Borg dyspnea score"
},
{
"measure": "Change in NYHA/WHO Functional Classification"
},
{
"measure": "Change in University of California San Diego Shortness of Breath Questionnaire score"
},
{
"measure": "Change in emPHasis-10 Questionnaire score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Emory University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Restylane line of dermal fillers and Dysport neuromodulator"
}
]
},
"conditionsModule": {
"conditions": [
"Aesthetic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Andreas Nikolis, MD",
"phone": "514-488-0163",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Erevna Innovations Inc.",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "H3R3A1"
}
]
},
"descriptionModule": {
"briefSummary": "The \"Holistic Individualized Treatment\" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.The \"Kiss and Smile HIT\" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Kiss and Smile HIT",
"nctId": "NCT06336785",
"orgStudyIdInfo": {
"id": "04-2023-HIT-K&S",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Global Aesthetic Improvement Scale (GAIS)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erevna Innovations Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Restylane Shaype"
},
{
"name": "Juvéderm Volux"
}
]
},
"conditionsModule": {
"conditions": [
"Chin Retrusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": null,
"country": "Canada",
"facility": "Erevna Innovations Inc.",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H3R3A1"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Restylane Shaype Versus Juvederm Volux for Chin Augmentation",
"nctId": "NCT06336772",
"orgStudyIdInfo": {
"id": "10-2023-GAL-SHYP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Statistically significant group differences in the average three-dimensional volumetric increase since baseline"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale)"
},
{
"measure": "Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale)"
},
{
"measure": "Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erevna Innovations Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-29"
}
}
} | false | null |
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