protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Liporaxel"
}
]
},
"conditionsModule": {
"conditions": [
"Gastrointestinal Stromal Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "Min-Hee Ryu, MD, PhD",
"phone": "82-2-3010-5936",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Hyung-Don Kim, MD, PhD",
"phone": "82-2-3010-0236",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Korea, Republic of",
"facility": "Asan Medical Center, University of Ulsan College of Medicine",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": "Songpagu",
"status": null,
"zip": "138-736"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "GIST Oral Paclitaxel(Liporaxel)",
"nctId": "NCT06326346",
"orgStudyIdInfo": {
"id": "AMC2401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "16 week disease control rate"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Objective response rate"
},
{
"measure": "Adverse event assessed by NCI-CTCAE Version 5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Asan Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Combined parasternal block and serratus anterior plane block"
}
]
},
"conditionsModule": {
"conditions": [
"Parasternal Block",
"Serratus Anterior Plane Block",
"Acute Pain",
"Postoperative Analgesia",
"Cardiac Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Çankaya",
"contacts": null,
"country": "Turkey",
"facility": "Ankara City Hospital",
"geoPoint": {
"lat": 39.9179,
"lon": 32.86268
},
"state": "Ankara",
"status": null,
"zip": "06290"
}
]
},
"descriptionModule": {
"briefSummary": "Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery",
"nctId": "NCT06326333",
"orgStudyIdInfo": {
"id": "E.Kurul-E2-24-6176",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
}
],
"secondaryOutcomes": [
{
"measure": "Remifentanyl Consumption"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Combined SAPB"
}
]
},
"conditionsModule": {
"conditions": [
"Serratus Anterior Plane Block",
"Acute Pain",
"Postoperative Analgesia",
"Minimal Invasive Cardiac Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Çankaya",
"contacts": [
{
"email": "[email protected]",
"name": "Emine N Zengin, MD",
"phone": "+905063370548",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara City Hospital",
"geoPoint": {
"lat": 39.9179,
"lon": 32.86268
},
"state": "Ankara",
"status": "RECRUITING",
"zip": "06290"
}
]
},
"descriptionModule": {
"briefSummary": "Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combined SAPB in MICS",
"nctId": "NCT06326320",
"orgStudyIdInfo": {
"id": "E.Kurul-E2-24-6175",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
},
{
"measure": "Pain Scores"
}
],
"secondaryOutcomes": [
{
"measure": "Remifentanyl Consumption"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tell Show and Do Guidance"
},
{
"name": "Puppet Guidance"
}
]
},
"conditionsModule": {
"conditions": [
"Behavioral Guidance in Pediatric Dentistry"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jeddah",
"contacts": null,
"country": "Saudi Arabia",
"facility": "King Abulaziz university dental hospital",
"geoPoint": {
"lat": 21.54238,
"lon": 39.19797
},
"state": "Makkah",
"status": null,
"zip": "21589"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'* The main question\\[s\\] it aims to answer are: 1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia. 2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.type of study: clinical trial participant population/health conditions: HealthyIn this randomized crossover clinical trial, study subjects were randomly allocated into two groups:* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)* Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Two evaluators, who are blinded to the experimented techniques, watched recorded videos of both groups separately and gave their behavior assessment.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 41,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures",
"nctId": "NCT06326307",
"orgStudyIdInfo": {
"id": "247-05-21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Heart rate"
},
{
"measure": "Facial Image Scale"
},
{
"measure": "Vehnam Anxiety Rating Scale"
},
{
"measure": "Frankl behavior rating scale"
},
{
"measure": "FLACC Pain scale"
},
{
"measure": "Venham Scale of Dental behavior"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "King Abdulaziz University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thermal ablation"
},
{
"name": "LOOP ELECTROSURGICAL EXCISION PROCEDURE"
}
]
},
"conditionsModule": {
"conditions": [
"HIV Infections",
"HPV Infection",
"CIN 2/3"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Maputo",
"contacts": null,
"country": "Mozambique",
"facility": "INSMozambique",
"geoPoint": {
"lat": -25.96553,
"lon": 32.58322
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "To compare TA, an ablative cervical treatment modality, and LEEP, an excisional cervical treatment modality, in screen-positive WLWH patients, for eradication of hrHPV and effectiveness of treating biopsy-confirmed CIN 2/3.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4844,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "49 Years",
"minimumAge": "25 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique",
"nctId": "NCT06326294",
"orgStudyIdInfo": {
"id": "727/CNBS/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "M.D. Anderson Cancer Center"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Instituto Nacional de Saúde, Mozambique"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "external oblique intercostal plane block group"
},
{
"name": "oblique subcostal TAP block group"
},
{
"name": "Local anesthetic infiltration group"
},
{
"name": "control group"
}
]
},
"conditionsModule": {
"conditions": [
"Cholecystitis/Cholelithiasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Bılkent City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Patients were not told which method would be used The person evaluating the patients did not know which method was applied to which patient.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postoperative Pain Management in Laparoscopic Cholecystectomies",
"nctId": "NCT06326281",
"orgStudyIdInfo": {
"id": "ACHBILKENT-ANEST-BK-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analogue Scale Score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Phototherapy system CareMin650TM"
}
]
},
"conditionsModule": {
"conditions": [
"Leukemia, Myeloid, Acute",
"Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Strasbourg",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": "(0)3 68 33 95 23",
"phoneExt": "+33",
"role": "CONTACT"
},
{
"email": null,
"name": "Anne ZILLIOX, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Institut de cancérologie Strasbourg Europe",
"geoPoint": {
"lat": 48.58392,
"lon": 7.74553
},
"state": null,
"status": "RECRUITING",
"zip": "67033"
}
]
},
"descriptionModule": {
"briefSummary": "Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"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": "PHOTO-TREAT",
"briefTitle": "Interest of Light Therapy in Hematology - The PHOTO-TREAT Study",
"nctId": "NCT06326268",
"orgStudyIdInfo": {
"id": "2023-019",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID-RCB Number",
"id": "2023-A02133-42",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption."
},
{
"measure": "Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction."
},
{
"measure": "Evaluate the impact of PBM in terms of reduction of the use of artificial feeding."
},
{
"measure": "Evaluate the impact of PBM in terms of reduction of the length of hospital stay."
},
{
"measure": "Evaluate the impact of PBM in terms of reduction of the number of transfusions."
},
{
"measure": "Evaluate the impact of PBM in terms of pain reduction"
},
{
"measure": "Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut de cancérologie Strasbourg Europe"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "laughter yoga"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder",
"Parenting Stress",
"Depression",
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": null,
"country": "Hong Kong",
"facility": "The Hong Kong Polytechnic University",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:1. Laughter yoga is acceptable to children with ASD and their parents.2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.3. Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents",
"nctId": "NCT06326255",
"orgStudyIdInfo": {
"id": "LYASD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Response rate"
},
{
"measure": "Attrition rate"
},
{
"measure": "Attendance rate"
},
{
"measure": "Perception on laughter yoga"
},
{
"measure": "Difficulties in laughter yoga"
},
{
"measure": "Safety issues"
}
],
"secondaryOutcomes": [
{
"measure": "Depression"
},
{
"measure": "Anxiety"
},
{
"measure": "Parenting Stress"
},
{
"measure": "Child-parent Relationships"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Solid Tumor"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": null,
"name": "Teresa Profeta",
"phone": "+390294372561",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "European Institute of oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20141"
}
]
},
"descriptionModule": {
"briefSummary": "An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies."
},
"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": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials",
"nctId": "NCT06326242",
"orgStudyIdInfo": {
"id": "IEO 1648",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO)."
}
],
"secondaryOutcomes": [
{
"measure": "The characterization of enrolled patients involves assessing their participation in clinical trials"
},
{
"measure": "The characterization of enrolled patients based on therapeutic compliance."
},
{
"measure": "The protocol prescriptions in relation to socioeconomic and geographical determinants."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ICF entities assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Musculoskeletal Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ólvega",
"contacts": [
{
"email": "[email protected]",
"name": "Héctor Hernández Lázaro, PhD",
"phone": "+34976645480",
"phoneExt": "38229",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Ólvega Primary Care Physiotherapy service",
"geoPoint": {
"lat": 41.77901,
"lon": -1.98391
},
"state": "Soria",
"status": null,
"zip": "42110"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.The main question it aims to answer is:- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 385,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy",
"nctId": "NCT06326229",
"orgStudyIdInfo": {
"id": "CEIm 3096",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Sociodemographic data of the sample"
}
],
"primaryOutcomes": [
{
"measure": "ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Castilla-León Health Service"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Valladolid"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eugene D. Kwon, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer",
"nctId": "NCT06326216",
"orgStudyIdInfo": {
"id": "19-011292",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2023-05221",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "19-011292",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy"
},
{
"measure": "Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls"
},
{
"measure": "Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs"
},
{
"measure": "Prostate cancer-derived EV levels"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-06-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CELULAS TRONCO"
},
{
"name": "CONVENTIONAL DRESSING"
}
]
},
"conditionsModule": {
"conditions": [
"Peripheral Arterial Disease",
"Leg Ulcer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia",
"nctId": "NCT06326203",
"orgStudyIdInfo": {
"id": "UPECLIN-MB-8",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Major Amputation"
},
{
"measure": "Ulcer Healing"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Conselho Nacional de Desenvolvimento Científico e Tecnológico"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "UPECLIN HC FM Botucatu Unesp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Local standard of Care"
},
{
"name": "177Lu-DOTATATE"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent Meningioma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine \"theranostic\" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \\[177Lu\\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \\[177Lu\\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \\[177Lu\\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 135,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LUMEN-1",
"briefTitle": "177Lu-DOTATATE for Recurrent Meningioma",
"nctId": "NCT06326190",
"orgStudyIdInfo": {
"id": "EORTC-2334-BTG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression Free Survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Radiological response rate"
},
{
"measure": "Radiological response rate"
},
{
"measure": "The magnitude of change in Health-related quality of life (HRQoL)"
},
{
"measure": "The magnitude of change in Health-related quality of life (HRQoL)"
},
{
"measure": "The magnitude of change in Health-related quality of life (HRQoL)"
},
{
"measure": "Neurological function (NANO scale)"
},
{
"measure": "Toxicity According to CTCAE Version 5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Novartis"
}
],
"leadSponsor": {
"class": "NETWORK",
"name": "European Organisation for Research and Treatment of Cancer - EORTC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spine Posture Assessment"
},
{
"name": "Spine Movement Assessment"
},
{
"name": "Core Muscle Endurance Assessment"
},
{
"name": "Scapular Dyskinesia"
},
{
"name": "Shoulder Strength"
}
]
},
"conditionsModule": {
"conditions": [
"Postural Kyphosis",
"Postural Lordosis",
"Movement, Abnormal",
"Spine Injury",
"Cervical Lordosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "PT Academy",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Kadıköy",
"status": null,
"zip": "34744"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this observational study is to investigate relationship between cervical, thoracic, lumbar and thoracolumbar spine posture, spine movement, isometric and eccentric shoulder strength, scapular dyskinesis and core muscle endurance in healthy competitive young swimmers in comparison with healthy recreational swimmers. The main question is whether spine posture affects spine movement, shoulder strength, scapular dyskinesia and core endurance. Participants will asked to complete a warm up period, after that spine posture, spine movement, scapular dyskinesia, shoulder strength and core endurance will be assessed by examiner. Researchers will compare competitive swimmer group and recreational swimmer group. Additionally correlation between spine posture, spine movement, scapular dyskinesia, shoulder strength and core muscle endurance will be investigated in competitive swimmer group. Aim of the study is to determine whether posture have any effect upon these parameters."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigating Association Between Spine, Scapular, Shoulder and Core in Swimmers",
"nctId": "NCT06326177",
"orgStudyIdInfo": {
"id": "Yeditepe U - Poyraz Tuncer",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Spinal Posture"
},
{
"measure": "Cervical Movement"
},
{
"measure": "Thoracic Movement"
},
{
"measure": "Lumbar Movement"
},
{
"measure": "Thoracolumbar Movement"
}
],
"secondaryOutcomes": [
{
"measure": "Anterior Core Musculature Assessment"
},
{
"measure": "Lateral Core Musculature Assessment"
},
{
"measure": "Posterior Core Musculature Assessment"
},
{
"measure": "Core Musculature Ratio Assessment"
},
{
"measure": "Shoulder Strength Assessment"
},
{
"measure": "Shoulder Strength Ratio Assessment"
},
{
"measure": "Scapular Dyskinesia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yeditepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "kinesio-taping."
},
{
"name": "A designed physiotherapy program."
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kafr Ash Shaykh",
"contacts": [
{
"email": "[email protected]",
"name": "asmaa M khalil",
"phone": "01101011588",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Asmaa Mohamed Khalil Sedeek",
"geoPoint": {
"lat": 31.11174,
"lon": 30.93991
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Kinesio-taping of Lower Limbs",
"nctId": "NCT06326164",
"orgStudyIdInfo": {
"id": "sample",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in gait."
},
{
"measure": "Change in balance."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kafrelsheikh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interdisciplinary Psychoeducational Programme"
},
{
"name": "Health Education Programme"
}
]
},
"conditionsModule": {
"conditions": [
"Dependent Older People",
"Family Caregiver",
"Interdisciplinary",
"Intervention",
"Occupational Therapy",
"Psychoeducational",
"Psychology"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salamanca",
"contacts": [
{
"email": "[email protected]",
"name": "Eduardo PhD Fernandez, PhD",
"phone": "923294500",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Eduardo Jose Fernandez Rodriguez",
"geoPoint": {
"lat": 40.96882,
"lon": -5.66388
},
"state": "Castilla Y Leon",
"status": null,
"zip": "37002"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The work of sequencing, randomisation, recruitment and allocation of the trial sample will be carried out by research staff who are not involved in the assessments or interventions of each group, thus avoiding any potential bias in the trial.Participants will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which they have been assigned, thus masking the blinded assessment by third parties in the clinical trial. In addition, the researchers responsible for the statistical analysis of the trial will be blinded in order to increase the rigour of the trial process and thus the scientific quality.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults",
"nctId": "NCT06326151",
"orgStudyIdInfo": {
"id": "UMAPS-UDATO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mini Mental State Examination (MMSE)"
},
{
"measure": "Barthel Index"
},
{
"measure": "Caregiver Burden Interview"
}
],
"secondaryOutcomes": [
{
"measure": "Centre for Epidemiological Studies Depression Scale"
},
{
"measure": "Adaptation of the Psychosocial Support Questionnaire"
},
{
"measure": "General Health Questionnaire"
},
{
"measure": "World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)"
},
{
"measure": "The Bayer-Activities of Daily Living Scale (B-ADL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Salamanca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Edoxaban Pharmacokinetics and Pharmacodynamics"
}
]
},
"conditionsModule": {
"conditions": [
"Bariatric Surgery Candidate"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery.Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 0,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EXPOSE",
"briefTitle": "Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery",
"nctId": "NCT06326138",
"orgStudyIdInfo": {
"id": "22121",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pharmacokinetics edoxaban parameter"
},
{
"measure": "Pharmacokinetics edoxaban parameter"
},
{
"measure": "Pharmacokinetics edoxaban parameter"
},
{
"measure": "Pharmacokinetics edoxaban parameter"
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacodynamics edoxaban parameter"
},
{
"measure": "Pharmacodynamics edoxaban parameter"
},
{
"measure": "Pharmacodynamics edoxaban parameter"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut universitaire de cardiologie et de pneumologie de Québec, University Laval"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "WITHDRAWN",
"primaryCompletionDateStruct": {
"date": "2024-03-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TICK-B"
},
{
"name": "TKTX-Cream"
},
{
"name": "TICK-B and TKTX-C"
}
]
},
"conditionsModule": {
"conditions": [
"Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Duhok",
"contacts": null,
"country": "Iraq",
"facility": "Sherzad Khudeida Suleman",
"geoPoint": {
"lat": 36.86709,
"lon": 42.98845
},
"state": "Erbil",
"status": null,
"zip": "42012"
}
]
},
"descriptionModule": {
"briefSummary": "This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures",
"nctId": "NCT06326125",
"orgStudyIdInfo": {
"id": "SherzadSH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "severity of Pain"
}
],
"secondaryOutcomes": [
{
"measure": "Fear"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Uppsala University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-04-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Furosemide Injection"
},
{
"name": "Metolazone Tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Fluid Overload",
"Critical Illness",
"Sepsis",
"ARDS",
"Trauma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "John C Marshall, MD",
"phone": "4168645225",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Unity Health Toronto",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5B 1W8"
}
]
},
"descriptionModule": {
"briefSummary": "The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Masking of the health care team will not be feasible as they must administer the intervention",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RADAR-Canada",
"briefTitle": "Role of Active Deresuscitation After Resuscitation:",
"nctId": "NCT06326112",
"orgStudyIdInfo": {
"id": "4588",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Inflammatory and renal biomarkers - change from baseline values"
}
],
"primaryOutcomes": [
{
"measure": "Efficacy: Mean cumulative fluid balance"
},
{
"measure": "Compliance with deresuscitation protocol"
},
{
"measure": "Acceptability of protocol"
}
],
"secondaryOutcomes": [
{
"measure": "All cause mortality"
},
{
"measure": "New onset organ dysfunction"
},
{
"measure": "Organ support-free days"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canadian Institutes of Health Research (CIHR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Unity Health Toronto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Brief Online Binge Eating and Drinking Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Binge Eating",
"Binge Drinking"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Brief Binge Eating and Drinking Online Intervention",
"nctId": "NCT06326099",
"orgStudyIdInfo": {
"id": "R34AA030655",
"link": "https://reporter.nih.gov/quickSearch/R34AA030655",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Frequency of past 28-day binge drinking"
},
{
"measure": "Frequency of past 28-day binge eating"
},
{
"measure": "Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Mental Health/Substance Use Disorder Treatment History Inventory"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern California"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Chemotherapy drug"
},
{
"name": "Targeted Agent"
},
{
"name": "Immunotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Lung Cancer",
"Sarcopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hat Yai",
"contacts": null,
"country": "Thailand",
"facility": "Prince of Songkla University",
"geoPoint": {
"lat": 7.00836,
"lon": 100.47668
},
"state": "Songkla",
"status": "RECRUITING",
"zip": "90110"
}
]
},
"descriptionModule": {
"briefSummary": "Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment.",
"nctId": "NCT06326086",
"orgStudyIdInfo": {
"id": "REC.65-080-7-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "2. To determine baseline association between CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) and physical performance using SPPB in advanced NSCLC patients."
},
{
"measure": "4. To determine differences in rate decline in skeletal muscle mass using CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) in patients receiving first line chemotherapy (CMT) and other line chemotherapy (OCMT)."
}
],
"primaryOutcomes": [
{
"measure": "To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment."
}
],
"secondaryOutcomes": [
{
"measure": "To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"facility": "Soka Sugiura Internal Medicine Clinic",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": "340-0015"
},
{
"city": "Soka-shi, Saitama",
"contacts": null,
"country": "Japan",
"facility": "Soka Sugiura Internal Medicine Clinic",
"geoPoint": null,
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "340-0015"
},
{
"city": "Tokyo",
"contacts": null,
"country": "Japan",
"facility": "Tokyo-Eki Center-building Clinic",
"geoPoint": {
"lat": 35.6895,
"lon": 139.69171
},
"state": null,
"status": "RECRUITING",
"zip": "103-0027"
},
{
"city": "Tokyo",
"contacts": null,
"country": "Japan",
"facility": "Fukuwa Clinic",
"geoPoint": {
"lat": 35.6895,
"lon": 139.69171
},
"state": null,
"status": "RECRUITING",
"zip": "104-0031"
},
{
"city": "Tokyo",
"contacts": null,
"country": "Japan",
"facility": "Fukuwa Clinic",
"geoPoint": {
"lat": 35.6895,
"lon": 139.69171
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "104-0031"
},
{
"city": "Gyeonggi-do",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul National University Bundang Hospital",
"geoPoint": {
"lat": 37.58944,
"lon": 126.76917
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "13620"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Nowon Eulji Medical Center, Eulji University",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "01830"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Korea University Anam Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "02841"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Kangbuk Samsung Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "03181"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Asan Medical Center",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "05505"
},
{
"city": "Bloemfontein",
"contacts": null,
"country": "South Africa",
"facility": "Josha Research",
"geoPoint": {
"lat": -29.12107,
"lon": 26.214
},
"state": "Free State",
"status": "WITHDRAWN",
"zip": "9301"
},
{
"city": "Johannesburg",
"contacts": null,
"country": "South Africa",
"facility": "Wits Bara Clinical Trial Site",
"geoPoint": {
"lat": -26.20227,
"lon": 28.04363
},
"state": "Gauteng",
"status": "WITHDRAWN",
"zip": "2013"
},
{
"city": "Midrand",
"contacts": null,
"country": "South Africa",
"facility": "Shop#1 Health Emporium",
"geoPoint": {
"lat": -25.98953,
"lon": 28.12843
},
"state": "Gauteng",
"status": "WITHDRAWN",
"zip": "1685"
},
{
"city": "Durban",
"contacts": null,
"country": "South Africa",
"facility": "Dr Pillay's Rooms",
"geoPoint": {
"lat": -29.8579,
"lon": 31.0292
},
"state": "KwaZulu-Natal",
"status": "WITHDRAWN",
"zip": "4450"
},
{
"city": "Umkomaas",
"contacts": null,
"country": "South Africa",
"facility": "Dr T Padayachee",
"geoPoint": {
"lat": -30.20674,
"lon": 30.79776
},
"state": "KwaZulu-Natal",
"status": "WITHDRAWN",
"zip": "4170"
}
]
},
"descriptionModule": {
"briefSummary": "This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 288,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes",
"nctId": "NCT06326047",
"orgStudyIdInfo": {
"id": "NN9541-4945",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "World Health Organization (WHO)",
"id": "U1111-1291-9196",
"link": null,
"type": "OTHER"
},
{
"domain": "JRCT",
"id": "jRCT2031230704",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Glycated haemoglobin (HbA1c)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Glycated haemoglobin (HbA1c)"
},
{
"measure": "Relative change in body weight"
},
{
"measure": "Change in body weight"
},
{
"measure": "Change in fasting plasma glucose (FPG)"
},
{
"measure": "Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))"
},
{
"measure": "Change in waist circumference"
},
{
"measure": "Change in systolic blood pressure (SBP)"
},
{
"measure": "Change in high sensitivity C-Reactive Protein (hsCRP)"
},
{
"measure": "Change in total cholesterol"
},
{
"measure": "Change in high-density lipoprotein (HDL) cholesterol"
},
{
"measure": "Change in low-density lipoprotein (LDL) cholesterol"
},
{
"measure": "Change in triglycerides"
},
{
"measure": "Number of adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novo Nordisk A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dapagliflozin"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetic Nephropathy Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baghdad",
"contacts": null,
"country": "Iraq",
"facility": "Mohammed Mahmood Mahmood",
"geoPoint": {
"lat": 33.34058,
"lon": 44.40088
},
"state": null,
"status": null,
"zip": "00964"
}
]
},
"descriptionModule": {
"briefSummary": "Type 2 Diabetes Mellitus (T2DM) is a syndrome of metabolic dysregulation that needs a multifactorial behavioral and pharmacological treatments to prevent or delay complications, morbidity and mortality. Uncontrolled hyperglycemia can be negatively affecting the patient's physical and psychological status and thus lower the patient's quality of life (QoL) (Verma \\& Dadarwal, 2017)(Vanstone et al., 2015)(Gebremedhin et al., 2019). According to American Diabetes Association (ADA), when hyperglycaemia remain uncontrolled (HbA1c ≥1.5% above the glycemic target), a second therapy for T2DM is needed (Davies et al., 2022).It has been certained by ADA, beside the glucose lowering effect the add-on antidibetic medication should have an impact on weight management to achieve and maintain the optimum glycemic and weight control which are the goals in people without established cardiorenal risks (Vijan et al., 2014((Inzucchi et al., 2012). Although metformin still the first-line pharmacotherapy in most T2DM patients, according to American Diabetes Association (ADA) (Association, 2020) but has little or even weight neutral effect, as well as gliptins (Hermansen \\& Mortensen, 2007)(Sazan et al., 2012). Other old antidibetic classes such as thiazolidinediones (TZDs) and sulfonylureas (SUs) inspite of their efficacy in controlling glycemia but their use is associated with weight gain and other adverse effects (Derosa \\& Maffioli, 2010)(Najim et al., 2014)(Fonseca, 2003). However, The newest class of antidibetic drugs, sodium-glucose cotransporter 2 inhibitors (SGLT2i), are approved for the treatment of T2DM as add-on or even initial therapy (Tamez-Pérez et al., 2013). This class is act by inducing glycosuria and thus improving glycemic status without affecting insulin level (Merovci et al., 2015). Dapagliflozin is a highly selective inhibitor of SGLT2. It has been well tolerated and its safety and efficacy approved in the clinical trials, mostly on cardio-renal outcomes with additional benefits of weight loss and low risk of hypoglycemia (Heerspink et al., 2020)(Solomon et al., 2022)(Wiviott et al., 2019)(McMurray et al., 2019). To date, no clinical data regarding SGLT2i recorded in Iraqi patients with limited data available on Arabic population. On Qatari, assessment of Dapagliflozin effectiveness revealed a significant improvement in the glycemic status after 6 months when used in combination with standard therapy, a reduction (Al AdAwi et al., 2019). In Saudi Arabia, Dapagliflozin was found to be well-tolerated and effective treatment option for T2DM patients after 6 months (Alguwaihes, 2021)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This interventional randomized clinical study was conducted from May to December 2022, at the National Diabetic Centre for treatment and research/ Mustansiriyah University/ Baghdad/ Iraq. Ethical approval from the diabetic center and college of pharmacy/ Mustansiriyah University, was taken prior to the study initiation. All investigations/ procedures carried out in this study involving human participants were in accordance with the 1975 Declaration of Helsinki and its later amendments.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients",
"nctId": "NCT06326034",
"orgStudyIdInfo": {
"id": "AAA234",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quality of Life Assessment tool"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mohammed Mahmood Mohammed"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "autologous FL-33 CAR T therapy"
},
{
"name": "prior-HSCT donor-derived FL-33 CAR T therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Refractory/Relapsed Acute Myeloid Leukaemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Tengyu Wang",
"phone": "18333186020",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "BeijingGoBroadH",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\\*10\\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\\*10\\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia",
"nctId": "NCT06326021",
"orgStudyIdInfo": {
"id": "BJGBYY-IIT-LCYJ-2024-004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose-limiting toxicity(DLT)"
},
{
"measure": "Adverse events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Long-term Adverse events (AEs)"
},
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "The persistence of FL-33 CAR T cells"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beijing GoBroad Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"B-cell Acute Lymphoblastic Leukemia",
"Acute Lymphoblastic Leukemia, in Relapse"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\\~12 cases in dose escalation phase and 36 cases in dose expansion phase."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial",
"nctId": "NCT06326008",
"orgStudyIdInfo": {
"id": "BJGBYY-IIT-LCYJ-2023-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose-limiting toxicity (DLT)"
},
{
"measure": "Adverse events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Long-term Adverse events (AEs)"
},
{
"measure": "Objective response rate(ORR)"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "Event-free survival (EFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "The persistence of CD19/CD22 CAR T cells."
},
{
"measure": "The Maximum concentration (Cmax) of CD19/CD22 CAR T cells."
},
{
"measure": "The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beijing GoBroad Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Conventional radiation therapy"
},
{
"name": "Hypofractionated radiation therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Localized Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Huojun Zhang, M.D.",
"phone": "+8613311732399",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Huojun Zhang, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Changhai hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200433"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 428,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer",
"nctId": "NCT06325995",
"orgStudyIdInfo": {
"id": "Changhai HHHospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "5-year progression-free survival (PFS)"
},
{
"measure": "quality of life (QoL)"
},
{
"measure": "medical expenses"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Prostate cancer-specific survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Changhai Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Triethanolamine cream"
}
]
},
"conditionsModule": {
"conditions": [
"Radiation Injuries",
"Rectal Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world."
},
"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": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury",
"nctId": "NCT06325982",
"orgStudyIdInfo": {
"id": "BYFFL-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Occurrence time of acute and chronic radiation rectal injury"
},
{
"measure": "Evaluation of acute and chronic radiation rectal injury"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical symptom assessment"
},
{
"measure": "Quality of life assessment assessed by IBDQ"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Fujian Cancer Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Detect the immune function of peripheral blood samples"
}
]
},
"conditionsModule": {
"conditions": [
"Polycystic Ovary Syndrom",
"Metformin",
"Immune Function"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Manna Zhang, Doctor",
"phone": "+86-021-66301004",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Endocrinology, Shanghai Tenth People's Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": "RECRUITING",
"zip": "200072"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PCOS Patients Immune Status Evaluation",
"nctId": "NCT06325969",
"orgStudyIdInfo": {
"id": "PCOS Immune",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry."
},
{
"measure": "The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry."
}
],
"secondaryOutcomes": [
{
"measure": "Homeostasis model assessment of insulin resistance"
},
{
"measure": "body mass index"
},
{
"measure": "menstrual frequency"
},
{
"measure": "fasting glucose"
},
{
"measure": "fasting insulin"
},
{
"measure": "Total cholesterol"
},
{
"measure": "Triglycerides"
},
{
"measure": "HDL-c"
},
{
"measure": "LDL-c"
},
{
"measure": "total testosterone"
},
{
"measure": "free testosterone"
},
{
"measure": "Sex hormone-binding globulin"
},
{
"measure": "Androstenedione"
},
{
"measure": "Dehydroepiandrosterone"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai 10th People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Metformin"
}
]
},
"conditionsModule": {
"conditions": [
"Polycystic Ovary Syndrome",
"Metformin",
"Immune Function"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Manna Zhang, Doctor",
"phone": "86-21-66301004",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Endocrinology, Shanghai Tenth People's Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": "RECRUITING",
"zip": "200072"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PCOS Immune Function Predicts Metformin Efficacy",
"nctId": "NCT06325956",
"orgStudyIdInfo": {
"id": "Immune status and metformin",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry."
},
{
"measure": "The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry."
}
],
"secondaryOutcomes": [
{
"measure": "Homeostasis model assessment of insulin resistance"
},
{
"measure": "body mass index"
},
{
"measure": "menstrual frequency"
},
{
"measure": "fasting glucose"
},
{
"measure": "fasting insulin"
},
{
"measure": "Total cholesterol"
},
{
"measure": "Triglycerides"
},
{
"measure": "HDL-c"
},
{
"measure": "LDL-c"
},
{
"measure": "total testosterone"
},
{
"measure": "free testosterone"
},
{
"measure": "Sex hormone-binding globulin"
},
{
"measure": "Androstenedione"
},
{
"measure": "Dehydroepiandrosterone"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai 10th People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rituximab"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rozzano",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Istituto Clinico Humanitas",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ACTUAL"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CIDPRIT",
"briefTitle": "Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy",
"nctId": "NCT06325943",
"orgStudyIdInfo": {
"id": "CIDPRIT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment"
},
{
"measure": "clinical form"
},
{
"measure": "response to rituximab in patients with antinerve antibodies"
}
],
"primaryOutcomes": [
{
"measure": "Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability"
},
{
"measure": "Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability"
},
{
"measure": "Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability"
}
],
"secondaryOutcomes": [
{
"measure": "Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability"
},
{
"measure": "Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability"
},
{
"measure": "treatment suspension"
},
{
"measure": "time to worsening"
},
{
"measure": "Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ospedale Mondino di Pavia"
},
{
"name": "University of Turin, Italy"
},
{
"name": "Istituto Neurologico Carlo Besta di Milano"
},
{
"name": "San Raffaele University Hospital, Italy"
},
{
"name": "Università di Messina"
},
{
"name": "Universita degli Studi di Genova"
},
{
"name": "Istituto Di Ricerche Farmacologiche Mario Negri"
},
{
"name": "Università di Napoli Federico II"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Clinico Humanitas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "[14C]-HU6"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": null,
"name": "Kristin Satterfield, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Pharmaron Clinical Pharmacology Center (CPC)",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21201"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \\[14C\\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing."
},
"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": "55 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6",
"nctId": "NCT06325930",
"orgStudyIdInfo": {
"id": "RIV-HU6-105",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess the mass balance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Rivus Pharmaceuticals, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "what's app ongoing support"
},
{
"name": "usual care"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amman",
"contacts": null,
"country": "Jordan",
"facility": "University of Jordan",
"geoPoint": {
"lat": 31.95522,
"lon": 35.94503
},
"state": null,
"status": null,
"zip": "11942"
}
]
},
"descriptionModule": {
"briefSummary": "Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness.purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes.Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "two arms parallel randomized controlled",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DSMES",
"briefTitle": "Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic",
"nctId": "NCT06325917",
"orgStudyIdInfo": {
"id": "101271-5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "glycemic control"
}
],
"secondaryOutcomes": [
{
"measure": "diabetes self management behaviors"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Jordan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Uniportal VATS"
},
{
"name": "Tube thoracostomy"
}
]
},
"conditionsModule": {
"conditions": [
"Empyema, Pleural"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minya",
"contacts": null,
"country": "Egypt",
"facility": "Minia University",
"geoPoint": {
"lat": 28.10988,
"lon": 30.7503
},
"state": null,
"status": null,
"zip": "61111"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Uniportal VATS Versus Chest Tube for Early Empyema",
"nctId": "NCT06325904",
"orgStudyIdInfo": {
"id": "9138930",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Need for further management"
},
{
"measure": "Mortality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Minia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gastric mucosal brusing"
},
{
"name": "Gastric mucosal biopsy"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": [
{
"email": "[email protected]",
"name": "Rapat Pittayanon, MD",
"phone": "+66813132112",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Thanrada Vimonsuntirungsri",
"phone": "+66853356240",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Thailand",
"facility": "King Chulalongkorn Memorial Hospital",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null,
"status": "RECRUITING",
"zip": "10330"
},
{
"city": "Bangkok",
"contacts": [
{
"email": "[email protected]",
"name": "Thanrada Vimonsuntirungsri, MD",
"phone": "+66853356240",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Thailand",
"facility": "King Chulalongkorn memorial hospital",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null,
"status": "RECRUITING",
"zip": "10330"
}
]
},
"descriptionModule": {
"briefSummary": "Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despites its favoring benefit in microbiota study. Therefore, our study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Microbiota in Gastric Cancer by Gastric Mucosal Brushing",
"nctId": "NCT06325891",
"orgStudyIdInfo": {
"id": "RP025",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Microbiome analysis using gastric mucosal brushing"
}
],
"secondaryOutcomes": [
{
"measure": "Microbiome analysis using gastric mucosal biopsy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "King Chulalongkorn Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Genome-wide association study"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Inflammatory Demyelinating Polyradiculoneuropathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rozzano",
"contacts": [
{
"email": "[email protected]",
"name": "Eduardo Nobile Orazio, Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Clinico Humanitas",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype \\>700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange)"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 3500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GEARCIDP",
"briefTitle": "Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy",
"nctId": "NCT06325878",
"orgStudyIdInfo": {
"id": "NEU2-OSS-2022-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "single nucleotide polymorphisms (SNPs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Clinico Humanitas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interview"
}
]
},
"conditionsModule": {
"conditions": [
"Amyotrophic Lateral Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Martina Sodano",
"phone": "+39-02619111",
"phoneExt": "2937",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico italiano IRCSS, San Luca Hospital",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20145"
}
]
},
"descriptionModule": {
"briefSummary": "Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PESALS",
"briefTitle": "Perception of Unpleasant Sensations During Study Procedures in ALS Patients",
"nctId": "NCT06325865",
"orgStudyIdInfo": {
"id": "23C305",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of experience of unpleasant sensations or pain"
},
{
"measure": "Study procedure that causes unpleasant sensations or pain"
},
{
"measure": "Duration of unpleasant sensations or pain caused by the study procedure"
}
],
"secondaryOutcomes": [
{
"measure": "HADS score"
},
{
"measure": "ALSFRS score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DBS programing"
}
]
},
"conditionsModule": {
"conditions": [
"Essential Tremor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Alfonso Fasano, MD, PhD",
"phone": "(416) 603-5800",
"phoneExt": "5961",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Movement Disorders Centre - Toronto Western Hospital",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5T 2S8"
}
]
},
"descriptionModule": {
"briefSummary": "Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Directional Bilateral Thalamic Patterned Stimulation (Chronos)",
"nctId": "NCT06325852",
"orgStudyIdInfo": {
"id": "22-5772",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Tremor Rating Scale (Part A-B)"
},
{
"measure": "Tremor analysis"
},
{
"measure": "Tremor Rating Scale (A-C)"
},
{
"measure": "Tremor analysis (meter per second squared)"
},
{
"measure": "Gait speed (meter per second)"
},
{
"measure": "Base of support (meter)"
},
{
"measure": "Step length (meter)"
},
{
"measure": "Stride length (meter)"
},
{
"measure": "Single stance time and double stance time (seconds)"
},
{
"measure": "Tandem gait"
},
{
"measure": "Posturography (newtons)"
},
{
"measure": "Quality of life in Essential Tremor Questionnaire (QUEST)"
},
{
"measure": "Speech analysis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Boston Scientific Corporation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Alfonso Fasano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HypnoBirthing training and oxytocin massage group"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Related"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giresun",
"contacts": null,
"country": "Turkey",
"facility": "Giresun Gynecology and Children's Diseases Hospital",
"geoPoint": {
"lat": 40.91698,
"lon": 38.38741
},
"state": "Center",
"status": null,
"zip": "28200"
}
]
},
"descriptionModule": {
"briefSummary": "This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The research is an experimental study with a randomized control group.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Pregnant women included in the study were randomly divided into two groups using the sealed envelope method.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants",
"nctId": "NCT06325839",
"orgStudyIdInfo": {
"id": "GRU-SBF-ES-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Wijma Birth Anticipation/Experience Scale A (W-DEQ-A)"
}
],
"secondaryOutcomes": [
{
"measure": "Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B)"
},
{
"measure": "Postpartum Breastfeeding Self-Efficacy Scale - Short Form"
},
{
"measure": "Mother-Infant Attachment Scale (MICS)"
},
{
"measure": "Birth satisfaction scale short form (BSS-SF)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Giresun University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "General Evaluation Score (GES)"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Talkha",
"contacts": null,
"country": "Egypt",
"facility": "Egyptian Liver Hospital",
"geoPoint": {
"lat": 31.0539,
"lon": 31.37787
},
"state": "Dakahlia",
"status": null,
"zip": "36681"
}
]
},
"descriptionModule": {
"briefSummary": "This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs",
"nctId": "NCT06325826",
"orgStudyIdInfo": {
"id": "GES",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hepatocellular Carcinoma"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Egyptian Liver Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Active repetitive TMS"
},
{
"name": "Sham repetitive TMS"
}
]
},
"conditionsModule": {
"conditions": [
"Attention Deficit Hyperactivity Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ADHD PreSMA Response Inhibition Therapy",
"nctId": "NCT06325813",
"orgStudyIdInfo": {
"id": "CIN001 - ADHD PreSMART",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "TMS-based Short-Interval Intracortical Inhibition (SICI)"
},
{
"measure": "EEG-based beta activity"
},
{
"measure": "TMS-based Cortical Silent Period (cSP)"
},
{
"measure": "EEG-based alpha activity"
}
],
"secondaryOutcomes": [
{
"measure": "Stop Signal Reaction Time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children's Hospital Medical Center, Cincinnati"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Oxidative Stress",
"Cardiovascular Risk",
"Target Organ Damage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santiago De Compostela",
"contacts": [
{
"email": "[email protected]",
"name": "Nestor Vazquez Agra, PhD",
"phone": "0034981950000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nestor Vazquez-Agra, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ana-Teresa Marques-Afonso, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sofia Barbosa-Gouveia, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Anton Cruces-Sande, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Carla Diaz-Louzao, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Iago Carballo, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lucia Barrera-Lopez, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Adela Lama-López, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lucia Gomez-Suarez, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ivan Fernandez-Castro, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Clara Casar-Cocheteux, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Alvaro Hermida-Ameijeiras, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Arturo Gonzalez-Quintela, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Antonio Pose-Reino, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Francisco Gude-Sampedro, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Complejo Hospitalario Universitario de Santiago de Compostela",
"geoPoint": {
"lat": 42.88052,
"lon": -8.54569
},
"state": "A Coruña",
"status": "RECRUITING",
"zip": "15706"
}
]
},
"descriptionModule": {
"briefSummary": "Vascular target organ damage (TOD), defined as structural or functional deleterious changes in large and small arteries, is related to unfavorable arterial biomechanics, atherosclerosis and arteriosclerosis. Endothelial dysfunction due to unfavorable redox and glycation states on the bases of these phenomena. However, little is known about the role of glycoxidation on arterial biomechanics and TOD in apparently healthy individuals. The main hypothesis is that glycation and glycoxidation status are associated with arterial biomechanical abnormalities and TOD in patients with moderate to high cardiovascular risk. This is an observational, ambispective, and multicenter project that will include non-smoking patients over 18 years, without diabetes mellitus or established cardiovascular disease. Demographic, epidemiological, and clinical-anthropometric variables will be collected, including data from ambulatory blood pressure monitoring. The investigators will measure the serum percentage of glycated hemoglobin, glycated albumin, and fructosamine levels; along with quantification of skin advanced glycation and glycoxidation end productos (AGEs). Plasma concentration, activity, and structure of catalase, glutathione peroxidase, and superoxide dismutase in relation to the patient's glycation and glycoxidation status will be also evaluated. Concurrently, several biomechanical parameters will be assessed in the Common, Internal Carotid Artery, and distal limb arteries using ultrasound exploration. Incipient microvasculature damage will be also evaluated by retinal image. Patients will be followed up for the development of arterial biomechanical abnormalities and TOD, along with cardiovascular events."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GlycOxiTod",
"briefTitle": "Glycoxidation, Arterial Biomechanics, and Target Organ Damage",
"nctId": "NCT06325800",
"orgStudyIdInfo": {
"id": "2021401/2023007",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Juan Rodés Grant (JR23/00018)",
"id": "Grant",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of redox status (1)"
},
{
"measure": "Assessment of redox status (2)"
},
{
"measure": "Evaluation of glycation status (1)"
},
{
"measure": "Evaluation of glycation status (2)"
},
{
"measure": "Evaluation of glycation status (3)"
},
{
"measure": "Evaluation of glycation status (4)"
},
{
"measure": "Assessment of Glycoxidation status (1)"
},
{
"measure": "Assessment of Glycoxidation status (2)"
},
{
"measure": "Quantification of arterial targen organ damage (TOD) during the follow-up (1)"
},
{
"measure": "Quantification of arterial targen organ damage (TOD) during the follow-up (2)"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of cardiovascular disease during the follow-up"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto de Investigación Sanitaria de Santiago de Compostela"
},
{
"name": "Instituto de Salud Carlos III"
},
{
"name": "University of Santiago de Compostela"
},
{
"name": "Hospital de Barbanza"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Complejo Hospitalario Universitario de Santiago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "thyroid lobectomy"
},
{
"name": "image-guided thermal ablation"
}
]
},
"conditionsModule": {
"conditions": [
"Papillary Thyroid Cancer"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1021,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma",
"nctId": "NCT06325787",
"orgStudyIdInfo": {
"id": "S2021-211-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "disease progression"
},
{
"measure": "disease-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "complications"
},
{
"measure": "procedure time"
},
{
"measure": "cost"
},
{
"measure": "estimated blood loss"
},
{
"measure": "hospitalization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese PLA General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2017-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hypofractionated radiation therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Localized Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Huojun Zhang, M.D.",
"phone": "+8613311732399",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Huojun Zhang, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Changhai hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200433"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Radical Hypofractionated Radiotherapy for Localized Prostate Cancer",
"nctId": "NCT06325774",
"orgStudyIdInfo": {
"id": "Changhai HHospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "biochemical progression-free survival (bPFS)"
},
{
"measure": "local progression-free-survival(LPFS)"
},
{
"measure": "distant metastasis free survival(DMFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Quality of life (QoL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Changhai Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SY-5007"
},
{
"name": "SY-5007"
}
]
},
"conditionsModule": {
"conditions": [
"Health Subjects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": [
{
"email": "[email protected]",
"name": "Li Zheng",
"phone": "86-28-85423655",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "West China Hospital of Sichuan University",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "610041"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects",
"nctId": "NCT06325761",
"orgStudyIdInfo": {
"id": "SY-5007-I-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cmax for SY-5007"
},
{
"measure": "Tmax for SY-5007"
},
{
"measure": "AUC0-t for SY-5007"
},
{
"measure": "AUC0-∞ for SY-5007"
},
{
"measure": "t½ for SY-5007"
},
{
"measure": "CL/F for SY-5007"
},
{
"measure": "Vz/F for SY-5007"
}
],
"secondaryOutcomes": [
{
"measure": "Safety of SY-5007"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shouyao Holdings (Beijing) Co. LTD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SENTI-202"
}
]
},
"conditionsModule": {
"conditions": [
"AML/MDS",
"CD33 Expressing Hematological Malignancies",
"FLT3 Expressing Hematological Malignancies"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 21,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "74 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS",
"nctId": "NCT06325748",
"orgStudyIdInfo": {
"id": "SENTI-202-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and tolerability for dose determination of SENTI-202"
}
],
"secondaryOutcomes": [
{
"measure": "Anti-cancer activity of SENTI-202"
},
{
"measure": "Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202"
},
{
"measure": "Host immune response to SENTI-202"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Senti Biosciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2040-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "None intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Systemic Inflammation Markers",
"Birth Weight",
"Combined Systemic Inflammatory Indices"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Napoli",
"contacts": null,
"country": "Italy",
"facility": "Università degli studi della Campania \"Luigi Vanvitelli\"- OB & Gyn -",
"geoPoint": {
"lat": 40.85216,
"lon": 14.26811
},
"state": "Italia",
"status": null,
"zip": "80138"
}
]
},
"descriptionModule": {
"briefSummary": "The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 199,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combined Systemic Inflammatory Indices and Birth Weight",
"nctId": "NCT06325735",
"orgStudyIdInfo": {
"id": "98",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Systemic inflammatory indices and birth weight"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Campania \"Luigi Vanvitelli\""
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low-carbohydrate Diet"
},
{
"name": "Low-fat Diet"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight",
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "Kevin Hall, Ph.D.",
"phone": "301-402-8248",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": null,
"zip": "20892"
}
]
},
"descriptionModule": {
"briefSummary": "Background:In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.Objective:To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.Eligibility:Adults aged 19 to 50 years with a body mass index of 25 or more.Design:Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered.Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period...."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change",
"nctId": "NCT06325722",
"orgStudyIdInfo": {
"id": "10001680",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001680-DK",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in total fat mass"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of body weight change from baseline to week 8"
},
{
"measure": "Rate of body weight change during low-carbohydrate diet"
},
{
"measure": "Rate of body weight change during low-fat diet"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Base-edited hematopoietic stem and progenitor cells"
},
{
"name": "Busulfan"
},
{
"name": "Palifermin"
},
{
"name": "Filgrastim"
},
{
"name": "Plerixafor"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Granulomatous Disease (CGD)",
"X-Linked Chronic Granulomatous Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": null,
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": null,
"zip": "20892"
}
]
},
"descriptionModule": {
"briefSummary": "Background:Chronic granulomatous disease (CGD) is a rare immune disorder caused by a mutation in the CYBB gene. People with CGD have white blood cells that do not work properly. This places them at risk of developing infections that may be life-threatening. Stem cell transplant can cure CGD but transplanting stem cells donated by other people can have serious complications. In addition, not everyone has a matched donor. Another approach is a type of gene therapy that involves base-editing to correct the mutation in a person s own stem cells. Researchers want to know if the base-edited stem cells can improve the white cells' functioning and result in fewer CGD-related infections.Objective:To learn if base-edited stem cells will improve white blood cells' ability to fight against infections in people with CGD.Eligibility:Males aged 18 years and older with X-linked CGD.Design:This is a non-randomized study. Participants with the specific mutation under study will be screened during the initial phase.During the development phase, participants will undergo apheresis to collect stem cells for base-editing correction of the mutation.During the treatment phase, participants will receive the base-edited cells after chemotherapy with busulfan. Participants will remain in the hospital until their immunity recovers.Follow-up visits will continue for 15 years."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease",
"nctId": "NCT06325709",
"orgStudyIdInfo": {
"id": "10001580",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001580-I",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the safety of base-edited autologous CD34+ cells"
},
{
"measure": "To evaluate the efficacy of base-edited autologous CD34+ cells"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate the efficiency of base-editing."
},
{
"measure": "Evaluate the engraftment capability of base-edited hematopoietic stem progenitor cells."
},
{
"measure": "Evaluate the efficiency in restoring gp91phox expression."
},
{
"measure": "Evaluate efficacy in restoring NADPH oxidase function."
},
{
"measure": "Evaluate clinical efficacy"
},
{
"measure": "Evaluate the stability of gene correction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute of Allergy and Infectious Diseases (NIAID)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2032-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hymecromone"
}
]
},
"conditionsModule": {
"conditions": [
"Interstitial Lung Disease",
"Idiopathic Pulmonary Fibrosis",
"Lung Diseases, Interstitial"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Research Triangle Park",
"contacts": [
{
"email": "[email protected]",
"name": "NIEHS Join A Study Recruitment Group",
"phone": "855-696-4347",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "NIEHS Clinical Research Unit (CRU)",
"geoPoint": {
"lat": 35.90567,
"lon": -78.90497
},
"state": "North Carolina",
"status": null,
"zip": "27709"
}
]
},
"descriptionModule": {
"briefSummary": "Background:Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.Objective:To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.Eligibility:People aged 18 years and older with interstitial lung disease or lung fibrosis.Design:Participants will have at least 7 clinic visits over 5 months.Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "H01 in Adults With Interstitial Lung Disease (The SOLIS Study)",
"nctId": "NCT06325696",
"orgStudyIdInfo": {
"id": "10001577",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001577-E",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate the safety and tolerability of oral H01 in participants with progressive ILD."
},
{
"measure": "Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01."
},
{
"measure": "Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01."
},
{
"measure": "Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute of Environmental Health Sciences (NIEHS)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Lomustine"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Nivolumab"
},
{
"name": "Relatlimab"
},
{
"name": "Surgical Procedure"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent Glioblastoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 178,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma",
"nctId": "NCT06325683",
"orgStudyIdInfo": {
"id": "NCI-2024-01995",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01995",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Alliance for Clinical Trials in Oncology",
"id": "A072201",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "A072201",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "U10CA180821",
"link": "https://reporter.nih.gov/quickSearch/U10CA180821",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "OS rate"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Radiographic response"
},
{
"measure": "Incidence of adverse events (AEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-07-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BED treatment"
},
{
"name": "Waitlist"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2",
"Binge-Eating Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense",
"contacts": [
{
"email": "[email protected]",
"name": "Pernille Fiil Nybo, Cand.psych.",
"phone": "+45 2042 7108",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jakob Linnet, Dr. med., cand.psych.",
"phone": "+45 2913 8045",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Region Of Southern Denmark Locations",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": "Region Of Southern Denmark",
"status": "RECRUITING",
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders.The main questions it aims to answer are:* Does treatment for Binge Eating Disorder lead to improvements in BED symptoms?* Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors?Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior.Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Type 2 Diabetes and Binge Eating Disorder (BED)",
"nctId": "NCT06325670",
"orgStudyIdInfo": {
"id": "23/50374",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Eating Disorder Examination Questionnaire (EDE-Q)"
},
{
"measure": "Major Depression Inventory (MDI)"
},
{
"measure": "Problem Areas In Diabetes (PAID20)"
},
{
"measure": "Lipid profile"
},
{
"measure": "Body Mass Index (BMI)"
},
{
"measure": "Blood Pressure"
}
],
"primaryOutcomes": [
{
"measure": "Number of binge eating episodes"
}
],
"secondaryOutcomes": [
{
"measure": "Binge Eating Disorder Questionnaire"
},
{
"measure": "Glucose Sensor Data for Blood Glucose Profile"
},
{
"measure": "HbA1c"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jascha Fonden"
},
{
"name": "Independent Research Fund Denmark"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Odense University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RSVpreF vaccine"
},
{
"name": "Placebp"
}
]
},
"conditionsModule": {
"conditions": [
"Respiratory Syncytial Virus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "East London",
"contacts": null,
"country": "South Africa",
"facility": "Synergy Biomed Research Institute",
"geoPoint": {
"lat": -33.01529,
"lon": 27.91162
},
"state": "Eastern CAPE",
"status": "NOT_YET_RECRUITING",
"zip": "5241"
},
{
"city": "Bloemfontein",
"contacts": null,
"country": "South Africa",
"facility": "Josha Research",
"geoPoint": {
"lat": -29.12107,
"lon": 26.214
},
"state": "FREE State",
"status": "NOT_YET_RECRUITING",
"zip": "9301"
},
{
"city": "Benoni",
"contacts": null,
"country": "South Africa",
"facility": "Worthwhile Clinical Trials",
"geoPoint": {
"lat": -26.18848,
"lon": 28.32078
},
"state": "Gauteng",
"status": "RECRUITING",
"zip": "1500"
},
{
"city": "Boksburg",
"contacts": null,
"country": "South Africa",
"facility": "REIMED Reiger Park",
"geoPoint": {
"lat": -26.21197,
"lon": 28.25958
},
"state": "Gauteng",
"status": "NOT_YET_RECRUITING",
"zip": "1459"
},
{
"city": "Johannesburg",
"contacts": null,
"country": "South Africa",
"facility": "Wits RHI",
"geoPoint": {
"lat": -26.20227,
"lon": 28.04363
},
"state": "Gauteng",
"status": "NOT_YET_RECRUITING",
"zip": "2001"
},
{
"city": "Johannesburg",
"contacts": null,
"country": "South Africa",
"facility": "University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)",
"geoPoint": {
"lat": -26.20227,
"lon": 28.04363
},
"state": "Gauteng",
"status": "NOT_YET_RECRUITING",
"zip": "2013"
},
{
"city": "Johannesburg",
"contacts": null,
"country": "South Africa",
"facility": "Wits VIDA Nkanyezi Research Unit",
"geoPoint": {
"lat": -26.20227,
"lon": 28.04363
},
"state": "Gauteng",
"status": "NOT_YET_RECRUITING",
"zip": "2093"
},
{
"city": "Johannesburg",
"contacts": null,
"country": "South Africa",
"facility": "Wits VIDA Nkanyezi",
"geoPoint": {
"lat": -26.20227,
"lon": 28.04363
},
"state": "Gauteng",
"status": "NOT_YET_RECRUITING",
"zip": "2093"
},
{
"city": "Pretoria",
"contacts": null,
"country": "South Africa",
"facility": "Botho Ke Bontle Health Services",
"geoPoint": {
"lat": -25.74486,
"lon": 28.18783
},
"state": "Gauteng",
"status": "RECRUITING",
"zip": "0184"
},
{
"city": "Tshwane",
"contacts": null,
"country": "South Africa",
"facility": "Setshaba Research Centre",
"geoPoint": null,
"state": "Gauteng",
"status": "NOT_YET_RECRUITING",
"zip": "0152"
},
{
"city": "Ladysmith",
"contacts": null,
"country": "South Africa",
"facility": "Qhakaza Mbokodo Research Clinic",
"geoPoint": {
"lat": -28.55874,
"lon": 29.77896
},
"state": "Kwazulu-natal",
"status": "NOT_YET_RECRUITING",
"zip": "3370"
},
{
"city": "Polokwane",
"contacts": null,
"country": "South Africa",
"facility": "Gole Biomed Research Centre",
"geoPoint": {
"lat": -23.90449,
"lon": 29.46885
},
"state": "Limpopo",
"status": "RECRUITING",
"zip": "0734"
},
{
"city": "Cape Town",
"contacts": null,
"country": "South Africa",
"facility": "MRC Unit on Child And Adolescent Health",
"geoPoint": {
"lat": -33.92584,
"lon": 18.42322
},
"state": "Western CAPE",
"status": "NOT_YET_RECRUITING",
"zip": "7700"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.The study will look at the safety, tolerability, and immune activity in mothers and their infants.This study is seeking pregnant women who are:* Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -* Receiving standard medical care during the pregnancy* Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).* Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.* agree to be present for all study visits, procedures, and blood draws.Participants will either receive:* RSVpreF vaccine* A placebo. A placebo does not have any medicine it but looks just like the study vaccine.Pregnant participants will be involved in the study from:* consent during their current pregnancy, and* for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"masking": "QUADRUPLE",
"maskingDescription": "This is a double-blinded, placebo-controlled study",
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 330,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "49 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "MORISOT",
"briefTitle": "A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants",
"nctId": "NCT06325657",
"orgStudyIdInfo": {
"id": "C3671032",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions"
},
{
"measure": "Maternal Participants Primary Safety - The proportion of participants reporting local reactions"
},
{
"measure": "Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)"
},
{
"measure": "Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs)"
},
{
"measure": "Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)"
},
{
"measure": "Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes"
},
{
"measure": "Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)"
},
{
"measure": "Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs)"
}
],
"secondaryOutcomes": [
{
"measure": "Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B"
},
{
"measure": "Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pfizer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketogenic Diet"
},
{
"name": "Ketone/Glucose Monitoring"
},
{
"name": "CGM/CKM"
},
{
"name": "Blood Draw"
},
{
"name": "Body Composition"
},
{
"name": "Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) ."
}
]
},
"conditionsModule": {
"conditions": [
"Polycystic Kidney Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Well-Formulated Ketogenic Diet Polycystic Kidney Disease",
"nctId": "NCT06325644",
"orgStudyIdInfo": {
"id": "2023H0258",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Departent of Defense",
"id": "CDMRP-PR212399-G",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Finger Stick Beta-Hydroxybutyrate"
},
{
"measure": "Finger Stick Glucose"
}
],
"secondaryOutcomes": [
{
"measure": "Blood Pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ohio State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-01-07",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 409140,
"typeAbbrev": "Prot",
"uploadDate": "2024-03-19T14:40"
},
{
"date": "2024-01-07",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 428384,
"typeAbbrev": "ICF",
"uploadDate": "2024-03-19T14:40"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intra-articular injection to lumbar facet joint"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain, Mechanical",
"Facet Syndrome of Lumbar Spine"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Öznur UZUN, MD",
"phone": "+905052912734",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara Bilkent Şehir Hastanesi",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Evaluation of the Results of Facet Joint Injections",
"nctId": "NCT06325631",
"orgStudyIdInfo": {
"id": "Ankara City Hospital Bilkent",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analogue Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Oznur Uzun"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention other than obtaining biopsies"
},
{
"name": "Indocyanine green (ICG)"
}
]
},
"conditionsModule": {
"conditions": [
"Turner Syndrome",
"Cardiovascular Diseases",
"Lymphedema",
"Inflammation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aarhus N",
"contacts": [
{
"email": "[email protected]",
"name": "Line Balsby, MD",
"phone": "+4520461203",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Claus Gravholt, MD, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Aarhus University Hospital",
"geoPoint": {
"lat": 56.15674,
"lon": 10.21076
},
"state": null,
"status": "RECRUITING",
"zip": "8200"
}
]
},
"descriptionModule": {
"briefSummary": "100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.The aim is to examine and quantify the cardiovascular and lymphatic system in women with TS. The investigators will study a possible causal mechanism between the known pathologic phenotype and alterations in these systems to understand, prevent or treat the life-threatening complications in TS."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TSCOR_V",
"briefTitle": "Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome",
"nctId": "NCT06325618",
"orgStudyIdInfo": {
"id": "1-10-72-138-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Grade dysfunction of clinical and subclinical lymphedema using Indocyanine Green Lymphography and Magnetic Resonance Lymphangiography."
},
{
"measure": "Detecting low-grade inflammation in Turner Syndrome preforming FDG-PET/CT-scans to locate low grade inflammation."
},
{
"measure": "Heat maps of the distribution of wall shear stress in the aorta"
}
],
"secondaryOutcomes": [
{
"measure": "MRI evaluation and description of vascular abnormalities in Turner Syndrome"
},
{
"measure": "Cardiac MRI to evaluate function"
},
{
"measure": "Cardiac MRI to evaluate fibrosis of the myocardium"
},
{
"measure": "Mapping DNA-methylations patterns in multiple tissues"
},
{
"measure": "Immunologic changes in Turner Syndrome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Aarhus University Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Aarhus"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bifidobacterium"
},
{
"name": "High-frequency rTMS"
},
{
"name": "Escitalopram Oxalate"
}
]
},
"conditionsModule": {
"conditions": [
"Adolescent Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tangshan",
"contacts": null,
"country": "China",
"facility": "Tangshan Workers' Hospital",
"geoPoint": {
"lat": 39.63333,
"lon": 118.18333
},
"state": "Hebei",
"status": null,
"zip": "063003"
}
]
},
"descriptionModule": {
"briefSummary": "A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression",
"nctId": "NCT06325605",
"orgStudyIdInfo": {
"id": "GRYY-LL-KJ2022-064",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "HAMD-24 scores"
},
{
"measure": "TNF-α"
},
{
"measure": "IL-1β"
},
{
"measure": "IL-6"
},
{
"measure": "DA"
},
{
"measure": "5-HT"
},
{
"measure": "COR"
},
{
"measure": "Serum miR-16"
},
{
"measure": "Serum miR-195"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhen-Hong Hu"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "surgical timing and operation path"
}
]
},
"conditionsModule": {
"conditions": [
"High-Grade Squamous Intraepithelial Lesions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": null,
"country": "China",
"facility": "Sichuan Cancer Hospital and Research Institute",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "610000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 826,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL",
"nctId": "NCT06325592",
"orgStudyIdInfo": {
"id": "REHSIL2023V1.1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative fever"
},
{
"measure": "Postoperative therapeutic use of antibiotics"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative complications"
},
{
"measure": "Postoperative hospitalization days"
},
{
"measure": "Postoperative hemoglobin"
},
{
"measure": "Postoperative white blood cell count"
},
{
"measure": "Postoperative erythrocyte count"
},
{
"measure": "Postoperative albumin number"
},
{
"measure": "Postoperative CRP value"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sichuan Cancer Hospital and Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Immersive Virtual Reality for Dysphagia Treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Virtual Reality",
"Dysphagia",
"Treatment Compliance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sheffield",
"contacts": null,
"country": "United Kingdom",
"facility": "Sheffield Hallam University",
"geoPoint": {
"lat": 53.38297,
"lon": -1.4659
},
"state": "South Yorkshire",
"status": null,
"zip": "S1 2NU"
}
]
},
"descriptionModule": {
"briefSummary": "People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DEVICE_FEASIBILITY",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IVRys",
"briefTitle": "Immersive Virtual Reality for Dysphagia",
"nctId": "NCT06325579",
"orgStudyIdInfo": {
"id": "AA29411356",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes."
},
{
"measure": "Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sheffield Hallam University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-24"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rexlemestrocel-L + HA mixture"
},
{
"name": "Saline"
}
]
},
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"conditions": [
"Degenerative Disc Disease"
]
},
"contactsLocationsModule": {
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},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment."
},
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]
},
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},
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},
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"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HyaluronicAcid",
"briefTitle": "Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain",
"nctId": "NCT06325566",
"orgStudyIdInfo": {
"id": "MSB-DR004",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score"
},
{
"measure": "Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of 30% VAS Pain Responders at 12 Months Post-treatment"
},
{
"measure": "Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment"
},
{
"measure": "Percentage of Minimal Pain Responders at 12 Months Post-treatment"
},
{
"measure": "Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment"
},
{
"measure": "Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment"
},
{
"measure": "Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment"
}
]
},
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"class": "INDUSTRY",
"name": "Mesoblast, Ltd."
}
},
"statusModule": {
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"date": "2027-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-08"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
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"interventions": null
},
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"conditions": [
"Platelet Refractoriness in Adult Acute Leukemia"
]
},
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"locations": [
{
"city": "Bangkok",
"contacts": [
{
"email": "[email protected]",
"name": "weerapat Owattanapanich, MD",
"phone": "0891081963",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Phakaporn Chamweha, DR",
"phone": "06855156615",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Thailand",
"facility": "Siriraj hospital",
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"lon": 100.50144
},
"state": null,
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"zip": "10700"
}
]
},
"descriptionModule": {
"briefSummary": "This research project is evaluate the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving PFB during induction and first consolidation phase chemotherapy compared to 2 historical control groups which are patients receiving non-leukocyte depleted blood product group and leukocyte depleted blood product group and demonstrate cost-effectiveness of using blood products with filtered process to prevent clinical platelet refractoriness compare with using HLA-matched blood products after platelet refractoriness occurs"
},
"designModule": {
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},
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},
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},
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PTR",
"briefTitle": "Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control",
"nctId": "NCT06325553",
"orgStudyIdInfo": {
"id": "022_2566",
"link": null,
"type": null
},
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},
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"measure": "Descriptive statistics"
},
{
"measure": "Inferential statistics"
}
],
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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": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "indirect pulp capping with theracal pt"
},
{
"name": "indirect pulp capping with therabase"
},
{
"name": "indirect pulp capping with biodentine"
}
]
},
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"conditions": [
"Dentin, Carious",
"Indirect Pulp Capping"
]
},
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{
"city": "Istanbul",
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},
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},
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"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "patients and the researcher who evaluates the follow-up results of the patients will not know which material was used for indirect pulp coating.",
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]
},
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},
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"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "9 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up",
"nctId": "NCT06325540",
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"id": "pulpcapping",
"link": null,
"type": null
},
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},
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"measure": "successful completion of research"
},
{
"measure": "unseccessful completion of research"
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],
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},
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"name": "Saglik Bilimleri Universitesi"
}
},
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"date": "2024-02-15"
},
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},
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},
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"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
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"Neurodegenerative Diseases",
"Cognitive Impairment",
"Mild Cognitive Impairment"
]
},
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"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Jinwen Xiao",
"phone": "13917310784",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gang Wang",
"phone": null,
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}
],
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"facility": "Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine",
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},
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"briefSummary": "The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.The main questions it aims to answer are:* incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)* to build a predictive model for the progression of cognitive impairment"
},
"designModule": {
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},
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},
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"minimumAge": "60 Years",
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"OLDER_ADULT"
]
},
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"id": "YuGarden-01",
"link": null,
"type": null
},
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},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Incidence of cognitive impairment"
}
],
"secondaryOutcomes": [
{
"measure": "The change of Mini-Mental State Examination (MMSE)"
},
{
"measure": "The change of Barthel Index for Activities of Daily Living (ADL)"
},
{
"measure": "The change of blood biomarkers"
},
{
"measure": "The change of urine biomarkers"
},
{
"measure": "The change of feces biomarkers"
},
{
"measure": "The change of gingival crevicular fluid biomarkers"
},
{
"measure": "The change of electroencephalogram (EEG)"
},
{
"measure": "The change of speech information"
},
{
"measure": "The change of structural MRI"
},
{
"measure": "The change of functional MRI"
},
{
"measure": "The change of magnetic susceptibility"
},
{
"measure": "The change of perfusion MR imaging"
},
{
"measure": "Positron emission tomography (PET)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Ruijin Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2031-04-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Artificial intelligence based program"
}
]
},
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"conditions": [
"Oral Cancer",
"Oral Lichen Planus",
"Fordyce Granule",
"Leukoplakia",
"Erythroplakia",
"Leukoedemas, Oral",
"Lichenoid Reaction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases."
},
"designModule": {
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},
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},
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis",
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"id": "NA2024",
"link": null,
"type": null
},
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"measure": "risk stratification"
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],
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}
},
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},
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},
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"date": "2024-08-01"
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"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Misoprostol 200mcg Tab"
},
{
"name": "Oxytocin"
}
]
},
"conditionsModule": {
"conditions": [
"Myoma;Uterus"
]
},
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{
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"contacts": [
{
"email": "[email protected]",
"name": "Mohammad A Taymour, MD",
"phone": "01555761995",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Waleed M Elkhyat",
"phone": "01005135542",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "faculty of medicine, Kasr el ainy hospital, Cairo university",
"geoPoint": {
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"lon": 31.24967
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"state": null,
"status": "RECRUITING",
"zip": "11562"
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]
},
"descriptionModule": {
"briefSummary": "Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy."
},
"designModule": {
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"sex": "FEMALE",
"stdAges": [
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]
},
"identificationModule": {
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"id": "AA-2024-1",
"link": null,
"type": null
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"primaryOutcomes": [
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"measure": "intra-operative blood loss"
}
],
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"measure": "blood transfusion"
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{
"measure": "post-operative Hb"
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{
"measure": "total surgery time"
}
]
},
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"name": "Cairo University"
}
},
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"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
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"conditions": [
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"Chronic Kidney Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": null,
"country": "Denmark",
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"briefSummary": "The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.The study will achieve this by:1) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.2) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy."
},
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"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FORTIFY",
"briefTitle": "Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease",
"nctId": "NCT06325488",
"orgStudyIdInfo": {
"id": "H-23035668",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Renal hypoxia (Fabry patients according to renal impairment)"
}
],
"secondaryOutcomes": [
{
"measure": "Renal hypoxia (Fabry patient vs controls)"
},
{
"measure": "Renal cortical perfusion (Fabry vs. controls)"
},
{
"measure": "Renal medullar perfusion (Fabry vs. controls)"
},
{
"measure": "Renal inflammation (Fabry vs. controls)"
},
{
"measure": "Renal fibrosis (Fabry vs. controls)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Sanofi"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Caroline Michaela Kistorp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
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},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
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"date": "2023-07-14",
"filename": "Prot_000.pdf",
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"hasProtocol": true,
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"label": "Study Protocol",
"size": 808560,
"typeAbbrev": "Prot",
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{
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"label": "Statistical Analysis Plan",
"size": 1460496,
"typeAbbrev": "SAP",
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "labor with neuraxial labor analgesia"
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{
"name": "labour without noroaxial labor analgesia"
}
]
},
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"conditions": [
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},
"contactsLocationsModule": {
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{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "Ayşenur Dostbil",
"phone": "+905333677796",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Atatürk University",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia",
"nctId": "NCT06325475",
"orgStudyIdInfo": {
"id": "B.30.2.ATA.0.01.00/530",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ObsQoR-10 scores of postpartum patients"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Oxygenation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Riyadh",
"contacts": [
{
"email": "[email protected]",
"name": "Muteb AlOtaibi, M.D.",
"phone": "00966544793370",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rashid Al-Otaibi, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Osama Shalaan, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Muteb Al-Otaibi, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Majid Al-Sherif",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Saudi Arabia",
"facility": "Prince Sultan Military Medical City",
"geoPoint": {
"lat": 24.68773,
"lon": 46.72185
},
"state": null,
"status": "RECRUITING",
"zip": "11159"
}
]
},
"descriptionModule": {
"briefSummary": "Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "68 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery",
"nctId": "NCT06325462",
"orgStudyIdInfo": {
"id": "E2232/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "regional cerebral oxygen saturation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prince Sultan Military Medical City"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "STREAM program"
}
]
},
"conditionsModule": {
"conditions": [
"Polycystic Ovary Syndrome",
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ottawa",
"contacts": [
{
"email": "[email protected]",
"name": "Judy Shiau, MD",
"phone": "613-701-1222",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Julie Laroche",
"phone": "613-701-1222",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "LEAF Weight Management Clinic",
"geoPoint": {
"lat": 45.41117,
"lon": -75.69812
},
"state": "Ontario",
"status": null,
"zip": "K1J9L3"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?Participants will complete a 24-week weight loss program (STREAM). During this program they will:* weigh themselves* complete regular bloodwork and* fill out a Quality of Life questionnaire at regular intervals"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FLOWERS-PCOS",
"briefTitle": "Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity",
"nctId": "NCT06325449",
"orgStudyIdInfo": {
"id": "5323",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Weight loss"
},
{
"measure": "Change in Endocrine parameters (EP) as measure by blood test"
},
{
"measure": "Change in insulin sensitivity (IS) as measure by blood test"
},
{
"measure": "Change in Lipid profile (LP) as measure by blood test"
},
{
"measure": "Change in liver enzyme profile (LEP) as measure by blood test"
},
{
"measure": "Change in Menstrual Cyclicity"
},
{
"measure": "Quality of Life (QoL) Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "LEAF Weight Loss Clinic"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ottawa Hospital Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Variceal Hemorrhage"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 85,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Objective Scores in Variceal Bleeding",
"nctId": "NCT06325436",
"orgStudyIdInfo": {
"id": "scores in variceal bleeding",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "neoadjuvant chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Muscle-Invasive Bladder Carcinoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer",
"nctId": "NCT06325423",
"orgStudyIdInfo": {
"id": "response to NAC in MIBC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the expression of NETs and CD8 in paraffin-embedded TUR biopsies"
},
{
"measure": "- Response to platinum-based chemotherapy in localized MIBC in relation to: NETs expression, CD8 expression, NET/CD8 ratio and baseline clinicopathological features"
}
],
"secondaryOutcomes": [
{
"measure": "Local recurrence-free survival (RFS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "resection of colorectal cancer"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zagazig",
"contacts": null,
"country": "Egypt",
"facility": "Zagazig University Hospitals",
"geoPoint": {
"lat": 30.58768,
"lon": 31.502
},
"state": null,
"status": null,
"zip": "44519"
}
]
},
"descriptionModule": {
"briefSummary": "over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.Data was collected from records in a retrospective cohort study"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience",
"nctId": "NCT06325410",
"orgStudyIdInfo": {
"id": "#11279-20-11-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "age"
},
{
"measure": "sex"
},
{
"measure": "medical disease"
},
{
"measure": "previous surgery"
},
{
"measure": "CEA"
},
{
"measure": "tumor grade"
},
{
"measure": "tumor site"
},
{
"measure": "tumor size"
},
{
"measure": "surgical margins of resected tumor"
},
{
"measure": "neoadjuvant therapy"
},
{
"measure": "adjuvant therapy"
},
{
"measure": "diet"
},
{
"measure": "occupation"
},
{
"measure": "family history"
},
{
"measure": "type of surgery(laparoscopic or open)"
},
{
"measure": "soiling by during surgery"
},
{
"measure": "hand sewen or stappled anastmosis"
},
{
"measure": "post operative complications"
},
{
"measure": "site of recurrence"
},
{
"measure": "type of resected tumor"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Zagazig University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High Intraocular Pressure (IOP)"
},
{
"name": "Low Intraocular Pressure (IOP)"
}
]
},
"conditionsModule": {
"conditions": [
"Nuclear Cataract"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "West Des Moines",
"contacts": [
{
"email": "[email protected]",
"name": "Robyn Kohler, RN",
"phone": "515-223-8685",
"phoneExt": "2305",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Hillery Joiner",
"phone": "5152238685",
"phoneExt": "2085",
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew Rauen, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Wolfe Eye Clinic",
"geoPoint": {
"lat": 41.57721,
"lon": -93.71133
},
"state": "Iowa",
"status": "RECRUITING",
"zip": "50266"
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)",
"nctId": "NCT06325397",
"orgStudyIdInfo": {
"id": "IIT #88313865",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Medication Rescue"
}
],
"secondaryOutcomes": [
{
"measure": "Physiologic Responses associated with pain/inflammation:"
},
{
"measure": "Physiologic Responses associated with pain/inflammation:"
},
{
"measure": "Surgeon Experience: Assessment on patient cooperation"
},
{
"measure": "Surgeon Experience: Surgeon intraoperative experience"
},
{
"measure": "Cost- analysis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Matthew Rauen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lifelight"
},
{
"name": "Blood Pressure Cuff"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VISION-RWE",
"briefTitle": "Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care",
"nctId": "NCT06325384",
"orgStudyIdInfo": {
"id": "IRAS ID:1008701",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood Pressure Measurement Non Inferiority"
}
],
"secondaryOutcomes": [
{
"measure": "Adherance to Blood Pressure Measurement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Barts & The London NHS Trust"
},
{
"name": "Mind Over Matter Medtech Ltd"
},
{
"name": "Health Innovation Wessex"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Xim Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Visceral aneurysm stenting"
}
]
},
"conditionsModule": {
"conditions": [
"Aneurysm Abdominal",
"Arterial Aneurysm"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DEDICATE",
"briefTitle": "Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2",
"nctId": "NCT06325371",
"orgStudyIdInfo": {
"id": "0028201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of the stenting in terms of patency and side branches"
},
{
"measure": "Efficacy of the stenting in terms of aneurysm thrombosis rate"
},
{
"measure": "Efficacy of the stenting in terms of aneurysm volume assessment"
},
{
"measure": "Safety in terms of morbidity"
},
{
"measure": "Safety in terms of mortality"
},
{
"measure": "Safety in terms of technical issues"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Turin, Italy"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis, Relapsing-Remitting",
"Environmental Exposure",
"Lifestyle Factors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pavia",
"contacts": [
{
"email": "[email protected]",
"name": "Eleonora Tavazzi",
"phone": "0382 380403",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": null,
"name": "Roberto Bergamaschi",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eleonora Tavazzi",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Hellas Cena",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Rachele de Giuseppe",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Beatrice Maccarini",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Aliki Kalmpourtzidou",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Elena Colombo",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eleonora Rigoni",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lara Ahmad",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Monica Bianchi",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Veronica Tosca",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Luciana Gracardi",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Romina Sarchi",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Anna Scarabotto",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Matteo Gastaldi",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ghanya Al-Naqeb",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Federica Loperfido",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Mulubirhan A. Alemayohu",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Maria Cristina Monti",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Cristina Montomoli",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Danilo Porro",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Gloria Bertoli",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Alessia Lo Dico",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Clarissa Consolandi",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Marco Severgnini",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Francesca Costabile",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Stefano Decesari",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS Foundation C. Mondino",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": null,
"status": null,
"zip": "27100"
}
]
},
"descriptionModule": {
"briefSummary": "This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EXPOSITION",
"briefTitle": "the EXPOSITION Study",
"nctId": "NCT06325358",
"orgStudyIdInfo": {
"id": "0040083/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "microRNAs"
},
{
"measure": "Air quality"
},
{
"measure": "Nutritional assessment"
},
{
"measure": "Neurofilament (NfL)"
},
{
"measure": "Cytokines"
},
{
"measure": "the Body Mass Index (BMI)"
},
{
"measure": "Physical activity"
},
{
"measure": "Quality of life related to MS"
},
{
"measure": "Sleep Quality"
},
{
"measure": "Smoking habits"
},
{
"measure": "Dietary supplements use"
},
{
"measure": "Adherence to Mediterranean diet"
},
{
"measure": "Effect of diet on inflammation"
},
{
"measure": "waist and height ratio (WHtR)"
},
{
"measure": "Bioelectrical impedance"
}
],
"secondaryOutcomes": [
{
"measure": "Microbiome and biological biomarkers of oxidative stress and inflammation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Research Council (Consiglio Nazionale delle Ricerche)"
},
{
"name": "IRCCS National Neurological Institute \"C. Mondino\" Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pavia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gut-directed hypnotherapy"
},
{
"name": "Standard Medical Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Ehlers-Danlos Syndrome",
"Irritable Bowel Syndrome",
"Hypermobility Syndrome",
"Gastrointestinal Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": null,
"country": "Canada",
"facility": "Toronto General Hospital",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5G 2C4"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in individuals diagnosed with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders (G-HSD). Consenting patients recruited from the Toronto General Hospital GoodHope Ehlers-Danlos Syndrome Clinic will be randomly assigned to one of two groups: (1) standard medical therapy or (2) standard medical therapy plus eight sessions of gut-directed hypnotherapy. The main questions this study will answer are:1. Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?2. Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?3. Is the activity of the parasympathetic nervous system (i.e. the body's \"rest and digest\" system) associated with IBS symptoms or treatment outcomes among individuals with EDS or G-HSD?All participants will be asked to meet with a gastroenterologist three times as part of the standard medical therapy. At each physician visit, they will undergo electrocardiogram recording and complete self-report measures of gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Participants randomized to receive gut-directed hypnotherapy will also eight weekly remotely-delivered sessions of gut-directed hypnotherapy delivered by a trained behavioral therapist in between the first and second physician visit. At each session of gut-directed hypnotherapy, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will also include 30 minutes of education on the nature of the gut-brain axis and hypnotherapy prior to hypnosis.Researchers will compare study groups to see if participants who engaged in gut-directed hypnotherapy had greater improvement in IBS symptoms, other gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Exploratory analyses will examine the relationships among heart rate variability, an index of parasympathetic nervous system activity, and study outcomes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders",
"nctId": "NCT06325345",
"orgStudyIdInfo": {
"id": "22-5277",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Weekly Ratings of GI Health and Medication Use"
}
],
"primaryOutcomes": [
{
"measure": "IBS Symptom Severity"
}
],
"secondaryOutcomes": [
{
"measure": "Upper Gastrointestinal Symptoms"
},
{
"measure": "IBS-related Quality of Life"
},
{
"measure": "Visceral Sensitivity"
},
{
"measure": "Emotional Distress"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Health Network, Toronto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nirsevimab"
}
]
},
"conditionsModule": {
"conditions": [
"Respiratory Syncytial Virus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oakland",
"contacts": null,
"country": "United States",
"facility": "Kaiser Permanente Northern California: Site number 0001",
"geoPoint": {
"lat": 37.80437,
"lon": -122.2708
},
"state": "California",
"status": "RECRUITING",
"zip": "94612"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.the secondary objectives are:1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.3. To estimate the impact of nirsevimab on PCR-confirmed RSV.4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.5. To estimate the impact of nirsevimab on antibiotic prescription."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 33000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "0 Days",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "BEAR",
"briefTitle": "BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)",
"nctId": "NCT06325332",
"orgStudyIdInfo": {
"id": "RSV00080",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)"
},
{
"measure": "Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis"
}
],
"secondaryOutcomes": [
{
"measure": "Number of respiratory-related medical encounters"
},
{
"measure": "Number of respiratory-related medical encounters for LRTD by ICD-10 codes"
},
{
"measure": "Incidence of PCR-confirmed RSV (first occurrence of season)"
},
{
"measure": "Number of medical encounters for otitis media by ICD-10 codes"
},
{
"measure": "Number of antibiotic prescriptions by National Drug Code (NDC) codes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sanofi Pasteur, a Sanofi Company"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women"
}
]
},
"conditionsModule": {
"conditions": [
"Obstetric Complication",
"Woman's Role"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dodoma",
"contacts": [
{
"email": "[email protected]",
"name": "Alex P Sanga, MSc. PH",
"phone": "0762144082",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Stephen Kibusi, PhD",
"phone": "0712600966",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Tanzania",
"facility": "University of Dodoma",
"geoPoint": {
"lat": -6.17221,
"lon": 35.73947
},
"state": null,
"status": null,
"zip": "259"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women.The following is the hypothesis being testedNull Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches.Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches.During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention.The control arm won't receive any intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "49 Years",
"minimumAge": "15 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Community Engagement Using M-Mama Champions",
"nctId": "NCT06325319",
"orgStudyIdInfo": {
"id": "Ref. No. MA.84/261/02/1/115",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women."
},
{
"measure": "Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women"
}
],
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"measure": "Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness"
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"measure": "Length of hospital stay (LOS)"
},
{
"measure": "Number of unscheduled medical visits"
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"measure": "Proportion of patients (re-)treated with antibiotics for any reason"
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{
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{
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"Heart Transplantation"
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"city": "Edmonton",
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},
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},
{
"measure": "sleep quality"
},
{
"measure": "24-hour step count"
},
{
"measure": "exercise bouts"
},
{
"measure": "resting heart rate"
},
{
"measure": "heart rate during exercise"
},
{
"measure": "heart rate variability"
},
{
"measure": "Hypo-METRICS questionnaire"
},
{
"measure": "Hypoglycemic Confidence Scale"
},
{
"measure": "Hypoglycemia Fear Survey-II"
},
{
"measure": "Attitudes to Awareness of Hypoglycaemia"
},
{
"measure": "Type 1 Diabetes Distress Scale"
},
{
"measure": "Diabetes Self-Management Questionnaire"
},
{
"measure": "Diabetes Management Experiences Questionnaire"
},
{
"measure": "PROMIS Sleep Disturbance - Short Form 8a"
},
{
"measure": "Hospital Anxiety and Depression Scale"
},
{
"measure": "12-Item Hypoglycemia Impact Profile"
},
{
"measure": "EQ-5D-5L"
},
{
"measure": "device-related adverse events"
},
{
"measure": "severe hypoglycemic events, self-reported on a CLEAR data collection form"
},
{
"measure": "diabetic ketoacidosis (DKA) events"
},
{
"measure": "number of participants with hospitalizations"
},
{
"measure": "number of participants with emergency room (ER) visits"
},
{
"measure": "major adverse cardiovascular events (MACE)"
},
{
"measure": "all-cause mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"
},
{
"name": "University of Minnesota"
},
{
"name": "University of Kentucky"
},
{
"name": "University of Pennsylvania"
},
{
"name": "University of California, San Diego"
},
{
"name": "AdventHealth"
},
{
"name": "University of Leicester"
},
{
"name": "University of Sheffield"
},
{
"name": "University of Melbourne"
},
{
"name": "Jaeb Center for Health Research"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Milton S. Hershey Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Aerobic Interval Training"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "Gulab Devi Chest Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?Participants will:Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In this parallel-group randomized controlled trial (RCT), post-angioplasty patients will be assigned to either the control group (receiving standard medication) or the experimental group (receiving medication along with aerobic interval training). The study aims to evaluate the impact of aerobic interval training on fatigue levels and functional performance in these patients.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The study was single-blinded, as assessors of the study were kept blind to the intervention group to which the participant was allocated.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 47,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients",
"nctId": "NCT06325189",
"orgStudyIdInfo": {
"id": "Rec-42336",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fatigue Severity Scale"
},
{
"measure": "Six Minute Walk Test"
},
{
"measure": "1 minute sit to stand:"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cryotherapy"
},
{
"name": "Infrared light therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Episiotomy Wound"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bahāwalpur",
"contacts": [
{
"email": "[email protected]",
"name": "Ghulam Fatima, PhD*",
"phone": "03034073057",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Bahawalpur Victoria Hospital(BVH)",
"geoPoint": {
"lat": 29.4,
"lon": 71.68333
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "63100"
}
]
},
"descriptionModule": {
"briefSummary": "The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound",
"nctId": "NCT06325176",
"orgStudyIdInfo": {
"id": "REC/RCR & AHS/23/0569",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric Pain Rating Scale"
},
{
"measure": "The standardized REEDA scale:"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CBCT"
},
{
"name": "clinical examination under dental operating microscope"
},
{
"name": "canal detection AI software (diagnocat)"
}
]
},
"conditionsModule": {
"conditions": [
"Missed Canals"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Misr International University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study",
"nctId": "NCT06325163",
"orgStudyIdInfo": {
"id": "MIU-IRB-2223-219",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of canals"
}
],
"secondaryOutcomes": [
{
"measure": "linear morphological variations in failed cases"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Misr International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Light emitting glasses"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "East Lansing",
"contacts": [
{
"email": "[email protected]",
"name": "Hanne M Hoffmann, PhD",
"phone": "517-353-1415",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Michigan State University",
"geoPoint": {
"lat": 42.73698,
"lon": -84.48387
},
"state": "Michigan",
"status": null,
"zip": "48824"
}
]
},
"descriptionModule": {
"briefSummary": "Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This study will test the effect of light emitting glasses, vs placebo, vs no-glasses to attention in college students. This is a crossover study, where participants will be randomly assigned to one of three groups, and tested in random order. The students will be tested on 2 or 3 different conditions (no glasses, placebo or light emitting glasses). The assignment to each of the groups, and the order of the intervention (+/- glasses) will be randomized.Note-light emitting glasses are not FDA regulated. Because light emitting glasses can change physiology, this is considered a phase 1 clinical trial.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Impact of Light Exposure on Cognitive Function in Classrooms",
"nctId": "NCT06325150",
"orgStudyIdInfo": {
"id": "STUDY00008572",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of attention"
}
],
"secondaryOutcomes": [
{
"measure": "Determine how time of day impacts attention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Michigan State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcriptome analyses"
}
]
},
"conditionsModule": {
"conditions": [
"Nephrotic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Marco Pennesi, MD",
"phone": "+39.040-3785263",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Barbara Bonifacio",
"phone": "+39.040.3785.422",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "Idiopathic nephrotic syndrome (INS) affects the glomerular barrier by damaging the podocytes with foot process effacement, leading to a pathological increase of permeability and protein loss. INS classification is based on the clinical response to glucocorticoid (GC) therapy. When GCs treatment fails to induce remission in a four-six weeks course, patients are defined as affected with steroid-resistant nephrotic syndrome (SRNS).The whole transcriptome sequencing could consent the INS classification at onset, prior to glucocorticoids (GCs) treatment, allowing to reduction of unuseful GCs treatment. RNA sequencing technologies allow an extensive characterization of the transcriptomic profile and permit global changes in gene expression levels between different conditions such as active and remission of the disease.Of great interest is the research of a molecular biomarker to predict steroid resistance, a predictor that is not yet available. Among the candidate biomarkers, pharmacogenomic determinants are promising, even if available studies are still limited. Among these, some epigenetic factors have been previously suggested. Data obtained in animal models suggests that nucleotide-binding oligomerization domain-like receptors (NOD-like receptor) pyrin domain containing 3 (NLRP3) inflammasome can be deregulated in a wide variety of glomerular diseases, including those causing INS. Another potential marker involved in steroid response is the long noncoding RNA GAS5. Data reported in the literature indicate that abnormal levels of GAS5 in peripheral blood mononuclear cells (PBMCs) may alter steroid effectiveness in autoimmune diseases, such as inflammatory bowel disease.Preliminary findings show that the study of NLRP3 promoter methylation could be reduced in the blood of SRNS compared with steroid-sensitive nephrotic syndrome (SSNS) patients. Moreover, unpublished encouraging results on the association between Growth Arrest Specific 5 (GAS5) expression and steroid response in INS in PBMCs were obtained in a preliminary study conducted on 8 patients with the first episode of INS. PBMCs were obtained and GAS5 gene expression was evaluated using TaqMan technology. Patients affected with SRNS presented significantly higher levels of GAS5 in comparison with the SSNS group. In PBMCs from SRNS patients, the GAS5 expression could reduce the availability for binding to GCs target genes of the activated GCs receptor and suppresses GC transcriptional activity."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transcriptome Analysis in Idiopathic Nephrotic Syndrome: Steroid Responsiveness",
"nctId": "NCT06325137",
"orgStudyIdInfo": {
"id": "RC 24/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Between groups differences in molecular signature by whole transcriptome analysis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Muscle energy technique"
},
{
"name": "Conventional PT"
}
]
},
"conditionsModule": {
"conditions": [
"Forward Head Posture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Islamabad",
"contacts": [
{
"email": "[email protected]",
"name": "KINZA ANWAR, MS-OMPT",
"phone": "+92-3239735427",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "MARIA NAWAZ, MS-OMPT*",
"phone": "+92-3435625466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "MARIA NAWAZ",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "We Care Physical Therapy Clinic street 13 phase 4A, Ghouri town Islamabad",
"geoPoint": {
"lat": 33.72148,
"lon": 73.04329
},
"state": "Punjab",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this randomized controlled trial is to find the effect of muscle energy technique of muscles involved in lower limb superficial backline (hamstring and Gastro-soleus) on improving craniovertebral angle and cervical proprioception and minimizing pain among patients with forward head posture"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Muscle Energy Technique of Lower Limb Muscles in Forward Head Posture",
"nctId": "NCT06325124",
"orgStudyIdInfo": {
"id": "REC/01805 MARIA NAWAZ",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neck disability index (NDI)"
},
{
"measure": "Numeric Pain Rating Scale NPRS"
}
],
"secondaryOutcomes": [
{
"measure": "Bubble inclinometer"
},
{
"measure": "FHP Mobile Application (To measure Craniovertebral angle)"
},
{
"measure": "Cervical Joint Position Error"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Determinants of T1D glycaemic control"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 1"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Eulalia Catamo, BSc",
"phone": "+39 040.3785470",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "20 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Determinants of Glycaemic Control in Children With Type 1 Diabetes",
"nctId": "NCT06325111",
"orgStudyIdInfo": {
"id": "RC 06/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of genes involved in T1D glycaemic control"
},
{
"measure": "Identification of DNA methylation patterns involved in T1D glycaemic control"
},
{
"measure": "Identification of microRNAs involved in T1D glycaemic control"
},
{
"measure": "Identification of oral microbiome characteristics associated to T1D glycaemic control"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anti-nephrin antibodies"
},
{
"name": "u-RPC cultures"
}
]
},
"conditionsModule": {
"conditions": [
"Nephrotic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Firenze",
"contacts": [
{
"email": null,
"name": "Paola Romagnani",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Nephrotic syndrome (NS) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. Currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. Some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, SSNS), especially in children and young adults. The prognosis of this group is generally favorable. In contrast, patients unresponsive to steroids (steroid-resistant NS, SRNS) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. Resistance to treatment is associated with a high likelihood of progression to chronic renal disease (CKD) and kidney failure (ESKD). Recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant NS recurrence and SSNS.Providing patients with NS with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to ESKD."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients with nephrotic syndrome (SSNS, SRNS)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome",
"nctId": "NCT06325098",
"orgStudyIdInfo": {
"id": "PER-NEPH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Role of anti-nephrin antibodies in the pathogenesis of NS"
}
],
"secondaryOutcomes": [
{
"measure": "Functional role of VUS in the pathogenesis of SRNS"
},
{
"measure": "Identification of potential predictive biomarkers of renal outcome."
},
{
"measure": "Cost-effectiveness analysis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meyer Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "compensatory and restorative rehabilitation techniques"
},
{
"name": "Traditional cognitive rehabilitation training"
}
]
},
"conditionsModule": {
"conditions": [
"Cognitive Impairment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dina",
"contacts": [
{
"email": "[email protected]",
"name": "Dr. Aroosa Tariq, MS:NMPT",
"phone": "03161578156",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ayesha Saddiqa, MS:NMPT*",
"phone": "0315-5568417",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Aroosa Tariq, MS:NMPT",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ayesha Saddiqa, MS:NMPT*",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Shafi Hospital Dina",
"geoPoint": null,
"state": "Punjab",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this randomized controlled trial is to find the combined effects of restorative and compensatory cognitive rehabilitation techniques in mild cognitive impairment after stroke."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "The",
"briefTitle": "Compensatory and Restorative Rehabilitation Techniques in Stroke",
"nctId": "NCT06325085",
"orgStudyIdInfo": {
"id": "Ayesha Saddiqa",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Montreal cognitive assessment test (Urdu version)"
},
{
"measure": "Cognitive assessment scale for stroke patients (CASP)"
}
],
"secondaryOutcomes": [
{
"measure": "Stroke specific quality of life questionnaire (Urdu version)"
},
{
"measure": "Modified Rankin Scale (MRS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Conclusive genetic testing"
},
{
"name": "Genotype-phenotype correlation for personalized diagnosis"
},
{
"name": "Personalized study of variants of uncertain clinical significance (VUS) through functional studies on 3D organ-on-a-chip"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Kidney Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Firenze",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Careggi",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Firenze",
"contacts": null,
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Firenze",
"contacts": null,
"country": "Italy",
"facility": "USL Toscana Centro",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Pisa",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Pisana",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Chronic kidney disease (CKD) is a major health problem, with steadily increasing incidence and prevalence and the threat of a true \"epidemic\". Converging evidence suggests a high prevalence of genetic etiology in rare kidney diseases and the list of new disease-causing genes is constantly updated. Recent advances in next-generation sequencing (NGS) technologies have prompted a significant improvement in the diagnosis of rare kidney diseases. Notwithstanding this, NGS generates high numbers of information that need to be properly analysed by the joint efforts of geneticists, nephrologists and bioinformatics in order to integrate clinical and genetic information in a personalized manner. In addition, in selected cases, the contribution of researchers proves essential for the development of experimental models of the disease to study and understand the pathogenic features and propose a personalized therapeutic approach. Such an innovative, integrated diagnostic paradigm is currently available in few centers all over the world and cannot be easily translated in daily clinical practice.The aim of the study is to set-up an integrated diagnostic algorithm to extend the newest personalized diagnostic and treatment strategies for rare kidney diseases to all patients in the Tuscany region, under 40 years of age with kidney disease. This algorithm will be based on a constant cross-talk between participating centers and a dedicated multidisciplinary team. Diagnostic and therapeutic performances will be validated at European level."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients selected based on the inclusion criteria will be evaluated by a multidisciplinary team of experts. All the selected patients will undergo genetic testing by clinical exome sequencing and in silico filtering for a panel of genes described as causing or in association with CKD. Identified variants will be classified according to the American College of Medical Genetics and Genomics (ACMG) guidelines. Reverse phenotyping will be performed according to the results of genetic testing. The results of the diagnostic work-up will be evaluated by a multi-disciplinary team of experts in order to establish conclusive diagnosis.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Set-up of a Platform for Personalized Diagnosis of Rare Kidney Diseases (NIKE)",
"nctId": "NCT06325072",
"orgStudyIdInfo": {
"id": "NIKE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Validation of genetic diagnosis"
}
],
"secondaryOutcomes": [
{
"measure": "Identification of molecular pathways"
},
{
"measure": "Explore the applicability of gene editing in rare kidney diseases"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meyer Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-06-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Study of renal progenitors"
}
]
},
"conditionsModule": {
"conditions": [
"Nephropathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Firenze",
"contacts": [
{
"email": null,
"name": "Paola Romagnani",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Patients affected by nephropathy",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases",
"nctId": "NCT06325059",
"orgStudyIdInfo": {
"id": "BIO-KIDNEY",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the role of renal progenitors in the progression of glomerular diseases"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI)"
},
{
"measure": "Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meyer Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2047-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2047-03-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-22"
}
}
} | false | null |
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